[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoplasms-by-histologic-type\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoplasms-by-histologic-type":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,48,61,146,188,221,278,313,335,357,377,408,438,476,517],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053608","phase-2-multitargeted-recombinant-ad5-psamuc-1brachyury-based-immunotherapy-triadeno-vaccine-with-il-15-superagonist-n-803-in-participants-with-clinically-localized-prostate-cancer-undergoing-active-surveillance-100053608",false,"NCT07574541","Multitargeted Recombinant Ad5 PSA\u002FMUC-1\u002FBrachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance","Phase II Trial of a Multitargeted Recombinant Ad5 PSA\u002FMUC-1\u002FBrachyury-based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance","* INCLUSION CRITERIA:\n* Histologically confirmed diagnosis of organ confined, low- or intermediate-risk PCa (Gleason grade group 1 or 2) identified in at least one prostate biopsy core. Biopsies performed at outside institutions should have Gleason score confirmed at the NCI by a genitourinary (GU) pathologist.\n* Participants must be on active surveillance.\n* Pre-study treatment tissue availability (at least one formalin-fixed paraffin embedded \\[FFPE\\] biopsy core or one H and E-stained slide and at least 5 unstained slides) obtained between 3 and 24 months prior to treatment initiation is mandatory for study initiation.\n* Serum PSA level of \\\u003C20 ng\u002FmL (or \\\u003C10ng\u002FmL for participants being treated with 5- alpha-reductase inhibitors)\n* Clinical stage \\\u003C=T2a by digital rectal exam (DRE)\n* Age \\>=18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C=1.\n* Adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>=1.0 x 109\u002FL\n  * Hemoglobin (Hgb) \\>=9 g\u002FdL\n  * Platelets \\>=75,000\u002FmcL\n  * Prothrombin International Normalized Ratio (INR) \\\u003C1.5 x upper limit of normal (ULN)\n  * Partial thromboplastin time (PTT) \\\u003C1.5 x ULN\n  * Total bilirubin \\\u003C1.5 x ULN\n  * Aspartate aminotransferase (AST) \\\u003C=2.5 x ULN\n  * Alanine aminotransferase (ALT) \\\u003C=2.5 x ULN\n  * Creatinine \\\u003C=1.5 x ULN\n\nOR\n\n--Calculated Creatinine clearance \\>=40 mL\u002Fmin\u002F1.73 m2 for individuals with creatinine levels above institutional normal (using either Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n\n* Treatment with steroid therapy must have a washout of at least 6 weeks prior to initiation of study treatment. Physiologic (replacement) doses of steroids as well as nasal, topical, or inhaled steroids are allowed.\n* Vaccination with a live (attenuated) vaccine (e.g., FluMist(R)) or a killed (inactivated)\u002Fsubunit vaccine (e.g., PNEUMOVAX(R), Fluzone(R)) must occur not sooner than 28 days or 14 days, respectively, prior to initiation of study treatment.\n* Participants must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to one (1) month after the last vaccine injection. We also will recommend participants with female partners of childbearing potential to ask them to be on highly effective birth control (hormonal, intrauterine device \\[IUD\\], surgical sterilization). Participants must not freeze or donate sperm within the same period.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Prior treatment for PCa by surgery, radiation, local ablative (i.e., cryosurgery or highintensity focused ultrasound), or androgen-deprivation therapy.\n* Evidence of PCa with metastatic disease.\n* Prior treatment with adenovirus-based vector immunotherapy, adenovirus-based vaccines, or investigational vaccines.\n* Prior solid organ or bone marrow transplant.\n* Immunodeficiency or splenectomy.\n* Presence of a known active acute or chronic infection, including human immunodeficiency virus (HIV), confirmed by PCR, and hepatitis B virus (HBV) and hepatitis C virus (HCV), as determined by hepatitis B surface antigen (HBsAg) and HCV serology.\n* History of autoimmune disease (active or past), except for autoimmune-related thyroid disease, type I diabetes, and vitiligo if the condition(s) is well controlled.\n* History of heart disease, such as congestive heart failure (class II, III, or IV defined by the New York Heart Association functional classification), history of unstable or poorly\n\ncontrolled angina, or history (\\\u003C1 year prior to initiation of study therapy) of ventricular arrhythmia.\n\n* Acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions.\n* Second malignancy within 3 years prior to initiation of study therapy. Note: Individuals with curatively treated non-melanoma skin cancers or non-muscle invasive bladder cancer will not be excluded.\n* History of herbal products that may decrease PSA levels (e.g., saw palmetto).\n* Participants who have undergone surgery within 4 weeks prior to initiation of study therapy.\n* Participants receiving any other investigational agents within 30 days prior to initiation of study therapy.\n* History of allergic reaction attributed to compounds of similar chemical or biological composition to the study drugs.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements suggested by medical history, physical examination, or standard clinical assessments such as imaging, EKG, and laboratory studies.","MALE","18 Years","120 Years",{"count":20,"type":21},52,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Background:\n\nProstate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers want to know if a new vaccine that targets 3 anti-cancer proteins (TriAdeno) plus a drug (N-803) approved for bladder cancer can help stop prostate tumors from growing.\n\nObjective:\n\nTo test TriAdeno and N-803 in people with early-stage prostate cancer.\n\nEligibility:\n\nPeople aged 18 years and older with early-stage low- or medium-risk prostate cancer.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have an imaging scan. They may have a rectal exam.\n\nTriAdeno is injected under the skin of the upper thigh; N-803 is injected under the skin of the abdomen. Participants will be treated in up to four 21-day cycles. They will get both injections on the first day of each cycle.\n\nParticipants may opt to complete a memory aid: They may record all of their symptoms for 7 days after each injection. They may also complete a questionnaire about their prostate symptoms.\n\nBlood tests, imaging scans, and other tests will be repeated during the study.\n\nA tissue sample (biopsy) of the tumor will be collected during or after cycle 2; a second biopsy may be taken about 1 year later.\n\nParticipants will have follow-up phone calls for 5 years....",[27,28,29,30,31,32],"Adenocarcinoma","Prostate Cancer","Neoplasms","Carcinoma","Neoplasms, Glandular and Epithelial","Neoplasms by Histologic Type",[34],"Immune Infiltration","NOT_YET_RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":21},"2026-07-16",{"date":43,"type":21},"2028-06-15",{"name":45,"class":46},"National Cancer Institute (NCI)","NIH",1,{"id":49,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":25,"conditions":52,"keywords":53,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":60,"locationsCount":47},"100641793",{"count":20,"type":21},[24],[27,28,29,30,31,32],[34],"2026-07-01",{"date":56,"type":39},"2026-07-02",{"date":58,"type":21},"2026-07-07",{"date":43,"type":21},{"name":45,"class":46},{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":75,"conditions":76,"keywords":107,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":145},"100355699","phase-1-hsv-g207-in-children-with-recurrent-or-refractory-cerebellar-brain-tumors-100355699","NCT03911388","HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors","Phase 1 Trial of Engineered HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors","Inclusion Criteria:\n\n* Age ≥ 36 months and \\\u003C 22 years\n* Pathologically proven malignant cerebellar brain tumor (including medulloblastoma, glioblastoma multiforme, giant cell glioblastoma, anaplastic astrocytoma, primitive neuroectodermal tumor, ependymoma, atypical teratoid\u002Frhabdoid tumor, germ cell tumor, or other high-grade malignant tumor) which is progressive or recurrent despite standard care including surgery, radiotherapy, and\u002For chemotherapy. A pathologically proven secondary malignant cerebellar tumor without curative treatment options is eligible.\n* Lesion must be ≥ 1.0 cm ≤ 3.0 cm in diameter and surgically accessible as determined by MRI. Larger tumors may be surgically debulked and treated if ≤ 3.0 cm after debulking\n* Patients must have fully recovered from acute treatment related toxicities of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study.\n* Myelosuppressive chemotherapy: patients must have received their last dose at least 3 weeks prior (or at least 6 weeks if nitrosurea)\n* Investigational\u002FBiologic agents: patients must have recovered from any acute toxicities potentially related to the agent and received last dose ≥ 7 days prior to entering this study (this period must be extended beyond the time during which adverse events are known to occur for agents with known adverse events ≥ 7 days). For viral therapy, patients must have received viral therapy ≥ 3 months prior to study entry and have recovered from all acute toxicities potentially related to the agent.\n* Monoclonal antibodies: The patient must have received last dose ≥ 21 days prior.\n* Radiation: Patients must have received their last fraction of craniospinal radiation (\\>24 Gy) or total body irradiation ≥ 3 months prior to study entry. Patients must have received focal radiation to symptomatic metastatic sites or local palliative radiation ≥ 28 days prior to study entry.\n* Autologous bone marrow transplant: Patients must be ≥ 3 months since transplant prior to study entry.\n* Normal hematological, renal and liver function (absolute neutrophil count \\> 1000\u002Fmm3, platelets \\> 100,000\u002Fmm3, prothrombin time (PT) or partial thromboplastin time (PTT) \\\u003C 1.3 x control, creatinine within normal institutional limits OR creatinine clearance \\>60 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal, total bilirubin \\\u003C 1.5 mg\u002Fdl, transaminases \\\u003C 3 times above the upper limits of the institutional norm)\n* Patients \\\u003C 16 years, Modified Lansky performance score ≥ 60; patients ≥ 16 years, Karnofsky performance score ≥ 60\n* Patient life expectancy must be at least 8 weeks\n* Written informed consent in accordance with institutional and FDA guidelines must be obtained from patient or legal guardian\n\nExclusion Criteria:\n\n* Any treatment outside the allowable guidelines outlined in section 5.1.\n* Diffuse, widespread, abnormal tumor pattern involving 3 or more lobes of the brain\n* Acute infection, granulocytopenia or medical condition precluding surgery\n* Pregnant or lactating females\n* Diagnosis of encephalitis or CNS infection \\\u003C 3 months prior, or receiving ongoing treatment for encephalitis, CNS infection or multiple sclerosis\n* Tumor involvement which would require ventricular or brainstem inoculation or would require access through a ventricle in order to deliver treatment\n* Required steroid increase within 1 week prior to G207 inoculation or patients requiring \\>2 mg of dexamethasone daily\n* Known HIV seropositivity\n* Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, gancyclovir, foscarnet, cidofovir) or any immunosuppressive drug therapy (except dexamethasone or prednisone).\n* Other current malignancy\n* Concurrent anticancer or investigational drug","ALL","3 Years","21 Years",{"count":72,"type":21},24,[74],"PHASE1","This study is a clinical trial to determine the safety of inoculating G207 (an experimental virus therapy) into a recurrent or refractory cerebellar brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication, tumor cell killing, and an anti-tumor immune response, will also be tested.\n\nFunding Source- FDA OOPD",[77,78,79,29,80,81,82,83,84,85,86,87,88,89,90,91,92,32,31,93,94,95,96,97,98,99,100,101,102,103,104,105,106],"Neoplasms, Brain","Glioblastoma Multiforme","Glioblastoma of Cerebellum","Astrocytoma","Astrocytoma, Cerebellar","Neuroectodermal Tumors","Neuroectodermal Tumors, Primitive","Cerebellar PNET, Childhood","Cerebellar Neoplasms","Cerebellar Neoplasms, Primary","Cerebellar Neoplasm, Malignant","Cerebellar Neoplasm Malignant Primary","Neoplasm Metastases","Neoplasm Malignant","Neoplasms, Neuroepithelial","Neoplasms, Germ Cell and Embryonal","Neoplasms, Nerve Tissue","Central Nervous System Neoplasms, Primary","Central Nervous System Neoplasms, Malignant","Nervous System Neoplasms","Neoplasms by Site","Brain Diseases","Central Nervous System Diseases","Nervous System Diseases","Medulloblastoma Recurrent","HSV","Virus","Pediatric Brain Tumor","Nervous System Cancer","Primitive Neuroectodermal Tumor (PNET) of Cerebellum",[108,109,78,110,111,112,113,114,115,116,117,118,119,120,121,122,29,123,124,125,126,127,128,129,130,103,102,131,132,133],"Brain Tumor, Recurrent","Glioma","Gliosarcoma","Medulloblastoma","Anaplastic Astrocytoma","Oligodendroglioma","Rhabdoid Tumor","Ependymoma","Germ Cell Tumor","Choroid Plexus Carcinoma","Cerebral Primitive Neuroectodermal Tumor","Giant Cell Glioblastoma","Atypical teratoid\u002Frhabdoid tumor","Secondary Malignant Cerebellar Tumor","Embryonal Tumor","Oncolytic Virus Therapy","Virotherapy, Oncolytic","Immunotherapy","Central Nervous System Agents","Antineoplastic Agents","Pediatric","Pediatrics","Oncolytic","Herpes Virus","G207","Oncolytic Herpes Virus","RECRUITING","2026-05-13",{"date":137,"type":39},"2026-05-15",{"date":139,"type":39},"2019-09-12",{"date":141,"type":21},"2027-09-01",{"name":143,"class":144},"M.D. Anderson Cancer Center","OTHER",3,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":157,"conditions":158,"keywords":172,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":187},"100598722","phase-1-a-study-to-evaluate-a-novel-gene-therapy-in-patients-with-relapsed-and-refractory-multiple-myeloma-100598722","NCT07075185","A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma","A Phase 1 Study to Evaluate the Safety of KLN-1010, a Novel, In Vivo Gene Therapy to Generate Anti-B Cell Maturation Antigen (Anti-BCMA) Chimeric Antigen Receptor-T Cells (CAR-T) in Patients With Relapsed and Refractory Multiple Myeloma","inMMyCAR","Inclusion Criteria:\n\n* Participants must have relapsed and refractory multiple myeloma (RRMM) with measurable disease\n* Participants must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and CD38-directed monoclonal antibody\n* Participants must have an Eastern Cooperative Group (ECOG) performance status of 0-1\n* Participants must have acceptable laboratory values as defined by the protocol\n\nExclusion Criteria:\n\n* Participants must not have known central nervous system (CNS) involvement with myeloma\n* Participants cannot have plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, or primary light chain amyloidosis\n* Participants cannot have ongoing acute systemic infection requiring antimicrobial therapy\n* Participants cannot require systemic steroids for any condition",{"count":155,"type":21},70,[74],"The goal of this clinical trial is to evaluate the safety, tolerability, and recommended Phase 2 Dose (RP2D) of KLN-1010 in patients with relapsed or refractory multiple myeloma.",[159,160,161,32,162,163,164,165,166,167,168,169,170,171],"Multiple Myeloma in Relapse","Myeloma Multiple","Multiple Myeloma Progression","Neoplasm","Hemostatic Disorders","Vascular Disorder","Paraproteinemias","Blood Protein Disorders","Hematologic Disease and Disorders","Lymphoproliferative Disorders","Immunoproliferative Disorders","Immune System Disease","Gene Therapy",[173,174,175,176],"in vivo CAR-T","multiple myeloma","gene therapy","BMCA","2026-04-22",{"date":179,"type":39},"2026-04-24",{"date":181,"type":39},"2025-07-16",{"date":183,"type":21},"2042-05",{"name":185,"class":186},"Kelonia Therapeutics, Inc.","INDUSTRY",7,{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":220},"100516228","phase-1-safety-and-tolerability-of-ziftomenib-combinations-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-100516228","NCT06001788","Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed\u002FRefractory Acute Myeloid Leukemia","Key Inclusion Criteria:\n\n* Has been diagnosed with relapsed\u002Frefractory AML.\n* Has a documented NPM1 mutation or KMT2A rearrangement.\n* Has a documented FLT3 mutation (cA-3 only).\n* Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.\n* Has adequate hepatic and renal function as defined per protocol.\n* Has an ejection fraction above a protocol defined limit.\n* Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.\n* Has agreed to use contraception as defined per protocol.\n\nKey Exclusion Criteria:\n\n* Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.\n* Has clinically active central nervous system leukemia.\n* Has an active and uncontrolled infection.\n* Has a mean corrected QT interval (QTcF) \\> 480ms.\n* Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.\n* Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy \\\u003C14 days or within 5 drug half-lives prior to the first dose of study intervention.\n* Has had major surgery within 4 weeks prior to the first dose of study intervention.\n* Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.\n* Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD\n* Participant is pregnant or lactating.",{"count":196,"type":21},171,[74],"The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed\u002Frefractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.",[200,201,202,203,204,205,206,207,208,209,210,32],"AML","AML With Mutated NPM1","Hematologic Malignancy","KMT2Ar","NPM1 Mutation","MLL Rearrangement","Leukemia","Acute Myeloid Leukemia","Leukemia, Myeloid","Leukemia, Myeloid, Acute","Acute Leukemia","2026-04-10",{"date":213,"type":39},"2026-04-14",{"date":215,"type":39},"2024-02-22",{"date":217,"type":21},"2027-08",{"name":219,"class":186},"Kura Oncology, Inc.",45,{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":68,"minAge":229,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":234,"conditions":235,"keywords":251,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":277},"100626796","phase-2-determine-trial-treatment-arm-07-dabrafenib-in-combination-with-trametinib-in-adult-paediatric-and-teenageyoung-adult-patients-with-braf-v600-mutation-positive-cancers-100626796","NCT07440290","DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and TYA Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 07 (DABRAFENIB AND TRAMETINIB) OUTLINED BELOW\\* \\*When dabrafenib- and trametinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the dabrafenib- and trametinib-specific criteria will take precedence.\n\nInclusion criteria:\n\nA. Confirmed diagnosis of a malignancy harbouring an oncogenic alteration in BRAF V600, including Langerhans cell histiocytosis, using an analytically validated next-generation sequencing method.\n\nB. Patients ≥1 year old and ≥8 kg in body weight.\n\nC. Women of childbearing potential are eligible provided that they meet the following criteria:\n\n• Have a negative serum or urine pregnancy test before enrolment and;\n\n• Agree to use one form of a non-hormonal highly effective contraception method (a method that can achieve a failure rate of \\\u003C1% when used consistently and correctly; the requirement for non-hormonal method is because dabrafenib may decrease the efficacy of oral or any systemic hormonal contraceptives), such as: i. intrauterine device (IUD), ii. bilateral tubal occlusion, bilateral tubal ligation (at least six weeks before taking trial treatment), iii. vasectomised partner, iv. total sexual abstinence. Effective from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nPatients who are breastfeeding must be willing to discontinue breastfeeding from the start of treatment, throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nD. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks after the last administration of dabrafenib and 16 weeks after the last administration of trametinib (whichever is later):\n\n* Agree to take measures not to father children by using a barrier method of contraception (male condom plus spermicide) or to sexual abstinence.\n* Non-vasectomised male partners with partners who are women of childbearing potential should also be advised of the benefit for their partner of using a highly effective method of contraception, such as:\n\n  i. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal or transdermal\\]), ii. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), iii. IUD, iv. intrauterine hormone-releasing system (IUS), v. bilateral tubal occlusion, vi. total sexual abstinence.\n* Male patients with pregnant or breastfeeding partners must be advised to use barrier method contraception (male condom) to prevent drug exposure of the foetus or neonate, even if vasectomised.\n* Male patients must refrain from donating sperm for the same period.\n\nE. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nF. Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility\n\nExclusion criteria:\n\nA. Diagnosis of one of the following BRAF V600E mutation-positive cancers:\n\n* Colorectal cancer in adult (≥18 years) patients;\n* Unresectable or metastatic melanoma in adult (≥18 years) patients;\n* Advanced non-small cell lung cancer in adult (≥18 years) patients;\n* Gliomas harbouring a BRAF V600E mutation in paediatric (1 to \\\u003C16 years) or TYA (16 to \\\u003C18 years) patients.\n\nB. Previous treatment with dabrafenib and trametinib in combination (or other BRAF and MEK inhibitors in combination) for the current indication.\n\nC. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for two weeks following their last dose of dabrafenib or 16 weeks following their last dose of trametinib, whichever is later.\n\nD. Known hypersensitivity to dabrafenib or trametinib or any of the excipients. See the current relevant SmPCs (UK) for the full lists.\n\nE. Patients with a history of retinal vein occlusion.\n\nF. Any impairment of gastrointestinal (GI) function of uncontrolled GI disease that may significantly alter the administration or absorption of dabrafenib and\u002For trametinib (e.g. history of diverticulitis, metastases to the GI tract, uncontrolled Crohn's disease, uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome or short gut syndrome).\n\nG. Clinically significant cardiac or cerebrovascular disease as defined by:\n\n* Unstable angina within three months prior to screening;\n* Myocardial infarction within three months prior to screening;\n* History of documented congestive heart failure (New York Heart Association functional classification III\u002FIV) etc.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]) within three months prior to screening.\n\n• Patients with primary central nervous system (CNS) tumours may be considered unless intratumoural bleeding has occurred within two weeks prior to the first dose of dabrafenib and trametinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nH. Patients who were administered a live, attenuated vaccine within 28 days prior to initiation of treatment, or anticipation of need for such a vaccine during investigational medicinal product (IMP) treatment or within six months after the final dose of dabrafenib and trametinib.\n\nI. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of dabrafenib and trametinib including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided that each of the following conditions are met:\n\n* CD4 count ≥350\u002FµL;\n* Undetectable viral load;\n* Receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* No HIV\u002Facquired immune deficiency syndrome associated opportunistic infection in the last 12 months.\n\nJ. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial (including absorption of oral medications) that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.","1 Year",{"count":231,"type":21},30,[24,233],"PHASE3","This clinical trial is looking at two drugs called dabrafenib and trametinib. Dabrafenib and trametinib are approved as standard of care treatment for adult patients with melanoma (a type of skin cancer) or lung cancer and in children with glioma (a type of brain tumour). This means they have gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Dabrafenib and trametinib work in patients with a particular mutation in their cancer known as BRAF V600.\n\nInvestigators now wish to find out if they will be useful in treating patients with other cancer types which have the same mutation. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[236,237,168,32,97,238,239,240,241,242,243,244,245,246,247,109,248,249,250],"Haematological Malignancy","Malignant Neoplasm","Gastrointestinal Cancer","Non-Melanoma Skin Cancer (NMSC)","Langerhans Cell Histiocytosis (LCH)","Cancer","Erdheim-Chester Disease","Thyroid Carcinoma, Papillary","Ovarian Neoplasms","Colorectal Neoplasms","Laryngeal Neoplasms","Carcinoma, Non-Small Cell-Lung","Multiple Myeloma","Thyroid Carcinoma, Anaplastic","Solid Tumour",[252,127,241,253,254,255,256,257,258,259,97,260,261,262,263,264,265,266,267],"Adult","Child","Dabrafenib","Malignancy","Malignant Neoplasms","Molecular Targeted Therapy","Mutation","Neoplasms by Histologic Site","Paediatric","Precision Medicine","Proto-Oncogene Proteins B-raf","Protein Kinase Inhibitors","Rare","Trametinib","Tumour-Agnostic","Young adult","2026-02-23",{"date":270,"type":39},"2026-02-27",{"date":272,"type":21},"2026-02",{"date":274,"type":21},"2029-10",{"name":276,"class":144},"Cancer Research UK",27,{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":227,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":287,"conditions":288,"keywords":292,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":311,"locationsCount":312},"100592057","phase-2-determine-trial-treatment-arm-06-capmatinib-in-adult-patients-with-cancers-harbouring-met-dysregulations-100592057","NCT06988475","DETERMINE Trial Treatment Arm 06: Capmatinib in Adult Patients With Cancers Harbouring MET Dysregulations","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 06: Capmatinib in Adult Patients With Cancers Harbouring MET Dysregulations","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 06 (CAPMATINIB) OUTLINED BELOW\\*\n\n\\*When capmatinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the capmatinib-specific criteria will take precedence.\n\nInclusion criteria:\n\nA. Confirmed diagnosis of a MET-positive malignancy using an analytically next-generation sequencing method (METex14 skipping, MET amplification, MET fusion, or MET activating mutation).\n\nB. Adult patients ≥18 years old.\n\nC. Women of childbearing potential are eligible, provided that they meet the following criteria:\n\n* Have a negative serum or urine pregnancy test before enrolment, and\n* Agree to use one form of highly effective birth control method (a method that can achieve a failure rate of \\\u003C1% when used consistently and correctly), such as:\n\nI. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal or transdermal\\])\n\nII. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable)\n\nIII. intrauterine device (IUD)\n\nIV. Intrauterine hormone-releasing system (IUS)\n\nV. bilateral tubal occlusion\n\nVI. vasectomised partner\n\nVII. sexual abstinence\n\nEffective from the first administration of capmatinib, throughout the trial and for seven days after the last administration of capmatinib.\n\nD. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from first administration of capmatinib, throughout the trial and for seven days after the last administration of capmatinib:\n\n* Agree to take measures not to father children by using a barrier method of contraception (e.g. condom) or sexual abstinence.\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly effective method of contraception, as in criterion C above.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nE. Patients must be able and willing to undergo a fresh biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nF. Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nExclusion criteria:\n\nA. Diagnosis of NSCLC with METex14 skipping mutation or MET amplification.\n\nB. Prior treatment with a selective MET inhibitor or HGF-targeting therapy unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to capmatinib.\n\nC. Carcinomatous meningitis.\n\nD. Presence or history of additional malignant disease that has been diagnosed and\u002For required therapy within the past three years. Exceptions to this exclusion include: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.\n\nE. Presence or history of interstitial lung disease (ILD) and\u002For interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention) and evidence of active pneumonitis on screening chest computed tomography (CT) scan. Prior localised radiotherapy related pneumonitis is permitted if resolved and off steroids and asymptomatic for at least six months.\n\nF. Clinically significant, uncontrolled heart disease such as:\n\n* Unstable angina within three months prior to screening\n* Myocardial infarction within three months prior to screening\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\n* Uncontrolled hypertension defined by a systolic blood pressure ≥160 mm Hg and\u002For diastolic blood pressure ≥100 mm Hg, with or without antihypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]) within three months before screening.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within two weeks of the first dose of capmatinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nG. History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for patients participating in the trial such as:\n\n* Concomitant clinically significant cardiac arrhythmias (atrial and ventricular), e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker\n* History of familial long QT syndrome or known family history of Torsades de Pointes\n* Resting QTcF (Corrected QT interval by Fridericia formula) ≥450 msec (male) or ≥460 msec (female) at screening ECG (as a mean of triplicate ECG)\n\nH. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within four weeks prior to starting trial treatment (two weeks for resection of brain lesions) or patients who have not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and patients can be enrolled in the trial at least one week after the procedure.\n\nI. Patients receiving treatment with strong inducers of cytochrome P450 (CYP) 3A that cannot be discontinued at least one week prior to the start of treatment with capmatinib and for the duration of the trial.\n\nJ. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial (including absorption of oral medications) that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.\n\nK. Any impairment of gastrointestinal (GI) function or GI disease that may significantly alter the administration or absorption of capmatinib (e.g., Crohn's disease, ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome or short gut syndrome). Unable to swallow capmatinib intact, without chewing or crushing the tablets (as per the dosing schedule).\n\nL. Active infections including, but not limited to, hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). Screening for known chronic conditions is not required. Patients with known serological evidence of chronic HBV or HCV infection whose disease is controlled under antiviral therapy according to local regulation are eligible. Patients with history of testing positive for human immunodeficiency virus (HIV) infection are eligible provided the each of the following conditions are met:\n\n* CD4 count ≥350\u002FμL;\n* undetectable viral load;\n* receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* no HIV\u002F acquired immune deficiency syndrome-associated opportunistic infection in the last 12 months.\n\nM. Known hypersensitivity to any of the excipients of capmatinib.\n\nN. Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the two weeks prior to trial entry to manage CNS symptoms. Primary brain or CNS malignancies are allowed providing the patient is clinically stable (if corticosteroids are required, they must be at a stable or decreasing dose for at least 14 days prior to Cycle 1 Day 1). If patients are on corticosteroids for endocrine deficiencies or tumour-associated symptoms other than CNS related, the dose must have been stabilised (or decreasing) for at least five days before Cycle 1 Day 1.\n\nO. Patients receiving treatment with any enzyme-inducing anticonvulsant that cannot be discontinued at least one week before first dose of capmatinib, and for the duration of the trial. Patients on non-enzyme-inducing anticonvulsants are eligible.\n\nP. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for seven days following their last dose of capmatinib.\n\nQ. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during capmatinib treatment or within six months after the final dose of capmatinib.",{"count":231,"type":21},[24,233],"This clinical trial is looking at a drug called capmatinib. Capmatinib is approved as standard of care treatment for adult patients with certain types of lung cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.\n\nCapmatinib works in patients with lung cancer with a particular mutation in their cancer known as a METex14 skipping mutation.\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which have the same mutation or other specific mutations or changes which take place in the MET gene. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[250,236,237,32,97,241,255,109,289,290,291],"Neuroblastoma","Gastric Cancer","Soft Tissue Sarcoma",[293,294,295,296,297,298,299,300,127,301,302,256,257,258,32,97,261,263,264,303,304],"adult","capmatinib","MET Tyrosine Kinase Receptor","MET exon 14 skipping","MET amplifications","MET fusions","MET activating mutations","MET dysregulations","cancer","malignancy","Tumour-agnostic","METex14 skipping","2025-11-19",{"date":307,"type":39},"2025-11-24",{"date":309,"type":39},"2024-11-19",{"date":274,"type":21},{"name":276,"class":144},17,{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":227,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":68,"minAge":4,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":22,"phases":321,"briefSummary":322,"conditions":323,"keywords":327,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":330,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":334,"locationsCount":277},"100498421","phase-2-determine-trial-treatment-arm-01-alectinib-in-adult-paediatric-and-teenageyoung-adult-patients-with-alk-positive-cancers-100498421","NCT05770037","DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With ALK Positive Cancers","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With ALK Positive Cancers","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 01 (ALECTINIB) OUTLINED BELOW\\*\n\n\\*When alectinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the alectinib-specific criteria will take precedence.\n\nInclusion Criteria:\n\nA. Confirmed diagnosis of an ALK-positive malignancy using an analytically validated next-generation sequencing method.\n\nB. Women of childbearing potential are eligible, provided that they meet the following criteria:\n\n* Have a negative serum or urine pregnancy test before enrolment and;\n* Agree to use one form of highly effective birth control method such as:\n\nI. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal or transdermal\\]\n\nII. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable)\n\nIII. intrauterine device (IUD)\n\nIV. intrauterine hormone-releasing system (IUS)\n\nV. bilateral tubal occlusion\n\nVI. vasectomised partner\n\nVII. sexual abstinence\n\nEffective from the first administration of alectinib, throughout the trial and for three months after the last administration of alectinib.\n\nC. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from first administration of alectinib, throughout the trial and for three months after the last administration of alectinib:\n\n* Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or sexual abstinence.\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly effective method of contraception, as in criterion B, above.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nD. Patients must be able and willing to undergo a fresh tissue biopsy. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nE. Paediatric patients (patients aged \\\u003C18 years) must have a body weight ≥40kg.\n\nF. ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nG. PAEDIATRIC PATIENTS (\\\u003C18 years): Adequate organ function as per haematological and biochemical indices within the ranges shown below. These measurements should be performed to confirm the patient's eligibility.\n\nExclusion Criteria:\n\nA. Diagnosis of ALK-positive non-small cell lung cancer.\n\nB. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for three months following their last dose of alectinib.\n\nC. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to alectinib. Patients who have previously received crizotinib (Xalkori\\^\\[®\\]) and did not respond, or who responded inadequately or responded adequately and subsequently progressed, are allowed into the trial.\n\nD. History of or radiological evidence of interstitial lung disease and\u002For pneumonitis. Prior localised radiotherapy related pneumonitis is permitted if resolved and off steroids and asymptomatic for \\>6 months.\n\nE. Patients at risk of gastrointestinal (GI) perforation e.g. history of diverticulitis, concomitant use of medicinal product with a recognized risk of GI perforation (unless patient has also been co-prescribed gastric protection).\n\n• Patients who present with a GI primary tumour or metastases to the GI tract may be considered.\n\nF. Patient unable to swallow or tolerate oral medication or any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or following major bowel resection. Paediatric patients will be excluded if they are unable to swallow the capsules, as per the dosing schedule (150 mg dose strength).\n\nG. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias (within three months), or New York Heart Association (NYHA) class III or IV congestive heart failure.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]), or cardiovascular event (including acute myocardial infarction \\[MI\\]), within three months before the first dose of alectinib.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of alectinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nH. History of organ transplantation.\n\nI. Symptomatic bradycardia for age.\n\nJ. Known hypersensitivity to alectinib or any of the excipients. See the current alectinib (Alecensa® 150 mg hard capsules) SmPC for the full list.\n\nK. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during alectinib treatment or within six months after the final dose of alectinib.\n\nL. Active hepatitis B or C virus or known human immunodeficiency virus (HIV) positivity or acquired immune deficiency syndrome (AIDS) related illness. Patients with history of testing positive for HIV infection are eligible provided the each of the following conditions are met:\n\n* CD4 count ≥350\u002FμL;\n* undetectable viral load;\n* receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* no HIV\u002FAIDS-associated opportunistic infection in the last 12 months.\n\nM. Familial or personal history of congenital bone disorders, bone metabolism alterations or known osteopenia in the patient.\n\nN. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.",{"count":231,"type":21},[24,233],"This clinical trial is looking at a drug called alectinib. Alectinib is approved as standard of care treatment for adult patients with certain types of lung cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Alectinib works in lung cancer patients with a particular mutation in their cancer known as ALK.\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which have the same mutation. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[236,237,168,32,97,241,324,325,326,289,250],"Anaplastic Large Cell Lymphoma","Lymphoma","Renal Cell Carcinoma",[252,328,329,127,241,253,255,256,257,258,259,97,260,261,263,264,303,267],"Alectinib","ALK Tyrosine Kinase Receptor",{"date":307,"type":39},{"date":332,"type":39},"2023-12-18",{"date":274,"type":21},{"name":276,"class":144},{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":227,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":68,"minAge":4,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":22,"phases":343,"briefSummary":344,"conditions":345,"keywords":348,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":356,"locationsCount":277},"100498460","phase-2-determine-trial-treatment-arm-03-entrectinib-in-adult-paediatric-and-teenageyoung-adult-patients-with-ros1-gene-fusion-positive-cancers-100498460","NCT05770544","DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With ROS1 Gene Fusion-Positive Cancers.","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With ROS1 Gene Fusion-Positive Cancers.","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 03 (ENTRECTINIB) OUTLINED BELOW\\*\n\n\\*When entrectinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the entrectinib-specific criteria will take precedence.\n\nInclusion Criteria:\n\nA. Confirmed diagnosis of a ROS1 gene fusion-positive malignancy, other than NSCLC, that has been identified using an analytically validated next-generation sequencing method.\n\nB. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nC. Patients with a BSA of 0.43m\\^2 and over.\n\nD. ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nE. PAEDIATRIC PATIENTS (\\\u003C18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nF. Women of childbearing potential are eligible provided that they meet the following criteria:\n\n* Have a negative serum or urine pregnancy test before enrolment and either:\n* Agree to use one form of highly effective birth control method such as:\n\nI. Oral, intravaginal or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation\n\nII. Oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation\n\nIII. Intrauterine device (IUD)\n\nIV. Intrauterine hormone-releasing system (IUS)\n\nV. Bilateral tubal occlusion\n\nVI. Vasectomised partner\n\nPlus a barrier method if using a hormonal method: male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide OR\n\n• Sexual abstinence;\n\nEffective from the first administration of entrectinib, throughout the trial and for five weeks after the last administration of entrectinib.\n\nG. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of entrectinib, throughout the trial and for three months after the last administration of entrectinib:\n\n* Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence.\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly effective method of contraception as in F above.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nExclusion Criteria:\n\nA. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or within five weeks following their last dose of entrectinib\n\nB. Diagnosis of ROS1 fusion-positive NSCLC\n\nC. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to entrectinib\n\nD. Patients with significant cardiovascular disease are excluded as defined by:\n\ni. Current congestive heart failure requiring therapy (New York Heart Association III or IV) or known left ventricular ejection fraction (LVEF) \\\u003C50% (moderate to severe).\n\nii. History of unstable angina pectoris or myocardial infarction up to three months prior to trial entry, or current poorly controlled angina (symptoms weekly or more).\n\niii. Presence of symptomatic or severe valvular heart disease (severe by local echo graphic criteria or American Heart Association\u002FAmerican Cardiac College Stage C or D).\n\niv. History of a clinically significant cardiac arrhythmia up to three months prior to trial entry (asymptomatic atrial fibrillation or asymptomatic first-degree heart block are permitted.\n\nv. History of stroke (ischaemic or haemorrhagic) within the last three months.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of entrectinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nE. Patients with a baseline QTcF (Corrected QT interval by Fridericia formula) interval longer than 450 milliseconds (ms) for male patients and 470 ms for female patients, patients with congenital long QTcF syndrome, and patients taking medicinal products that are known to prolong the QTc interval.\n\nF. History of additional risk factors for Torsades de Pointes (e.g., family history of long QT syndrome)\n\nG. Grade ≥2 peripheral neuropathy\n\nH. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of entrectinib, including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided the each of the following conditions are met:\n\n* CD4 count ≥350\u002FμL;\n* undetectable viral load;\n* receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* no HIV\u002F acquired immune deficiency syndrome (AIDS)-associated opportunistic infection in the last 12 months.\n\nI. Known hypersensitivity to entrectinib or any of the excipients\n\nJ. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during entrectinib treatment or within six months after the final dose of entrectinib\n\nK. Patient unable to swallow entrectinib intact, without chewing, crushing or opening the capsules (as per the dosing schedule and suitable dosing strengths available). Any active gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably affect drug absorption\n\nL. Patients with personal history of significant osteopenia (screening for osteopenia not required)\n\nM. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial",{"count":231,"type":21},[24,233],"This clinical trial is looking at a drug called entrectinib. Entrectinib is approved as standard of care treatment for adult patients with non-small cell lung cancer (NSCLC) which have a particular molecular alteration called ROS1-positive, and patients 12 years old or above with solid tumours which have another type of change in the cancer cells. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which have the same molecular alteration (ROS1-positive). If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[236,255,237,168,32,97,241,346,347,109,250],"Brain Neoplasms","Melanoma",[252,127,241,253,349,255,256,257,258,259,97,350,260,263,264,351,303,267],"Entrectinib","Oncogene","ROS1 Protein, human",{"date":307,"type":39},{"date":354,"type":21},"2025-11-30",{"date":274,"type":21},{"name":276,"class":144},{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":227,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":68,"minAge":4,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":365,"briefSummary":366,"conditions":367,"keywords":370,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":376,"locationsCount":277},"100498426","phase-2-determine-trial-treatment-arm-02-atezolizumab-in-adult-paediatric-and-teenageyoung-adult-patients-with-cancers-with-high-tumour-mutational-burden-tmb-or-microsatellite-instability-high-msi-high-or-proven-constitutional-mismatch-repair-deficiency-cmmrd-disposition-100498426","NCT05770102","DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage\u002FYoung Adult Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage\u002FYoung Adult Patients With Cancers With High TMB or MSI-high or Proven CMMRD Disposition.","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 02 (ATEZOLIZUMAB) OUTLINED BELOW\\*\n\n\\*When atezolizumab-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the atezolizumab-specific criteria will take precedence.\n\nInclusion Criteria:\n\nA. Confirmed diagnosis of a malignancy that is high TMB (defined as ≥10 mut\u002FMb), MSI-high or of proven (previously diagnosed) CMMRD disposition using an analytically validated next-generation sequencing method. Patient cases with TMB between 10-15 mut\u002FMb may be discussed in an MTB meeting. TMB ≥19 mut\u002FMb will be fast-tracked for an MTB recommendation, unless there are any patient-specific individualities (such as multiple gene amplifications) that require MTB discussion.\n\nB. Women of childbearing potential are eligible provide they meet the following criteria:\n\n* Have a negative serum or urine pregnancy test before enrolment and;\n* Agree to use one form of effective birth control method such as:\n\nI. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (\\[oral, intravaginal or transdermal\\]);\n\nII. progestogen-only hormonal contraception associated with or without inhibition of ovulation (oral, injectable or implantable);\n\nIII. intrauterine device (IUD),\n\nIV. intrauterine hormone-releasing system (IUS),\n\nV. bilateral tubal occlusion,\n\nVI. vasectomised partner,\n\nVII. sexual abstinence,\n\nVIII. male or female condom with or without spermicide;\n\nIX. cap, diaphragm or sponge with spermicide.\n\nEffective from the first administration of atezolizumab, throughout the trial and for five months after the last administration of atezolizumab.\n\nC. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of atezolizumab, throughout the trial until the last administration of atezolizumab:\n\n* Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or sexual abstinence.\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses an effective method of contraception.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nD. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nE. ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nF. PAEDIATRIC PATIENTS (\\\u003C18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nG. Patients must have stable thyroid function tests. Patients on stable doses of thyroxine replacement are permitted.\n\nExclusion Criteria:\n\nA. Diagnosis of urothelial cancer, non-small cell lung cancer, extensive-stage small cell lung cancer, hepatocellular carcinoma or triple negative breast cancer.\n\nB. Patients with rapidly progressing or symptomatically deteriorating brain metastases and\u002For leptomeningeal disease. Patients with previously treated brain metastases are eligible, provided the patient has not experienced a seizure or had a clinically significant change in neurological status within 14 days (for adult patients) or 7 days (for paediatric patients) prior to the start of IMP administration. Such patients must be non-dependent on steroids or on a stable or reducing dose of steroid treatment for at least 14 days (or 7 days for paediatric patients) prior to the start of IMP administration. Primary brain or central nervous system (CNS) malignancies are allowed providing the patient is clinically stable (if requiring corticosteroids must be at stable or decreasing doses for at least 14 days for adults and 7 days for paediatric patients prior to the start of IMP administration). Patients who have received brain irradiation must have completed whole-brain radiotherapy and\u002For stereotactic radiosurgery at least 14 days prior to the start of IMP administration.\n\n• Paediatric patients with either primary brain tumours or extracranial solid tumours with intracranial metastases with one or more intracranial lesions should only be considered for inclusion if largest intracranial lesion is ≤6 cm in longest axis. Consideration should also be given to the intracranial location of the tumour and potential risk should swelling occur. This is because of the class risk of immune checkpoint inhibitors such as atezolizumab causing immune-mediated inflammatory response and 'tumour flare' which may result in acute neurological deterioration.\n\nC. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or within five months following their last dose of atezolizumab.\n\nD. History or clinical evidence of current inflammatory lung disease:\n\n* History of idiopathic pulmonary fibrosis, organising pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.\n* Evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n\nE. Active autoimmune disease that requires the use of systemic immunomodulatory therapy (i.e. with disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy for hypothyroidism and adrenal or pituitary insufficiency is acceptable.\n\nF. Ongoing lung pathologies which, in the opinion of the Investigator present a compromise to safety (e.g. active tuberculosis).\n\nG. Systemic immunomodulatory agents within 14 days prior to trial entry (immunostimulatory agents within four weeks). Exceptions to this are:\n\n* Patients who received acute, low dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g. 48 hours of corticosteroids for a contrast allergy) are eligible for the trial.\n* Patients who received corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma equivalent to ≤10 mg prednisolone a day or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the trial.\n* Patients with primary CNS disease can be receiving concurrent treatment with corticosteroids. Patients must be receiving a stable or decreasing dose for ≥14 days for adults and ≥7 days for paediatric patients prior to the screening magnetic resonance imaging (MRI) scan and at the time of drug initiation.\n* Patients who receive physiological doses of steroid replacement (e.g. hydrocortisone) are permitted.\n\nH. Known to be serologically positive (as detected by polymerase chain reaction) for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).\n\nI. History of severe allergic anaphylactic reactions to chimeric, human or humanised antibodies, or fusion proteins including other immune checkpoint inhibitors.\n\nJ. Known hypersensitivity to Chinese hamster ovary cell products.\n\nK. Known hypersensitivity to atezolizumab or any of the excipients.\n\nL. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during atezolizumab treatment or within six months after the final dose of atezolizumab.\n\nM. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or NYHA class III or IV congestive heart failure.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attacks \\[TIA\\]) or cardiovascular event (including acute myocardial infarction \\[MI\\]) within three months before the first dose of atezolizumab.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of atezolizumab, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nPatients with a prior history of pericardial disorders, including pericarditis, pericardial effusion and cardiac tamponade.\n\nN. Prior allogeneic stem cell or solid organ transplantation on immunosuppression.\n\nO. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to atezolizumab.\n\nP. Uncontrolled diabetes.\n\nQ. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.\n\nR. Severe infection within four weeks prior to the first IMP administration or the administration of antibiotics within two weeks prior to the first IMP administration, with the exemption of patients requiring prophylaxis.",{"count":231,"type":21},[24,233],"This clinical trial is looking at a drug called atezolizumab. Atezolizumab is approved as standard of care treatment for adult patients with urothelial cancer, non-small cell lung cancer, extensive-stage small cell lung cancer, hepatocellular carcinoma and triple negative breast cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.\n\nAtezolizumab works in patients with these types of cancers which have certain changes in the cancer cells called high tumour mutational burden (TMB) or high microsatellite instability (MSI) or proven (previously diagnosed) constitutional mismatch repair deficiency (CMMRD).\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which are also TMB\u002FMSH-high or show CMMRD. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[255,237,168,32,97,241,245,368,347,369],"Endometrial Neoplasms","Solid Tumours",[252,127,371,241,253,255,256,257,32,97,260,261,264,303,267],"Atezolizumab",{"date":307,"type":39},{"date":374,"type":39},"2023-10-25",{"date":274,"type":21},{"name":276,"class":144},{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":22,"phases":386,"briefSummary":387,"conditions":388,"keywords":394,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":407},"100406441","phase-1-safety-of-sbrt-with-anti-pd1-and-anti-il-8-for-the-treatment-of-multiple-metastases-in-advanced-solid-tumors-and-melanoma-100406441","NCT04572451","Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma","Phase I Study Investigating the Safety of Stereotactic Body Radiotherapy (SBRT) With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma","Inclusion Criteria:\n\n* SAFETY COHORT\n\n  1. Patients with advanced\u002Fmetastatic\u002Funresectable solid tumors progressed on standard therapies. Patients with melanoma and RCC will make up approximately 30% of total cohort.\n  2. Patients with 1-4 tumor sites that can be irradiated safely\n  3. Age \\> or equal 18 years\n  4. ECOG performance status 0 or 1\n  5. Patients must have normal organ and marrow function as defined below:\n\n     * Leukocytes ≥ 3000\u002FmcL;\n     * absolute neutrophil count ≥ 1500\u002FmcL;\n     * Platelets ≥ 100,000\u002FmcL;\n     * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) ;\n     * Total bilirubin ≤ 1.5 × ULN (except participants with Gilbert's Syndrome who must have normal direct bilirubin)\n     * Serum creatinine ≤ 1.5 × ULN Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non- nodal lesions and short axis for nodal lesions) as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam\n  6. Ability to understand and the willingness to sign a written informed consent document.\n  7. Reproductive status\n\n     * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study treatment.\n     * Women must not be breastfeeding.\n     * WOCBP must agree to follow instructions for method(s) of contraception (Appendix 5) for the duration of study treatment plus 5 half-lives of nivolumab plus 30 days (duration of ovulatory cycle), for a total of 155 days post treatment completion. Local laws and regulations may require use of alternative and\u002For additional contraception methods.\n     * WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, but should still undergo pregnancy testing as described in this section.\n     * Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (Appendix4) during combination treatment with study treatment BMS-986253 and nivolumab, plus 5 half-lives of nivolumab (∼125 days), plus 90 days (duration of sperm turnover), for a total of 215 days post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time.\n* EFFICACY COHORT\n\n  1. Patients with anti-PD1\u002FPDL1 refractory melanoma\n  2. Patients with 1-4 tumor sites that can be irradiated safely\n  3. Age ≥ 18 years\n  4. ECOG performance status 0 or 1\n  5. Patients must have normal organ and marrow function as defined above for safety cohort\n  6. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non- nodal lesions and short axis for nodal lesions) as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam\n  7. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Known or suspected CNS metastases, with the following exceptions:\n\n   a) Subjects with controlled brain metastases will be allowed to enroll. Controlled brain metastases are defined as no radiographic progression for at least 4 weeks following 18 radiation and\u002For surgical treatment at the time of randomization. b) Subjects must be off steroids for at least 2 weeks prior to initiation of investigational therapy c) Subjects with signs or symptoms of brain metastases are not eligible unless brain metastases are ruled out by computed tomography or magnetic resonance imaging.\n2. Medical History and Concurrent Diseases\n\n   * Patients who are receiving any other investigational agents.\n   * History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab and BMS-986253\n   * Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n   * Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:\n\n     i. Myocardial infarction (MI) or stroke\u002Ftransient ischemic attack (TIA) within the 6 months prior to consent ii. Uncontrolled angina within the 3 months prior to consent iii. Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes, or poorly controlled atrial fibrillation) within a month prior to consent iv. QTc prolongation \\> 480 msec v. History of other clinically significant cardiovascular disease (i.e., cardiomyopathy, congestive heart failure with New York Heart Association \\[NYHA\\] functional classification III-IV, pericarditis, significant pericardial effusion, significant coronary stent occlusion, poorly controlled deep venous thrombosis, etc) vi. Cardiovascular disease-related requirement for daily supplemental oxygen vii. History of two or more coronary revascularization procedures within the 3 months prior to consent viii. Subjects with history of myocarditis, regardless of etiology\n   * A confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent\n   * Subjects with history of life-threatening toxicity related to prior immune therapy (eg. anti-CTLA-4 or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hormone replacement after endocrinopathy).\n   * Subject has been administered prior chemotherapy or immunotherapy at any time, and any with radiation therapy within 4 weeks prior to time of consent or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to previously administered agent.\n\n     1. Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.\n     2. Subjects with endocrinopathy which is adequately controlled with hormone replacement therapy are an exception to this criterion and may qualify for the study.\n   * If subject underwent major surgery, subject must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n   * Subject has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n   * A known or underlying medical condition that, in the opinion of the investigator could make the administration of study drug hazardous to the subject or could adversely affect the ability of the subject to comply with or tolerate study therapy.\n   * Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated with the study drugs.\n   * Subjects who are unable to undergo venipuncture and\u002For tolerate venous access\n   * Evidence of active infection that requires systemic antibacterial, antiviral, or antifungal therapy ≤ 7 days prior to initiation of study drug therapy\n   * Subjects who are on immunosuppressive therapy (systemic steroids 10mg and more daily use)\n   * Prisoners or subjects who are involuntarily incarcerated\n   * Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness\n   * Inability to comply with restrictions and prohibited activities and treatments",{"count":385,"type":21},50,[74],"Nivolumab (and other agents affecting the anti-programmed death-1 \\[anti-PD-1\\] pathway) have demonstrated anti-tumor activity in multiple tumor types. Combinations of immune-oncology (IO) agents with complimentary mechanisms as well as radiation represent a promising strategy to improve response rates to immunotherapy and overcome resistance. In this phase I\u002FIb study, radiation will be used in combination with IO agents nivolumab and anti-IL-8 (BMS-986253) to assess toxicity by organ system and then assess the preliminary efficacy of the treatment regimen. In Part 1, the study will determine the safe doses of radiation by organ site in conjunction with nivolumab and BMS-986253. In Part 2, the treatment regimen will be investigated in melanoma, prioritizing acral melanoma, to describe the response rate to treatment as well as other clinical and safety outcomes. The study will also provide the opportunity to evaluate changes in the tumor microenvironment induced by the treatment.",[347,389,29,32,97,390,127,391,392,393],"Unresectable Solid Tumors","Antineoplastic Agents, Immunological","Immune Checkpoint Inhibitors","Molecular Mechanisms of Pharmacological Action","Nivolumab",[395,396,397],"Anti-PD-1 monoclonal antibody (mAb)","Anti-IL-8","Stereotactic Body Radiotherapy (SBRT)","2025-07-29",{"date":400,"type":39},"2025-08-01",{"date":402,"type":39},"2021-11-29",{"date":404,"type":21},"2027-05-31",{"name":406,"class":144},"Yana Najjar",2,{"id":409,"slug":410,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":415,"enrollmentInfo":416,"targetDuration":4,"studyType":22,"phases":418,"briefSummary":419,"conditions":420,"keywords":427,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":47},"100536932","phase-1-a-study-to-evaluate-the-safety-pkpd-of-oricar-017-in-subjects-with-rrmm---rigel-study-100536932","NCT06271252","A Study to Evaluate the Safety, PK\u002FPD of (OriCAR-017) in Subjects With RR\u002FMM - RIGEL Study","A Phase I\u002FII, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Anti-GPRC5D CAR-T Cell Product (OriCAR-017) in Subjects With Relapsed\u002FRefractory Multiple Myeloma.","Inclusion Criteria:\n\nCapable of giving signed informed consent\n\nSubjects aged 18 to 75 years (inclusive) at Screening (signing the ICF).\n\nExpected survival period is \\>12 weeks.\n\nDiagnosis of MM according to the IMWG criteria (2016 version).\n\nOne of the following criteria must be met:\n\nIf immunoglobulin (Ig)G type MM, then serum M protein \\>10 g\u002FL; if IgA, IgD, IgE or IgM type MM, then serum M protein \\>5 g\u002FL\n\nUrine M protein level \\>200 mg\u002F24 hour\n\nIf light chain type MM, then serum free light chain (sFLC) \\>100 mg\u002FL and K\u002Fλ FLC ratio is abnormal.\n\nExtramedullary lesions (\\>1 cm for diameter of the short axis).\n\nFor Phase I (dose-escalation) - Subjects who had received at least 3 prior lines of therapy, had previous exposure to BCMA-Ag+ therapies, and were refractory to the last line of therapy.\n\nFor Phase I (dose-expansion) and Phase II: Subjects with previous exposure to BCMA directed therapies including BCMA bispecific antibody (e.g., teclistamab), BCMA antibody directed conjugate (such as BLENREP), and BCMA-CAR-T (such as CARVYKT1TM)\n\nSubjects with adequate hematologic, renal, hepatic, pulmonary and cardiac function.\n\nSubject and partners willing to take and or use effective contraceptive measures until 2 years post IMP infusion.\n\nExclusion Criteria:\n\nPregnant or breastfeeding.\n\nSeropositive for history of human immunodeficiency virus Active Hepatitis B infection and or Hepatitis C infection\n\nKnown active or prior history of CNS involvement\n\nHistory of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) caused damage to terminal organs or required systemic application of immunosuppressive or other drugs in the past 2 years\n\nPresence of uncontrolled active infection\n\nSubjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study.\n\nSubjects who received allogeneic stem cell therapy.\n\nAny condition that in the opinion of the Investigator, would interfere with evaluation of the IMP.\n\nReceived Bendamustine treatment 1 year prior to Screening Visit.","75 Years",{"count":417,"type":21},81,[74],"The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed\u002Frefractory multiple myeloma.\n\nRIGEL Study",[421,32,29,163,422,423,165,166,424,425,168,169,426,248],"Neoplasms, Plasma Cell","Vascular Diseases","Cardiovascular Diseases","Hematologic Diseases","Hemorrhagic Disorders","Immune System Diseases",[428],"R\u002FR MM, CAR-T","2024-08-01",{"date":431,"type":39},"2024-08-02",{"date":433,"type":39},"2024-04-03",{"date":435,"type":21},"2028-04-12",{"name":437,"class":186},"OriCell Therapeutics Co., Ltd.",{"id":439,"slug":440,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":68,"minAge":445,"maxAge":446,"enrollmentInfo":447,"targetDuration":4,"studyType":22,"phases":449,"briefSummary":451,"conditions":452,"keywords":463,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":47},"100473080","phase-4-percutaneous-needle-fasciotomy---corticosteroid-injection-for-dupuytrens-contracture-100473080","NCT05440240","Percutaneous Needle Fasciotomy +\u002F- Corticosteroid Injection for Dupuytren's Contracture","Percutaneous Needle Fasciotomy (PNF) +\u002F- Corticosteroid Injection for Dupuytren's Contracture (DC) Affecting Metacarpophalangeal Joints (MCP) . A Randomized Controlled Trial","Sufficient correction of metacarpophalangeal (MCP) joint during the PNF treatment, defined as \\\u003C20° passive extension deficit (PED), is a prerequisite for inclusion.\n\nInclusion Criteria:\n\n* Dupuytren contracture (DC) of ≥ 20° PED in MCP joint measured with a goniometer\n* DC of either II-V finger\n* Well-defined\u002Fpalpable cord\n\nExclusion Criteria:\n\n* Legally incapacitated\n* Previous study inclusion with another finger ray\n* Isolated proximal interphalangeal (PIP) or distal interphalangeal (DIP) joint contracture, defined as MCP joint contracture \\\u003C 20° PED regardless of the deficit in the PIP or DIP joint\n* Previous hand surgery of the affected finger for any reason\n* Known allergy to the study medication\n* Anticoagulant therapy (Acetylsalicylic acid is NOT an exclusion criterion)\n* Pregnant or lactation\n* Insulin dependent diabetes mellitus\n* Ongoing systemic infection or local infection at the site of the procedure\n* Rheumatoid arthritis\n* Amyloidosis or mucopolysaccharidosis\n* Unable to communicate, cooperate or participate in follow-up","45 Years","99 Years",{"count":448,"type":21},400,[450],"PHASE4","Comparing percutaneous needle fasciotomy +\u002F- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial.",[453,454,455,456,457,458,459,460,461,32,29,462],"Dupuytren Contracture","Dupuytren's Disease","Contracture","Joint Diseases","Musculoskeletal Diseases","Fibroma","Neoplasm, Fibrous Tissue","Neoplasms, Connective Tissue","Neoplasms, Connective and Soft Tissue","Connective Tissue Diseases",[464,465,466],"Percutaneous needle fasciotomy","Corticosteroid","Randomized controlled trial","2023-05-15",{"date":469,"type":39},"2023-05-17",{"date":471,"type":39},"2023-01-10",{"date":473,"type":21},"2030-03",{"name":475,"class":144},"Regionshospitalet Silkeborg",{"id":477,"slug":478,"hasResults":11,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":484,"enrollmentInfo":485,"targetDuration":4,"studyType":487,"phases":4,"briefSummary":488,"conditions":489,"keywords":502,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":516},"100435367","spanish-series-of-patients-treated-with-the-radionuclide-lutetium177-100435367","NCT04949282","Spanish Series of Patients Treated With the Radionuclide Lutetium177","SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177","SEPTRALU","Inclusion Criteria:\n\n* Written informed consent must be obtained prior to any data collection.\n* Patients must be diagnosed with unresectable or metastatic, progressive, somatostatin receptor positive tumour\n* Aged ≥18 years.\n\nExclusion Criteria:\n\n* None","100 Years",{"count":486,"type":21},5000,"OBSERVATIONAL","This study aims to pool the clinical experience of Spanish centers treating patients with 177Lu-DOTATATE to evaluate the efficacy, tolerance, and safety of the drug in routine clinical practice and to learn about the profiles of patients and tumors treated and the results in each type of patient and tumor.",[490,491,492,493,82,92,32,29,93,494,495,97,496,497,498,499,500,501],"Neuroendocrine Tumors","Intestinal Neoplasms","Pancreatic Neoplasms","Stomach Neoplasms","Gastrointestinal Neoplasms","Digestive System Neoplasms","Endocrine Gland Neoplasms","Digestive System Diseases","Gastrointestinal Disease","Intestinal Diseases","Pancreatic Disease","Endocrine System Diseases",[503,504,505,506],"GEP-NET","Gastro-Entero-Pancreatic Neuroendocrine Tumour","Luthatera","Somatostatin receptor positive tumour","2022-12-22",{"date":509,"type":39},"2022-12-23",{"date":511,"type":39},"2021-05-10",{"date":513,"type":21},"2035-12-31",{"name":515,"class":144},"Sociedad Española de Medicina Nuclear e Imagen Molecular",20,{"id":518,"slug":519,"hasResults":11,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":523,"eligibilityCriteria":524,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":22,"phases":526,"briefSummary":527,"conditions":528,"keywords":4,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":47},"100458627","phase-2-anlotinib-hydrochloride-capsules-combined-with-tqb2450-injection-in-esophageal-squamous-cell-carcinoma-patients-100458627","NCT05252078","Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients","An Open, Single Arm, Multicenter, Exploratory Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients as Postoperative Adjuvant Therapy","ALTER-E005","Inclusion Criteria:\n\n* Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.\n* ≥ 18 years old.\n* ECOG performance status of 0-1\n* Patients with esophageal squamous cell carcinoma pathologically diagnosed as T1-2N1-3M0 or T3-4NanyM0.\n* Patients received radical (R0) resection of squamous cell carcinoma with no recurrence in imaging examination within 6-12 weeks after surgery, and need adjuvant therapy assessed by the researchers.\n* Laboratory tests must be met:\n* Neutrophils count =\u002F\\> 1.5 x 109\u002FL, platelets count =\u002F\\> 75 x 109\u002FL, Hb =\u002F\\> 90 g\u002FL, WBC =\u002F\\> 3 x 109\u002FL.\n* total bilirubin =\u002F\\\u003C 1.5 x ULN, ALT and AST =\u002F\\\u003C 2.5 x ULN.\n* Creatinine =\u002F\\\u003C 1.5 x ULN.\n* APTT, INR, PT =\u002F\\\u003C 1.5 x ULN.\n* TSH =\u002F\\\u003C ULN.\n* Myocardial enzymes in the normal range.\n* LVEF =\u002F\\> 50%.\n\nExclusion Criteria:\n\n* Patients received other antitumor adjuvant therapy after surgical resection.\n* Concurrent malignancy (except cured basal cell carcinoma of the skin).\n* Patients was diagnosed cervical esophageal carcinoma.\n* Patients who have received prior targeted therapy (anti-VEGF\u002FVEGFR) or immunity therapy (anti-PD-1\u002FPD-L1\u002FCTLA-4).\n* Patients who are allergic to other monoclonal antibodies.\n* Patients with a history of immunodeficiency (or active autoimmue disease), or other acquired congenital immunodeficiency diseases.\n* Immunosuppressant, systemic, or absorbable local hormone therapy (\\> 10mg\u002F day of prednisone or other equivalent hormone) is required for immunosuppression and continued within 2 weeks of initial administration.\n* Patients with multiple factors affecting oral administration.\n* Uncontrolled pleural effusion, pericardial effusion or ascites that requires repeated drainage.\n* With bleeding tendency. Patients with any bleeding or bleeding event CTC AE grade 3 in the 4 weeks prior to initial administration. The presence of digestive diseases or active bleeding of unresected tumors, or other conditions that the investigator determined which could lead to gastrointestinal bleeding or perforation.\n* Active or untreated CNS metastases as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments.\n* Patients with hypertension who could not be well controlled by antihypertensive drugs (systolic blood pressure \\> 160 mmHg, diastolic blood pressure \\> 100 mmHg).\n* Patients with myocardial infarction, myocardial ischemia, arrhythmias with poor control (including QTC interval male \\> 450 ms, female\\> 470 ms) and cardiac insufficiency of grade II according to NYHA standard.\n* Active or uncontrolled severe infection (≥ CTC AE Grade 2 infection).\n* HIV test positive.\n* Proteinuria =\u002F\\>2+ and confirmed 24-hour urinary protein quantification \\> 1.0 g.\n* Vaccination with prophylactic or attenuated vaccine within 4 weeks prior to initial administration.\n* According to the investigators' judgment, there are factors that endanger patient or prevent patients from completing the study.",{"count":231,"type":21},[24],"This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma (ESCC) Patients as Postoperative Adjuvant Therapy. In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with TQB2450 Injection in treatment of patients with ESCC. The primary endpoint is disease free survival (DFS).",[529,530,531,494,532,495,497,97,32,533,534],"Esophageal Squamous Cell Carcinoma","Esophageal Neoplasms","Esophageal Diseases","Gastrointestinal Diseases","Neoplasms, Squamous Cell","Carcinoma, Squamous Cell","2022-12-14",{"date":537,"type":39},"2022-12-16",{"date":539,"type":39},"2022-06-02",{"date":541,"type":21},"2026-11",{"name":543,"class":144},"Jiangxi Provincial Cancer Hospital"]