[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Gustave Roussy, Cancer Campus, Grand Paris\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":696},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,61,0,25,[9,42,72,94,124,150,177,198,238,268,295,322,345,382,406,426,449,476,501,524,544,574,597,623,646],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100459845","prospective-multicenter-study-evaluating-feasibility-and-efficacy-of-tumor-organoid-based-precision-medicine-in-patients-with-advanced-refractory-cancers-100459845",false,"NCT05267912","Prospective Multicenter Study Evaluating Feasibility and Efficacy of Tumor Organoid-based Precision Medicine in Patients With Advanced Refractory Cancers","Prospective Multicenter Study Evaluating the Feasibility and Efficacy of Tumor Organoid-based Precision Medicine in Patients With Advanced Refractory Cancers","ORGANOTREAT","Inclusion Criteria:\n\n* Age ≥18 years\n* ECOG performance status 0-1\n* Life expectancy \\>3 months\n* Histologically-confirmed, unresectable, locally advanced or metastatic solid tumor\n\n  * ORGANOTREAT-01: CRC\n  * ORGANOTREAT-02A: Colorectal adenocarcinoma (CRC) or pancreatic ductal adenocarcinoma (PDAC)\n  * ORGANOTREAT-02B: solid cancers with a PDO take-on rate ≥50%:\n\n    * Stratum 1: PDAC\n    * Stratum 2: CRC\n    * Other strata: to be added by protocol amendment\n* ≥1 measurable lesion according to RECIST v1.1\n* ≥1 tumor site accessible to biopsy without significant risk, outside from lung lesion\n* Patients are to be biopsied before the start or within the 3 first weeks of the SoC line.\n* Failure (disease progression or intolerance) or contraindication to validated treatments in the advanced setting; patients MUST be still eligible for at least 1 (ORGANOTREAT-01 and -2A) or 2 (ORGANOTREAT-02B) validated systemic treatment lines according to approved guidelines:\n\n  * CRC (ORGANOTREAT-01): failure (disease progression or intolerance) or contraindication to fluoropyrimidines, oxaliplatin, irinotecan, anti-EGFR (in RAS wild-type tumors), anti-BRAF (in BRAF V600E mutated tumors), and antiangiogenics; patients must be still eligible for trifluridine-tipiracil and\u002For regorafenib\n  * CRC (ORGANOTREAT-2A): failure (disease progression or intolerance) or contraindication to fluoropyrimidines, oxaliplatin, irinotecan, anti-EGFR (in RAS wild-type tumors), anti-BRAF (in BRAF V600E mutated tumors), and trifluridine-tipiracil\u002Fbevacizumab; patients must be still eligible for regorafenib\n  * PDAC (ORGANOTREAT-2A): Patients will be included at the beginning of their second line of standard therapy\n  * PDAC (ORGANOTREAT-02B stratum 1): patients will be included at the beginning of their first- or second-line of therapy\n  * Specifications for supplementary tumor strata in ORGANOTREAT-02 will be defined by protocol amendment\n* Adequate hepatic, renal and hematological functions (AST\u002FALT \\\u003C 2.5 ULN (5 ULN in cases of liver metastases); Total bilirubin \\\u003C 1.5 ULN; Albumin \\> 30 g\u002FL; International normalized ratio (INR) \\\u003C1.5 ULN; Calculated creatinine clearance \\>50 mL\u002Fmin; Absolute neutrophil count \\>1000\u002Fmm3, platelets \\>100 000\u002Fmm3, hemoglobin \\>9 g\u002FdL) To be performed until 7 days before enrollment\n* Informed consent signed by the patient or his\u002Fher legal representative\n* Affiliation to or beneficiary of a social security system\n* A female participant is eligible to participate if she is not pregnant not breastfeeding, and\n\n  1. Not a woman of childbearing potential (WOCBP) OR\n  2. A WOCBP should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* A WOCBP must agree to follow the contraceptive guidance or abstain from heterosexual activity during the treatment period and for at least 180 days, after the last dose of treatment.\n\nExclusion Criteria:\n\n* History of other invasive cancer within 5 years prior to entry into the trial other than adequately treated basal-cell skin cancer or in situ carcinoma of the cervix\n* Concomitant medications\u002Fcomorbidities that may prevent the patient from being biopsied\n* Patients with brain or meningeal metastasis, unless definitive therapy occurred more than 6 months ago and with a confirmation of tumoral control and absence of symptoms within 4 weeks of starting study treatment\n* Pregnancy or breast-feeding\n* Privation of liberty or guardianship\n* Geographical, social or psychological reasons precluding study participation and monitoring\n* Coagulation abnormality prohibiting a biopsy","ALL","18 Years",{"count":21,"type":22},152,"ESTIMATED","INTERVENTIONAL",[25],"NA","* PDOs are tridimensional multicellular structures expanded in vitro which retain the genotypic and phenotypic features of their tissue or tumor of origin. PDOs can be exposed to a panel of drugs (chemotherapy, hormonal therapy, targeted therapy) in order to study their sensitivity to each agent (or combination of agents) tested ('chemogram'). Recent studies showed that PDOs can accurately predict the response to treatment of solid tumors and could therefore inform clinical decision on the best therapeutic option for each patient.\n* ORGANOTREAT is a multicenter prospective study program of organoid-based precision oncology encompassing 3 studies: ORGANOTREAT-01, a pilot study restricted to advanced CRC, and ORGANOTREAT-02A and -2B, two Phase 2 studies in advanced solid cancers.",[28],"Advanced, Pretreated Solid Tumors","RECRUITING","2026-06-23",{"date":32,"type":33},"2026-06-26","ACTUAL",{"date":35,"type":33},"2022-01-19",{"date":37,"type":22},"2029-01-18",{"name":39,"class":40},"Gustave Roussy, Cancer Campus, Grand Paris","OTHER",11,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100637698","phase-2-kortuc-krc-01-plus-radiotherapy-for-organ-preservation-in-rectal-cancer-100637698","NCT07622017","KORTUC (KRC-01) Plus Radiotherapy for Organ Preservation in Rectal Cancer","Phase II Clinical Trial of KORTUC (KRC-01) Combined With Radiotherapy for Locally Advanced Rectal Cancer: Towards a New Organ Preservation Approach","K-BOOST","Inclusion Criteria:\n\n1. Males and females ≥ 18 years of age.\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n3. Histopathologically confirmed locally advanced rectal adenocarcinoma, stage III (high risk)\n4. No evidence of metastatic disease on computed tomography (chest and abdomen), including resectable metastases. (M0, and no oligometastases)\n5. At least one of the following criteria: cT4a, cT4b, presence of extramural invasion (EMVI+), cN2, involvement of the mesorectal fascia (MFI+), involvement of lateral lymph nodes (lat LN+)\n6. Adenocarcinoma located with a lower border less than 15 cm from the anal margin\n7. Primary resection without chemoradiotherapy is unlikely to achieve clear margins.\n8. Tumor lesion must be mesurable by endoscopic visual assessment\n9. Target tumor is accessible for intratumoral injections.\n10. Intention to undergo treatment including 5 Fu based chemoradiotherapy and CAPOX (6 cycles) or FOLFOX (9 cycles)\n11. Life expectancy \\> 6 months\n12. Acceptable organ functions, as evidenced by the following laboratory data:\n\n    1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0×upper limit of normal (ULN).\n    2. Total serum bilirubin ≤ 1.5×ULN.\n    3. Absolute neutrophil count (ANC): ≥ 1500 cells\u002Fmm³.\n    4. Platelet count: ≥ 100,000 cells\u002Fmm³.\n    5. Hemoglobin: ≥ 9.0 g\u002FdL.\n    6. Serum creatinine levels ≤ 1.5×ULN, or calculated (by Cockcroft-Gault formula or other accepted formula) and measured creatinine clearance ≥50 mL\u002Fmin.\n    7. Amylase and lipase ≤ 1.5xULN.\n    8. Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) ≤ 1.5.\n13. Women of childbearing potential must have a negative serum β-HCG pregnancy test within 7 days prior to the administration of the first study treatment and\u002For urine pregnancy 12 hours prior to the administration of the first study treatment.\n\n    1. Female subjects of childbearing potential should be willing to use a highly effective method of contraception or be surgically sterile or abstain from heterosexual activity during the study treatment and for at least 15 months after the last dose of oxaliplatin and 6 months after the last dose of capecitabine or 5-fluorouracil, whichever period is longer.. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year. cf. section 7.8 \"Pregnancy and contraception\") Note: A woman is considered of childbearing potential following menarche and until becoming post-menopausal (≥ 12 months of non-therapy-induced amenorrhea) unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral oophorectomy, and bilateral salpingectomy. A \"highly effective\" birth control method is one which can achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include: combined (estrogen and progestogen containing) hormonal contraception; progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner (on the understanding that this is the only partner during the whole study duration), and sexual abstinence during the entire period of risk associated with study treatment. To prevent the risk of interaction between the study drug and hormonal contraceptives, hormonal contraceptives should be supplemented with a barrier method (preferably male condom). Following methods are considered as unacceptable methods (non-exhaustive list): periodic abstinence (calendar, symptothermal, post-ovulation methods) and withdrawal (coitus interruptus).\n    2. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy until at least 12 months after the last dose of oxaliplatin and 3 months after the last dose of capecitabine or 5-fluorouracil, whichever period is longer.\n\n    Also, it is recommended that women of childbearing potential partner use a highly effective method of contraception.\n14. Patients who either do not consent to a tumor biopsy or do not have accessible lesions will not be eligible.\n15. Patients should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed.\n16. Patient should be able and willing to comply with study visits and procedures as per protocol.\n17. Patient must be affiliated to a social security system or beneficiary of the same.\n\nExclusion Criteria:\n\n1. Patients not deemed fit for radiotherapy or preexisting condition which would deter radiotherapy, e.g., fistulas, severe ulcerative colitis (including subjects currently taking sulphasalazine), active Crohn's disease, prior adhesions.\n2. Patients with hypokalemia below the lower limit of normal, hypomagnesemia, hypocalcemia, or QT\u002FQTc interval \\>450 msec in males or \\>470 msec in females at inclusion are not eligible.\n3. Any Previous radiotherapy in the pelvic region.\n4. Contraindications to MRI (e.g., subjects with pacemakers, claustrophobia, excessive weight, etc.).\n5. Participation in another clinical study with an investigational product during the last 3 months.\n6. Prior rectal surgery.\n7. Prior investigational treatment for rectal cancer.\n8. Patients with known high microsatellite instability (MSI-H) or mismatch repair deficient (dMMR) tumors are not eligible, as these patients may benefit from standard-of-care immunotherapy.\n9. High medical risk because of systemic diseases (e.g., uncontrolled infections, uncontrolled diabetes) in addition to the qualifying disease under study. Patients must not have any uncontrolled concurrent illness including, but not limited to, severe active or uncontrolled infection, symptomatic congestive heart failure, unstable, angina pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n10. Patients receiving therapeutic anticoagulation are not eligible. Prophylactic anticoagulation at low dose (e.g., thromboprophylaxis) may be allowed at the investigator's discretion, provided that the bleeding risk is considered minimal.\n11. Patients receiving concomitant treatment with brivudine or who have received brivudine within the previous 4 weeks.\n12. Peripheral sensory neuropathy grade ≥2 (for the future administration of oxaliplatin)\n13. Dihydropyrimidine deshydrogenase (DPD) deficiency. DPD status must be assessed prior to inclusion, and uracilemia testing is mandatory before initiation of fluorouracil-based treatment. Patients with unknown DPD status are not eligible.\n14. Concomitant medications\u002Fcomorbidities that may prevent the patient from receiving study treatments,\n15. Contraindication to fluoropyrimidines or oxaliplatin and capecitabin as mentioned in the SMPC of investigational medicinal products: FOLFOX is contraindicated in patients with known hypersensitivity to 5-fluorouracil, oxaliplatin, leucovorin, or other platinum compounds; in those with severe renal impairment (CrCl \\\u003C30 mL\u002Fmin), significant bone marrow suppression, uncontrolled infections, or pre-existing grade ≥2 peripheral neuropathy. It is also contraindicated in individuals with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency due to the risk of severe 5-FU toxicity, as well as in cases of severe hepatic dysfunction, pregnancy, and breastfeeding. Caution is advised in patients with poor performance status (ECOG ≥3).\n16. Yellow fever vaccine and live attenuated vaccines are contraindicated due to the risk of severe vaccine-induced infection. Note: The currently authorized COVID-19 vaccines are not live vaccines and therefore can be safely administered.\n17. Known history of human immunodeficiency virus (HIV) infection or seropositive results consistent with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.\n18. Pregnant or breastfeeding women or intending to become pregnant during the clinical investigation.\n19. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.",{"count":51,"type":22},24,[53],"PHASE2","This phase II clinical trial is evaluating whether adding KRC-01 injections to standard chemoradiotherapy may improve treatment outcomes in patients with locally advanced rectal cancer without metastases.\n\nKRC-01 is an investigational product designed to improve the effectiveness of radiotherapy by increasing oxygen levels inside tumors, which may help radiation work better. KRC-01 contains hydrogen peroxide and sodium hyaluronate and is injected directly into the tumor before radiotherapy sessions.\n\nPrevious clinical experience in Japan, including studies in several types of cancer, suggested that this approach may improve tumor oxygenation and enhance the effect of radiotherapy.\n\nThe main objective of the K-BOOST study is to evaluate how many patients achieve a complete clinical response after treatment with chemoradiotherapy combined with intratumoral KRC-01 injections, potentially allowing some patients to avoid surgery. Surgery may still be recommended depending on the individual response to treatment.\n\nApproximately 24 patients will participate in this multicenter French study. The experimental treatment period lasts approximately 26 weeks, and participants will be followed for up to 2 years.",[56],"Rectal Cancer",[58,59,60,61],"Intratumoral","chemoradiotherapy","advanced rectal cancer","Organ Preservation","NOT_YET_RECRUITING","2026-05-27",{"date":65,"type":33},"2026-06-02",{"date":67,"type":22},"2026-07",{"date":69,"type":22},"2030-07",{"name":39,"class":40},2,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":51},"100632376","cohort-of-patients-with-chronic-myelomonocytic-leukemia-100632376","NCT07512882","Cohort of Patients With Chronic Myelomonocytic Leukemia","MYELOMONO-3","Inclusion Criteria:\n\n* Adults aged 18 years and over\n* Blood monocytosis ≥ 0.5 × 10⁹\u002FL and ≥ 10% of total white blood cells or\n* Confirmed diagnosis of chronic myelomonocytic leukemia\n* Regardless of stage (chronic or transformed), and whether or not currently being treated\n* Signed informed consent\n\nExclusion Criteria:\n\n* Active, uncontrolled infection (particularly hepatitis B, hepatitis C, HIV)\n* Refusal informed consent",{"count":80,"type":22},5000,"OBSERVATIONAL","A prospective, non-interventional study involving the collection of biological samples with associated anonymised data.\n\nBiological samples will be collected at the time of diagnosis and\u002For as the disease progresses, with or without treatment, always in conjunction with tests scheduled as part of routine care or within the context of a clinical trial.",[84,85],"Leukemia","Myelomonocytic Leukemia, Chronic","2026-05-15",{"date":88,"type":33},"2026-05-19",{"date":90,"type":33},"2026-05-05",{"date":92,"type":22},"2040-03",{"name":39,"class":40},{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":104,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100640660","phase-3-adjuvant-trial-in-pancreatic-neuroendocrine-tumors-100640660","NCT07591493","Adjuvant Trial in Pancreatic Neuroendocrine Tumors","First Adjuvant Trial in Locally Resected Aggressive Pancreatic Neuroendocrine Tumors: a Randomized Phase III Investigating the Efficacy of Systemic Chemotherapy","ADJUPANET","Inclusion Criteria:\n\n1. Pathologically proven well differentiated neuro-endocrine tumour of the pancreas by local teams\n2. Availability of the primary tumor specimen, allowing accurate WHO classification and determination of MGMT status\n3. Stage I-III based ENETS-UICC 8th classification\n4. Early postoperative context (≤ 4 months)\n5. R0 resection\n6. Absence of distant metastasis or local tumor remnant as defined by a negative post-operative thorax CT and -abdomen CT or MRI and negative (best of DOTA-peptide 68Ga or, FDG) PET imaging if performed preoperatively\n7. ECOG 0-1\n8. No prior systemic therapy\n9. Intermediate to high risk of recurrence as defined by the following situations:\n\n   * Ki67 ≥ 10% (i.e.: Grade 3 or high Ki67 Grade 2)\n   * Ki67 5-9% AND (tumor size \\> 3 cm OR Node positive)\n   * Ki67 3-5% AND tumor size \\> 3 cm AND Node positive\n   * Ki67 \\\u003C 3% AND tumor size \\> 3 cm AND Node positive AND (Vascular Emboli OR perineural invasion)\n10. Age ≥ 18 years at the time of consent, no superior limit\n11. Adequate bone marrow reserve (hemoglobine \\> 8 g\u002FdL, absolute neutrophils count ≥ 1500\u002Fmm³ and platelets ≥ 80 000\u002Fmm³)\n12. Effective contraception\n13. Written, dated and signed informed consent by the patient prior to any specific protocol procedure\n14. Ability to comply with the protocol procedures\n15. Patient affiliated to a social security system or beneficiary of the same\n\nExclusion Criteria:\n\n1. Poorly differentiated tumours (NEC)\n2. Mixed NeuroEndocrine Non NeuroEndocrine tumors (MiNEN)\n3. Neoadjuvant treatment or treatment with chemotherapy regimen used for another malignancy\n4. Pregnant women or breastfeeding women\n5. ECOG performance status \\> 1\n6. Age \\\u003C 18 years\n7. PanNET arising in a genetic syndrome with other NETs already diagnosed (NF1, VHL or MEN)\n8. History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least five years\n9. Severe renal insufficiency (measured GFR according to MDRD \\\u003C 30 ml\u002Fmn or nephrotic syndrome) or hepatic insufficiency (ALT \u002F AST \\> 2.5 x ULN or ALT\u002FAST \\> 5 x ULN if liver function abnormalities are due to the underlying malignancy and\u002For total serum bilirubin \\> 2.5 x ULN)\n10. Serum albumin \\\u003C 3.0 g\u002FdL unless prothrombin time is within the normal range\n11. Current treatment with another investigational drug\n12. Unrecovered toxicity from surgery\n13. Active or suspected acute or chronic uncontrolled disease that would impart, in the judgment of the Investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the Investigator, would make the patient inappropriate for entry into this study\n14. Dihydropyrimidine dehydrogenase (DPD) deficiency or not done\n15. Recent or concomitant treatment with brivudine\n16. Hypersensitivity to Capecitabine or Temozolomide or to any of the excipients",{"count":103,"type":22},300,[105],"PHASE3","ADJUPANET is an open label, double arm, multicenter, phase 3 trial that aims to investigate the efficacy of systemic chemotherapy in locally resected aggressive pancreatic neuroendocrine tumors. The two arms of patients are the following : i. control arm : active surveillance only, standard of care. ii. experimental arm : adjuvant chemotherapy with 6 cycles of CAPECITABINE-TEMOZOLOMIDE (per os) and active surveillance. Patients enrolled in the experimental arm will receive Capecitabine CAPECITABINE per os 750 mg\u002Fm² (twice a day: D1 to D14) D1=D28 and TEMOZOLOMIDE per os 200 mg\u002Fm² (once a day: D10 to D14) D1=D28.",[108,109],"Pancreatic Neuroendocrine Tumors (pNET)","Pancreatic Neuroendocrine Tumors",[111,112,113,114,115],"R0 resected","stage I-III","CAPECITABINE","TEMOZOLOMIDE","active surveillance","2026-05-11",{"date":86,"type":33},{"date":119,"type":22},"2026-09",{"date":121,"type":22},"2035-06",{"name":39,"class":40},1,{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":132,"minAge":19,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":136,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},"100639735","phase-3-carboplatin-enhanced-therapy-in-brca-mutated-or-neuroendocrine-differentiated-aggressive-metastatic-castration-sensitive-prostate-cancer-100639735","NCT07591467","Carboplatin-Enhanced Therapy in BRCA-Mutated or Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer","A Phase III Randomized Trial of Carboplatin-Enhanced Therapy in BRCA-Mutated or Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer","CaBRA","Inclusion Criteria:\n\n1. Histologically or cytologically proven adenocarcinoma of the prostate (any T stage, Gleason score or PSA level).\n2. De novo metastatic disease documented by a positive bone scan or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either: at least one extra-pelvic lymph node ≥ 2 cm, or extra-pelvic lymph node(s)≥1 cm if the patients also have at least one pelvic lymph node ≥ 1.5 cm.\n3. Presence of pathogenic BRCA gene alteration (BRCAm cohort) OR histologically adenocarcinoma of the prostate with neuroendocrine differentiation (NED cohort)\n\n   1. For the BRCAm cohort: confirmation of a pathogenic BRCA gene alteration by historical analysis, using one of the following:\n\n      * Circulating tumor DNA (ctDNA) analysis\n      * Tumor tissue analysis (archival sample permitted)\n      * Historical germline testing results\n   2. For the NED cohort: histologically adenocarcinoma of the prostate with neuroendocrine differentiation41. NED is defined as either:\n\n      * Presence of mixed tumors with prostate adenocarcinoma associated with small cell or large cell neuroendocrine carcinoma according to WHO classification55 (5th edition). Pure small cell or large cell neuroendocrine carcinoma is not accepted (prostate adenocarcinoma component should express NKX3.1, AR and\u002For PSA to exclude pure small cell or large cell NE carcinoma)\n      * Or immunohistochemical staining showing some degree of neuroendocrine differentiation within adenocarcinoma (positivity of at least 2 of the following: chromogranin A, synaptophysin, TTF1 or INSM1). Threshold for NE markers positivity is ≥ 1% tumor cells. Co-expression of neuroendocrine markers with AR, NKX3.1 and\u002For PSA is allowed for these cases. If the patient has both a BRCA alteration and evidence of NED on his biopsy, he will be randomized in the BRCA cohort.\n4. Patients with ECOG PS ≤ 1, or patient with PS 2, provided PS alteration is disease-related.\n5. Life expectancy of at least 6 months.\n6. Male aged ≥ 18 years old and ≤ 80 years old.\n7. Hematology values: Hemoglobin ≥ 10.0 g\u002FdL, Platelet count ≥ 100,000\u002FmL, Neutrophil ≥ 1500 cells\u002Fmm³ (or neutrophil ≥ 1000 cells\u002Fmm³ in case of ethnic neutropenia).\n8. Biochemistry values: Renal function: Serum creatinine \\\u003C 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL\u002Fmin, Liver function: Serum bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's disease), AST and ALT ≤ 1.5 x ULN (and ≤ 5 ULN in case of liver metastases), ALK-P ≤ 2.5 x ULN (in case of bone metastasis, ALK-P\\\u003C1000U\u002FL if bilirubin is normal).\n9. Patients must have received ADT and ARPI (abiraterone, enzalutamide, apalutamide, darolutamide) for a maximum of 3 months before randomization. Prior ARPI in mHSPC is allowed if required prior to randomization, with no radiographic evidence of disease progression or rising PSA levels prior to Day 1.\n10. Patients willing and clinically fit to receive docetaxel with no contraindication to docetaxel according to the Summary of Product Characteristics (SmPC) of the drug.\n11. Patients able to take oral medication.\n12. Patients who have received the information sheet and signed the informed consent form\n13. Patients must be affiliated to a social security system or beneficiary of the same.\n14. Male patients who have partners of childbearing potential and\u002For pregnant partners must use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 6 months after the last dose of Docetaxel.\n\nExclusion criteria:\n\n1. Patients with previous definitive local treatment directed to prostate primary cancer (radiotherapy, brachytherapy, radical prostatectomy, ultrasound, cryotherapy, or other). A previous trans-urethral resection of the prostate (TURP) and previous local treatments of metastases are allowed.\n2. Prior cytotoxic chemotherapy or biological therapy for the treatment of prostate cancer. Prior exposure to carboplatin or other platinum containing compounds.\n3. Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropath\\\\\\>= grade 2, per the Common Terminology Criteria for Adverse Events version 6.0.\n4. Patients known to be human immunodeficiency virus (HIV) positive, symptomatic viral hepatitis or chronic liver disease.\n5. Patient with administration of live or live attenuated vaccines (strongly discouraged in patients) and is formally contraindicated in the case of the yellow fever vaccine.\n6. Severe or moderate hepatic impairment (Child - Pugh class C or B).\n7. Clinically known significant heart disease in the past 6 months as evidenced by myocardial infarction, or arterial thrombotic events, severe or unstable angina, or New York Heart association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \\\u003C 50% at baseline, atrial fibrillation, or other cardiac arrhythmia requiring therapy.\n8. History of malignancy, except non-melanoma skin cancer, with low risk of recurrence within 24 months.\n9. Known allergies, hypersensitivity or intolerance to carboplatin or other platinum containing compounds.\n10. Pathological finding consistent with pure small cell carcinoma of the prostate.\n11. Patients already included in another therapeutic trial involving an experimental drug (patient in a non-experimental trial with no modification of the patient's care can be included).\n12. Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial.\n13. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.","MALE","80 Years",{"count":135,"type":22},330,[105],"The current standard of patients with de novo metastatic hormone sensitive prostate cancer (mHSPC) is to offer androgen deprivation therapy (ADT) with androgen receptor pathway inhibitors (ARPI). In addition, upfront 6 cycles of docetaxel, if patient is eligible, and prostate radiotherapy for those with low-volume disease are recommended. BRCA mutations (BRCAm) and neuroendocrine differentiation (NED) confer a poor prognosis in mHSPC and the current standard of care for these patients remains suboptimal. While PARP inhibitors have shown efficacy in BRCAm castration-resistant prostate cancer, concerns exist about their toxicity and resistance when used earlier in the mHSPC setting. Carboplatin has demonstrated activity in BRCAm and neuroendocrine tumors but has not been extensively studied in mHSPC. The combination of carboplatin and docetaxel is expected to enhance treatment efficacy and delay progression.",[139,140,141],"BRCA-Mutated","Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer","Prostate Cancer",[143],"De novo mHSCPC, neuroendocrine differentiation, BRCA mutations (BRCAm)",{"date":86,"type":33},{"date":119,"type":22},{"date":147,"type":22},"2036-12",{"name":39,"class":40},5,{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},"100626490","impact-of-consumption-of-ultra-processed-foods-in-individuals-at-high-risk-of-cancer-100626490","NCT07436312","Impact of Consumption of Ultra-processed Foods in Individuals at High Risk of Cancer","Impact of a Mixed Intervention Aiming to Decrease the Consumption of Ultra-processed Foods on the Global Diet Quality in Individuals at High Risk of Cancer","U-TRANS","Inclusion Criteria:\n\n1. Age \\> 18 years,\n2. Individuals at increased risk of different cancers as defined within the Interception program,\n3. With a baseline WCRF score ≤ 5 at entry in the Interception program,\n4. Agreeing to participate and who have given their written agreement for the study,\n5. Agreeing to fill in the questionnaires on the dedicated platform for the duration of the study,\n6. Participant have and accept to use their smartphone,\n7. All participants must understand spoken and written French language\n\nExclusion Criteria:\n\n1. Psychiatric disorders or cognitive impairments precluding participation,\n2. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.",{"count":159,"type":22},170,[25],"The U-TRANS study was initiated by Gustave Roussy, which is its sponsor\\*. It is part of the Interception Program and aims to reduce the consumption of ultra-processed foods in order to improve the overall quality of the diet among people at high risk of cancer (WCRF score ≤ 5, corresponding to low adherence to nutritional cancer prevention recommendations: eating a diet rich in whole grains, vegetables, fruit and fibre, and limiting ultra-processed foods, red meat, processed meats, sugary drinks and alcohol). It assesses the impact of a digital intervention (based on the use of the Open Food Facts app) as a complement to the nutritional education provided by the Interception program.",[163,164,165,166,167,168],"Breast Cancer","Pancreas Cancer","Colon Cancer","Lynch Syndrome","Germline BRCA1 Gene Mutation","Germline BRCA2 Gene Mutation",{"date":170,"type":33},"2026-05-08",{"date":172,"type":33},"2026-05-04",{"date":174,"type":22},"2028-03",{"name":39,"class":40},3,{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":132,"minAge":19,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":23,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},"100348615","phase-3-trial-of-acetylsalicylic-acid-and-atorvastatin-in-patients-with-castrate-resistant-prostate-cancer-100348615","NCT03819101","Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer","A Phase III Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer","PEACE-4","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate and no curative local therapy considered possible\n* Age ≥ 18 years, life expectancy of at least 6 months\n* CRPC defined as tumor progression (PSA increase on at least 2 separate values separated by at least 1 week or progression on imaging) while on Androgen Deprivation Therapy (orchiectomy, LHRH agonist or -antagonist) with documented serum testosterone levels ≤ 1.7 nmol\u002FL (≤ 0.50 ng\u002FmL). Ongoing concurrent use of LHRH agonist or antagonist is required if the patient has not been surgically castrated\n* Presence (M1) or absence (M0) of metastases on imaging\n* Performance status 0, 1 or 2\n* No previous use of life- prolonging treatments for CRPC (including abiraterone, enzalutamide, radium-223, docetaxel, cabazitaxel, and sipuleucel-T). The use of these agents together with Androgen Deprivation Therapy (ADT) for castrate-sensitive disease is allowed.\n* Adequate renal function within 30 days prior to registration: calculated creatinine clearance ≥ 50 mL\u002Fmin, according to the formula of Cockcroft-Gault and adequate liver function with levels of AST and ALT ≤ 3xULN and no signs for cholestasis.\n* Participation in other clinical trials is allowed except for trials with the same primary endpoint, i.e. OS\n* Patient authorized to participate to a clinical trial by specific country regulation (eg patient affiliated to a social security system or beneficiary of the same)\n* Information delivered to patient and informed consent form signed by the patient.\n\nExclusion Criteria:\n\n* Previous localised malignancy within 2 years with the exception of localized non-melanoma skin cancer and Ta or Tis bladder cancer (patients with asymptomatic Chronic Lymphocytic Leukemia can be included)\n* Previous metastatic malignancy within 5 years\n* Patient currently taking daily acetylsalicylic acid or a daily statin within the last 6 months\n* Patients with active liver disease (hepatitis B or C, cirrhosis) or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal or cholestasis\n* Patients with excessive alcohol intake or history of a relevant liver disease\n* Known hypersensitivity or intolerance to acetylsalicylic acid or atorvastatin or hypersensitivity to any of its components\n* Contra-indication to acetylsalicylic acid or atorvastatin according to label, including known high-risk for haemorrhage,\n* History of or active myopathy or significantly elevated (\\> 5 times ULN) CK levels\n* History of recent stroke or transient ischemic attack (TIA).\n* Any concomitant drugs contraindicated for use with the trial drugs according to the product information (e.g. Fusidic acid, potent inhibitors of CYP3A4 or transport proteins: ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors including ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir, telaprevir, saquinavir, darunavir, fosamprenavir, boceprevir, gemfibrozil, fenofibrate, etc)\n* Any serious underlying medical condition (by the investigator's judgement) which could impair the ability of the patient to participate in the trial\n* Patients with hereditary galactose intolerance, Lapp-lactase deficiency or Glucose-Galactose-malabsorption\n* Compliance with trial medical follow-up impossible due to geographic, social or psychological reasons\n* Psychiatric disorder precluding understanding of information about trial related topics, providing informed consent, or interfering with compliance for oral drug intake",{"count":186,"type":22},1210,[105],"This is a 2x2 factorial randomized, multicenter, international, open phase III trial.\n\nThe primary objective is to evaluate the benefit of acetylsalicylic acid and atorvastatin on overall survival (OS) (main endpoint) for patients with castrate-resistant prostate cancer starting first line treatment for CRPC",[141],{"date":191,"type":33},"2026-05-06",{"date":193,"type":33},"2019-06-06",{"date":195,"type":22},"2042-03",{"name":39,"class":40},30,{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":132,"minAge":206,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":210,"briefSummary":211,"conditions":212,"keywords":217,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":4},"100636885","helping-young-people-with-testicular-cancer-using-virtual-and-extended-reality-100636885","NCT07571499","Helping Young People With Testicular Cancer Using Virtual and Extended Reality","Addressing TesticulaR cANcer Unmet Supportive CarE NeeDs in Adolescents and Young Adults Using eXtended Reality","TRANSCEND-XR","Inclusion Criteria:\n\n1. Any person assigned male at birth who is diagnosed with stage I-III TC (germ cell tumour of the testicles).\n2. Aged between 15 and 39 years at the time of study inclusion.\n3. Completed curative treatment comprising of at least one standard treatment modality (surgery, chemotherapy and\u002For radiotherapy) for treatment of their cancer. A maximum of 9 months from the end of curative treatment will be allowed.\n4. Permitted treatment modalities:\n\n   * Localised disease: orchiectomy with or without chemotherapy and\u002For radiotherapy.\n   * Metastatic disease: orchiectomy and chemotherapy or radiotherapy or retroperitoneal surgery, or a combination of aforementioned treatments. First-line treatment only allowed.\n5. Willing and able to provide a valid and signed informed consent and\u002For assent, as appropriate.\n6. ECOG performance status 0-2.\n7. Patients accept to use personal smartphone\n8. Patients able to read and understand the local language\n\nExclusion Criteria:\n\n1. Non-testicular germ cell tumours (e.g., mediastinal primary or retroperitoneal primary tumours).\n2. Non-germ cell TC.\n3. Previous chemotherapy, radiotherapy, or surgery for TC other than that allowed in IC 4.\n4. History of contralateral TC.\n5. Any illness that would prevent the AYA TC survivor from giving a valid and signed informed consent, as assessed by the investigator.\n6. Any illness that might be exacerbated by the use of an XR digital tool, as assessed by the investigator, including history of severe motion sickness, brain lesions and epilepsy.\n7. Uncontrolled medical condition such as uncontrolled infection, uncontrolled diabetes mellitus or cardiac disease (including but not limited to grade 2 or higher cardiac failure, arrythmia, unstable angina, history of myocardial infract in the 6 months which, in the opinion of the treating physician, would influence the assessment of long-term side effect of TC treatment.\n8. AYA TC survivors with a \"currently active\" second malignancy other than non-melanoma skin cancers, superficial non-invasive (pTa or pTis) TCC of the bladder, or intratubular germ cell neoplasia. Patients are not considered to have a \"currently active\" malignancy if they have completed therapy and are free of disease for ≥ 3 years.\n9. Chemotherapy or radiotherapy for malignant disease other than TC within the past 3 years.","15 Years","39 Years",{"count":209,"type":22},245,[25],"TRANSCEND-XR is a European research project designed to better support adolescents and young adults who have been cured of testicular cancer. Even after treatment has ended, many young people continue to face physical, psychological, or social difficulties that are often poorly understood and insufficiently addressed.\n\nThe project aims to develop an innovative digital tool using extended reality (XR) to help these young people better understand the potential long-term effects of the disease and its treatments, recognize signs that require medical attention, and become more active participants in their own health follow-up.\n\nTRANSCEND-XR first includes a pilot phase to test feasibility and improve the tool, followed by a larger clinical study comparing its use with usual medical follow-up. Researchers will assess, in particular, its impact on patients' knowledge, quality of life, and ability to seek help.\n\nThe ultimate goal is to sustainably improve information, autonomy, and well-being among young survivors of testicular cancer through a digital approach tailored to their needs and daily practices.",[213,214,215,216],"Testicular Cancer","Testis Cancer","AYA Cancer Survivors","Survivor Patients",[218,219,220,221,222,223,224,225,226,227,228,229,230],"Testicular cancer survivors","Adolescents and young adults (AYA)","Survivorship care","Supportive care needs","Late effects of cancer treatment","Post-cancer follow-up","Quality of life","Patient education","Extended reality (XR)","Virtual reality in healthcare","Digital health intervention","Immersive digital tools","Long-term cancer effects","2026-04-30",{"date":191,"type":33},{"date":234,"type":22},"2027-01-04",{"date":236,"type":22},"2029-06-30",{"name":39,"class":40},{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":249,"conditions":250,"keywords":254,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":267},"100616267","phase-2-efficacy-and-safety-of-the-valemetostat-in-patients-with-selected-solid-tumors-100616267","NCT07303387","Efficacy and Safety of the Valemetostat in Patients With Selected Solid Tumors.","An Open Label Phase II Platform Modular Study Exploring the Efficacy and Safety of the Valemetostat (EZH1\u002F2 Inhibitor) in Patients With Selected Solid Tumors","EZHiSWITCH","Inclusion Criteria:\n\n1. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed.\n2. Ability to comply with the protocol.\n3. Age ≥ 18 years.\n4. Patients must have histologically or cytologically confirmed progressive metastatic or recurrent solid tumor (as defined below for each tumor type). Diagnosis must be stated in a pathology report and confirmed by the investigator.\n5. Evidence of disease progression prior to trial entry.\n6. Have exhausted all other standard-of-care therapeutic options which have shown efficacy in their disease and are expected to be more effective than valemetostat based on current evidence for standard-of-care and EZH1\u002F2 inhibitors\n7. Have an archival tissue sample available with sufficient tumor tissue for IHC confirmation of loss expression (20 slides required). If patients do not have sufficient archival material, a new biopsy should be scheduled.\n8. Have documented bi-allelic (homozygous) deletion of SMARCB1, SMARCA4\u002F2, ARID1A\u002FB, PBRM1, BAP1, SMARCC1\u002F2 or other SWI\u002FSNF in a tumor detected by a validated NGS test (solid or liquid) and confirmed loss of expression in tumour cells by centralized IHC.\n\n   Cohort 1.A - SMARCB1-defective (maximum of 1 prior treatment line) Cohort 1.B - SMARCA4 (maximum of 3 prior treatment lines) Cohort 1.C - ARID1A (maximum of 2 prior treatment lines) Cohort 1Ca: Endometrial and ovarian clear cell only Cohort 1Cb: Other ARID1A-defective tumors Cohort 1.D - PBRM1 (with a minimum of 6 clear cell renal cell carcinoma during stage 1; maximum of 3 prior treatment lines) Cohort 1.E - BAP1 (with a maximum of 5 mesothelioma during stage 1; maximum of 2 prior treatment lines) Cohort 1.F - SMARCA2 or other SWI\u002FSNF subunits (maximum of 2 prior treatment lines) Cohort 1.G - Clear cell Endometrial or Ovarian carcinoma SWI\u002FSNF wild-type (maximum of 2 prior treatment lines) Tissue used for assessing SWI\u002FSNF or BAP1 status must be \\\u003C 3 years old; otherwise, a new fresh biopsy should be performed.\n9. At least one lesion, not previously irradiated, measurable according to RECIST v1.1 (PCWG3\u002FRECIST1.1 for prostate cancer and mRECIST for pleural mesothelioma) as ≥10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and suitable for repeated assessment.\n10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration at the time of enrollment.\n11. Estimated life expectancy of greater than 12 weeks.\n12. Adequate hematologic and organ function, defined by the following laboratory results obtained within 3 days prior to the first study treatment (Cycle 1 Day 1):\n\n    1. Absolute neutrophil count (ANC) ≥ 1500 cells\u002FμL (without granulocyte colony-stimulating factor support within 14 days prior to the screening assessment).\n    2. Lymphocyte count ≥ 500\u002FμL.\n    3. Platelet count ≥ 100.000\u002FμL (platelet transfusion is not allowed within 14 days prior to the screening assessment).\n    4. Hemoglobin ≥ 9g\u002FdL (packed red blood cell transfusion is not allowed within 14 days prior to the screening assessment).\n    5. Total bilirubin ≤ 1.5 ULN (subjects with documented\u002Fsuspected Gilbert's disease can have total bilirubin ≤3x ULN and direct bilirubin ≤1.5x ULN or subjects with liver metastases at baseline can have total bilirubin ≤ 3 × ULN).\n    6. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤ 3.0x upper normal limit (ULN) or ≤ 5 × ULN in case of liver metastases.\n    7. Albumin ≥ 2.5g\u002FdL.\n    8. Creatinine clearance ≥ 40 mL\u002Fmin (according to Cockroft and Gault formula).\n    9. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular weight heparin or warfarin) should be on stable dose and must have PT-INR within therapeutic range as deemed appropriate by the Investigator.\n13. Women of childbearing potential must have at least one negative serum β-HCG pregnancy test during the screening assessment. Prior to the administration of the first study treatment, there must be a negative serum β-HCG pregnancy test within 72 hours prior or a negative urine pregnancy test within 24 hours prior. Women of childbearing potential must have a negative serum pregnancy test at Screening and must be willing to use highly effective birth control, upon enrollment, during the Treatment Period, and for 3 months, following the last dose of study drug administration.\n\n    A woman is considered of childbearing potential following menarche and until becoming post-menopausal (≥ 12 months of non-therapy-induced amenorrhea) unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral oophorectomy and bilateral salpingectomy with surgery at least 1 month before the first dose of study drug or confirmed by follicle stimulating hormone (FSH) test \\>40 mIU\u002FmL and estradiol \\\u003C40 pg\u002FmL (\\\u003C140 pmol\u002FL).\n14. Sexually active women of childbearing potential must agree to use a highly effective method of contraception \\\u003C\\\u003C supplemented by a barrier method \\>\\>, or to abstain from sexual activity during the study and for at least 3 months after the last dose of study treatment.\n15. Participant must agree to not breastfeed during the study or for 3 months after the last dose of study treatment.\n16. Sexually active male's patients with partner of childbearing potential, the subject must be surgically sterile or willing to use highly effective birth control upon enrollment, during the Treatment Period, and for 3 months following the last dose of study drug.\n17. Participant must agree to not donate blood during the study or for 3 months days after the last dose of study treatment.\n18. Male subjects must not freeze or donate sperm starting at Screening and throughout the study period, and for at least 3 months after the final study drug administration.\n19. Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 3 months after the final study drug administration.\n20. Patient should be able and willing to comply with study visits and procedures as per protocol.\n21. Patients must be affiliated to a social security system or beneficiary of an equivalent system.\n\nExclusion Criteria:\n\n1. Participation in another clinical study with an investigational product during the last 4 weeks (excepting observational or non-interventional clinical studies).\n2. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 21 days prior to the first dose of study drug, or five half-lives of the previous agent, whichever is the longer.\n3. Participant has had radiation therapy encompassing \\>20% of the bone marrow within 2 weeks prior to Cycle 1 Day 1; or curative radiation therapy or major surgery within 4 weeks or palliative radiation therapy within 2 weeks prior to Cycle 1 Day 1.\n4. History of another primary malignancy within 5 years prior to Cycle 1 Day 1 except for:\n\n   1. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study drug and of low potential risk for recurrence.\n   2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n   3. Adequately treated carcinoma in situ without evidence of disease (eg, carcinoma in situ of the cervix, ductal carcinoma in situ treated surgically with curative intent).\n5. Treatment with systemic (\\>10 mg daily prednisone equivalents). or other immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents) within 2 weeks prior to Cycle 1 Day 1, or anticipated requirements for systemic immunosuppressive medications during the trial:\n\n   The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids for patients with orthostatic hypotension, low-dose supplemental corticosteroids for adrenocortical insufficiency and topical steroids for cutaneous diseases are allowed.\n6. Acute toxicities from previous therapies that have not resolved to Grade ≤ 1, with the exception of alopecia.\n7. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. Known or suspected hypersensitivity to valemetostat tosylate or any of the excipients.\n8. Uncontrolled or significant cardiovascular disease, including the following:\n\n   1. Evidence of prolongation of QT\u002FQTc interval (eg, repeated episodes of QT corrected for heart rate using Fridericia's method \\[QTcF\\] \\>470 ms) (average of triplicate determinations) refer to APPENDIX 9.\n   2. Myocardial infarction within 6 months prior to Screening.\n   3. Uncontrolled angina pectoris within 6 months prior to Screening.\n   4. New York Heart Association (NYHA) Class 3 or 4 congestive heart failure.\n   5. Uncontrolled hypertension (resting systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg).\n   6. Patients with known left ventricular ejection fraction (LVEF) \\\u003C 40%; patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF \\\u003C 50% must be on a stable cardiologic treatment.\n9. Known positive test for HIV or known acquired immunodeficiency syndrome\n10. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection within 28 days prior to the first dose of study drug (hepatitis B surface antigen positive or have detectable HBV DNA or detectable HCV RNA).\n11. Active tuberculosis.\n12. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection requiring treatment with intravenous antibiotics, antivirals, or antifungals. Note: Subjects with localized fungal infections of skin or nails are eligible.\n13. Any active uncontrolled systemic diseases or other medical conditions considered to be poorly controlled by the investigator, including, but not limited to, bleeding diatheses\n14. Current use of moderate or strong cytochrome P450 (CYP)3A inducers (Table 8)\n15. Administration of attenuated or live vaccine within 4 weeks prior to Cycle 1 Day 1 or anticipation that such a live attenuated vaccine will be required during the study (except anti-COVID-19 vaccines).\n16. Major surgical procedure within 20 days prior ty Cycle 1 Day 1 or anticipation of need for a major surgical procedure during the course of the study.\n17. Uncontrolled tumor-related pain: patients requiring pain medication must be on a stable regimen at study entry and symptomatic lesions amenable to palliative radiotherapy should be treated prior to enrolment.\n18. Uncontrolled effusion (pleural, pericardial or ascites) requiring recurrent drainage procedures (once a month or more frequently); patients with indwelling catheters (e.g. PleurX) are allowed.\n19. Uncontrolled hypercalcemia (\\>1.5mmol\u002FL ionized calcium or Ca \\> 12mg\u002FdL or corrected serum calcium \\>ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab.\n20. History of leptomeningeal disease\n21. Symptomatic CNS metastasis or uncontrolled CNS metastasis, requiring increasing doses of steroids or stable dose of steroids \\> 10mg prednisone QD.\n22. Spinal cord compression without evidence that disease has been clinically stable for ≥ 2 weeks prior to Cycle 1 Day 1.\n23. Female subjects who are pregnant, breast-feeding or male \u002F female patients of reproductive potential who are not employing an effective method of birth control.\n24. Previous treatment with EZH2 (or EZH1\u002F2) inhibitors, except for cohort 1A where EZH2 inhibitors are approved.\n25. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study result.\n26. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.",{"count":247,"type":22},900,[53],"Rational, objective and design: Some cancer-protecting genes are inactivated when the EZH2 enzyme is too active or the SWI\u002FSNF complex is less active. The EZH1\u002F2 enzymes and the SWI\u002FSNFs complex play opposing roles in gene expression: we hypothesize that valemetostat, an inhibitor of the EZH1\u002F2 enzymes, will stop\u002Fslow down the growth of cancer cells by reactivating these genes. Numerous clinical trials are currently underway worldwide to optimize the development of valemetostat tosylate and potentially offer a new targeted therapeutic option for patients suffering from various cancer pathologies.\n\nThe aim of this research is to evaluate the efficacy of valemetostat on solid tumors, which have an alteration in certain genes: SMARC (B1\u002FA4\u002FA2\u002FC1\u002FC2), ARID (1A\u002F1B), PBRM1, BAP1 and other SWI\u002FSNF sub-units. The research will be conducted in two phases: 1) Pre-selection of patients with the desired alterations. 2) Treatment with valemetostat, 200mg\u002Fday, for a maximum of 2 years, with examinations every 28 days.\n\nThis is a multicenter, international, phase II open-label, multicenter modular study exploring the efficacy and safety of valemetostat. Module 1 will be the SWI\u002FSNF basket monotherapy study describe below. Such design will allow the study to evolve considering signals for further monotherapy and\u002For combination modules.\n\nThe Primary endpoint of the study is Overall Response Rate at 24 weeks, defined as the proportion of patients with a confirmed best overall response.\n\nTrial population: Adult patients with histologically\u002Fcytologically confirmed progressive metastatic or recurrent solid tumor, who have selected chromatin remodeling deficiency in at least one of the following genes: SMARCB1, SMARCA4, SMARCA2, SMARCC1, SMARCC2, ARID1A, ARID1B, PBRM1, BAP1and other SWI\u002FSNF sub-units; or molecularly (Wildtype) and phenotypically-selected Clear cell endometrial or ovarian carcinoma cancers. Patients must be using an effective method of contraception and have signed the consent form. They must not participate in another clinical study with an investigational product during the last 3 weeks, during the study treatment and not have a contraindication to the study treatment (…) Intervention: After confirmation by IHC of the loss of expression in tumors cells of SMARCB1, SMARCA4, SMARCA2, SMARCC1, SMARCC2, ARID1A, ARID1B, PBRM1, BAP1and other SWI\u002FSNF sub-units and validation of inclusion\u002Fexclusion criteria patients will included in different cohorts (refer to investigation scheme). All patients will receive Valemetostat (200 mg per day), divided into 28-day periods called treatment cycles, for a maximum of two years. The main interventions scheduled are blood samples (to evaluate biological parameters and for translational research), electrocardiogram, echocardiography and CTscan. For patients who have consented, sequential biopsies will be performed as follow: at baseline, on treatment and at progression.\n\nEthical consideration: This research will make it possible to collectively evaluate the interest of EZH1\u002F2 inhibitor in solids tumors with SWI\u002FSNF defect. Individually, by participating in this research, patients could benefit from these treatments based on cell-based results and in the treatment of relapsed\u002Frefractory peripheral T-cell lymphomas, with an improvement in symptoms and quality of life. As with any research, the investigational drug and other procedures that take place may involve risks, some of which are already known and others not yet described. The main risks (described in the consent form) are side effects of the valemetostat. If they agree, patients will also be monitored more closely with their safety assessed through patient-reported outcomes (PRO), the evaluation of their experience through qualitative interviews \\& assessment of quality of care and the evaluation of their biometric physiological via a wearable device.",[251,252,253],"Solid Tumor Malignancies","Clear Cell Endometrial Carcinoma","Ovarian Cancer",[255,256,257,258],"solid tumor","chromatin remodeling deficiency","Valemetostat","EZH1\u002F2 inhibitor","2026-04-16",{"date":261,"type":33},"2026-04-21",{"date":263,"type":33},"2026-03-05",{"date":265,"type":22},"2032-02-28",{"name":39,"class":40},4,{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":275,"enrollmentInfo":276,"targetDuration":4,"studyType":23,"phases":278,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":123},"100634787","phase-1-study-investigating-the-safety-of-anti-cd19-car-t-cells-therapy-produced-at-gustave-roussy-for-adults-with-severe-and-refractory-systemic-autoimmune-rheumatic-diseases-100634787","NCT07544225","Study Investigating the Safety of Anti-CD19 CAR-T Cells Therapy Produced at Gustave Roussy for Adults With Severe and Refractory Systemic Autoimmune Rheumatic Diseases","CELL-ATTACK 1","Inclusion Criteria:\n\n* Adults aged 18-75 with ECOG PS 0-2 with written informed consent, valid health insurance, and eligibility for CAR T cell infusion are required may be included. Patients must have a treatment refractory systemic autoimmune rheumatic disease (RA, SLE, Sjögren's, SSc, or IIM) with severe, progressive activity with adequate renal function (creatinine clearance \\> 30 mL\u002Fmin)\n\nExclusion Criteria:\n\n* Patients with any significant active infection, including hepatitis B or C, HIV, or other opportunistic or recurrent infections, are excluded. Prior gene therapy, previous CAR T treatment, active cancer within 2 years, or any history of allogeneic stem cell or solid organ transplantation exclude participation. Inadequate organ function-renal, hepatic, cardiac (LVEF \\\u003C 50%), or lung function requiring oxygen- and uncontrolled comorbidities prevents inclusion. Pregnancy, breastfeeding, or refusal to use highly effective contraception for 12 months post infusion","75 Years",{"count":277,"type":22},6,[279],"PHASE1","This is an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced therapy medicinal product in adult patients; with severe and refractory systemic autoimmune rheumatic diseases, including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), Sjogren's disease (SjD), systemic sclerosis (SSc) and idiopathic inflammatory myositis (IIM).",[282,283,284,285,286],"Rheumatoid Arthritis (RA)","Systemic Lupus Erythematosus (SLE)","Sjogren's Disease With Dry Eyes","Systemic Sclerosis (SSc)","Idiopathic Inflammatory Myositis (IIM)","2026-04-15",{"date":289,"type":33},"2026-04-22",{"date":291,"type":22},"2026-09-01",{"date":293,"type":22},"2043-02-01",{"name":39,"class":40},{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":305,"briefSummary":306,"conditions":307,"keywords":309,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":277},"100593067","phase-2-oral-pooled-fecal-microbiotherapy-maat033-concomitant-to-cemiplimab-versus-best-investigators-choice-in-patients-with-resistance-to-treatment-due-to-antibiotics-uptake-with-advanced-non-small-cell-lung-cancer-100593067","NCT07001618","Oral Pooled Fecal Microbiotherapy (MaaT033) Concomitant to Cemiplimab Versus Best Investigator's Choice in Patients With Resistance to Treatment Due to Antibiotics Uptake With Advanced Non-small Cell Lung Cancer","A Randomized Multicenter Phase II Trial Evaluating Oral Pooled Fecal Microbiotherapy (MaaT033) Concomitant to Cemiplimab (CB) Versus Best Investigator's Choice (BIC) in Resistance to PD-1\u002FPD-L1 Blockade Due to Antibiotics (ATB) Uptake in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)","IMMUNOLIFE2","Inclusion Criteria:\n\n1. Participants who are at least 18 years of age on the day of signing informed consent,\n2. All participants must understand spoken and written national language,\n3. Histologically confirmed diagnosis of NSCLC (adenocarcinoma versus squamous cell carcinoma versus others)\n4. Have metastatic or unresectable NSCLC and considered by their physician to be indicated for a new line of immunotherapy.\n5. Have an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 2. Evaluation of ECOG-PS is to be performed within 7 days prior to the date of treatment allocation.\n6. Patients who have progressed after immunotherapy or immunotherapy plus platinum-based chemotherapy (with platinum-based chemotherapy and ICI either sequentially or concomitantly).\n7. Have received ATB within 60 days before and 42 days after the first ICI administration and have progressed within 6 months after the first ICI.\n8. There are no restrictions on the number of prior lines of treatment. Patients may be included regardless of the number of previous therapies received.\n9. A male participant must abstain from heterosexual activity or must agree to use a contraception as detailed below (or in Appendix 2 of this protocol) during the treatment period and for at least 9 months after the last dose of CB or BIC and refrain from donating sperm during this period. (In application of the new recommendations of the CTFG)\n10. A female participant is eligible to participate if she is not pregnant (see Appendix 2), not breastfeeding, and if at least one of the following conditions applies:\n\n    1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 2.\n    2. A WOCBP should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. A WOCBP must agree to follow the contraceptive guidance in Appendix 2 or abstain from heterosexual activity during the treatment period and for at least 180 days, after the last dose of treatment.\n11. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.\n12. Patients must be affiliated to a social security system or beneficiary of the same\n13. Have an estimated life expectancy greater than 3 months (from inclusion).\n14. Meet acceptable steroid dose thresholds (i.e., not above the acceptable threshold \\\u003C10 mg prednisone daily or equivalent) if receiving systemic steroids at physiologic doses\n15. Have measurable disease based on RECIST 1.1 criteria. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n16. Have adequate organ function as defined in the Table 1. All screening laboratory tests must be performed within 28 days prior to the start of study treatment.\n\nExclusion Criteria:\n\n1. Immunodeficiency or systemic steroid therapy equivalent to prednisolone \\>10mg\u002Fday or equivalent within 7 days prior to the first dose of trial treatment.\n2. Active ongoing infection requiring ATB treatment.\n3. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years prior to enrollment. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n4. Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.\n5. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n6. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Participants who have entered the follow-up phase of an investigational study may participate if it has been 4 weeks after the last dose of the previous investigational agent and that all study drug-related AEs have resolved to grade 1 or less.\n7. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.\n8. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n9. Has a known history of Human Immunodeficiency Virus (HIV).\n10. Has a known history of Hepatitis B virus (HBV, defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (HCV, considered active if HCV RNA is detected) infection. Note: no testing for HBV and HCV is required unless mandated by local health authority.\n11. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n12. Any condition which, in the Investigator's opinion, makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol.\n13. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent\n14. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of treatment.\n15. Persistent toxicities related to prior treatment of grade greater than 1.\n16. Swallowing disorders which can affect the intake of the oral pooled fecal microbiotherapy (MaaT033).",{"count":304,"type":22},162,[53],"The goal of IMMUNOLIFE2 is to overcome primary resistance to immune checkpoint inhibitors (ICIs), such as pembrolizumab or nivolumab used alone or in combination with chemotherapy, observed in patients with advanced non-small cell lung cancer (NSCLC) following antibiotic exposure, which induces intestinal dysbiosis. The reintroduction of immunotherapy with Cemiplimab, combined with oral pooled fecal microbiotherapy (MaaT033), aims to restore gut microbiota and potentially reverse resistance to ICIs.\n\nThe main objective is to determine whether the combination of MaaT033 and Cemiplimab provides a superior disease control rate compared to the current best investigator's choice as comparator.\n\nPatients will be randomized to receive either:\n\n* Experimental arm: MaaT033 administered orally for one week prior to each cycle of Cemiplimab, which will be given in hospital care every 3 weeks for 6 months, followed by Cemiplimab alone thereafter;\n* Control arm: Best investigator's choice",[308],"NSCLC (Advanced Non-small Cell Lung Cancer)",[310,311,312,313],"MAAT033","ORAL POOLED FECAL MICROBIOTHERAPY","ADVANCED NON SMALL CELL LUNG CANCER","ANTIBIOTICS INDUCED RESISTANCE","2026-03-30",{"date":316,"type":33},"2026-04-03",{"date":318,"type":33},"2025-11-17",{"date":320,"type":22},"2032-09",{"name":39,"class":40},{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":330,"enrollmentInfo":331,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":344},"100399169","securing-access-to-innovative-molecules-in-oncology-and-hematology-for-children-adolescents-and-young-adults-100399169","NCT04477681","Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults","Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults in Therapeutic Failure or Relapse and Not Eligible for a Clinical Trial: a Project of the SFCE","SACHA","Inclusion Criteria:\n\n* Age ≤ 25 years old at the time of inclusion in the study\n* Patient with a pediatric tumor or leukemia in therapeutic failure or relapse without standard therapeutic options. Exceptionally, patients on the first line of treatment without standard therapeutic options may also be included (eg g: inoperable plexiform neurofibroma and MEK inhibitors, childhood fibrosarcoma and NTRK inhibitors).\n* Patient not eligible for an early phase clinical trial open to inclusion on French territory or refusal of inclusion\n* Patient treated with a new drug discussed at a RCPPI as part of a compassionate use issued by the ANSM or an off-label prescription of a drug of interest already authorized in adults.\n* Patients treated in one of the SFCE centers authorized to prescribe chemotherapy\n* Patient who did not object to participate after being informed of the study. The patient must be able and willing to cooperate in the study.\n\nExclusion Criteria:\n\n* Patient included in an early phase clinical trial open to inclusions on French territory.\n* Oral refusal to participate by the patient or their legal representatives, in reading the information note specific to the study\n* Patient under guardianship or curatorship, deprived of liberty or in the impossibility of expressing opposition to participating in the study","25 Years",{"count":332,"type":22},1150,"It involves collecting safety and efficacy data, under the actual conditions of use of medicines in children and adolescents, using a validated tool (Ennov EDC) and relying on the network of Interregional pediatric oncology appeal organizations (RIOs) identified by INCa since 2010 and responsible for the organization of Pluridisciplinary Pediatric Interregional (RCPPI) and National Consultative Meetings which discuss each case of relapse in order to define the best therapeutic options.",[335],"Pediatric Cancer","2026-03-27",{"date":338,"type":33},"2026-03-31",{"date":340,"type":33},"2020-04-09",{"date":342,"type":22},"2027-04",{"name":39,"class":40},32,{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":23,"phases":355,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":123},"100585801","cohort-evaluation-of-body-fluids-early-detection-of-cancer-in-high-risk-individuals-100585801","NCT06907095","Cohort Evaluation of Body Fluids Early Detection of Cancer in High-risk Individuals","A Prospective Cohort to Evaluate the Ability of Different Body fLuid-derived Approaches to Detect EArly-stage Cancers Among High-risk Individuals","LEAH","Inclusion Criteria increased risk cohort:\n\n1. Are aged 18 or more\n2. Have a cumulative 3-year risk of developing any cancer ≥ 4% (including the situation specific cancers + other cancers) defined as follows:\n\n   1. Situations at increased risk of breast cancer\n\n      * Women carrying germline pathogenic (P) or likely pathogenic (LP) variants of BRCA1, BRCA2, TP53, PALB2, PTEN, CDH1 genes without prophylactic mastectomy, aged ≥ 40 years, or\n      * Men with germline (P) or (LP) variants in the BRCA2 gene, aged ≥ 40 years, or\n      * Women with a personal history of an histological atypical breast lesion in the past 5 years and aged ≥ 50 years, or\n      * Women with a personal history of unilateral breast cancer (including ductal carcinoma in situ) diagnosed more than 5 years before inclusion, and currently aged ≥ 60 years, or\n      * Women who received chest radiotherapy before age 30 years and currently aged ≥ 25 years, or\n      * Women with an invasive breast cancer risk \\> 2.5% over the next 5 years, as defined by risk scores +\u002F- genotyping, and aged ≥ 50 years, or\n      * Individuals identified at increased risk in MyPeBS trial (\\> 2.5% over the next five years) (www.mypebs.eu) can be eligible for the study, if aged ≥ 50 years, or\n   2. Situations at increased risk of gynaecological cancer\n\n      * Women with a Lynch syndrome - germline (P) or (LP) variants in hMLH1, MSH2, hMLH6, PMS2, and aged ≥ 30 years, or\n      * Women carrying germline (P) or (LP) variants of BRCA1, BRCA2, PALB2, RAD51C or RAD51D, PTEN genes without prophylactic oophorectomy, aged ≥ 40 years, or POLE and POLD1, and aged \\> 30 years; or SMARCA4 or DICER1 and aged \\> 18 years or\n   3. Situations at increased risk of colorectal cancer\n\n      * Men or women with a Lynch syndrome - germline (P) or (LP) variants in hMLH1, MSH2, hMLH6, PMS2, APC, POLE, POLD1, BMPR1A, SMAD4 or biallelic MuTYH genes, and aged ≥ 40 years, or\n      * Individuals with an increased risk of colorectal cancer defined by the following criteria and aged ≥ 50 years, or\n      * First-degree relative diagnosed with colorectal cancer before the age of 60 years, or\n      * Two or more 1st degree relatives diagnosed with colorectal cancers at any age, or\n      * Personal history of any colorectal adenoma before the age of 50 years or adenomatous polyps \\> 1 cm, villous adenomas, dysplastic adenomas, or ≥ 3 adenomatous polyps after the age of 50 years, or\n      * Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis) after the age of 50 years, or\n   4. Situations at increased risk of upper gastrointestinal cancers\n\n      * Carriers of an STK11 or CDH1 germline (P) or (LP) variants and aged \\> 30, or\n      * Individuals with an increased risk of esophageal adenocarcinoma: Barrett's esophagus with high-grade dysplasia, or\n   5. Situations at increased risk of hepatic cancers\n\n      \\- Individuals at increased risk of hepatocellular carcinoma because of documented liver fibrosis or cirrhosis (whether secondary to non-alcoholic steatohepatitis, alcohol-related, or virus-related), or\n   6. Situations at increased risk for pancreatic cancers\n\n      * Patients with a family history with \\> 2 pancreatic cancers in close relatives and aged \\>50 or\n      * Chronic pancreatitis and aged \\>50 or carriers of PRSS1 or SPINK1 germline (P) or (LP) variants or\n      * Patients at increased risk of pancreatic cancer based on a composite score or\n      * Carriers of CDKN2A germline (P) or (LP) variants or\n      * Carriers of germine (P) or (LP) variants in BRCA2, ATM, BRCA1, PALB2, or Lynch syndrome-associated gene alterations with a first-degree or multiple family history of pancreatic ductal carcinoma (PDAC) or\n      * Patients with a Peutz-Jeghers syndrome (STK11 germline (P) or (LP) variants) or\n   7. Situations at increased risk of lung cancer\n\n      \\- History of heavy smoking \\> 20 pack-years among active or previous smokers who have quitted up to 10 years ago, and aged ≥ 50 years, or\n   8. Situations at increased risk of skin cancers except basal-cell carcinomas\n\n      * Carriers of germline (P) or (LP) variants in CDKN2A\u002FCDK4 or BAP1 genes, aged ≥ 50 years or\n      * Carriers of germline (P) or (LP) variants of genes that predispose to skin cancers (Xeroderma pigmentosum, etc…) or\n   9. Situations at increased risk of head and neck cancers\n\n      * Individuals with high-grade dysplasia or carcinoma in situ of the upper aero digestive tract within the last 10 years, and aged ≥ 50 years, or\n      * Individuals with oral lichen planus diagnosed more than 10 years ago, and aged ≥ 50 years or\n      * Previous history of a head and neck cancer in complete remission for ≥ 5 years, aged ≥ 50 years, and at least one of the following criteria:\n\n      Current or former smoker \\> 10 pack-years Current or former alcohol consumption \\> 14 units\u002Fweek\n   10. Situations at increased risk of mesothelioma\n\n       \\- Individuals with a history of relevant professional exposure to asbestos, and\u002For germline (P) or (LP) variants in BAP1, and aged ≥ 50 years, or\n   11. Situations at increased risk of kidney cancer\n\n       \\- Carriers of germline (P) or (LP) variants in the BAP1, VHL, FH, cMET, FLCN, SDH-B genes, and aged ≥ 50 years, or\n   12. Situations at increased risk of prostate cancer\n\n       * Men aged ≥ 40 year with any of the following:\n       * Strong family history: a first- or second-degree relative with metastatic prostate cancer, ovarian cancer, male breast cancer, female breast cancer aged ≤ 45 years, colorectal or endometrial cancer aged ≤ 50 years, pancreatic cancer or two or more first- or second-degree relatives with breast, prostate (but not clinically localized grade group 1), colorectal or endometrial cancer at any age, or\n       * Carriers of germline (P) or (LP) variants in BRCA1, BRCA2, ATM, HOXB13, hMLH1, MSH2, hMLH6, and PMS2, and aged \\> 45\n   13. Situations at increased risk of urothelial cancers\n\n       * History of heavy smoking \\> 30 pack-years, among active or previous smokers who have quitted up to 10 years ago, and aged ≥ 50 years, or\n       * Lynch syndrome with a germline (P) or (LP) variants in hMLH1, MSH2, hMLH6, PMS2, and aged ≥ 40 years, or\n   14. Situations at increased risk of endocrine cancers\n\n       * Increased risk of pheochromocytoma paraganglioma in individuals with germline (P) or (LP) variants in RET, VHL, SDHB, SDHD, and aged ≥ 35 years, or\n       * Multiple endocrine neoplasia syndrome in individuals with germline (P) or (LP) variants in RET or MEN1, and aged ≥ 40 years, or\n   15. Situations at increased risk of hematologic malignancies\n\n       * Individuals aged ≥ 50 years with any of the following:\n       * Clonal hematopoiesis of indeterminate potential, or\n       * Aplastic anemia, or\n       * Predisposing genetic alterations (P) or (LP) variants in GATA2, RUNX1, ANKRD26, ETV6, TP53, CEBPA, or DDX41 genes, or copy number variation of chromosome 14q32 region (CNVdup14), or\n       * Patients who received high doses of platinum or other compounds who are estimated to have a \\> 2% risk of secondary hematological malignancies at 3 years, or\n   16. Situations at increased risk of several cancer types\n\n       * Germline deleterious mutations of TP53 (Li-Fraumeni syndrome), and aged \\> 18 or\n       * Germline deleterious (P) or (LP) variants in PTEN, Cowden syndrome, and other PTEN-opathies, aged ≥ 30 years, or\n       * Personal history of allogenic organ transplantation at least five years before the inclusion, with long-term ongoing immunosuppressive treatment, and aged ≥ 50 years, or\n       * Chronic HIV carriers aged \\> 50, or\n   17. Situations at increased risk of second malignancy in individuals treated for a childhood cancer\n\n       * Brain radiation therapy during childhood, and aged ≥ 18 years, or\n       * Childhood malignancy which required chemotherapy and\u002For radiation therapy, and aged ≥ 40 years, or\n3. Beyond the situations described previously, the following individuals are also eligible for LEAH:\n\n   1. Increased risk of neoplasia linked to an underlying professional exposure, with a specific cancer risk estimated to be at least 2 % at 3 years, and aged ≥ 50 years, or\n   2. Other situation: Any particular situation with accumulation of several risk factors likely to induce cancer with a specific risk of cancer estimated at least 2% at 3 years.\n4. Participants with a personal cancer or hematological malignancy history are allowed if they are in complete remission at least 5 years from the primary diagnosis\n5. All participants must understand spoken and written French language,\n6. All participants must agree to comply with the protocol requirements,\n7. All participants must understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed.\n8. All participants must be able to access internet through their telephone or a computer\n\nInclusion criteria, control group\n\n1. Individuals seen for a rapid diagnostic procedure at the center as part of the Instadiag programme, that led to a diagnosis of a benign condition\n2. Who do not have a high risk situation as defined previously\n3. Agree to participate\n4. Aged \\>18\n5. They must understand spoken and written French language,\n6. They must agree to comply with the protocol requirements,\n7. They must understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed.\n8. They must be able to access internet through their telephone or a computer\n\nExclusion Criteria:\n\n1. Known prior diagnosis of cancer or hematological malignancy within the past 5 years except for non-melanoma skin cancers, in situ cervical cancers and for patients with germline TP53 alterations,\n2. Presence of signs or symptoms of cancer at enrolment,\n3. Acute exacerbation of an autoimmune condition requiring escalation in medical therapy within 14 days prior to enrolment,\n4. Any medical condition with a high likelihood of mortality within three years,\n5. Physical or psychological conditions considered not to be compatible with the study and not likely to comply with follow up requirements,\n6. Individuals under guardianship or deprived of their liberty by a judicial or administrative decision or incapable of giving their consent,\n7. Women carriers of (P) or (LP) variants in BRCA1, BRCA2, PALB2, gene considering prophylactic mastectomy in a near future or aged less than 40 years (since their absolute risk of cancer is lower than the expected threshold)\n8. Received a blood transfusion within the last week before inclusion.",{"count":354,"type":22},5909,[25],"LEAH is a prospective, observational, single-centre, non-randomised, open-label study of people at increased risk of cancer or malignant disease.\n\nThe main objective of LEAH is to evaluate and compare the sensitivity of different tests on body fluids to detect cancers that will occur within 3 years of inclusion in the study, in a cohort of individuals identified as being at increased risk of cancer.",[358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374],"Risk of Breast Cancer","Risk of Gynaecological Cancer","Risk of Colorectal Cancer","Risk of Upper Gastrointestinal Cancers","Risk of Hepatic Cancers","Risk of Lung Cancer","Risk of Skin Cancers Except Basal-cell Carcinomas","Risk of Head and Neck Cancers","Risk of Mesothelioma","Risk of Kidney Cancer","Risk of Prostate Cancer","Risk of Urothelial Cancers","Risk of Endocrine Cancers","Risk of Hematologic Malignancies","Risk of Several Cancer Types","Risk of Second Malignancy in Individuals Treated for a Childhood Cancer","Risk of Neoplasia","2026-03-25",{"date":314,"type":33},{"date":378,"type":33},"2026-03-16",{"date":380,"type":22},"2030-06",{"name":39,"class":40},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":23,"phases":392,"briefSummary":393,"conditions":394,"keywords":397,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":277},"100630154","phase-2-study-investigating-asp3082-in-patients-with-metastaticlocally-advanced-non-small-cell-lung-cancer-nsclc-and-pancreatic-ductal-adenocarcinoma-pdac-with-biomarker-analysis-to-characterize-responseresistance-100630154","NCT07483983","Study Investigating ASP3082 in Patients With Metastatic\u002FLocally Advanced Non-small-cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC), With Biomarker Analysis to Characterize Response\u002FResistance","Phase 2, Multicenter, Open Label, Platform Study Investigating ASP3082 in Patients With Metastaic\u002FLocally Non-Small-Cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC), With Biomarker Analysis to Characterize Response\u002FResistance","UNLOCK ASP3082","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Patients with histologically confirmed diagnosis of locally advanced (unresectable) or metastatic NSCLC (cohort 1) or PDAC (cohort 2) and documented KRAS G12D mutation on the most recent tumor biopsy or circulating tumor DNA (ctDNA) analysis\n3. For patients with NSCLC :\n\n   1. Patients with no known targetable genomic alterations, or an alteration for which no targeted therapy is approved (or accessible), must have been treated with at least 1 line of prior therapy, including a platinum-based regimen and a PD-(L) 1 blocker, combined or sequenced, and they must have experienced progression\n   2. Patients who have known actionable genomic alterations (EGFR, BRAF, and MET mutations or ALK, ROS1, RET, NTRK fusions) must have exhausted the available targeted therapy and have experienced disease progression after a platinum-based regimen\n4. Patients with PDAC must have received only one prior line of chemotherapy for a minimum duration of 5 months and have experienced disease progression\n5. Patients must have an ECOG performance status ≤1 at the time of screening\n6. Patients must have a minimum life expectancy of 3 months\n7. Patients must have at least one radiologically measurable lesion according to response evaluation criteria in solid tumors (RECIST) v1.1 criteria\n8. Patients must have a tumor site easily accessible to biopsy, avoiding bone biopsy when possible. Patient must have accepted to perform pre-treatment, on-treatment, and end-of-treatment tumor and blood biopsies\n9. Patients must have adequate bone marrow reserve and organ function, based on local laboratory data within 21 days prior to cycle 1, day 1 defined as :\n\n   * Platelet count ≥100 000\u002Fmm3 or ≥100 × 109\u002FL (platelet transfusions are not allowed up to 14 days prior to cycle 1 Day 1 to meet eligibility)\n   * Hemoglobin (Hgb) ≥9.0 g\u002FdL (transfusion and\u002For growth factor support is allowed)\n   * Absolute neutrophil count (ANC) ≥1500\u002Fmm3 or ≥1.5 × 109\u002FL (use of growth factors is not allowed in the 14 days prior cycle 1)\n   * Creatinine clearance (CrCl) : Creatinine clearance (CrCl) ≥60 mL\u002Fmin as calculated using the Cockcroft-Gault equation or measured CrCl; confirmation of CrCl is only required when SCr is \\>1.5 × ULN\n   * Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) and alkaline phosphatase (ALP) \\\u003C3 x ULN (or \\\u003C5 x ULN for patients with liver metastases)\n   * Total bilirubin (TBL) \\\u003C1.5 x ULN (\\\u003C3 x ULN in the presence of documented Gilbert's Syndrome \\[unconjugated hyperbilirubinemia\\]) or \\\u003C2 X ULN for patients with liver metastases\n   * Serum albumin ≥ 3.0 g\u002FdL\n   * Prothrombin time (PT) or Prothrombin time- international normalized ratio (PT-INR) and activated partial thromboplastin time (aPTT)\u002Fpartial thromboplastin time (PTT) ≤1.5 × (ULN), except for patients on coumarin-derivative anticoagulants or other similar anticoagulant therapy, who must have PT-INR within therapeutic range as deemed appropriate by the Investigator\n10. Patients must have baseline oxygen saturation \\> 93% on room air\n11. Females of reproductive\u002Fchildbearing potential must have a negative serum or urine pregnancy test at screening and must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 6 months for females after the last dose of study drug.\n12. Female patients must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 6 months after the final study drug administration\n13. Male patients must be surgically sterile or must withhold heterosexual intercourse or must be willing to use a highly effective birth control upon enrollment, during the treatment period, and for at least 3 months following the last dose of study drug\n14. Male patients must not freeze or donate sperm starting at screening and throughout the study period, and at least 3 months after the final study drug administration\n15. Patients must understand, sign and date the written informed consent form prior to any protocol-specific procedures performed. Patients should be able and willing to comply with study visits and procedures as per protocol\n16. Patients must be affiliated to a Social Security System or beneficiary of the same.\n\nExclusion criteria :\n\n1. Patients unwilling to participate in the biological investigations and to perform blood and tissue sample collection as required in the protocol\n2. Patients with NSCLC or PDAC amenable for treatment with curative intent\n3. Patients with a history of severe hypersensitivity reactions to either the drug substances or any components of the formulation used\n4. Inadequate washout period prior to cycle 1 day 1, defined as:\n\n   1. Whole brain radiation therapy or stereotactic brain radiation therapy \\\u003C14 days\n   2. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation \\\u003C28 days or palliative radiation therapy \\\u003C7 days. Participant must have recovered from all radiation-related toxicities and not have active radiation pneumonitis.\n   3. Any investigational agents or other anticancer drug(s), including immunotherapy, from a previous cancer treatment regimen or clinical study \\\u003C21 days or \\\u003C5 half-lives, whichever is shorter, prior to first dose of ASP3082\n   4. Major surgery (excluding placement of vascular access) \\\u003C 28 days\n   5. Live virus and live-attenuated vaccination \\\u003C28 days\n   6. Systemic steroid therapy or other immunosuppressive therapy \\\u003C 7 days.\n5. Prior treatment with a specific KRAS G12D inhibitor\u002Fdegrader or pan-RAS inhibitor\u002Fdegrader targeting KRAS G12D\n6. Evidence of spinal cord compression or brain metastases, defined as being clinically active (symptomatic), or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms or untreated. Patients with treated brain metastases and clinically inactive (asymptomatic) (i.e., without neurologic signs or symptoms and do not require treatment with corticosteroids or anticonvulsants) may be included in the study. Patients must have a stable neurologic status for at least 28 days prior to cycle 1 day 1.\n7. Patients with evidence of any leptomeningeal disease\n8. Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade 1 or baseline according to the NCI-CTCAE v5.0\n9. Any evidence of primary malignancy other than metastatic\u002Flocally advanced NSCLC or PDAC within 2 years prior to cycle 1 day 1, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated\n10. Any evidence of severe or uncontrolled systemic diseases including active bleeding diatheses, active infection, psychiatric illness\u002Fsocial situations, geographical factors, substance abuse, or other factors which in the Investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol. Screening for chronic conditions is not required\n11. Patients have an active infection requiring intravenous antibiotic within 14 days prior cycle 1 day 1\n12. Patients with clinically significant pleural effusion will be excluded and ascites requiring medical treatment within 30 days prior to ICF signature.\n13. Uncontrolled or significant cardiovascular disease prior to cycle 1 day 1, including:\n\n    1. Corrected QT interval \\>470 ms for females and \\>450 ms for males according to Fridericia's formula (QTcF) assessed by ECG\n    2. LVEF \\\u003C50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan\n    3. Myocardial infarction or unstable angina within 6 months\n    4. NYHA \\> class II within 6 months\n    5. Clinically significant pericardial effusion as determined by an ECHO or MUGA scan\n    6. Symptomatic congestive heart failure, clinically significant cardiac disease\n14. Participant with active hepatitis B (including acute HBV or chronic HBV) or HCV (RNA detected by qualitative assay). HCV RNA testing is not required in participants with negative HCV antibody testing.\n15. Patient with diagnosis of human immunodeficiency virus (HIV). Patients with HIV infection on antiviral therapy and undetectable viral load are allowed with a requirement for regular monitoring for reactivation for the duration of treatment on study per local or institutional guidelines\n16. Female patients who are pregnant or breastfeeding or intend to become pregnant during the study and for 6 months after study intervention administration\n17. Patients with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial\n18. Patients under guardianship, curatorship, judicial protection, family habilitation or deprived of his\u002Fher liberty by a judicial or administrative decision or incapable of giving his\u002Fher consent\n19. Patients require treatment with concomitant drugs that are strong inhibitors or inducers of CYP3A or CYP2D6\n20. Participant requires treatment with concomitant drugs that are sensitive substrates of CYP2C8\n21. Participation in another clinical trial (\\\u003C30 days or \\\u003C5 half-lives, whichever is longer) evaluating an experimental drug (except non-interventional research) and while on study treatment.",{"count":391,"type":22},60,[53],"UNLOCK ASP3082 is an open label, single arm, multicenter, phase 2 platform study that aims to evaluate the mechanisms of action and resistance to ASP3082 in metastatic\u002Flocally advanced Non-Samll-Cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC) with the presence of KRAS G12D mutation. The two cohorts of patients are the following : i. cohort NSCLC : patients with NSCLC with KRAS G12D mutation. ii. cohort PDAC : patients with PDAC with KRAS G12D mutation. Patients enrolled in the both cohorts will receive treatment with ASP3082 at the dose of 600 mg QW thereafter in a 21-day cycle. ASP3082 will be administred in intravenous route until disease progression, unacceptable toxicity, or consent withdrawal. Tumor and blood samples will be collected at baseline, on-treatment and at the end of treatment visit only from patients who develop acquired resistance (acquired resistance is defined as a best response of CR, PR, or SD lasting more than 6 months, followed by PD).",[395,396],"Metastatic\u002FLocally Advanced Non-Small-Cell Lung Cancer","Metastatic\u002FLocally Pancreatic Ductal Adenocarcinoma",[398],"KRASG12D","2026-03-23",{"date":336,"type":33},{"date":402,"type":22},"2026-03",{"date":404,"type":22},"2027-10",{"name":39,"class":40},{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":413,"minAge":19,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":23,"phases":416,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":425,"locationsCount":123},"100286551","prognostic-and-predictive-biomarkers-in-ovarian-cancers-100286551","NCT03010124","Prognostic and Predictive Biomarkers in Ovarian Cancers","OvBIOMark","Inclusion Criteria:\n\n1. New patient with a diagnosis of OC, or\n2. Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center presenting with progressive disease, and consenting to CT guided biopsy of relapsed disease, or\n3. Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center scheduled for surgery for relapsed disease.\n4. Signed informed consent\n5. Age ≥ 18\n6. Patient affiliated to a social security regimen or beneficiary of the same\n\nExclusion Criteria:\n\n1. Patients who do not fit the inclusion criteria and those who refuse an antitumoral treatment;\n2. Coagulation abnormalities that contra-indicates the biopsy","FEMALE",{"count":415,"type":22},350,[25],"The investigators therefore propose to conduct a biological study of prospectively collected patient tumour samples, ascites, blood and other residual samples (feces, urine, vaginal smear) throughout the disease course where markers (at diagnosis and their change with treatment) will be correlated to outcome in order to investigate how genetic diversity in OC prior to treatment and adaptation following treatment contribute to chemotherapy resistance. In addition freshly collected ascitic samples (and tumour samples) will be subjected to ex vivo DNA repair functional assays and isolated in primary culture (and established as xenografts) for target validation experiments.",[253],"2026-03-18",{"date":421,"type":33},"2026-03-20",{"date":423,"type":33},"2016-09-26",{"date":320,"type":22},{"name":39,"class":40},{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":434,"targetDuration":436,"studyType":81,"phases":4,"briefSummary":437,"conditions":438,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":448},"100629188","survival-without-persistent-limiting-toxicity-real-life-prospective-cohort-of-advanced-neuroendocrine-tumor-100629188","NCT07471425","Survival Without Persistent Limiting Toxicity: Real Life Prospective Cohort of Advanced Neuroendocrine Tumor","Survival Without Persistent Limiting Toxicity: a Real Life Prospective Cohort of Advanced Neuroendocrine Tumor Followed in the French ENDOCAN-RENATEN and GTE Networks","TOLERATE","Inclusion Criteria:\n\n* Unresectable local or metastatic NET naive of treatment tumor except somatostatin analogues or primary surgery.\n* Unresectable local or metastatic NET newly diagnosed\\\u003C6 months whatever the primary NET site\n* Well differentiated neuroendocrine tumor (WHO classifications) pathologically reviewed locally\n* No initial medical absolute contraindication to any of the authorized or recommended treatments (no AE\\>grade 1 according to NCI CTC v.5 criteria),\n* Patient who have full medical follow-up in an expert center of the French ENDOCAN network for the management of their advanced neuroendocrine tumor\n* Patient not opposed to data collection in the on GTE databasis\n* Patient not opposed to participate in the clinical study\n\nExclusion Criteria:\n\n* Patients with severe illness that contraindicates participation to any study\n* Age \\\u003C18 years old",{"count":435,"type":22},1100,"5 Years","Advanced neuroendocrine tumors (NETs) are rare cancers, characterized by prolonged survival (median\\>5 years). If five medical options are now approved and 4 others are only recommended, the best sequence is still unknown. No single study on long-term cumulative toxicity of consecutive treatment interventions has been published so far. Taking into account real-world context is required for sound decision- making that cannot be answered by randomized trials.\n\nProject objectives and brief description of the methods, which will be used to achieve them: Study team will construct a longitudinal prospective cohort of consecutive non resectable or metastatic NET patients using the GTE-RENATEN network to evaluate the real world cumulative and limiting toxicities. They will expect, as primary endpoint, a difference in survival without limiting (\\>grade 1 adverse event according to nci.ctc V5) persistent (\\>6 months) toxicity between therapeutics classes or therapeutics sequences in the real life conditions all along the treatments lines, since metastasis diagnosis. All NET primary patients will be enrolled.\n\nPatients will be followed until the primary endpoint is reached, death or until 5 years.\n\nBased on our pilot study, we plan to enroll 1100 patients to detect 150 events and adjust for 15 cofounders and 10% of lost to follow-up. Cox model adapted to time-related dependency will be used to analyze the data and machine learning will be utilized to take into account the number of confounding factors, interactions and nonlinear relationship. The best model of prediction will be validated in a subgroup of the cohort population.\n\nExpected results: Study team will create a tool to help therapeutic decision in order to identify in a given patient the best therapeutic class or sequence with the lowest risk of persistent limiting toxicity.",[439],"Neuroendocrine (NE) Tumors","2026-03-12",{"date":442,"type":33},"2026-03-13",{"date":444,"type":22},"2026-06",{"date":446,"type":22},"2034-06",{"name":39,"class":40},14,{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":457,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":4},"100626120","phase-3-trial-to-evaluate-nonavalent-hpv-vaccine-as-a-secondary-prevention-in-patients-treated-for-human-papilloma-virus-related-high-grade-squamous-intraepithelial-lesions-100626120","NCT07431502","Trial to Evaluate Nonavalent HPV Vaccine as a Secondary Prevention in Patients Treated for Human Papilloma Virus Related High-grade Squamous Intraepithelial Lesions","Randomized, Placebo-controlled Phase 3 Trial to Evaluate Nonavalent HPV Vaccine as a Secondary Prevention in Patients Treated for Human Papilloma Virus Related High-grade Squamous Intraepithelial Lesions","BioHPV","Inclusion Criteria:\n\n* Women, men, transgender,18 ≤age ≤55\n* ECOG performance status ≤ 1\n* Patients infected with HIV are eligible for the study provided they are receiving antiretroviral therapy with undetectable viral load.\n* Biopsy-proven HPV related HSIL at any site (vulvar VIN, vaginal VaIN, cervical CIN, anal AIN, penile PeIN) at baseline.\n* Women of childbearing potential must have a negative urine pregnancy test 24 hours prior to the administration of the first vaccine injection.\n* Sexually active patients must agree to use acceptable and appropriate contraception while included in BIO-HPV study and until the last dose of vaccine.\n* Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.\n* Patients must be affiliated to a social security system or beneficiary of the same\n* Life expectancy of greater than 5 years\n\nExclusion Criteria:\n\n* History of HPV related cancer (i.e. anal, genital, head and neck, cutaneous, penile)\n* History of prior treatment of HSIL\n* Warts so extensive that they preclude the clinician from determining the extent and location of HSIL Prior HPV vaccination\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 21 days prior to the first dose of trial treatment.\n* Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study treatment.\n* Prior malignancy active within the previous 3 years except from cancers with an expected PFS at 5 years of \\>95%.\n* Hypersensitivity to the active substances or to any of the excipients (Listed in the SmPC).\n* Acute or severe febrile illness. Vaccination must be postponed until the individual has fully recovered.\n* Pregnant women or intent to become pregnant\n* Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.","55 Years",{"count":459,"type":22},984,[105],"Randomized, placebo-controlled phase 3 trial to evaluate nonavalent HPV vaccine as a secondary prevention in patients treated for human papilloma virus related high-grade squamous intraepithelial lesions.",[463,464,465,466,467],"Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vulvar Site","Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vaginal Site","Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Penile Site","Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Cervical Site","Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Anal Site","2026-02-24",{"date":470,"type":33},"2026-02-27",{"date":472,"type":22},"2026-05",{"date":474,"type":22},"2030-11",{"name":39,"class":40},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":330,"enrollmentInfo":484,"targetDuration":4,"studyType":23,"phases":486,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":71},"100507699","engineering-immune-organoids-to-study-pediatric-cancer-100507699","NCT05890781","Engineering Immune Organoids to Study Pediatric Cancer","Engineering Immune Organoids to Study Pediatric Cancer (IMMUNE-ORGANOIDS)","IMMUNEORGANOID","Inclusion Criteria:\n\n* Age at diagnosis ≤ 25 years except for patients with malignant gliomas and renal tumors for whom no upper age limit is applied\n* Medical suspicion or diagnosis of one of the following diseases, regardless of stage:\n* Brain tumors\n* Renal tumors\n* Neuroblastoma\n* Sarcomas\n* Adult patient or parents or guardians should understand, sign and date the appropriate written informed consent from prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.\n* Affiliated to a social security system or beneficiary of the same.\n\nExclusion Criteria:\n\n* Any histology not mentioned in the inclusion criteria\n* Adult patient or parents\u002Fguardians incapable\u002Fincapable of giving its\u002Ftheir consent\n* Patients deprived of their liberty by a judicial or administrative decision",{"count":485,"type":22},108,[25],"To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC)",[489,490,491,492],"Brain Tumor","Kidney Tumor","Neuroblastoma","Sarcoma","2026-02-05",{"date":495,"type":33},"2026-02-09",{"date":497,"type":33},"2023-05-12",{"date":499,"type":22},"2028-05",{"name":39,"class":40},{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":510,"briefSummary":511,"conditions":512,"keywords":514,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":267},"100434084","gustave-roussy-cancer-profiling-100434084","NCT04932525","Gustave Roussy Cancer Profiling","STING","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Histology: solid malignant tumor or hematological malignancy.\n3. Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code)\n4. Voluntary signed and dated written informed consent prior to any study specific procedure.\n\nExclusion Criteria:\n\n1. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol\n2. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent\n3. Pregnant or breast-feeding women\n4. Minors (Age \\\u003C 18 years)",{"count":509,"type":22},20000,[25],"The objective of STING study is to perform high throughput molecular analysis (next generation sequencing +\u002F- immunological profiling) to estimate the proportion of patients with cancer presenting at least one targetable genomic alteration.",[513],"Solid Tumor, Unspecified, Adult",[515,516],"immunological profiling","targetable oncogenic aberration",{"date":518,"type":33},"2026-02-06",{"date":520,"type":33},"2021-05-10",{"date":522,"type":22},"2033-05-10",{"name":39,"class":40},{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":530,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":18,"minAge":532,"maxAge":330,"enrollmentInfo":533,"targetDuration":4,"studyType":23,"phases":535,"briefSummary":536,"conditions":537,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":539,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":543,"locationsCount":149},"100361224","phase-3-low-level-laser-therapy-in-the-prevention-of-chemotherapy-induced-mucositis-in-children-and-young-adults-100361224","NCT03983369","Low-level Laser Therapy in the Prevention of Chemotherapy-induced Mucositis in Children and Young Adults","Multicenter Double Blind Randomized Placebo-controlled Trial Assessing the Efficacy of Low-level Laser Therapy in the Prevention of Chemotherapy-induced Mucositis in Children and Young Adults","MUCILA","Inclusion Criteria:\n\n1. Age \\> 4 and ≤ 25 years\n2. No mucositis or other mouth lesions at the beginning of chemotherapy that could prevent the laser session and chemotherapy\n3. Cooperative patient, able to wear black glasses and to sit with his open mouth during laser session\n4. Patients treated in one of the SFCE centers that participate to the study\n5. Patients undergoing chemotherapy course with high risk of severe mucositis :\n\n   1. high-dose chemotherapy with hematological stem cell transplantation (stratum A) including but not limited to 8 HDC conditioning regimens for solid tumors intensive treatment (Busilvex-Melphalan, VP16-Thiotepa, BAM, BEAM, Thiotepa 900mg\u002Fm\\^2, Carboplatine-Thiotepa (typical teratoid rhabdoid tumor or medulloblastoma), VP16-Carboplatine-Thiotepa, Endoxan-Busilvex and VP16 - Melphalan) and 5 myeloablative conditioning regimens (for example : TBI-VP16, Busilvex-Endoxan-Thiotepa, Busilvex-Endoxan+\u002F-Melphalan and Thiotepa-Busulfan-Fludarabine),\n   2. Conventional chemotherapy courses (stratum B) but not limited to COPADM (B lymphoma), CAV\u002FICE (plexus choroid carcinoma or B lymphoma), Head start induction course (medulloblastoma), N6 course (neuroblastoma), VIDE or VCD (Ewing sarcoma), API\u002FAP (osteosarcoma), Cyclophosphamide and Doxorubicine (nephroblastoma), PLADO\u002FCarboplatine and Doxorubicine (hepatoblastoma), IVADo (rhabdomyosarcoma), induction and consolidation of the Myechild protocol (Cytarabine\u002FMithoxantrone Fludarabine Aractine +\u002F- Darubicine) (acute myeloid leukemia) and 5FU-cisplatine (undifferentiated carcinoma of nasopharyngeal),\n   3. Others courses of chemotherapy (stratum A or B) which may cause mucositis can be considered (please refer to the non-inclusion criterion n° 5 to see the prohibited chemotherapy list). In this case, the coordinating investigator approval is required.\n6. Women of childbearing potential must have a negative serum β-HCG pregnancy test prior to the administration of the first laser treatment.\n7. French speaking patients\n8. Patient and\u002For parents\u002Flegal representatives should understand, sign, and date the written informed consent form prior to any protocol specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.\n9. Patients must be affiliated to a social security regimen or beneficiary of the same\n\nNB : all patients who respect all the eligibility criteria are recruitable even if the patient haven't a cancer (Patients undergoing a chemotherapy with high risk of severe mucositis for another clinical reason than cancer).\n\nExclusion Criteria:\n\n1. Treatment by opioids on daily basis\n2. Orthodontic appliance\n3. Pregnant or breastfeeding young ladies or women\n4. Patients with cognitive disorder who could not self-evaluate his pain or with a mucositis difficult to evaluate\n5. None of this chemotherapy is allowed : Methotrexate, VA or VAD (nephroblastoma), Carboplatine - Etoposide (3 or 5 days), Temozolomide single agent or in combination with Topotecan\u002FIrinotecan or Bevacizumab, Gemzar, Taxotere, Ifosfamide - Etoposide (Ewing sarcoma), OEPA, COPDAC, IgEV (Hodgkin lymphoma)","4 Years",{"count":534,"type":22},315,[105],"To assess the efficacy of preventive Low-Level Laser Therapy (LLLT) for reducing the incidence of WHO's grade 3-4 oral mucositis in children and young adults receiving chemotherapy regimens associated with a high rate of mucositis: conventional chemotherapy or High Dose Chemotherapy (HDC) conditioning regimens with Hematological Stem Cell Transplantation (HSCT).",[538],"Mucositis Oral",{"date":518,"type":33},{"date":541,"type":33},"2018-08-29",{"date":119,"type":22},{"name":39,"class":40},{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":18,"minAge":552,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":23,"phases":555,"briefSummary":556,"conditions":557,"keywords":561,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":573},"100475900","phase-3-biological-medicine-for-diffuse-intrinsic-pontine-glioma-dipg-eradication-20-100475900","NCT05476939","Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0","Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication","BIOMEDE 2","Eligibility criteria for the inclusion (registration) in BIOMEDE 2.0 study:\n\n* Diagnosis Criteria:\n\n  * Diagnosis of DIPG (clinical and radiological). As biopsy is not standard for these tumors, an informed consent is required for the necessary histological verification. \\[Biopsy-part of BIOMEDE 2.0 trial\\]. OR\n  * Histological diagnosis of DIPG (i.e. H3K28M or EZHIP positive Diffuse Midline Glioma located in the pons) in case the tumor biopsy was performed before study entry. The diagnosis will be defined by 1\u002F diffuse glioma, 2\u002F H3K28M mutation or loss of H3K28 trimethylation together with EZHIP overexpression. In this situation, patient will sign the consent after the diagnosis to allow central review and biomarkers assessment thereafter. OR\n  * Molecular diagnosis of DIPG (i.e. H3K28M) in case a liquid biopsy (CSF or blood) was performed before study entry, in a patient who could not undergo a tumor biopsy because it was too dangerous according to the patient's clinical condition. The diagnosis will be defined by 1\u002F DIPG, 2\u002F H3K28M mutation. In this situation, patient will sign the consent after the diagnosis to allow collection of the molecular report. OR\n  * Non-DIPG diffuse midline gliomas (ND-DMG), H3K28M mutant or with H3K28 trimethylation loss together with EZHIP overexpression, will be eligible for the trial after biopsy or surgery. As biopsy and surgery is considered as standard practice for these locations, informed consent for the biopsy will not be necessary. Patient will sign the consent after the diagnosis to allow central review and biomarkers assessment thereafter. OR\n  * Non-DIPG diffuse midline gliomas (ND-DMG) will be eligible for the trial before the biopsy in case the diagnosis is clinically or radiologically suspected. Informed consent for the biopsy and molecular analysis will be necessary. Then, if the central pathology review concludes to a ND-DMG with H3K28M mutant or H3K28 trimethylation loss together with EZHIP overexpression, these patients will be eligible for the treatment part of the trial.\n* Eligible for a biopsy, or biopsy material available for the biomarker assessment.\n* Age \\> 6 months, with no upper age limit. Children between 6 months and 3 years will be discussed on a case by case basis for inclusion in the study for the feasibility of the stereotactic biopsy.\n* Eligible for cerebral or craniospinal radiotherapy.\n* Tumor at diagnosis: no prior chemotherapy for the present cancer; no prior cerebral radiation therapy even for another neoplasm. Surgery is allowed when performed for diagnostic or therapeutic purpose.\n* Metastatic diseases or spinal tumors allowed; in this case, patients would receive craniospinal or spinal radiotherapy and medical treatment (everolimus or ONC201) will be postponed and only started after the end of radiotherapy.\n* Patients must be affiliated to a social security system or beneficiary of the same according to local requirements.\n* Written informed consent from parents\u002Flegal representative, patient, and age-appropriate assent before any study-specific procedures are conducted according to local, regional or national guidelines.\n\nNon eligibility criteria for the inclusion (registration) in BIOMEDE 2.0 study:\n\n* Uncontrolled spontaneous massive intratumor bleeding. Patients with post-operative bleeding will be allowed to enter the study provided the hemorrhage is controled. Same rule applies for the other post-operative complications (infection, CSF leakage, absence of wound closure, subdural collection…).\n* Any other concomitant anti-cancer treatment not foreseen by this protocol is not allowed, except corticosteroids and Bevacizumab which are allowed during the protocol. Bevacizumab is not allowed before and until 15 days after the surgery. The use of bevacizumab and corticosteroids will be taken into account when judging the possibility of progression\u002Fpseudoprogression.\n* Any other cancer diagnosed during the last 5 years.\n* Uncontrolled intercurrent illness or active infection.\n* Any other co-morbid condition that in the investigator's opinion would impair study participation.\n* Unable for medical follow-up (geographic, social or mental reasons).\n* Patient previously treated with irradiation on the brainstem for another neoplasm.\n* Participation in another clinical study with an investigational product while on study treatment.\n* Patient under guardianship or deprived of his\u002Fher liberty by a judicial or administrative decision or incapable of giving his\u002Fher consent.\n\nEligibility criteria for the randomization in BIOMEDE 2.0 study:\n\n* Patient enrolled in the BIOMEDE 2.0 study.\n* Life expectancy \\> 12 weeks after the start of study treatment.\n* Histological diagnosis of DIPG (as per the WHO criteria) confirmed by central pathology review, OR Typical radiology of a DIPG (mandatory central radiological review) as well as the short clinical history (less than three months of pre-existing symptoms) in case of suspected DIPG but no histological confirmation (tumor biopsy performed but not informative), or suspected DIPG with detection of H3K28M mutation in the CSF or blood (ctDNA analysis in the CSF or blood), OR Histological diagnosis of ND-DMG confirmed by central pathology review, with mutation in the histone H3.1, H3.2, H3.3 genes, or loss of H3K28me3 and EZHIP overexpression by immunohistochemistry.\n* Karnofsky performance status scale or Lansky Play Scale \\> 50%. The PS should not take the neurologic deficit per se into account. NB: Children and adults with a worse performance status due to glioma-related motor paresis can be included.\n* Highly effective and appropriate contraception for patients (male and female) of reproductive potential during their entire participation in the study and during 6 months after the end of treatment.\n* Negative pregnancy test (serum beta-HCG or urinary test) evaluated within one week prior randomization in sexually active females of reproductive potential.\n* Absolute neutrophil count \\> 1.0 x 10\\^9\u002Fl, Platelets \\> 100 x 10\\^9\u002Fl.\n* Total bilirubin \\\u003C 1.5 x ULN, AST and ALT\\\u003C 2.5 x ULN.\n* Serum creatinine \\\u003C 1.5 X ULN for age. If serum creatinine \\> 1.5 x ULN, creatinine clearance must be \\> 70 ml\u002Fmin\u002F1.73 m² (as per local practice).\n* Normal coagulation tests within the local reference ranges.\n* Written informed consent from parents\u002Flegal representative, patient, and age-appropriate assent before randomization according to local, regional or national guidelines.\n\nNon Eligibility criteria for the randomization in BIOMEDE 2.0 study:\n\n* Current organ toxicity \\> grade 2 according to the NCI-CTCAE version 5.0, especially cardiovascular or renal disease (including but not limited to: congenital long QT syndrome, nephrotic syndrome, glomerulopathy, uncontrolled high blood pressure despite adequate treatment).\n* Patients with the following cardiac history cannot take ONC201:\n\n  * Prolongation of QT\u002FQTcF interval (QTc interval \\> 480 milliseconds) preferably using Frederica's QT correction formula on two ECGs separated by at least 48 hours.\n  * A history of Torsades de pointes or heart failure, hypokalemia, or family history of prolonged QT Syndrome.\n  * Required concomitant use of medication(s) known to prolong the QT\u002FQTc interval.\n\nIn this case, patients will be treated in the Everolimus arm without randomization (except if contra-indication to Everolimus).\n\n* Pregnant or breastfeeding women.\n* Patients with chronic HBV disease compatible with the trial are not excluded from the study. These patients randomized to everolimus treatment will have regular viral load monitoring throughout the study.\n* Patients taking strong P450 inhibitors or inducers or PgP inhibitors are not excluded from the study but drug concentration of everolimus should be monitored carefully to avoid toxicity. Preferably alternative medications should be considered.\n* Patient with known congenital galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption will not be randomized and will be treated in the ONC201 arm (except if contra-indication to ONC201).\n* Patients with known hypersensitivity to any component of Everolimus (active substance, other rapamycin derivatives or excipients) will not be randomized and will be treated in the ONC201 arm (except if contra-indication to ONC201).\n* Patients with known hypersensitivity to any component of ONC201 (drug product or excipients) will not be randomized and will be treated in the Everolimus arm (except if contra-indication to Everolimus).","6 Months",{"count":554,"type":22},433,[105],"The BIOMEDE 2.0 study is the second stage of the BIOMEDE multi-arm, multistage rolling programme (adaptive platform protocol).\n\nIt is a multicenter, randomized, open-label, controlled phase-3 trial evaluating efficacy of ONC201 in comparison with everolimus (primary objective based on internal comparison) and subsequently to historical controls.\n\nTwo treatment groups will be compared. A switch between treatment groups is allowed after confirmation of the disease progression (real-time central review blinded to the treatment arm allocation). Study treatment will be continued until centrally confirmed disease progression (either radiologically or histologically), unacceptable toxicity or consent withdrawal.\n\nThe final conclusion of the trial will be successful for ONC201, if ONC201 is found significantly superior to everolimus in terms of centrally-reviewed PFS (Progression-free survival) from randomization (internal comparison) either overall, considering ND-DMG and DIPG-patients together, or in the subgroup of ND-DMG patients alone. In other cases, Everolimus will remain the standard arm unless it appears associated with an excess of toxicity compared to ONC201 which could then be discussed as a new standard.",[558,559,560],"Diffuse Intrinsic Pontine Glioma","Diffuse Midline Glioma, H3 K27M-Mutant","Diffuse Midline Glioma, H3K27-altered",[562,563,564,565],"Children","Adolescents","Adults","Newly diagnosed","2026-02-03",{"date":493,"type":33},{"date":569,"type":33},"2022-09-29",{"date":571,"type":22},"2031-09",{"name":39,"class":40},50,{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":413,"minAge":19,"maxAge":4,"enrollmentInfo":581,"targetDuration":4,"studyType":23,"phases":583,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":596},"100570840","phase-3-randomized-phase-iii-trial-testing-maintenance-olaparib-versus-observation-after-adjuvant-chemoradiation-for-p53abn-endometrial-cancer-100570840","NCT06712472","Randomized Phase III Trial Testing Maintenance Olaparib Versus Observation After Adjuvant Chemoradiation for p53abn Endometrial Cancer","RAINBO-RED","Key inclusion criteria for RAINBO program:\n\n* Histologically confirmed diagnosis of EC (all grades and the following histologic subtypes : endometrioid, serous, clear cell, de-\u002Fundifferentiated carcinomas, and uterine carcinosarcoma).\n* Molecular classification performed following the diagnostic algorithm described in WHO 2020 (adapted from Vermij et al.)\n* TLH-BSO or TAH-BSO with or without lymphadenectomy or sentinel node biopsy, without macroscopic residual disease after surgery\n* No distant metastases as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or PET-CT scan)\n* Written informed consent prior to any study specific procedures\n* Age \\>= 18 years\n* Patients must have a life expectancy ≥ 16 weeks\n* Patients must be accessible for treatment and follow-up\n* Written informed consent for one of the RAINBO trials and the overarching research project according to the local Ethics Committee requirements.\n\nInclusion criteria specific for p53abn-RED Trial:\n\n* WHO Performance score 0-1\n* Histologically confirmed Stage I to III EC with myometrial invasion\n* Molecular classification: p53abn EC\\*\n* Body weight \\> 30 kg\n* Patient must receive or have received a sequential radiotherapy and chemotherapy preferably given according to the PORTEC-3 regimen and should be started within 6 to 8 weeks after surgery and no later than 10 weeks: two cycles of intravenous cisplatin 50mg\u002Fm² in the first and fourth week of the pelvic external beam radiotherapy (EBRT) +\u002F- vaginal brachytherapy followed by four cycles of intravenous carboplatin AUC 5 and paclitaxel 175 mg\u002Fm² at 21-day intervals.\n\nHowever the sequence of chemotherapy , number of cycles and inclusion of cisplatin may be altered according to local practice at the investigator's discretion.\n\nThis may include;\n\n* 4 cycles carboplatin \\& paclitaxel before or after radiotherapy with 2 cycles cisplatin\n* 4 cycles carboplatin \\& paclitaxel before or after radiotherapy (no cisplatin)\n* 6 cycles carboplatin \\& paclitaxel before or after radiotherapy (no cisplatin)\n\n  * Patients registered after their standard treatment must:\n  * provide a tumor assessment performed within the 4 weeks before the start of RT\u002FCT. This will be considered as the M0.\n  * have started RT\u002FCT 6 to 8 weeks after surgery. A maximum gap of 10 weeks is accepted.\n  * be randomized within two weeks before maintenance or observation.\n  * Adequate systemic organ function: Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:\n\n    * Creatinine clearance (\\> 50 cc\u002Fmin): Patients must have creatinine less than 1.5 ULN or calculated creatinine clearance estimated of ≥ 51 mL\u002Fmin using the Cockcroft-Gault equation or based on a 24 hour urine test. Estimated creatinine clearance = (140-age \\[years\\]) x weight (kg) (x F) \u002F serum creatinine (mg\u002FdL) x 72\n    * Adequate bone marrow function : hemoglobin ≥10.0 g\u002Fdl with no blood transfusion in the past 28 days, Absolute neutrophil count (ANC) ≥1.5 x 109\u002Fl, platelet count ≥ 100 x 109\u002Fl.\n    * Adequate liver function: bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\n    * ALT (SGPT) and\u002For AST (SGOT) ≤2.5 x ULN\n  * \\*Molecular classification must be performed according to the diagnostic algorithm presented in the WHO 2020 (Vermij et al. 2020). For the p53abn-RED trial this means that MMR and POLE status must be determined, and must be pMMR and POLE wildtype (or non-pathogenic) for inclusion. For details on the molecular classification see 7.1: Diagnostic algorithm for molecular classification.\n  * Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.\n  * Patients must be affiliated to a social security system or beneficiary of the same\n\nExclusion Criteria:\n\nExclusion criteria for RAINBO program\n\n* FIGO Stage IV disease of any histology even if there is no evidence of disease after surgery\n* Prior pelvic irradiation\n\nExclusion criteria specific for p53abn-RED Trial:\n\n* Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.\n* Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation \\>500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.\n* Persistent toxicities (\\>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.\n* Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n* Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.\n* Major surgical procedure (as defined by the Investigator) within 2 weeks prior randomization and patients must have recovered from any effects of any major surgery.\n* Significant traumatic injury within 4 weeks of the first dose of olaparib.\n* History of allogenic organ transplantation.\n* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n* Patient with severe hepatic impairment\n* Any previous treatment with a PARP inhibitor, including olaparib.\n* History of active primary immunodeficiency\n* History or evidence of hemorrhagic disorders within 6 months prior to randomization\n* Patients with myelodysplastic syndrome\u002Facute myeloid leukemia history or with features suggestive of MDS\u002FAML.\n* Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)\n* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immuno-deficiency virus (positive HIV 1\u002F2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.\n* Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.\n* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.\n* Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent\n* Patients with a known hypersensitivity to olaparib or any of the excipients of the product.\n* Treatment with an unlicensed or investigational product within 4 weeks of trial entry.\n* Breastfeeding patients",{"count":582,"type":22},554,[105],"The RAINBO program is a studies group which proposes personalized treatment of patients suffering from endometrial cancer according to their molecular profile.\n\nthe RAINBO-RED study allows observation or maintenance treatment with targeted therapy for one year (olaparib). This after standard therapy. The goal is to improve recurrence-free survival of patients treated with Olaparib.",[586,587],"Endometrial Cancer","p53abn","2026-01-16",{"date":590,"type":33},"2026-01-20",{"date":592,"type":33},"2024-06-26",{"date":594,"type":22},"2031-12",{"name":39,"class":40},15,{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":603,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":605,"targetDuration":552,"studyType":81,"phases":4,"briefSummary":607,"conditions":608,"keywords":610,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":123},"100552897","proact-is-a-prospective-master-protocol-for-a-cohort-study-focused-on-evaluating-the-implementation-of-integrated-proactive-supportive-care-pathways-at-gustave-roussy-100552897","NCT06479057","PROACT is a Prospective Master Protocol for a Cohort Study Focused on Evaluating the Implementation of Integrated Proactive Supportive Care Pathways at Gustave Roussy","Integrating PROACTive Care Pathways to Empower and Support Cancer Patients (PROACT)","PROACT","Inclusion Criteria:\n\n* Histological confirmation of cancer (any cancer type, any stage)\n* Age ≥ 18 years old\n* Received an integrated supportive care need assessment.\n* Sign the consent form for the PROACT study.\n\nExclusion Criteria:\n\n* Absence or inability of written consent from the patient.\n* Does not understand or speak French.",{"count":606,"type":22},700,"PROACT is a prospective master protocol for a cohort study focused on evaluating the implementation of integrated proactive pathways of supportive care.\n\nThis is an observational cohort study in the context of a quality-of-care initiative.\n\nIt will be evaluated by its impact on patient's distress measured by the NCCN's Distress thermometer at 12 weeks after entering the pathway.",[609],"Any Cancer",[611,612,613,614,615],"supportive care pathway","cancer","master protocol","supportive care","Distress","2026-01-15",{"date":588,"type":33},{"date":619,"type":33},"2024-01-11",{"date":621,"type":22},"2027-07",{"name":39,"class":40},{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":627,"acronym":628,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":630,"targetDuration":4,"studyType":23,"phases":632,"briefSummary":633,"conditions":634,"keywords":635,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":639,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":645},"100271443","phase-1-european-proof-of-concept-therapeutic-stratification-trial-of-molecular-anomalies-in-relapsed-or-refractory-tumors-100271443","NCT02813135","European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors","ESMART","Inclusion Criteria:\n\n1. Patients must be diagnosed with a haematologic or solid tumor malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists.\n2. Age \\\u003C 18 years at inclusion; patients 18 years and older may be included after discussion with the sponsor if they have a pediatric recurrent\u002Frefractory malignancy.\n3. Patient must have had advanced molecular profiling (i.e. WES\u002FWGS +\u002F- RNAseq) of their recurrent or refractory tumor i.e. at the time of disease progression\u002Frelapse; exceptionally patients with advanced molecular profiling at diagnosis may be allowed.\n4. Evaluable or measurable disease as defined by standard imaging criteria for the patient's tumor type (RECIST v1.1, RANO criteria for patients with HGG, INRC criteria for patients with NB, Leukemia criteria, etc.).\n5. Patients with relapsed or refractory leukemia are eligible for this study.\n6. Performance status: Karnofsky performance status (for patients \\>12 years of age) or Lansky Play score (for patients ≤12 years of age) ≥ 70%. Patients who are unable to walk because of paralysis or stable neurological disability, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n7. Life expectancy ≥ 3 months\n8. Adequate organ function:\n\n   Hematologic criteria (Leukemia patients are excluded from hematological criteria):\n   * Peripheral absolute neutrophil count (ANC) ≥ 1000\u002FμL(unsupported)\n   * Platelet count ≥ 100,000\u002FμL (unsupported)\n   * Hemoglobin ≥ 8.0 g\u002FdL (transfusion is allowed)\n\n   Cardiac function:\n   * Shortening fraction (SF) \\>29% (\\>35% for children \\\u003C 3 years) and left ventricular ejection fraction (LVEF) ≥50% at baseline, as determined by echocardiography (mandatory only for patients who have received cardiotoxic therapy).\n   * Absence of QTc prolongation (QTc \\> 450 msec on baseline ECG, using the Fridericia correction \\[QTcF formula\\]) or other clinically significant ventricular or atrial arrhythmia.\n\n   Renal and hepatic function:\n   * Serum creatinine ≤ 1.5 x upper limit of normal (ULN) for age\n   * Total bilirubin ≤ 1.5 x ULN\n   * Alanine aminotransferase (ALT)\u002Fserum glutamic pyruvic transaminase (SGPT) ≤ 2,5 x ULN; aspartate aminotransferase (AST)\u002Fserum glutamic oxaloacetic transaminase\u002FSGOT ≤ 2,5 x ULN except in patients with documented tumor involvement of the liver who must have AST\u002FSGOT and ALT\u002FSGPT ≤ 5 x ULN.\n9. Able to comply with scheduled follow-up and with management of toxicity.\n10. Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to initiation of treatment. Sexually active women of childbearing potential must agree to use acceptable and appropriate contraception during the study and for at least 6 months after the last study treatment administration. Sexually active males patients must agree to use condom during the study and for at least 6 months (7 months for arm J) after the last study treatment administration. Acceptable contraception are defined in CTFG Guidelines \"Recommendations related to contraception and pregnancy testing in clinical trials\"\n11. For all oral medications patients must be able to comfortably swallow capsules (except for those for which an oral solution is available); nasogastric or gastrostomy feeding tube administration is allowed only if indicated.\n12. Written informed consent from parents\u002Flegal representative, patient, and age-appropriate assent before any study-specific screening procedures are conducted according to local, regional or national guidelines.\n13. Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.\n\nExclusion Criteria:\n\n1. Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of corticosteroids or local CNS-directed therapy to control their CNS disease. Patients on stable doses of corticosteroids for at least 7 days prior to receiving study drug may be included.\n2. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).\n3. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality, unstable ischemia,congestive heart failure within 12 months of screening)\n4. Active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection.\n5. Presence of any ≥ CTCAE grade 2 treatment-related toxicity with the exception of alopecia, ototoxicity or peripheral neuropathy.\n6. Systemic anticancer therapy within 21 days of the first study dose or 5 times its half-life, whichever is less.\n7. Previous myeloablative therapy with autologous hematopoietic stem cell rescue within 8 weeks of the first study drug dose\n8. Allogeneic stem cell transplant within 3 months prior to the first study drug dose. Patients receiving any agent to treat or prevent graft-versus host disease (GVHD) post bone marrow transplant are not eligible for this trial.\n9. Radiotherapy (non-palliative) within 21 days prior to the first dose of drug (or within 6 weeks for therapeutic doses of MIBG or craniospinal irradiation).\n10. Major surgery within 21 days of the first dose. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumor biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48 hour interval must be maintained before the first dose of the investigational drug is administered.\n11. Currently taking medications with a known risk of prolonging the QT interval or inducing Torsades de Pointes (Refer to Appendix 8).\n12. Currently taking medications that are mainly metabolized by CYP3A4\u002F5, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or the drug transporters Pgp (MDR1), BCRP, OATP1B1, OATP1B3, OCT1 and OCT2 and have a low therapeutic index that cannot be discontinued at least 7 days or 5 x reported elimination half-life prior to start of treatment with any of the investigational drugs and for the duration of the study (Refer to Appendix 9).\n13. Known hypersensitivity to any study drug or component of the formulation.\n14. Pregnant or nursing (lactating) females.\n15. Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study drug.",{"count":631,"type":22},472,[279,53],"This proof-of-concept platform trial is designed to cover the targeting of several survival pathways in oncogenesis that are currently not adequately employed for pediatric patients in Europe (Geoerger 2017; Geoerger 2019).\n\nThe aims of the trial are:\n\n1. To determine the recommended phase II dose (RP2D) of a specific anticancer agent and\u002For a relevant combination in a pediatric population, to document its tolerability and\n2. To explore first signals of activity in a molecularly enriched study population.",[335],[562,563,636,637,638],"Young adults","Recurrent malignancies","Refractory malignancies",{"date":588,"type":33},{"date":641,"type":33},"2016-08-03",{"date":643,"type":22},"2031-02",{"name":39,"class":40},21,{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":651,"acronym":652,"eligibilityCriteria":653,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":654,"targetDuration":4,"studyType":23,"phases":656,"briefSummary":657,"conditions":658,"keywords":661,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":688,"lastUpdatePostDateStruct":689,"startDateStruct":691,"completionDateStruct":693,"leadSponsor":695,"locationsCount":41},"100436630","phase-2-patritumab-deruxtecan-u3-1402-in-unresectable-locally-advanced-or-metastatic-breast-cancer-100436630","NCT04965766","Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer","Phase 2, Open Label Study of Patritumab Deruxtecan (U3-1402), an Anti-HER3-Antibody Drug Conjugate (ADC), in Patients With Advanced Breast Cancer, With Biomarker Analyses to Characterize Response to Therapy","ICARUS BREAST","Inclusion Criteria:\n\n* Adults with histologically-confirmed HER2 negative, unresectable locally advanced or metastatic breast cancer that is hormone receptor positive (HR+) at the time of the first breast cancer diagnosis\n* Participants with a documented radiologic unresectable or metastatic progression\n* Participants may have received anthracyclines and taxanes as (neo) adjuvant treatment and must have received one line of chemotherapy for Advanced breast cancer (ABC), but not more than one line. Participants must have a clinically or radiologically documented evidence of tumor progression on or after cyclin dependent kinase 4\u002F6 (CDK 4\u002F 6) inhibitor combined with endocrine therapy. Previous treatments with PI3K inhibitors, mTOR inhibitors, AKT-inhibitors and poly ADP ribose polymerase (PARP)-inhibitors are allowed\n* Participants must have a tumor site easily accessible to biopsy (with exception of bone metastasis)\n* Participants must have at least one radiologically measurable lesion (different from the biopsy site)\n* Participants must have an ECOG PS equals to 0 or 1\n* Participants must have a life expectancy of 12 weeks or more\n* Participants must have adequate bone marrow reserve and organ function, based on local laboratory data within 14 days prior to Cycle 1, Day 1\n* Female patients of reproductive\u002Fchildbearing potential must have a negative pregnancy test at screening (serum test within 14 days or urine test within 72 hours of enrollment). A positive urine pregnancy test result must be confirmed by a serum test. Patients must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months after the last dose of study drug.\n\nThe following contraception methods are considered highly effective:\n\n1. Hormonal or nonhormonal intrauterine device (IUD)\n2. Progestogen-only subdermal contraceptive implant\n3. Bilateral tubal occlusion\n4. Vasectomized partner\n5. Complete sexual abstinence defined as refraining from heterosexual intercourse during and upon completion of the study and for at least 7 months for females after the last dose of study drug.\n\nPeriodic abstinence (calendar, symptothermal, post-ovulation methods) is not an acceptable method of contraception. Penile\u002Fexternal condoms for male partners must be used in addition to the female patient's hormonal contraception for the duration treatment intervention and until 7 months following the last dose of trial intervention. Female patients must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration.\n\n* A male participant capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate each trial intervention. The length of time required to continue contraception after last dose for each trial intervention is 4 months. Avoid donating sperm. Note: Preservation of sperm should be considered prior to enrollment\u002Frandomization in this trial. Use a penile\u002Fexternal condom when having penile-vaginal intercourse with a nonparticipant of childbearing potential, PLUS partner use of an additional contraceptive method (see below), as a condom may break or leak:\n\n  1. Progestogen-only contraceptive implant\n  2. Hormonal or nonhormonal IUD\n  3. Bilateral tubal occlusion (includes tubal ligation)\n  4. Combined (estrogen- and progestogen-containing) hormonal contraception (oral, intravaginal, transdermal, injectable)\n  5. Progestogen-only hormonal contraception (oral, injectable)\n  6. Progesterone-only hormonal contraception where inhibition of ovulation is not the primary mode of action\n  7. Cervical cap, diaphragm, or sponge with spermicide Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n     If the contraception requirements in the local label for any of the trial interventions are more stringent than the requirements above, the local label requirements are to be followed. Note: If the participant is azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview), no contraception is required.\n\n     Male participants must not freeze or donate sperm starting at screening and throughout the study period, and for at least 4 months after the final study drug administration\n* Participant must understand, sign, and date the written ICF prior to any protocol-specific procedures performed. Participant should be able and willing to comply with study visits and procedure as per protocol\n* Participant must be affiliated to a social security system or beneficiary of the same\n\nExclusion Criteria:\n\n* Breast cancer amenable for resection or radiation therapy with curative intent\n* Any history of interstitial lung disease (ILD), actual ILD, or a suspicion of an ILD\n* Clinically severe pulmonary compromise (based on investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to:\n\n  1. Any underlying pulmonary disorder\n  2. Any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement\n  3. OR prior pneumonectomy\n* The use of chronic systemic corticosteroids at a dose superior to 10 mg daily of prednisone or equivalent or any form of immunosuppressive therapy prior to Cycle 1 Day 1. Participants who require use of bronchodilators, inhaled steroids, or local steroid injections may be included in the study\n* Evidence of any leptomeningeal disease\n* Evidence of corneal disease\n* Any evidence of severe or uncontrolled systemic diseases including active bleeding diatheses, active infection, psychiatric illness\u002Fsocial situations, geographical factors, substance abuse, or other factors which in the investigator's opinion makes it undesirable for the participant to participate in the study or which would jeopardize compliance with the protocol\n* Evidence of clinically active spinal cord compression or brain metastases defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms\n* Exposure to prior systemic anticancer therapy (including investigational agents) within 4 weeks or 5 half-lives (whichever is shorter) before enrollment.\n* Inadequate washout period prior to Cycle 1 Day 1, defined as:\n\n  1. Whole brain radiation therapy \\\u003C14 days or stereotactic brain radiation therapy \\\u003C7 days.\n  2. Immune checkpoint inhibitor therapy \\\u003C21 days\n  3. Hormonal therapy \\\u003C21 days\n  4. Major surgery (excluding placement of vascular access) \\\u003C28 days.\n  5. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation \\\u003C28 days or palliative radiation therapy \\\u003C14 days.\n  6. Chloroquine or hydroxychloroquine ≤ 14 days\n  7. Live virus vaccination \\\u003C28 days.\n* Prior treatment with an anti-HER3 antibody and\u002For ADC containing an exatecan derivative that is a topoisomerase I inhibitor\n* Participants with a grade equals or greater than 2 unresolved toxicities from previous anticancer therapy (other than alopecia)\n* A history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of U3-1402, or to other monoclonal antibodies\n* Any evidence of primary malignancy other than locally advanced or metastatic lung cancer within three years prior to Cycle 1 Day 1, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated\n* Uncontrolled or significant cardiovascular disease prior to Cycle 1 Day :\n\n  1. Corrected QT interval higher than 470 ms for females and 450 ms for males according to Fridericia's formula (QTcF) and assessed based on triplicate ECGs, approximately 1 minute apart\n  2. Left ventricular ejection fraction (LVEF) less than 50% by either ECHO or cardiac MRI or multigated acquisition scan (MUGA)\n  3. Resting systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than 90 mmHg\n  4. Myocardial infarction within six months\n  5. Symptomatic congestive heart failure (NYHA Classes 2 to 4 within 28 days before treatment)\n  6. Uncontrolled angina pectoris within six months.\n  7. Cardiac arrhythmia requiring antiarrhythmic treatment\n* Evidence of active or uncontrolled hepatitis B virus infection (HBV)\n\nParticipants are eligible:\n\n1. If HBsAg positive with chronic HBV infection (lasting 6 months or longer) and meet conditions below:\n\n   * HBV DNA viral load \\\u003C2000 IU\u002FmL\n   * Start or maintain antiviral treatment if clinically indicated as per the investigator.\n2. Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST\u002FALT \\\u003C3 × ULN, which are not attributable to HBV infection - Evidence of active or uncontrolled hepatitis C virus infection (HCV).\n\nParticipants are eligible if:\n\n1. History of hepatitis C infection eligible if the HCV viral load is below the level of detection in the absence of antiviral therapy during the previous 4 weeks\n2. Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST\u002FALT \\\u003C 3 × ULN, which are not attributable to HCV infection - Evidence of active or uncontrolled human immunodeficiency virus (HIV infection. Subjects must be tested for HIV viral load during the Screening Period if acceptable by local regulations or IRBs\u002FIECs.\n\nParticipants are eligible if:\n\n1. CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening 16\n2. Virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) at the time of screening and for at least 12 weeks before screening\n3. No AIDS-defining opportunistic infections or conditions within the past 12 months\n4. On stable ART regimen, without changes in drugs or dose modification, for at least 4 weeks before trial entry (Day 1) and agree to continue ART throughout the trial.\n\n   * Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's judgment, could affect the safety of the subject; alter the absorption, distribution, metabolism or excretion of the study drug; or confound the assessment of study results.\n   * Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection. Subjects with localized fungal infections of skin or nails are eligible.\n   * Female patient who is pregnant or breastfeeding or intends to become pregnant during the study.\n   * Patient with any psychological, familial, sociological or geographical condition potentially hindering compliance with the study protocol procedures and follow-up schedule.\n   * Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent\n   * Participation in another clinical trial evaluating an experimental drug (except non-interventional research",{"count":655,"type":22},139,[53],"This study aims to evaluate the efficacy and safety of U3-1402 in participants with advanced breast cancer (ABC). Participants have to be hormone-receptor positive (HR+) and have to be resistant to endocrine therapy and cyclin-dependent kinases 4 and 6 (CDK4\u002F6) inhibitors. Participants may have received multiple lines of endocrine therapy with or without targeted therapies and must have received only one line of chemotherapy for ABC.\n\nMoreover, the immune effects, the predictors of resistance and response to treatment, the effect of the chemotherapy on deoxyribonucleic acid (DNA) replication will be assessed and will help identify the subgroups that will mostly benefit from the treatment. The pharmacokinetics of the product and the anti-drug antibody (ADA) will be also evaluated.\n\nA total of 99 participants are planned to be treated in the study. Participants will receive, every three weeks, a dose of U3-1402 equivalent to 5.6 mg\u002Fkg of body weight until progression or until unacceptable toxicity.\n\nTumor evaluation will be performed every six weeks by the mean of a computed tomography for the thorax, abdomen and pelvis (TAP CT-scan) or a magnetic resonance imaging (MRI). Brain and\u002For bone CT scans will be also performed throughout the study for participants with brain and\u002For bone metastasis. A PET scan combined with contrast enhanced CT scan can replace all the above-mentioned imaging if performed at baseline considering that the same imaging technique should be used throughout the study.\n\nThe safety of the product will be assessed at each cycle, through complete clinical exams, biological tests, electrocardiograms (ECGs), cardiac echographies (ECHOs) and through the collection of ongoing toxicities or adverse events.",[659,660],"Metastatic Breast Cancer","Advanced Breast Cancer",[662,663,664,665,666,667,668,669,670,671,672,673,674,675,676,677,678,679,680,681,682,683,684,685,686,687],"Metastatic breast cancer","Advanced breast cancer","Unresectable breast cancer","HER2- Breast Cancer","Hormone-receptor positive breast cancer","HR+ breast cancer","Antibody drug conjugate","ADC","Patritumab deruxtecan","U3-1402","Refractory metastatic breast cancer","HER2 Negative","MBC","ABC","Metastatic BC","Advanced BC","Unresectable BC","Refractory advanced breast cancer","Refractory ABC","Refractory MBC","HER3-DXd","estrogen receptor positive","progesterone receptor positive","ER+","PR+","ER+\u002FPR+","2025-12-16",{"date":690,"type":33},"2025-12-23",{"date":692,"type":33},"2021-05-11",{"date":694,"type":22},"2030-04-11",{"name":39,"class":40},""]