[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"German Cancer Research Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":323},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,43,73,104,134,164,189,217,240,270,292],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100581809","treatment-guided-by-comprehensive-genome-and-transcriptome-analysis-versus-standard-of-care-in-advanced-rare-cancers-100581809",false,"NCT06855134","Treatment Guided by Comprehensive Genome and Transcriptome Analysis Versus Standard of Care in Advanced Rare Cancers","Randomized Comparison of Treatment Guided by Comprehensive Genome and Transcriptome Analysis Versus Standard of Care in Patients With Advanced Rare Cancers (RATIONALE)","RATIONALE","Inclusion Criteria:\n\n* Age ≥ 18years, no upper age limit\n* Patients with locally advanced and\u002For metastatic rare epithelial or mesenchymal cancer (equal numbers of patients) without curative treatment option\n* Progressive disease or expected progression of the disease estimated by clinical parameters, suitable biomarkers, and other (e.g. radiographic) methods \\* At least one measurable lesion that has been accurately assessed by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline and is amenable to repeat evaluation in MRI\u002FCT images\n* Patients must have received at least one standard therapy for advanced disease according to current guidelines or consensus recommendations or have no standard therapy available\n* Possibility to perform fresh tumor biopsy according to local SOPs or Availability of fresh frozen tumor samples with sufficient tumor cell content collected within 3 months prior to enrolment\n* ECOG PS ≤ 2.\n* Ability of patient to understand character and consequences of the clinical trial\n* Patient must be willing and able to undergo subsequent treatment (e.g. in a clinical trial) with molecularly guided therapy according to the MTB recommendation\n* Availability of complete information about all medical treatment given before study participation, i.e. remission status before start of treatment, dosage and timing of drugs applied, remission status and date of progression after treatment\n\nExclusion Criteria:\n\n* Dementia or significant cognitive impairment\n* Epilepsy requiring pharmacologic treatment\n* Prior allogeneic bone marrow or solid organ transplantation\n* Hematological malignancies and primary brain tumors.\n* Prior comprehensive molecular profiling by WGS, WES, RNA-Seq, or large targeted panels.\n* Patients with symptomatic or uncontrolled brain metastases and patients with symptomatic or uncontrolled spinal cord compression. Patients with previously treated brain metastases are eligible, provided that the patient has neither experienced a seizure nor had a clinically significant change in neurological status within the three months prior to enrollment. All patients with previously treated brain metastases must be clinically stable for at least 1 month after completion of treatment and off steroid treatment for one month, both prior to study enrollment.\n* Malignancy other than study indication within the last 5 years except: curatively treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma, low-risk prostate cancer, or other malignancies curatively treated with no evidence of disease for ≥5 years.\n* History of intracranial hemorrhage or spinal cord haemorrhage; no ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted\n* Known uncontrolled or significant cardiovascular disease, including any of the following:\n* History of heart failure NYHA class 3 or 4\n* History of uncontrolled angina pectoris, arrhythmias, or myocardial infarction within 12 months prior to screening.\n* History of liver cirrhosis\n* Neurologic or psychiatric disorder interfering with ability of giving informed consent.\n* Known or suspected active alcohol or drug abuse.\n* Patients with inability to receive oral medications.\n* Failure to provide consent for the registration, storage, and processing of individual disease characteristics and clinical course, as well as for informing the primary care physician about the participant's involvement in the study.","ALL","18 Years",{"count":20,"type":21},946,"ESTIMATED","48 Months","OBSERVATIONAL","Rare cancers, defined by an incidence of fewer than 6 cases per 100,000 persons per year, constitute nearly 25% of adult malignancies. They are associated with poor patient outcomes due to incomplete biological understanding and inadequate representation in clinical trials. To address this gap, the DKFZ\u002FNCT\u002FDKTK MASTER (Molecularly Aided Stratification for Tumor Eradication Research) program, developed by NCT and DKFZ, integrates whole-genome\u002Fexome sequencing (WGS\u002FWES), RNA sequencing (RNA-seq), and genome-wide DNA methylation profiling to inform clinical decision-making in patients with advanced rare cancers. This approach has demonstrated significant improvements in overall response rates (ORR) in 24% and disease control rates (DCR) in 55% of cases, with a progression-free survival (PFS) ratio greater than 1.3 in 36% of patients.\n\nThe randomized, multi-basket, phase II, Italian multicenter ROME study conducted among pretreated patients with metastatic cancer, demonstrated that targeted therapy guided by comprehensive genomic profiling and molecular tumor board (MTB) recommendations significantly improved overall response rate and progression-free survival. Additionally, the study revealed a substantial long-term PFS benefit extending to 12 months and beyond. Although the toxicity profiles differed between the targeted therapy and standard-of-care groups, the incidence of adverse events was comparable. These findings, reported at the ESMO Congress 2024, emphasize the pivotal role of MTBs in advancing precision oncology through a tumor agnostic, molecularly guided therapeutic approach.\n\nThe objective of the randomized, multicentric, diagnostic RATIONALE trial is to evaluate the efficacy of molecularly guided treatment versus standard treatment in patients with rare cancers by comparing progression-free survival (PFS) between the two arms: an immediate molecular profile-informed treatment arm (MPI arm) and a standard treatment arm with molecular profile-informed treatment upon progression or intolerable toxicity after standard therapy (MPP arm).\n\nPatients with rare epithelial and mesenchymal neoplasms are evenly randomized in a 1:1 ratio to either the MPl arm or MPP arm. Comprehensive molecular profiling includes WGS and RNA-seq for both arms. A multidisciplinary MTB evaluates these molecular profiles and provides clinically relevant management recommendations, including diagnostic reevaluation, genetic counseling, and molecularly informed treatment options. Recommendations may include matching patients to molecularly stratified clinical trials or - if no suitable clinical trials can be identified - coordinated applications will be provided for off-label use in routine clinical care. The primary efficacy endpoint is progression-free survival (PFS), whereas secondary endpoints are overall survival (OS), overall response rate (ORR), disease control rate (DCR) after three and six months, and patient-reported outcomes (PROs).\n\nBased on data from the MASTER cohort, it is anticipated a median PFS of three months with treatment selected by the physician's discretion. Drawing on findings from the CRAFT trial (ClinicalTrials.gov: NCT04551521), MTB-guided treatment is expected to positively impact the primary endpoint with a hazard ratio (HR) ranging from 0.4 to 0.6. Assuming 30% implementation rate of MTB recommendations, a sample size of 756 eligible patients will be required to demonstrate a significant improvement in PFS with immediate MTB guided treatment, yielding an HR of 0.5 for the MPI arm and overall study HR of 0.7862. The calculation is based on a type 1 error of 5% and a statistical power of 90%. Considering a conservative estimate that that 20% of patients will not be evaluable, the total rounded required sample size is 946 patients.",[26],"Rare Cancer",[28,29],"Molecular tumor board","molecularly informed treatment recommendation","RECRUITING","2026-05-07",{"date":33,"type":34},"2026-05-12","ACTUAL",{"date":36,"type":34},"2025-09-29",{"date":38,"type":21},"2030-04",{"name":40,"class":41},"German Cancer Research Center","OTHER",16,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100489396","catch-implementation-of-genomics-guided-precision-medicine-in-metastatic-breast-cancer-100489396","NCT05652569","CATCH: Implementation of Genomics-guided Precision Medicine in Metastatic Breast Cancer","Comprehensive Assessment of Clinical Features and Biomarkers to Identify Patients With Advanced or Metastatic Breast Cancer for Marker Driven Trials in Humans (CATCH)","CATCH","Inclusion Criteria:\n\n* Female and male breast cancer patients ≥ 18 or if the legal guardian has agreed to the respective informed consent form (ICF)\n* Patients with advanced or metastatic breast cancer (irrespective of clinical parameters such as TNM, subgroups, therapy lines)\n* Patients, who agreed to and were able to sign the informed consent form.\n\nExclusion Criteria:\n\n* Early breast cancer\n* Inability to take a tissue bioptic sample due to reasons such as physical location of the lesion or health of the patient\n* Any physical or mental handicap or severe comorbidities that would hamper the adequate cooperation with the patient.","14 Years","100 Years",{"count":54,"type":21},5000,"CATCH is an indication-specific diagnostic platform, which drives the implementation of integrative, genomic profiling for metastatic breast cancer into the clinics. The main objective of this approach is to identify biomarkers and drug targets to guide targeted therapeutic interventions.\n\nEligible are all metastatic breast cancer patients (independent of gender), irrespective of molecular subtype.\n\nAt initial diagnosis of distant metastasis or progress at disease progression, biopsy samples from a prognostic-relevant metastasis are retrieved during standard-of-care procedures for central analyses, together with blood samples. In parallel to all standard-diagnostic measures, genomic and transcriptomic profiling is conducted to infer the underlying biology of the disease and identify patients who might profit from biomarker-guided interventions in clinical trials.\n\nSamples not required for standard-of-care clinical procedures or genomic profiling are systematically collected in a dedicated bio-repository to fuel translational scientific companion programs. The continuously growing comprehensive database serves as an integrative resource for systematic, prospective multidimensional data collection (clinical records, biomaterial, genomic data).\n\nIn summary, the overarching goal is to generate a precision oncology platform to i) identify clinically-actionable biomarkers and drug targets that drive genomics-guided therapies and ii) couple the observational, diagnostic registry platform to an increasing number of independent, biomarker-stratified clinical therapy trials (CATCH-GUIDE).",[57],"Metastatic Breast Cancer",[57,59,60,61,62,63],"Stage IV Breast Cancer","Precision Oncology","Genomics-Guided Biomarker-Stratification","Personalized Oncology","Genomic Profiling","2026-01-26",{"date":66,"type":34},"2026-01-28",{"date":68,"type":34},"2017-06-12",{"date":70,"type":21},"2030-12-31",{"name":40,"class":41},12,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":17,"minAge":18,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100455297","early-phase-1-panhpvax-study-of-a-new-hpv-vaccine-in-healthy-volunteers-100455297","NCT05208710","PANHPVAX, Study of a New HPV Vaccine in Healthy Volunteers","A First-in-human, Phase I, Single-center, Open-label, Dose-escalation Trial in Healthy Volunteers to Assess Safety, Tolerability, and Immunogenicity of PANHPVAX, a Vaccine Targeting Human Papilloma L2 Antigen Formulated With Cyclic Di-AMP","PANHPVAX","Inclusion Criteria:\n\n1. Written, personally signed and dated informed consent to participate in the trial prior to any trial-related interventions,\n2. Understanding, ability, and willingness to fully comply with trial interventions and restrictions,\n3. Age 18-45 years (y) inclusive at the time of consent,\n4. Males or females of child-bearing potential who are willing to use a highly effective method of contraception during the treatment and for 4 weeks after each vaccination with the IMP, or women not of child-bearing potential (WNCBP), or individuals who are convincingly sexually abstinent. Highly effective methods of contraception are described in section 7.6.9,\n5. No current desire to have children, and\n6. Consent not to be vaccinated with a commercially available HPV vaccine during the trial until the end-of-study visit.\n\nExclusion Criteria:\n\n1. Clinically significant or relevant abnormalities as assessed by the investigator in the medical history, or findings from physical examination, or laboratory evaluation that may require treatment or make the participant unlikely to fully complete the trial, or any condition that presents undue risk from the IMP or trial interventions,\n2. Any acute or chronic illness expected to influence the immune response to vaccination,\n3. Immunoglobulin administration in the past 3 months prior to first immunization,\n4. Any known history of severe anaphylactic reactions to drugs or vaccinations, or any known history to allergies against the excipients of the investigational medicinal product (IMP),\n5. Clinically relevant findings in any of the following investigations at screening (SCR) I. Hemoglobin (Hb) \\\u003C 12 g\u002Fdl (males) or \\\u003C 11 g\u002Fdl (females), II. Estimated Creatinine clearance (eCrCl) \\\u003C 60 ml\u002Fmin (Cockcroft-Gault), III. Total bilirubin \\> upper limit of normal (ULN) x 1.2; In case of suspected Gilbert´s disease: total bilirubin ≤ ULN x 3 is acceptable , IV. Alanine aminotransferase (ALT) \\> ULN x 1.1, V. Aspartate aminotransferase (AST) \\> ULN x 1.2,\n6. Use of an IMP within 30 d prior to the expected date of receiving the first dose of IMP or active enrolment in another drug or vaccine clinical trial,\n7. Use of any medication (prescription medication, non-prescription medication including herbal preparations) with active ingredients (except hormonal contraception, iodine, and thyroid hormones) within a period of less than 5 times the respective elimination half-life (t1\u002F2) with regard to the expected date of the first dose of IMP. This does not apply to topical preparations if no relevant systemic exposure is expected,\n8. Known prior vaccination against HPV,\n9. Any vaccination within the 28 days (d) prior to the expected Visit 1,\n10. A positive human immunodeficiency virus (HIV) or hepatitis C (HCV) antibody screen, or positive result for Hepatitis-B-Surface-Antigen (HBsAg),\n11. A positive result in the drug screening test at SCR, and\n12. Pregnancy or breast feeding.",true,"45 Years",{"count":84,"type":21},45,"INTERVENTIONAL",[87],"EARLY_PHASE1","First-in-human, phase I, single-center, open-label, dose-escalation trial in healthy volunteers. Investigation of safety and tolerability of ascending doses of PANHPVAX, a vaccine against human papilloma L2 antigens formulated with cdA (adjuvant) as compared to the formulation without cdA.",[90],"HPV",[92,93,94],"HPV Vaccines","Cyclic-di AMP","First in Human","2025-12-15",{"date":97,"type":34},"2025-12-19",{"date":99,"type":34},"2022-11-07",{"date":101,"type":21},"2027-12",{"name":40,"class":41},1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":85,"phases":114,"briefSummary":116,"conditions":117,"keywords":122,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":103},"100516044","phase-1-fih-bispecific-cd276xcd3-antibody-cc-3-in-patients-with-colorectal-cancer-100516044","NCT05999396","FIH, Bispecific CD276xCD3 Antibody CC-3 in Patients With Colorectal Cancer","First in Human Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Bispecific CD276xCD3 Antibody CC-3 in Patients With Colorectal Cancer","CoRe_CC-3","Inclusion Criteria:\n\nwritten signed informed consent\n\n* Patient is able to understand and comply with the protocol for the duration of the clinical trial including undergoing treatment and scheduled visits and examinations\n* Patients with progressing metastatic CRC who were previously treated with FOLFOX, FOLFIRI, FOLFOXIRI, TAS-102, or regorafenib, if applicable in combination with anti-VEGFR monoclonal antibody (mAb) and anti-EGFR mAb (the latter, if RAS-wild-type and left sided tumors).\n\nIn case of MSI-high\u002FdMMR tumors, patients should have received checkpoint inhibitor therapy and at least two further lines of therapy of that stated above.\n\nIn case of patients BRAF V600E mutation patients should have received: Cetuximab in combination with encorafenib in second- or third-line treatment.\n\n* At least one measurable lesion that can be accurately assessed at baseline by CT or MRI and is suitable for repeated assessment per RECIST 1.1.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2\n* Patient aged ≥ 18, no upper limit\n* Female patients of child bearing potential (FCBP) and male patients with partners of child bearing potential, who are sexually active, must agree to the use of two effective forms (at least one highly effective method) of contraception. This should be started from the signing of the informed consent and continue throughout period of taking study treatment and for 2 months after last dose of study drug.\n* For FCBP two negative pregnancy test (sensitivity of at least 25 mU\u002Fml) prior to first application of CC-3\n* All subjects must agree to refrain from donating blood while on study drug and for 2 months after last dose of CC-3.\n* Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment:\n\n  * Hemoglobin ≥ 9 g\u002Fdl (Transfusion of packed red blood cells prior to enrolment allowed)\n  * Neutrophil count ≥ 1,500\u002Fmm3\n  * Platelet count ≥ 75,000\u002Fµl\n  * Serum creatinine ≤ 1.5mg\u002Fdl or creatinine clearance ≥ 60ml\u002Fmin\n  * hepatic function of patients without current hepatic metastasis:\n\n    * Bilirubin ≤ 1.5x upper limit of normal (ULN), in case of known Gilbert syndrome higher values are allowed if due to increase of indirect bilirubin\n    * ALT and AST ≤ 2.5 x ULN\n  * hepatic function of patients with current hepatic metastasis:\n\n    * Bilirubin ≤ 2.5 x upper limit of normal (ULN)\n    * ALT and AST ≤ 5. x ULN\n\nExclusion Criteria:\n\n* Other malignancy requiring treatment within the last year except: adequately treated non-melanoma skin cancer and low-grade non-muscle invasive papillary bladder cancer.\n* Concurrent or previous treatment within 30 days in another interventional clinical trial with an investigational anticancer therapy\n* Persistent toxicity (≥ Grade 2 according to Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0) caused by previous cancer therapy, excluding alopecia and neurotoxicity\n* Clinical signs of active infection (\\> grade 2 according to CTCAE version 5.0)\n* Known cerebral\u002Fmeningeal manifestation of CRC\n* History of HIV infection\n* Viral active or chronic hepatitis (HBV or HCV)\n* Ongoing autoimmune disease\n* History of relevant CNS pathology or current relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia\u002Fhemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)\n* Therapeutic anticoagulation therapy\n* Major surgery within 4 weeks of starting study treatment. Patients must have recovered from any effects of major surgery.\n* Patients receiving any systemic chemotherapy, mAb or radiotherapy within 2 (for mAb 4) weeks prior to study treatment or a longer period depending on the defined characteristics of the agents used\n* Heart failure NYHA III\u002FIV\n* Severe obstructive or restrictive ventilation disorder\n* Known intolerance to CC-3 or other immunoglobulin drug products as well as hypersensitivity to any of the excipients present in CC-3\n* Live and live-attenuated vaccination 30 days prior to treatment\n* Pregnant or breast-feeding women\n* Current ileus with severely altered GI function",{"count":113,"type":21},89,[115],"PHASE1","This trial is a first in human (FIH) clinical trial in patients with Colorectal cancer (CRC) after failure of at least three lines of previous therapy aiming to evaluate safety and efficacy of CC-3, a bispecific antibody (bsAb) with CD276xCD3 specificity developed within DKTK. CC-3 binds to CD276 on cancer cells as well as to tumor vessels of CRC, thereby allowing for a dual mode of anti-cancer action. CC-3 was developed in a novel format which not only prolongs serum half-life, but most importantly reduces off-target T cell activation with expected fewer side effects. A similar construct in this format with PSMAxCD3 specificity is presently undergoing clinical evaluation in patients with prostate cancer (NCT04104607), with very favorable safety and preliminary efficacy. The optimized format that CC-3 shares with its PSMAxCD3 \"sister molecule\" allows for application of effective bsAb doses with expected high anticancer activity. The clinical trial comprises two phases: The first phase is a dose-escalation part to evaluate the maximally tolerated dose (MTD) of CC-3. This is followed by a dose-expansion part to defined the recommended phase II dose. A translational research program comprising, among others, analysis of CC-3 half-life and the induced immune response will serve to better define the mode of action of CC-3.",[118,119,120,121],"Colorectal Cancer","Breast Carcinoma","Sarcoma","Penile Carcinoma",[123,124,125],"new therapy","bispecific antibody","colorectal cancer","2025-05-16",{"date":128,"type":34},"2025-05-21",{"date":130,"type":34},"2024-01-12",{"date":132,"type":21},"2027-03-31",{"name":40,"class":41},{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":85,"phases":143,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},"100464812","phase-2-genomics-guided-targeted-post-neoadjuvant-therapy-in-patients-with-early-breast-cancer-cognition-guide-100464812","NCT05332561","Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE)","Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer - a Multicenter, Open-label, Umbrella Phase-II Study - COGNITION-GUIDE","Inclusion Criteria:\n\n1. Provision of written informed consent\n2. Female and male patients with non-metastatic early (stage I-III) breast cancer aged ≥ 18 years\n3. Conducted neoadjuvant chemotherapy and surgery as well as conducted standard post-neoadjuvant treatment +\u002F- radiotherapy (standard according to German guidelines except Abemaciclib and Olaparib)\n4. For patients with initially triple negative (TNBC) or HER2-positive breast cancer:\n\n   • Non-pCR defined as other than ypT0\u002Fis ypN0\n5. For patients with initially hormone receptor positive and HER2-negative breast cancer: Non-pCR and CPS-EG score\n\n   * ≥ 3 and ypN0, or\n   * ≥ 2 and ypN+\n6. ECOG Performance Status ≤ 1\n7. Acute effects of any prior therapy resolved to baseline severity or National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) Grade ≤ 1 except for adverse effects not constituting a safety risk by investigator judgement\n8. Postmenopausal or evidence of non-childbearing status. For women of childbearing potential negative urine pregnancy test at post-operative screening and baseline as well as highly effective forms of contraception have to be in place thereafter\n\n   * Evidence of childbearing potential is defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile\n   * Postmenopausal or evidence of non-childbearing status is defined as:\n\n     * Amenorrhea for 1 year or more without an alternative medical cause following cessation of exogenous hormonal treatments plus follicle stimulating hormone (FSH) levels in the postmenopausal range in women not using hormonal contraception or hormonal replacement therapy\n     * Chemotherapy-induced menopause\n     * Surgical sterilisation (bilateral oophorectomy, bilateral salpingectomy, total hysterectomy or tubal ligation at least 6 weeks before IMP treatment)\n     * Female patients with age ≥ 60 years\n   * A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy\n9. Female patients of childbearing potential and male patients with partners of childbearing potential who are sexually active must agree to the use of two forms of contraception in combination (male condom and one highly effective method). These should be started immediately after signing the informed consent form and continued throughout the period of study treatment plus a substance-depending time period (see respective sub-protocol) for female patients and a substance-depending time period for male patients. Details on contraception and pregnancy testing for male and female patients (and if indicated their partners) under IMP treatment are described within the respective sub-protocol\n10. Ability of patient to understand and comply with the protocol for the duration of the study, including treatment and scheduled visits and examinations\n11. Adequate bone marrow, renal, and hepatic function defined by laboratory tests\\*\n\nThe biomarker-guided eligibility for the respective study arm is evaluated and determined exclusively by the NCT molecular tumor board on the basis of results of the COGNITION molecular diagnostic registry platform. Biomarkers that allow inclusion in the respective arm are:\n\n* Arm 1 (Atezolizumab, Immune Evasion ): PD-L1 positivity measure by IHC (≥1% on immune cells within the tumor), MSI-high status (validated by PCR), TMB-H (≥10mut\u002FMB), CD274 amplification\n* Arm 2 (Inavolisib, PI3K): Known\u002Freported oncogenic mutation in PIK3Ca\n* Arm 3 (Ipatasertib, AKT): Aberrations predicting increased PI3K-AKT pathway activity except PI3K-mutations, HR positive histology\n* Arm 4 (Olaparib, PARP, DNA-Repair): Inactivating somatic or germline BRCA1\u002F2 mutation including homozygous deletions, Inactivating germline PALB2 mutations\n* Arm 5 (Sacituzumab Govitecan, TROP-2): Trop-2-overexpression (with IHC and except known\u002Freported homozygous polymorphism in UGT1A1\\*28)\n* Arm 6 (Trastuzumab \u002F Pertuzumab, ERBBB): HER2 exon-20 insertion, Activating HER2-mutation\n\nExclusion Criteria:\n\n1. Other malignancy within the last 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, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥ 5 year\n2. Concurrent severe, uncontrolled systemic disease that would place patient at undue risk or interfere with planned treatment\n3. Concurrent participation or previous treatment within 30 days in another interventional clinical trial\n4. Persistent toxicity (≥ Grade 2 according to NCI CTCAE v5.0 caused by previous cancer therapy, excluding alopecia\n5. Clinical signs of active infection (\\> Grade 2 according NCI CTCAE v5.0)\n6. History of or newly diagnosed human immunodeficiency virus (HIV) infection and immunocompromised patients\n7. Active Hepatitis A virus infection\n8. Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test. Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study if active HBV infection is ruled out on the basis of HBV DNA viral load per local guidelines\n9. Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at screening confirmed by a polymerase chain reaction (PCR) positive for HCV RNA\n10. Dementia or significant impairment of cognitive state\n11. Epilepsy requiring pharmacologic treatment\n12. Pregnancy and breast feeding\n13. Inability to take oral medication and gastrointestinal disorders likely to interfere with absorption of study medication\n14. Major surgery (any invasive operative procedure in which a more extensive resection is performed, e.g. a body cavity is entered, organs are removed, or normal anatomy is altered) within four weeks before screening and baseline excluding breast-tumor resection after neoadjuvant chemotherapy. Patients must have recovered from any effects of any major surgery\n15. Systemic chemotherapy or radiotherapy within four weeks or a longer period depending on the characteristics of the agents used\n16. Heart failure classified as New York Heart Association (NYHA) II\u002FIII\u002FIV\n17. Severe obstructive or restrictive ventilation disorder\n18. Patients with clinically active tuberculosis\n19. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug\n20. Is taking or requiring the continued use of any of the prohibited concomitant medications listed in the respective subprotocols at baseline\n21. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression or, superior vena cava syndrome.",{"count":142,"type":21},240,[144],"PHASE2","In early breast cancer (eBC), pathological complete response (pCR) after neoadjuvant therapy acts as surrogate marker for metastasis and overall survival. Therapy intensification by adding an adjuvant therapy line (post-neoadjuvant treatment) substantially lowers the risk of relapse in high-risk breast cancer patients with residual disease after neoadjuvant treatment (non-pCR). While this approach was exemplified in two phase III trials without biomarker-stratification (CREATE-X, KATHERINE), even higher efficiency might be achieved by individualized genomic-guided post-neoadjuvant therapies.\n\nWithin the seven-arm umbrella phase-II clinical trial COGNITION-GUIDE, we aim to deliver molecularly-tailored cancer care by implementing an additional response- and genomics-guided post-neoadjuvant therapy after finishing the guideline-compliant post-neoadjuvant treatment in high-risk breast cancer patients with residual cancer burden after neoadjuvant therapy to reduce the substantial risk of local and distant relapse.\n\nThe trial evaluates not a single drug but rather a general strategy of precision oncology in the curative setting and provides the basis for future confirmatory biomarker-driven trials.\n\nAllocation to the therapy-arms is conducted by in depth molecular characterization of tumors within the COGNITION registry program.\n\nThe study aims to show an overall benefit of the precision medicine approach in high-risk eBC patients and to allow for secondary exploratory evaluation of each study-arm.\n\nThe primary endpoint of the study is invasive Disease-Free Survival (IDFS) after 4 years measured from surgery to local or distant relapse or death. The sample size of the entire trial is 240 eligible patients.",[147],"Early-stage Breast Cancer",[149,150,151,152,153,154],"Breast Cancer","Post-neoadjuvant therapy","genomics-guided","molecular diagnostic","targeted therapy","high risk","2025-03-19",{"date":157,"type":34},"2025-03-20",{"date":159,"type":34},"2023-06-29",{"date":161,"type":21},"2030-12",{"name":40,"class":41},9,{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":175,"conditions":176,"keywords":179,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":72},"100508898","cognition-genomics-guided-precision-oncology-in-early-high-risk-breast-cancer-100508898","NCT05906407","COGNITION: Genomics-Guided Precision Oncology in Early High-Risk Breast Cancer","COGNITION: Comprehensive Assessment of Clinical Features, Genomics and Further Molecular Markers to Identify Patients with Early Breast Cancer for Enrolment on Marker Driven Trials (Molecular Diagnostic Platform)","COGNITION","Inclusion Criteria:\n\n* Female and male breast cancer patients aged ≥18 years.\n* Patients with primary early breast cancer (irrespective of subtypes) or - as an exception - patients with isolated loco-regional relapses that can be treated with a curative intention\n* Study entry is possible for patients with primary eBC at three timepoints:\n\n  * Option A: patients planned to receive neoadjuvant chemotherapy are enrolled before starting the neoadjuvant treatment\n  * Option B: patients with clinical non-complete response can be enrolled after the last cycle of neoadjuvant chemotherapy before surgery Note: Option A\u002FB are strongly preferred entry time-points\n  * Option C: eBC patients after surgery and planned or conducting standard-of-care (SoC) post-neoadjuvant chemotherapy can be enrolled after surgery until the last cycle of standard post-neoadjuvant chemotherapy, if they fulfill the following criteria\n\n    * HER2+ BC or TNBC: non-pCR\n    * HR+\u002FHER2- BC: non-pCR and CPS-EG score ≥ 3 or non-pCR, ypN+ and CPS-EG-score ≥ 2 Note: Option C is not the preferred entry time-point Note: in case of loco-regional relapse, neoadjuvant treatment is not mandatory\n* Patients must be willing to donate a recent tumour sample to the registry Note: fresh tumour tissue is preferred\n* Patients, who agreed to and were able to sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n* Patients who did not sign or withdrew the informed consent form (ICF).\n* Inability to retrieve tissue for molecular profiling Any physical or mental handicap or severe comorbidities that would hamper the adequate cooperation with the patient.","80 Years",{"count":174,"type":21},2000,"The COGNITION diagnostic platform elucidates the biomarker profile of neoadjuvant chemotherapy-resistant residual bulk tumors in high risk early breast cancer patients. The major goal is to provide a framework for genomic profiling, which serves as infrastructure for systematic biomarker-screening and -stratification for concise therapy-arm allocation in the interventional clinical phase II trial COGNITION-GUIDE (NCT05332561).\n\nIn patients, who display a poor response to standard-of-care neoadjuvant chemotherapy, tissue samples before and after neoadjuvant therapy are subjected together with blood samples to comprehensive genomic profiling to identify patients potentially benefiting from biomarker-guided interventions in COGNITION-GUIDE.\n\nSamples not required for standard-of-care clinical procedures or genomic profiling are systematically collected in a dedicated bio-repository to fuel translational scientific companion programs. The continuously growing comprehensive database serves as an integrative resource for systematic, prospective multidimensional data collection (clinical records, biomaterial, genomic data).\n\nIn summary, the overarching goal is to generate a precision oncology platform i) to identify clinically-actionable biomarkers and drug targets that drive genomics-guided therapies and ii) to couple the observational, diagnostic registry platform to the independent, biomarker-stratified clinical therapy trial COGNITION-GUIDE.",[177,178],"Early-Stage Breast Cancer","Neoadjuvant Therapy",[180,60,62,63,61,181],"Early Breast Cancer","Postneoadjuvant-Therapy","2025-03-17",{"date":155,"type":34},{"date":185,"type":34},"2019-04-19",{"date":187,"type":21},"2028-12-31",{"name":40,"class":41},{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":85,"phases":198,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":207,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},"100490190","phase-1-genetic-ablation-of-cd33-in-hsc-to-broaden-the-therapeutic-index-of-cd33-directed-immunotherapy-in-patients-with-aml-100490190","NCT05662904","Genetic Ablation of CD33 in HSC to Broaden the Therapeutic Index of CD33-directed Immunotherapy in Patients with AML","Genetic Ablation of CD33 in Hematopoietic Stem Cells to Broaden the Therapeutic Index of CD33-directed Immunotherapy in Patients with Acute Myeloid Leukemia (AML)","GALAXY33","Key Inclusion Criteria:\n\n* confirmed AML according to the WHO classification\n* relapsed disease after allo-SCT from an HLA-identical family donor (≥ 2 months after allo-SCT at time of inclusion)\n* ≤ 29% of bone marrow blasts as detected by cytomorphology or immunohistochemistry\n* age ≥ 18 years\n* confirmed CD33 expression on leukemic blasts at current relapse (as detected by flow cytometry)\n* adequate organ function:\n\n  * Renal function defined as: serum creatinine of ≤ 2x ULN or eGFR ≥ 30 mL\u002Fmin\u002F1.73 m2\n  * Liver function defined as:\n\n    * ALT ≤ 3 times the ULN for the respective age\n    * Bilirubin ≤ 2.0 mg\u002Fdl with the exception of patients with hyperbilirubinemia explained by Gilbert-Meulengracht syndrome (may be included if total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) or extrahepatic disease (e.g. chronic hemolytic anemia)\n* Minimum level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation \\> 90% on room air\n* Hemodynamic stability and LVEF ≥ 40% as confirmed by echocardiogram\n* Absolute lymphocyte count (ALC) ≥ 100\u002Fmm3\n\nKey Exclusion Criteria:\n\n* ECOG performance status \\>2\n* Confirmed CNS involvement\n* Acute or chronic Graft versus Host disease (GvHD)\n* Availability of other curative standard treatment options\n* Prior treatment with GO\n* Prior hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS)\n* Uncontrolled active hepatitis B or C\n* HIV-positivity\n* Uncontrolled bacterial, viral or fungal infection\n* Participation in another clinical trial at the time of screening\n* Organ dysfunction (liver, kidney, lung, heart) that is a contraindication for conditioning therapy\n* Severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure NYHA III-IV, uncontrolled diabetes mellitus, uncontrolled hyperlipidemia)\n* Unstable angina and\u002For myocardial infarction within 3 months prior to screening\n* Pregnant or nursing (lactating) women",{"count":72,"type":21},[115],"The study \"GALAXY33\" is an open-label, prospective, nonrandomized, one arm phase I clinical trial in which patients with relapsed AML after allogeneic hematopoietic stem cell transplantation will be transplanted with CD33-deleted CD34+ HSC derived from the initially matched family donor.",[201],"Relapsed\u002FRefractory Acute Myeloid Leukemia (AML)",[203,204,205,206],"AML","allogeneic stem cell transplantation","gene editing","chemotherapy resistance","NOT_YET_RECRUITING","2025-03-12",{"date":210,"type":34},"2025-03-14",{"date":212,"type":21},"2028-01",{"date":214,"type":21},"2030-01",{"name":40,"class":41},2,{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":225,"targetDuration":227,"studyType":23,"phases":4,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":103},"100504760","molecularly-aided-stratification-for-tumor-eradication-research-100504760","NCT05852522","Molecularly Aided Stratification for Tumor Eradication Research","NCT MASTER Plattform Molecularly Aided Stratification for Tumor Eradication Research","NCT-MASTER","Inclusion Criteria:\n\nRare cancer (Incidence \\\u003C6\u002F100,000 persons\u002Fyear) or Rare subtype of a more common entity (case-by-case decision; example: pancreatic ductal adenocarcinoma without KRAS mutation)\n\nMetastatic and\u002For locally advanced cancer with no curative therapy option and indication for systemic therapy\n\nExclusion Criteria:\n\nSevere neurological or psychiatric disorder interfering with the ability to give oral and written informed consent",{"count":226,"type":21},10000,"10 Years","NCT\u002FDKFZ\u002FDKTK MASTER is a prospective, continuously recruiting, multicenter observational study for biology-guided stratification of adults with rare cancers, including rare subtypes of common entities, using comprehensive molecular profiling, and clinical decision-making in a multidisciplinary molecular tumor board.",[230,231],"Rare Cancers","Multiomics","2025-02-28",{"date":234,"type":34},"2025-03-04",{"date":236,"type":34},"2018-11-11",{"date":238,"type":21},"2029-10",{"name":40,"class":41},{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":81,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":250,"conditions":251,"keywords":255,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":269},"100563872","artificial-intelligence-based-melanoma-early-diagnosis-and-risk-prediction-in-children-adolescents-and-young-adults-100563872","NCT06621810","Artificial Intelligence Based Melanoma Early Diagnosis and Risk Prediction in Children, Adolescents and Young Adults","AI-MEL: Image Analysis and Machine Learning for Early Diagnosis and Risk Prediction in Children, Adolescents and Young Adults","AI-MEL","Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* Patients without a melanoma or nevus diagnosis\n* images with insufficient image quality",{"count":249,"type":21},3000,"The goal of this study is to develop supportive diagnostic artificial intelligence algorithms to distinguish melanoma from nevi or other benign pigmented skin lesions, especially in younger patients (below the age of 30). The main goals it aims to achieve are:\n\n* development of an algorithm based on dermatoscopic images, targeting skin cancer screening in vulnerable populations\n* development of another algorithm based on histological images, intended to be used by pathologists on lesions that are still suspicious of melanoma after dermatologic assessment\n* implementation of explainability methods to enable the user to better comprehend the systems' decisions, avoid biases and increase trust in these applications\n\nThere is no additional time commitment for the study participants for this study, as the data used in this project will be collected in routine clinical practice anyway.",[252,253,254],"Melanoma (Skin Cancer)","Artificial Intelligence (AI)","Pediatric Cancer",[256,257,258,259,260],"melanoma","AI","pediatric","image analysis","Children Adolescence Young Adults (CAYA)","2024-09-27",{"date":263,"type":34},"2024-10-01",{"date":265,"type":34},"2022-12-01",{"date":267,"type":21},"2026-11-30",{"name":40,"class":41},3,{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":85,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":207,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":4},"100463788","phase-1-natural-killer-cell-immunotherapy-in-combination-with-parp-inhibition-in-acute-myeloid-leukemia-100463788","NCT05319249","Natural Killer Cell Immunotherapy in Combination With PARP-inhibition in Acute Myeloid Leukemia","Natural Killer Cell Immunotherapy in Combination With PARP-inhibition to Overcome NKG2D Mediated Immune Evasion in Acute Myeloid Leukemia","NAKIP-AML","Inclusion Criteria:\n\n1. Patients with confirmed diagnosis of AML according to WHO-2016 (Arber, Orazi et al. 2016) (except acute promyelocytic leukemia) with either de novo AML, AML after preceding myelodysplastic or myeloproliferative syndrome (MDS\u002FMPD), and therapy- related AML (t-AML) after previous cytotoxic therapy or radiation are eligible.\n\n   A) Relapsed or Refractory AML with less than 20% bone marrow blasts and less than 20% blasts in peripheral blood.\n\n   B) Rising MRD levels (\\>3 fold) as detected by either molecular genetics or flow cytometry in patients still in hematologic remission.\n2. Patients who received at least one line of AML therapy. This is defined as either stem cell transplantation or intensive AML therapy or palliative AML therapy containing at least one of the following drugs Azacitidine, Decitabine, Cytarabine, Venetoclax or an FLT3 inhibitor..\n3. Discontinuation of prior AML treatment before the start of study treatment for at least 107 days for cytotoxic agents and ≥ 53 half-lives for non-cytotoxic \u002F investigational drug treatment preceding the first dose of trial medications.\n4. Age ≥ 18 years\n5. ECOG ≤2\n6. Pregnancy and childbearing potential:\n\n   * Non-pregnant and non-nursing women of childbearing potential must have a negative serum or urine ß-HCG pregnancy test within a sensitivity of at least 25 mIU\u002FmL within 72 hours prior to registration. (\"Women of childbearing potential\" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months).\n   * Female patients of reproductive age must agree to avoid getting pregnant while on therapy.\n   * Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin highly effective methods (referring to recommendation of the CTFG) of birth control during study and at least 6 months (women), after end of treatment.\n   * Men must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy and must agree to avoid to father a child during study and until 6 months after end of treatment.\n7. Willingness of patients to adhere to protocol specific requirements and capacity to give written informed consent\n8. Ability of patient to understand the character and individual consequences of clinical trial\n9. Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out.\n10. Suitable donor for NK cell transplantation\n\nExclusion Criteria:\n\nPatients presenting with any of the following criteria will not be included in the trial:\n\n1. Acute promyelocytic leukemia (AML M3)\n2. AML in which less than 10% of the blasts express the CD34 surface marker expression as analyzed at the local laboratory.\n3. Known central nervous system manifestation of AML\n4. Uncontrolled or significant cardiovascular disease, including any of the following:\n\n   * Heart failure NYHA class 3 or 4\n   * Left ventricular ejection fraction (LVEF) ≤ 40% by echocardiogram ECHO)\n   * History of uncontrolled angina pectoris or myocardial infarction within 12 months prior to screening\n   * History of second (Mobitz II) or third-degree heart block or any cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)\n5. Pregnant or nursing women\n6. Chronically impaired renal function (creatinine clearance \\\u003C 30 ml \u002F min)\n7. Organ dysfunction (e.g. liver, kidney, lung, heart) which in the opinion of the treating physician decreases life expectancy to less than three months.\n8. Kidney failure with a calculated glomerular filtration rate \\\u003C30 ml\u002Fmin or bilirubin \\>2-fold the upper reference limit of the local laboratory.\n9. HIV infection and\u002For active hepatitis B or C infection (active hepatitis B defined by HBs Ag positivity, anti HBs positivity or anti-HBC positivity, active hepatitis C defined by positive virus load).\n10. Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy\n11. Uncontrolled active infection\n12. Concurrent malignancies other than AML with an estimated life expectancy of less than two years\n13. Known hypersensitivity to PARP inhibitors\n14. Isolated extramedullary manifestation of AML\n15. Patients \\\u003C 100 days after allogeneic stem cell transplantation at the time of screening\n16. Expected non-compliance of patient",{"count":279,"type":21},54,[115,144],"Therapy resistance remains the major obstacle to cure in many types of cancer. In particular in leukemia, therapy resistance depends on leukemic stem cells (LSC) that exhibit inherent therapy resistance to multiple drugs and contribute to overt leukemic relapse. Cellular therapies alone or in combination with other targeted or chemotherapeutic approaches can overcome drug mediated therapy resistance and induce long lasting remissions. Several trials have shown that adoptive transfer of allogeneic NK cells can induce clinical remission in patients with myeloid malignancies. In addition, the antileukemic efficacy of alloreactive NK cells has been shown to facilitate cure after T cell depleted haploidentical stem cell transplantation. Recently, it was demonstrated that absence of NKGD2 ligand expression on leukemic stem cells determines therapy resistance and immune escape towards NK cells in AML. PARP1 inhibitors can induce re-expression of NKG2D ligands. This phase I\u002FII clinical trial will evaluate the combination of NK cell therapy and PARP inhibition by Talazoparib in patients with poor prognosis AML as characterized by Minimal Residual Disease (MRD) or overt relapse with less than 20% bone marrow blasts. The hypothesis that allogeneic NK cell therapy combined with PARP inhibition will increase the response rate (CR\u002FCRi for relapsed\u002F refractory patients and MRD-response for MRD positive patients) from 35% to 60% will be tested. The co-primary endpoints are i) response to treatment defined as complete remission (CR) for patients with overt leukemia at time of inclusion and MRD decrease \\>1log10 for patients with rising MRD at time of inclusion as well as ii) safety and feasibility of the protocol. Key secondary endpoints are event free survival and overall survival. Two cohorts will be assessed independently: patients with i) overt leukemia and ii) patients with rising MRD at time of inclusion. Safety and feasibility will be analyzed continuously during the entire trial. The NAKIP-AML trial will analyze efficacy and feasibility of NK cell transplantation together with PARP1 inhibition.",[283],"Acute Myeloid Leukemia","2024-04-04",{"date":286,"type":34},"2024-04-05",{"date":288,"type":21},"2024-06",{"date":290,"type":21},"2028-06",{"name":40,"class":41},{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":172,"enrollmentInfo":300,"targetDuration":4,"studyType":85,"phases":302,"briefSummary":303,"conditions":304,"keywords":306,"overallStatus":207,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":4},"100488242","phase-2-perioperative-platelet-inhibition-with-acetylsalicylic-acid-in-patients-with-resectable-tumors-of-the-pancreatic-head-100488242","NCT05637567","Perioperative Platelet Inhibition With Acetylsalicylic Acid in Patients With Resectable Tumors of the Pancreatic Head","Perioperative Platelet Inhibition With Acetylsalicylic Acid Targeting Intraoperative Tumor Cell Seeding in Patients With Resectable Tumors of the Pancreatic Head - a Randomized, Controlled Multicenter Study","ASAP","Inclusion Criteria:\n\n1. Indication: Patients with (histologically confirmed or clinically suspected) surgically resectable, non-metastatic ductal adenocarcinoma of the pancreatic head\n2. Patients planned for pylorus-preserving partial pancreaticoduodenectomy (PPPD \u002F \"ppWhipple\" \u002F Traverso-Longmire procedure) (conventional or minimally invasive)\n3. Male and female patients aged 18 to 80 years\n4. Written informed consent of the participating person\n5. ECOG≤2\n\nExclusion Criteria:\n\n1. Metastatic disease (distant or peritoneal metastases or lymph node involvement considered distant metastasis (i.e., interaortocaval nodes))\n2. Preoperative use of anticoagulants \u002F thrombolytics (e.g. warfarin, heparin), platelet aggregation inhibitors (e.g. ASA, ticlopidine, clopidogrel), chronic NSAID or metamizole use\n3. Neoadjuvant treatment for locally advanced disease\n4. Presumed necessity of arterial resection (other than gastroduodenal artery)\n5. Advanced liver (INR \\>1.5 or hepatic encephalopathy) or renal failure (stage IV or higher)\n6. Advanced heart disease (NYHA class ≥ 3)\n7. Known hypersensitivity to ASA or to drugs with a similar chemical structure\n8. History of asthma attacks triggered by salicylates or substances with similar effects\n9. Haemorrhagic diathesis, blood coagulation disorders such as haemophilia or thrombocytopenia\n10. Thrombocytosis \\> 450,000 \u002F μL\n11. Methotrexate at a dosage of 15 mg or more per week\n12. Participation in competing trials affecting the effects of the investigational medicinal product (IMP) or outcome measures\n13. Addictive or other medical conditions that do not allow the subject to appreciate the nature and scope of the clinical trial and its potential consequences\n14. Pregnant or breast-feeding women\n15. Women of childbearing potential, except women who meet the following criteria:\n\n    * Post-menopausal (12 months natural amenorrhoea or six months amenorrhoea with serum follicle-stimulating hormone (FSH) \\> 40 U\u002Fml)\n    * Postoperative (six weeks after bilateral ovariectomy with or without hysterectomy)\n    * Regular and correct use of a contraceptive method with a failure rate \\\u003C 1% per year (e.g. implants, depot injections, oral contraceptives, intrauterine devices)\n    * Sexual abstinence\n    * Vasectomy of partner\n16. Indications that the patient is unlikely to comply with the protocol (e.g. unwillingness to cooperate)",{"count":301,"type":21},170,[144],"This randomized, controlled clinical trial compares the perioperative treatment with acetylsalicylic acid (aspirin) in patients with cancer of the pancreatic head. The main question it aims to answer is: Do patients treated perioperatively with aspirin develop less metastasis after curative resection of pancreatic head tumors?\n\nParticipants will be asked to :\n\n* take a daily aspirin tablet starting 1-4 weeks before surgery until 6 months after surgery\n* participate in regular follow-up visits.",[305],"Pancreatic Cancer Resectable",[307,308,309,310,311,312,313,314],"pancreatic cancer","pancreatic head cancer","acetylsalicylic acid","aspirin","pancreatic head resection","liver metastases","distant metastases","circulating tumor cells","2023-11-08",{"date":317,"type":34},"2023-11-13",{"date":319,"type":21},"2024-04",{"date":321,"type":21},"2029-03",{"name":40,"class":41},""]