[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Canadian Cancer Trials Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":547},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,38,67,90,112,139,158,178,199,219,238,259,278,298,319,338,357,378,401,427,447,467,487,505,527],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":4},"100564522","canadian-initiative-to-measure-predict-and-assess-cancer-treatment-outcomes-in-patients-treated-with-immuno-oncotherapeutics-100564522",false,"NCT06630273","Canadian Initiative to Measure, Predict and Assess Cancer Treatment Outcomes in Patients Treated With Immuno-Oncotherapeutics","(CAN-IMPACT-IO","Inclusion Criteria:\n\n* Willingness to submit a blood sample for buffy-coat and at least one tumour biospecimen.\n* CAN-PREDICT-IO subgroup:\n\nProvision of pre-treatment fresh tumour biopsy\u002Fresection tumour tissue for patients who will receive IO treatment, in a specified list of IO therapeutic trials currently active in CCTG.\n\nOR\n\n* CAN-PIVOT subgroup:\n\nProvision of on-treatment or at-progression fresh tumour biopsy\u002Fresection tumour tissue for patients who have received IO treatment, in a specified list of IO therapeutic trials currently active in CCTG.\n\nThere are 2 CAN-PIVOT subgroups: Primary resistance is defined as disease progression evident in initial on-treatment imaging or disease stability lasting less than six months. Acquired resistance, on the other hand, manifests as disease progression subsequent to an initial partial or complete response or after a period of disease stability lasting six months or more. Patients on adjuvant treatment, with no evidence of disease (NED) by radiological assessment who develop disease (local recurrence or metastases) after or while on immunotherapy are included.\n\n* Archived formalin fixed paraffin embedded (FFPE) blocks or slides would only be collected from patients who met CAN-IMPACT-IO study criteria and underwent fresh tumour biopsy\u002Fresection following consent but had a tumour specimen deemed insufficient for WGTS. The FFPE sample may be used to provide an alternate source of tumour tissue for WGTS in such cases. Where local centre regulations prohibit submission of blocks of tumour tissue, a predetermined number of unstained slides of representative tumour tissue may substitute the tumour block.\n* Participant consent for the CAN-IMPACT-IO study must be appropriately obtained in accordance with applicable local and regulatory requirements.","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","OBSERVATIONAL","The researchers doing this study are interested in doing the following:\n\n* Biomarker research using fresh tumour tissue and normal blood cells, and if required, tumour tissue already collected.\n* Bio-banking for use in future research using the collected tumour tissue \u002F blood .",[25],"Carcinoma","NOT_YET_RECRUITING","2026-06-29",{"date":29,"type":30},"2026-06-30","ACTUAL",{"date":32,"type":21},"2026-07-31",{"date":34,"type":21},"2027-12-31",{"name":36,"class":37},"Canadian Cancer Trials Group","NETWORK",{"id":39,"slug":40,"hasResults":12,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100475367","smartphone-app-based-mindfulness-intervention-for-french-and-english-speaker-cancer-survivors-100475367","NCT05470010","Smartphone App-Based Mindfulness Intervention for French and English Speaker Cancer Survivors","The SEAMLESS Study: A Pragmatic Multi-Site Randomized Waitlist-Controlled Trial of a Smartphone App-Based Mindfulness Intervention for French and English Speaker Cancer Survivors","SEAMLESS","Inclusion Criteria:\n\n* Adult ≥ 18 years\n* Diagnosed with any type of cancer (stages I-IV)\n* Completed primary treatment (i.e. surgery, chemotherapy, radiation therapy) at least 2 weeks (14days) prior. Note: ongoing maintenance therapy, hormone-blocking therapies, intermittent bone-modifying agents, herceptin and targeted therapy with trastuzumab are not exclusionary.\n* Have access to a smartphone with data or wifi connection.\n* Willing to devote 20-30 mins of time to mindfulness practices daily during the 4-week intervention period.\n* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form (e-consent) prior to enrollment in the study to document their willingness to participate.\n* Participant is able (i.e. sufficiently fluent) and willing to complete the MBCS Journey and outcome measures in either English or French. The baseline assessment must be completed within required timelines, prior to randomization.\n* In accordance with CCTG policy, protocol intervention is intended to begin within 7 calendar days of patient randomization.\n* Participants must be willing to complete the MBCS Journey and complete the follow-up questionnaires\n\nExclusion Criteria:\n\n* Major communication difficulties at the time of recruitment, as assessed by the research team (e.g. severe hearing impairment or cognitive impairment (score of ≤ 6; as assessed by the centre CRA using the three questions from the Brief Screen for Cognitive Impairment (BSCI)) listed in the screening CRF, which could interfere with completing the intervention and\u002For the questionnaires (i.e. inability to read or write)\n* Suffering from untreated Major Depressive Disorder or other psychiatric disorders that would interfere with participation. (Note: Participants will be referred for treatment and invited to call back once in remission).\n* Previous experience practicing in-person or app-based mindfulness once a week or more within the last year.",{"count":47,"type":21},345,"INTERVENTIONAL",[50],"NA","There is a need to develop, evaluate, and disseminate self-directed, easily accessible, safe, affordable, and effective psychosocial interventions to people living with cancer (PLWC) post-treatment. Smartphone app-based health interventions are an innovative way to deliver psychosocial cancer-care. The Mindfulness-Based Cancer Survivorship (MBCS) Journey app is a mobile app format of the Mindfulness-based Cancer Recovery program. In the SEAMLESS Study, the investigators aim to evaluate the MBCS Journey app (a 4 week mind-body intervention) in cancer survivors post-treatment. This is a randomized wait-list controlled trial. Participants will either be assigned into the immediate group (will receive intervention immediately after enrollment) or the waitlist group (wait for 3 months before receiving the intervention).",[53,54],"Cancer","Psychological",[56,57,58],"Cancer survivors","Smartphone app","Mindfulness","RECRUITING",{"date":29,"type":30},{"date":62,"type":30},"2025-03-07",{"date":64,"type":21},"2026-12-31",{"name":36,"class":37},7,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":48,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100604692","phase-3-botensilimab--balstilimab-vs-best-supportive-care-as-therapy-in-chemo-refractory-unresectable-colorectal-adenocarcinoma-100604692","NCT07152821","Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma","Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma: The BATTMAN Trial","BATTMAN","Inclusion Criteria:\n\n* Must have histologically confirmed colorectal adenocarcinoma that is not deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H).\n* Received and failed all prior available therapies, such that the standard of care for the patient would be best supportive care (BSC).\n* Must have an Eastern Cooperative Oncology Group (ECOG) performance status 0, or 1.\n* Must have presence of measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1).\n* A life expectancy of ≥ 12 weeks at the time of study entry.\n* Must be ≥ 18 years of age.\n* Participants must consent to provision of, and investigator must agree to submit, a representative archival formalin fixed paraffin block of tumour tissue for correlative analyses when tumour tissue is available.\n* Participants must have adequate organ and marrow function measured within 14 days prior to randomization.\n* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and health utility questionnaires in either English or French.\n* Participant consent must be appropriately obtained in accordance with applicable local and national regulatory requirements.\n* Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.\n* In accordance with CCTG policy, protocol treatment is to begin within 2 working days of participant enrolment.\n* Participants of childbearing potential or partners of participants of childbearing potential must have agreed to use a highly effective contraceptive method\n\nExclusion Criteria:\n\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen may be eligible for this trial, however, consultation with CCTG in advance of enrolment is required.\n* A history of primary immunodeficiency, solid organ transplant or allogeneic bone marrow transplant.\n* Current or prior use of immunosuppressive medication within 7 days before the first dose of study drugs, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid.\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease that has required systemic treatment within 2 years of the start of study drug.\n* Active or uncontrolled intercurrent illness.\n* Active brain metastases or leptomeningeal metastases.\n* Receipt of live attenuated vaccination administered within 30 days prior to randomization.\n* Lactating women who choose to breast feed.\n* Any active disease condition which would render the protocol treatment dangerous or impair the ability of the participant to receive protocol therapy.\n* Any condition that does not permit compliance with the protocol.\n* Receipt of anti-cancer chemotherapy or biologic therapy within the lesser of i) 21 days, or ii) the usual cycle length of the regimen prior to the first planned dose of study drug.\n* Receipt of radiotherapy or investigational agents within four weeks of first planned dose of study drug.\n* Any unresolved toxicity (≥ CTCAE grade 2) from previous anti-cancer therapy.\n* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n* History of partial or complete bowel obstruction within the last 3 months prior to study enrolment, signs\u002Fsymptoms of bowel obstruction or known radiologic evidence of impending obstruction.\n* Refractory ascites defined as requiring 2 or more therapeutic paracenteses within the last 4 weeks or ≥ 4 times within the last 3 months or ≥ 1 time within the last 2 weeks or requiring diuretics within 2 weeks prior to study enrolment.\n* Active or ongoing diarrhea of CTCAE grade 2 or higher.\n* Tumour is mismatch repair deficient (dMMR) or microsatellite instability- high (MSI-H) per a standard local testing method.\n* Prior exposure to anti-PD-1\u002FPD-L1\u002FCTLA-4 therapy.",{"count":76,"type":21},834,[78],"PHASE3","This study is being done to answer the main question of: Do patients with colorectal cancer that cannot be removed by surgery, that is treated with two new immunotherapy drugs, botensilimab and balstilimab, live longer? Other important questions include: Is their quality of life better? Do their tumours slow in growth or possibly shrink in size? Are there markers in their tumour or blood that can predict whether they achieve any of these benefits? In addition, the study is done to confirm the safety of these immunotherapy drugs and to determine how long it takes for the body to metabolize them.",[81],"Colorectal Cancer","2026-06-26",{"date":27,"type":30},{"date":85,"type":30},"2026-03-31",{"date":87,"type":21},"2029-06-30",{"name":36,"class":37},55,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":48,"phases":99,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100350810","phase-2-a-phase-ii-study-of-durvalumab-treatment---substudy-a-in-patients-who-discontinued-prior-checkpoint-therapy-due-to-immune-related-toxicity---substudy-b-for-continued-treatment---tremelimumab-of-patients-previously-enrolled-to-completed-cctg-studies-100350810","NCT03847649","A Phase II Study of Durvalumab Treatment - Substudy A: In Patients Who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity - Substudy B: For Continued Treatment (+\u002F- Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies","A Phase II Study of Durvalumab Treatment Substudy A: In Patients Who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity Substudy B: For Continued Treatment (+\u002F- Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies","Substudy A: Inclusion Criteria:\n\n* Patients must have histologically and\u002For cytologically confirmed solid tumour, that is advanced\u002F metastatic\u002Frecurrent or unresectable and for which no curative therapy exists.\n* Patients must live within Canada and have received durvalumab alone, or durvalumab in combination with tremelimumab, with or without chemotherapy\u002Ftargeted therapy. Patients who have received other anti PD-1\u002FPD-L1 agents +\u002F- anti CTLA agents are eligible, providing full details of prior therapy, toxicity and management are available. Consult with CCTG for further details.\n* Patients must have previously discontinued immunotherapy due to an irAE.\n* Immune-related adverse events must have resolved to ≤ grade 1 or baseline and patient must have completed corticosteroid therapy at least 28 days prior to registration in this current study.\n* Complete response, partial response or prolonged stable disease (SD ≥ 8 weeks) to initial immunotherapy. Patients that received prior adjuvant\u002Fneoadjuvant\u002Fconsolidation immunotherapy are eligible providing there has been at least a 6 month treatment free interval prior to enrollment and patient has received at least one standard-of-care chemotherapy regimen in the palliative setting (discuss with CCTG if chemotherapy is not considered standard of care or not indicated or patient refused\u002Fnot eligible as such patients are eligible).\n* Patients must have a life expectancy of at least 12 weeks.\n* Tumour material may have already been submitted to CCTG for the initial trial. If an additional formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour) is available from tissue collected after immunotherapy discontinuation, patients must have provided informed consent for the release of the block. All patients must have provided informed consent for correlative studies. If patients from non-CCTG trials or commercial use are eventually enrolled, tumour material is also required if available, preferably from tissue collected after immunotherapy discontinuation.\n* Presence of clinically and\u002For radiologically documented disease. All radiology studies must be performed within 28 days prior to enrollment (within 35 days if negative). Patients ideally should have measurable disease.\n* ECOG performance status 0 or 1\n* Previous Therapy\n* Patients who received other relevant standard cancer therapies since discontinuing immunotherapy remain eligible for inclusion as follows:\n\n  * Patients may have received prior cytotoxic chemotherapy following discontinuation of immunotherapy for irAE.\n  * Patients may have received other prior therapies such as tyrosine kinase inhibitors or other targeted agents, following discontinuation of immunotherapy for irAE.\n  * Patients may not have received subsequent immune checkpoint inhibitors (anti-PD-(L)1 and anti-CTLA-4) following discontinuation of immunotherapy for irAE. Vaccines and oncolytic viruses are permitted.\n* Patients must have recovered from all reversible toxicity related to prior chemotherapy or systemic therapy (unless grade 1, irreversible, or considered by investigator as not clinically significant) and have adequate washout as follows: Longest of one of the following:\n\n  * Two weeks;\n  * 5 half-lives for investigational agents;\n  * Standard cycle length of standard therapies.\n* Prior external beam radiation is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and date of enrollment. Exceptions may be made for low-dose, non-myelosuppressive radiotherapy after consultation with CCTG. Concurrent radiotherapy is not permitted.\n* Previous surgery is permitted provided that a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of enrollment, and that wound healing has occurred.\n* Absolute neutrophils ≥ 1.5 x 10\\^9\u002FL\n* Platelets ≥ 100 x 10\\^9\u002FL\n* Hemoglobin ≥ 90 g\u002FL\n* Bilirubin ≤ 1.5 x ULN (upper limit of normal)\n* AST and ALT ≤ 2.5 x ULN - ≤ 5.0 x ULN (if patient has liver metastases)\n* Serum creatinine \\\u003C 1.25 x ULN or\n* Creatinine clearance ≥ 40 mL\u002Fmin\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.\n* Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial.\n* In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient enrollment\n* Women\u002Fmen of childbearing potential must have agreed to use a highly effective contraceptive method\n* Subjects should not donate blood while participating in this study, or for at least 90 days following the last infusion of durvalumab\n\nExclusion Criteria:\n\n* In general, patients with prior grade 4 non-hematological, non-endocrine immune-related adverse events are not eligible.\n* History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of enrollment.\n* Live attenuated vaccination administered within 30 days prior to enrollment or within 30 days of receiving durvalumab.\n* History of hypersensitivity to durvalumab or any excipient.\n* Any immune-related adverse event that required biologic agents such as infliximab, or mycophenolate motefil to manage.\n* Documented progressive disease (PD) while on initial immunotherapy. Exception: patients who had iUPD but continued on immunotherapy, and did not have documented iCPD within 8 weeks of discontinuing immunotherapy\n* Patients who have experienced untreated and\u002For uncontrolled cardiovascular conditions and\u002For have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, should have a LVEF ≥ 50%.\n* Concurrent treatment with other investigational drugs or anti-cancer therapy.\n* Patients with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol (including corticosteroid administration), or would put the patient at risk. This includes but is not limited to:\n\n  * History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements.\n  * Active infection requiring systemic therapy; (including any patient known to have active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) or tuberculosis or any infection requiring systemic therapy).\n  * Active peptic ulcer disease or gastritis.\n  * Untreated symptomatic brain metastases or brain metastases in whom radiation or surgery is indicated.\n  * Patients with diabetes mellitus are eligible but must be clinically stable on therapy (if applicable) and investigator and patient should be aware of the potential risk of immune mediated pancreatic toxicity and B cell destruction.\n* Pregnant or lactating women\n\nSubstudy B: Inclusion Criteria\n\n* Patients must be currently enrolled and receiving active treatment on a treatment arm containing durvalumab +\u002F- tremelimumab with or without maintenance pemetrexed with no contraindications to continue receiving their current study regimen according to the protocol to which the patient is currently enrolled.\n* For BR.34 ONLY: patients who have disease progression (iUPD) on durvalumab may receive one dose of tremelimumab (75 mg) along with their next durvalumab infusion as long as all the following criteria are met:\n\n  * Patient is clinically stable\n  * According to the judgement of the treating physician, the patient had clinical benefit while receiving tremelimumab in the induction phase on BR.34\n  * ECOG performance status of 0 or 1\n  * Laboratory values meet the criteria below:\n\nAbsolute neutrophils ≥ 1.5 x 10\\^9\u002FL Platelets ≥ 100 x 10\\^9\u002FL Hemoglobin ≥ 90 g\u002FL Bilirubin ≤ 1.5 x ULN (upper limit of normal)\\* AST and ALT ≤ 2.5 x ULN (if liver metastases are present, ≤ 5.0 x ULN) Serum creatinine \\\u003C 1.25 x ULN or Creatinine clearance ≥ 45 mL\u002Fmin",{"count":98,"type":21},60,[100],"PHASE2","I238A: The purpose of this study is to find out what effects being treated with durvalumab has on cancer. The researchers doing this study also want to evaluate if prednisone (a type of steroid), when given together with durvalumab, can reduce any side effects.\n\nI238B: The purpose of this study is to allow patients previously enrolled on a completed CCTG trial to continue treatment with durvalumab (+\u002F- tremelimumab)",[53],"2026-06-15",{"date":105,"type":30},"2026-06-17",{"date":107,"type":30},"2020-03-09",{"date":109,"type":21},"2031-04-30",{"name":36,"class":37},12,{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":120,"minAge":18,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":48,"phases":123,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100561650","phase-3-docetaxel-to-androgen-receptor-pathway-inhibitors-in-patients-with-metastatic-castration-sensitive-prostate-cancer-and-suboptimal-psa-response-100561650","NCT06592924","Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response","A Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response","TRIPLE-SWITCH","Inclusion Criteria:\n\n* Histologically\u002Fcytologically confirmed adenocarcinoma of the prostate or participants with a PSA \\>100 ng\u002Fml (100 ug\u002FL) and radiographic evidence of metastatic disease at diagnosis.\n* Metastatic disease by conventional imaging (bone scan or CT and\u002For MRI or PSMA-PET scan at the time of ADT initiation.\n* PSA of ≥ 2.0 ng\u002Fml (2.0 ug\u002FL) prior to commencement of ADT (this refers to patients who have histologically\u002Fcytologically confirmed adenocarcinoma of the prostate)\n* Patients will have recovered from any treatment-related toxicities prior to enrollment (unless ≤ grade 1, irreversible, or considered by investigator as not clinically significant).\n* Patients may enroll with persistent toxicities attributable to ADT, including hot flushes and fatigue, of any grade, provided these toxicities are clinically stable, not rapidly worsening, and not considered by the Investigator to pose a safety risk or impair the patient's ability to comply with study procedures. Such toxicities do not need to resolve to Grade ≤1 prior to study entry.\n* Receipt of ADT for mCSPC for at least 6 months and no greater than 12 months (+\u002F- 3 weeks) at time of enrollment.\n* Receipt of ARPI (e.g. abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for at least 4 months (+\u002F- 2 weeks) at time of enrollment\n* Patients may have had radiotherapy to prostatic bed and\u002For metastatic sites prior to enrollment. Potential trial participants should have recovered from radiotherapy-related toxicities prior to enrollment.\n* Serum testosterone \\\u003C1.7 nmol\u002FL or 50 ng\u002FdL.\n* PSA ≥ 0.2 ng\u002Fml (0.2 ug\u002FL) within 28 days of enrollment.\n* Candidate for docetaxel chemotherapy\n* ECOG Performance Status (PS) 0 to 2.\n* Adequate organ and marrow function measured within 28 days prior to enrollment.\n* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate.\n* Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.\n* In accordance with CCTG policy, protocol treatment is to begin within 10 working days of participant enrollment.\n* If the participant and the participant's partner are of childbearing potential, they must agree to use medically accepted methods of contraception\n* HIV-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Participant access to all protocol therapies must be confirmed prior to enrollment\n\nExclusion Criteria:\n\n* Confirmed PSA progression, defined by an increase in PSA of 25% above the nadir since achieving castration on ADT, an absolute increase in PSA value of 2.0 ng\u002Fml (ug\u002FL) above nadir, and a subsequent increase in PSA of 25% further separated by 3 or more weeks.\n* Evidence of confirmed radiographic progression or clinical progression since start of ADT. Participants may be enrolled on the study if, in the opinion of the investigator, any new bone lesions on bone scan and CT represent flare or treatment effect.\n* Docetaxel criteria:\n\n  * Prior treatment with taxane chemotherapy\n  * Grade 2 or worse peripheral neuropathy\n  * Severe hypersensitivity to drugs formulated with polysorbate 80\n* Clinically significant cardiac disease including:\n\n  * History of unstable angina pectoris, symptomatic pericarditis, or myocardial infarction within 6 months prior to study entry.\n  * History of documented congestive heart failure (New York Heart Association functions classification III-IV).\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous.\n* Patients with a prior or concurrent malignancy whose natural history of treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Concurrent treatment with other anti-cancer systemic therapy other than ADT and ARPI.\n* Live attenuated vaccination administered within 30 days prior to enrollment\u002Frandomization.\n* For participants with a history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* High-grade neuroendocrine prostate cancer or small cell features (except if a participant has no histological diagnosis but a PSA \\>100 ng\u002Fml (\\>100 ug\u002FL) at diagnosis and radiographic evidence of metastatic disease)","MALE",{"count":122,"type":21},830,[78],"This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs?\n\nThis study would like to find out if this approach is better or worse than the usual approach for prostate cancer.\n\nThe usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI).",[126],"Prostate Cancer (Adenocarcinoma)",[128,129],"PR26","Castration sensitive","2026-06-09",{"date":132,"type":30},"2026-06-10",{"date":134,"type":30},"2025-05-28",{"date":136,"type":21},"2031-04-15",{"name":36,"class":37},368,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},"100622962","feasibility-and-acceptability-of-collecting-sociodemographic-data-in-cctg-trials-100622962","NCT07390435","Feasibility and Acceptability of Collecting Sociodemographic Data in CCTG Trials","FACTOR","Inclusion Criteria:\n\n* Adults (≥18 years) who are either:\n\n  * Currently being screened and consented to a CCTG trial (prospective).\n  * Already enrolled in an ongoing CCTG trial and still under follow-up (retrospective).\n\nExclusion Criteria:\n\n* Participants already enrolled or expected to enroll in a CCTG trial that is also collecting the SDoH Questionnaire.",{"count":147,"type":21},1000,"This study is being done to answer the following question: Are patients on a clinical trial willing to provide answers to questions about their social, economic, and environmental factors-sometimes called social determinants of health-which affect people's health experiences and access to care. These factors may include income, education, employment, housing, social supports, and experiences with discrimination or stress. Participation will help researchers better understand barriers to participating in clinical trials and access to health care.",[53],"2026-06-08",{"date":130,"type":30},{"date":153,"type":30},"2026-05-15",{"date":155,"type":21},"2027-06-30",{"name":36,"class":37},4,{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":48,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":111},"100583761","phase-2-stride-durvalumab--tremelimumab-with-lenvatinib-vs-stride-alone-in-unresectable-hepatocellular-carcinoma-100583761","NCT06880523","STRIDE (Durvalumab + Tremelimumab) With Lenvatinib vs STRIDE Alone in Unresectable Hepatocellular Carcinoma","A Phase II Study of STRIDE (Durvalumab + Tremelimumab) With Lenvatinib Versus STRIDE Alone in Patients With Unresectable Hepatocellular Carcinoma (SLIDE-HCC)","SLIDE-HCC","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Body weight \\> 30 kg.\n* Life expectancy of at least 12 weeks.\n* Confirmed HCC based on histopathological findings from tumour tissues or clinically by AASLD criteria in cirrhotic participants.\n* Must not have received prior systemic therapy for HCC.\n* Must not be eligible for locoregional therapy for unresectable HCC. For patients who progressed after locoregional therapy for HCC, locoregional therapy must have been completed ≥28 days prior to the baseline scan of the abdomen and pelvis for the current study.\n* Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.\n* Child-Pugh Score class A or B7 based on low albumin (albumin 25-27 g\u002FL) only.\n* Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* At least 1 measurable lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have a short axis ≥15 mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines. A lesion which progressed after previous ablation or TACE could be measurable if it meets these criteria.\n* Participants with active HBV infection \\[characterized by positive hepatitis B virus surface antigen (HBsAg) and\u002For positive hepatitis B core antibodies (anti-HBcAb) with detectable HBV deoxyribonucleic acid (DNA) (≥10 IU\u002FmL or above the limit of detection per local lab standard)\\] are eligible if:\n* The participant is being treated with antiviral therapy, as per institutional practice. The HBV antiviral therapy must be initiated prior to randomization, and the participant must remain on antiviral therapy for the study duration and for 6 months after the last dose of study medication.\n* The participant must show evidence of HBV stabilization or signs of viral response (eg, reduction of HBV DNA levels) prior to enrollment\n* Participants who test positive for HBsAg or anti-hepatitis B core (HBc) with undetectable HBV DNA (\\\u003C 10 IU\u002FmL or under the limit of detection per local lab standard) are eligible and do not require antiviral therapy prior to randomization.\n* These participants will be tested at every cycle to monitor HBV DNA levels and initiate antiviral therapy if HBV DNA is detected (≥ 10 IU\u002FmL or above the limit of detection per local lab standard).\n* If HBV DNA becomes detectable during study treatment, antiviral therapy must be initiated, and the participant must remain on antiviral therapy during the study treatment period and for 6 months after the last dose of study medication.\n* Participants with active HCV infection (as characterized by the presence of detectable HCV ribonucleic acid \\[RNA\\] or anti-HCV antibody \\[anti-HCV\\]) must be managed per local institutional practice for the study and for 6 months after the last dose of study treatment.\n* Adequate organ and marrow function, within 14 days prior to enrollment.\n* Participants of childbearing potential must have agreed to use a highly effective contraceptive method from enrollment to 90 days after the last dose of durvalumab or 180 days after the last dose of tremelimumab (whichever date is later).\n* Participants must agree not to donate blood for at least 90 days following the last infusion of durvalumab or tremelimumab, or until 7 days after the last dose of lenvatinib, whichever is longest.\n\nExclusion Criteria:\n\n* Participants with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other tumours curatively treated with no evidence of disease for ≥ 5 years.\n* Any concurrent chemotherapy, study drug, or biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n* Known fibrolamellar HCC, sarcomatoid HCC, infiltrative-type HCC or mixed cholangiocarcinoma and HCC.\n* Clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention\n* Uncontrolled arterial hypertension defined by a systolic pressure ≥ 150 mm Hg or diastolic pressure ≥ 90 mm Hg or other hypertensive cardiovascular complications despite standard medical management.\n* Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab, or an anti-CTLA4, including tremelimumab.\n* History of primary immunodeficiency, history of organ transplant or prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.\n* Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n* Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab\n* Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), diverticulitis (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\n* Patients with active or uncontrolled intercurrent illness\n* History of leptomeningeal carcinomatosis.\n* Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and\u002For corticosteroids.\n* Major surgical procedure (as defined by the Investigator) within 28 days prior to enrollment.\n* Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).\n* Receipt of live attenuated vaccination (examples include, but are not limited to, vaccines for measles, mumps, and rubella, live attenuated influenza vaccine (nasal), chicken pox vaccine, oral polio vaccine, rotavirus vaccine, yellow fever vaccine, BCG vaccine, typhoid vaccine and typhus vaccine) within 30 days prior to enrollment.\n* Lactating participants.\n* Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.\n* Receipt of radiotherapy within four weeks of first planned dose of durvalumab or tremelimumab, except for a single dose of radiation up to 8 Gray (equal to 800 RAD) delivered with palliative intent for pain control up to 14 days before enrollment.\n* Active or prior documented GI bleeding (e.g. esophageal varices or ulcer bleeding) within 6 months. (Note: For patients with a history of GI bleeding more than 6 months prior or assessed as high risk for esophageal varices by the Investigator or main trunk portal vein thrombosis (Vp4), adequate endoscopic assessment and treatment of varices as per institutional standards is required prior to enrollment.)",{"count":167,"type":21},140,[100],"The purpose of this study is to compare the effects on participants' and liver cancer by adding a drug that is used on its own to treat this disease to a combination of two other drugs which is also used to treat liver cancer, compared to the two-drug combination alone.",[171],"Hepatocellular Carcinoma",{"date":130,"type":30},{"date":174,"type":30},"2025-10-21",{"date":176,"type":21},"2028-12-31",{"name":36,"class":37},{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":48,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},"100568864","phase-3-radiotherapy-to-block-oligoprogression-in-metastatic-non-small-cell-lung-cancer-100568864","NCT06686771","Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer","Consolidative Use of Radiotherapy to Block (CURB2) Oligoprogression In Patients With Metastatic Non-Small-Cell Lung Cancer","CURB2","Inclusion Criteria:\n\n* Metastatic disease (stage IV) detected on imaging and histologically and\u002For cytologically confirmed NSCLC as per the WHO Classification of Tumors and AJCC 8th Edition TNM Classification, without a driver mutation with an actionable first-line targeted therapy, for whom either ICI alone or combination ICI + chemotherapy is indicated\n* Oligoprogression on first-line ICI +\u002F- chemotherapy systemic therapy after at least 3 cycles.\n* All sites of oligoprogression can be safely treated with SBRT or ablative radiotherapy as determined by radiation treatment preplan, including availability and tolerability of necessary technologies (e.g., active breathing control, MRLinac, fiducial insertion, etc.) and accounting for previous radiotherapy overlap. Safety must be assessed and determined by a radiation oncologist.\n* Patients with treated CNS disease who have radiologic and clinical evidence of stable brain metastases, with no evidence of cavitation or hemorrhage in the brain lesion, are eligible providing that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to randomization).\n* Candidate for regulatory approved SOC first-line orsecond-line systemic therapy options.\n* Participants must be ≥ 18 years of age.\n* ECOG performance status of 0, 1 or 2.\n* Participants that received prior adjuvant\u002Fneoadjuvant\u002Fconsolidation systemic therapy (including chemotherapy and ICI ) are eligible if at least 6 months have elapsed between the completion of prior therapy and start of first-line treatment for metastatic disease.\n* Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior systemic therapy. If participants experienced prior immune-mediated toxicity and have not yet re-initiated ICI therapy, please contact CCTG. Please also contact CCTG if participants have ongoing toxicity ≥ grade 1 felt to be clinically insignificant.\n* Previous surgery related to NSCLC in the curative or metastatic disease setting is permitted. Previous major surgery is permitted provided that surgery occurred at least 28 days prior to participant enrollment and that wound healing has occurred.\n* Prior external beam radiation related to NSCLC in the metastatic disease setting is permitted provided a minimum of 14 days (2 weeks) have elapsed between the last dose of radiation and date of enrollment. Patients that received prior external beam radiation therapy in the NSCLC curative disease setting (including the primary lesion) are eligible. Oligoprogressive lesions previously treated with external beam radiation are eligible as long they are clinically asymptomatic, and re-treatment is possible according to the investigator.\n* Prior conventional, non-stereotactic radiotherapy for palliative purposes is allowed, and if the palliated lesion subsequently progressed but asymptomatic not requiring immediate RT, the lesion can still be counted toward one of the five oligoprogressive lesions.\n* For Arm 1, SBRT must be initiated within 3 weeks of participant enrollment.\n* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and\u002For health utility questionnaires in either English, French, or Spanish.\n* Reimbursement of continued SOC ICI and chemotherapy systemic therapies may not be uniform across all sites. In the event that site\u002Finvestigator is unable to provide access to the drug, participant will not be eligible for this trial.\n* Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.\n* Participants of childbearing potential must have agreed to use a highly effective contraceptive method.\n\nExclusion Criteria:\n\n* Large-cell neuroendocrine carcinoma (LCNEC), pulmonary carcinoid tumour or mixed small cell and non-small cell lung cancer are not eligible.\n* Presence of leptomeningeal disease.\n* Pregnancy.\n* Serious medical conditions in which radiotherapy of target lesions is contraindicated (e.g., scleroderma, Ataxia Telangiectasia (ATM), interstitial lung disease (ILD), Child-Pugh C liver function).\n* Any other condition in which in the judgement of the investigator would make the patient inappropriate for study entry.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Concomitant medications should only exclude participants from trial participation when clinically relevant known or predicted drug-drug interactions or potential overlapping toxicities will impact safety or efficacy; please consult the relevant product monographies.\n* Concurrent treatment with other anti-cancer therapy, including investigational agents.\n* Live attenuated vaccination administered within 30 days prior to enrollment\u002Frandomization.",{"count":187,"type":21},320,[78],"This study is being done to answer the following question: Can the chance of lung cancer growing or spreading be lowered by adding targeted radiotherapy to the usual combination of drugs?\n\nThis study is being done to find out if this approach is better or worse than the usual approach for lung cancer. The usual approach is defined as the care most people get for non-small cell lung cancer.",[191],"Non-small Cell Lung Cancer",{"date":130,"type":30},{"date":194,"type":30},"2025-12-16",{"date":196,"type":21},"2030-12-31",{"name":36,"class":37},74,{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":48,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":218},"100565408","phase-3-palliative-steroeotactic-body-radiotherapy-vs-palliative-standard-radiotherapy-in-patients-with-advanced-head-and-neck-cancer-100565408","NCT06641791","Palliative Steroeotactic Body Radiotherapy vs Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer","A Phase III Randomized Controlled Trial Comparing Palliative Stereotactic Body Radiotherapy vs. Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer","Inclusion Criteria:\n\n* Histologically confirmed mucosal squamous cell carcinoma (SCC) of the head and neck arising from at least one of the following sites: oro\u002Fhypopharynx, oral cavity, supraglottic larynx, maxillary sinus, nasal cavity, or unknown primary\n* Stages TX or T0-T4\u002FN0-N3\n* Must be considered unfit for curative intent RT as determined by the treating oncologist(s)\n* Geriatric 8 score \\\u003C14\n* Patient must be ≥18 years of age\n* Staging CT or MRI of the head and neck within 8 weeks prior to randomization\n* Chest CT or x-ray. PET CT is permitted if CT is of diagnostic quality.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3\n* Participants of childbearing potential must have agreed to use a highly effective contraceptive method during protocol therapy.\n* Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational treatment are eligible for this trial.\n\nExclusion Criteria:\n\n* Patients with nasopharyngeal carcinoma.\n* Prior systemic therapy (including immunotherapy).\n* Prior radiotherapy to the head and neck excluding superficial radiotherapy for head and neck skin cancer that does not overlap with current protocol treatment.\n* Prior head and neck cancer excluding skin cancer.\n* Patients with tumour locations\u002Fat risk of SBRT toxicity, including glottic\u002Fsubglottic larynx, T4 hypopharynx, post-cricoid, cervical esophagus, circumferential pharyngeal involvement, extension\u002Fproximity to brain\u002Foptic structures, any single tumour mass \\>8 cm (in one dimension).\n* \\> 2 nodal levels (Level 1a\u002Fb not counted); retropharyngeal lymph nodes (where the closest edge is \\\u003C 2cm from the closest edge of CTV (primary or nodal) will not be considered as a different level). Note: a single lymph node mass that spans 2 levels will be considered as 1 level.\n* Gross tumour poorly visualized on CT\u002FMRI.\n* Definitive radiological or clinically evident distant metastases.\n* Scleroderma\u002FCREST syndrome.",{"count":207,"type":21},196,[78],"This study is being done to answer the following question: Does stereotactic body radiation therapy (SBRT) provide better cancer control compared to standard radiation therapy (RT) for those with advanced head and neck cancer?",[211],"Advanced Head and Neck Cancer",{"date":130,"type":30},{"date":214,"type":30},"2025-04-07",{"date":216,"type":21},"2031-06-01",{"name":36,"class":37},8,{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":48,"phases":228,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":234,"leadSponsor":236,"locationsCount":237},"100546154","phase-3-stereotactic-body-radiotherapy-vs-conventional-palliative-radiotherapy-for-painful-non-spine-bone-metastases-100546154","NCT06391242","Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone Metastases","A Randomized Phase III Trial Comparing Stereotactic Body Radiotherapy to Conventional Palliative Radiotherapy (SBRT) Versus Conventional Palliative Radiotherapy (CRT) for Participants With Painful Non-Spine Bone Metastases","Inclusion Criteria:\n\n* Histologic confirmation of solid tumour.\n* Patient with a dominant painful non-spine bone metastasis and a worst minimum pain score of 2 using the BPI attributed to that dominant site\n* Expected overall survival of greater than 6 months as determined by the treating physician\n* Suitable for protocol defined SBRT and CRT.\n* Stable pain with no immediate plan to alter analgesic regimen.\n* ECOG performance status of 0-2.\n* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrolment in the trial to document their willingness to participate\n\nExclusion Criteria:\n\n* Metastases of the hands, feet, cranium or spine (including sacrum) as the dominant\u002Findex pain site.\n* Bone metastasis arising from a small cell or germ cell.\n* Radionuclide therapy within 30 days of randomization.\n* Patient treated with prior palliative RT to the dominant painful bone metastasis site (prior radiation exposure is permitted if prior to development of the dominant metastasis and would not influence the applicability of either treatment arm of the current study).\n* Received systemic chemotherapy within 1 week of the protocol RT, or who are expected\u002Fplanned to receive chemotherapy within one week of completing protocol RT.\n* Participants with an unstable pathologic fracture at the dominant painful bone metastasis, or for whom surgical fixation would be the preferred intervention if possible.\n* Pregnant or lactating individuals.",{"count":227,"type":21},230,[78],"This study is being done to answer the following question: Is Stereotactic Body Radiation Therapy or SBRT (a form of radiation therapy which can deliver high doses of radiation to the specific painful area of the body most affected by cancer, while keeping the radiation beams away from the healthy parts of the body that surround the cancer) better for pain relief than the standard treatment of conventional radiation therapy or CRT (a form of radiation therapy which delivers radiation to the painful area but can also negatively affect other parts of the body in the same area)",[231],"Cancer Metastatic",{"date":130,"type":30},{"date":62,"type":30},{"date":235,"type":21},"2028-01-01",{"name":36,"class":37},9,{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":48,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":252,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":258},"100531875","phase-3-neoadjuvant-chemotherapy-excision-and-observation-vs-chemoradiotherapy-for-rectal-cancer-100531875","NCT06205485","Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer","A Phase 3 Randomized Trial Of Neoadjuvant Chemotherapy, Excision And Observation Versus Chemoradiotherapy For Early Rectal Cancer","NEO-RT","Inclusion Criteria:\n\n* Histologically confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient.\n* MRI stage cT1 not eligible for transanal surgery or cT2-T3ab\\*. \\* T3a: \\\u003C1mm depth invasion, T3b: 1-5mm depth of invasion.\n* cN0 stage based on pelvic MRI - including absence of radiographic evidence of mesorectal nodal metastasis, tumour deposits or extramural venous invasion (EMVI).\n* M0 stage based on no evidence of metastatic disease by CT imaging of chest, abdomen and pelvis.\n* Mid to low-lying tumour eligible for transanal excision in the opinion of the treating surgeon.\n* Medically fit to undergo radical TME surgery as per treating surgeon's decision.\n* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French or Spanish.\n* Age of at least 18 years.\n* No contraindications to protocol chemotherapy.\n* Adequate normal organ and marrow function: ANC ≥ x 10\\^9\u002FL; platelet count ≥ 100 x 10\\^9\u002FL; bilirubin \\\u003C 1.5 UNL, excluding Gilbert's syndrome; Estimated creatinine clearance of ≥ 50ml\u002Fmin\n* Patient must have an ECOG performance of \\\u003C2 (or Karnofsty ≥ 60%).\n* Must be accessible for treatment and follow-up\n* Males and females of reproductive potential must have agreed to use a highly effective contraceptive method during and for 6 months after completion of chemotherapy.\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n\nExclusion Criteria:\n\n* Pathologic high-risk factors on diagnostic biopsy: high histologic grade (poorly differentiated), mucinous or signet ring histology.\n* Patients with visible pelvic sidewall nodes on MRI.\n* Patients with unequivocal determination of nodal disease that, in the opinion of the investigator, would prohibit protocol therapy administration.\n* Previous pelvic radiation for any reason, including brachytherapy alone.\n* Patients who have had primary lesion excised prior to enrollment. If a patient has had partial excision prior to enrollment, there must be gross residual disease endoscopically for patient to be eligible.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Prior treatment for rectal cancer.\n* Patients with known dihydropyrimidine dehydrogenase deficiency (DYPD).\n* Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy\u002Fintervention prior to enrollment.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n* Any contra-indications to undergo MRI imaging.\n* Presence of anterior lesions above or near peritoneal reflection rendering the patient ineligible for a transanal tumour excision.\n* T3 tumours invading or abutting the internal sphincter.",{"count":247,"type":21},250,[78],"This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?",[251],"Rectal Cancer",{"date":130,"type":30},{"date":254,"type":30},"2024-06-26",{"date":256,"type":21},"2030-06-30",{"name":36,"class":37},109,{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":48,"phases":268,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":276,"locationsCount":277},"100519429","phase-2-paclitaxel-and-ramucirumab---zanidatamab-in-her2-postive-advanced-gastroesophageal-adenocarcinoma-100519429","NCT06043427","Paclitaxel and Ramucirumab +\u002F- Zanidatamab in HER2 Postive Advanced Gastroesophageal Adenocarcinoma","A Randomized Phase II Study of Paclitaxel and Ramucirumab +\u002F- Zanidatamab in HER2 Positive Advanced Gastroesophageal Adenocarcinoma","Inclusion Criteria:\n\n* Participants must have histologically or pathologically confirmed gastroesophageal adenocarcinoma (stomach, gastroesophageal junction or esophagus) that is unresectable or metastatic and which must be HER2 positive as confirmed by central testing using FDA-approved HER2 assay. HER2 positive is defined as IHC 3+, or IHC 2+ and FISH positive.\n* Participants must have received and failed at least one prior trastuzumab-containing regimen in combination with platinum-based chemotherapy for treatment of locally advanced or metastatic disease. Failure is defined as demonstrated objective disease progression (radiologic) on the most recently administered HER2 targeting agent.\n* Participants must have presence of measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1).\n* Participants must be considered a suitable candidate for, and able to receive chemotherapy for advanced disease with paclitaxel and ramucirumab.\n* Participants must consent to the provision of samples of blood, serum and plasma in order that the specific correlative marker assays may be conducted.\n* Participants must consent to provision of, and investigator(s) must confirm access to a representative formalin fixed paraffin embedded (FFPE) block of tumour tissue\u002F or a predetermined number of freshly cut slides of representative tumour tissue of adequate amount and quality in order that the central HER2 testing may be done\n* Participants must be ≥ 18 years of age.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Participants must have a life expectancy of at least 12 weeks at the time of study entry\n* Imaging investigations including CT\u002FMRI of chest\u002Fabdomen\u002Fpelvis or other scans as necessary to document all sites of disease must be done within 28 days prior to randomization\n* Participants must have adequate cardiac function by ECHO or MUGA defined as EF ≥ 50%. This is to be performed within 4 weeks (preferred) but no more than 8 weeks prior to randomization\n* Participants must have adequate normal organ and marrow function\n* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and\u002For health utility questionnaires in either English or French\n* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements.\n* Participant must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.\n* In accordance with CCTG policy, protocol treatment is to begin within 2 working days of participant enrollment\n* Participants of childbearing potential must have agreed to use a highly effective contraceptive method for the entire period of study treatment and for at least 7 months after discontinuing study therapy.\n\nExclusion Criteria:\n\n* Participants with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years. Patients with a history of other malignancies detected at an early stage and whom the investigator believes have been curatively treated and are at a low risk of recurrence MAY be eligible\n* Participants receiving therapy in a concurrent clinical study. Patients must agree not to participate in other clinical studies during their participation in this trial while on study treatment\n* Participants with active or uncontrolled intercurrent illness\n* Participants with human immunodeficiency virus infection (positive HIV 1\u002F2 antibodies), active hepatitis B infection (positive HBV surface antigen (HBsAg)) or positive for hepatitis C (HCV) antibody may be considered for enrollment, if infection is adequately controlled in the opinion of the investigator.\n* Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy\n* Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol\n* Any unresolved toxicity (CTCAE grade 2 or greater) from previous anti-cancer therapy which in the opinion of the investigator puts the participant at higher than expected risk during protocol treatment. However, participants with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational products in the Investigator's opinion may be included.",{"count":267,"type":21},168,[100],"This study is being done to answer the following question:\n\nCan the chance of gastroesophageal cancer growing or spreading be lowered by adding a drug called zanidatamab to the usual combination of drugs?\n\nWe are doing this study because we want to find out if this approach is better or worse than the usual approach for this type of cancer. The usual approach is defined as care most people get for gastroesophageal cancer",[271],"Gastroesophageal Adenocarcinoma",{"date":130,"type":30},{"date":274,"type":30},"2024-04-16",{"date":64,"type":21},{"name":36,"class":37},18,{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":285,"minAge":18,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":48,"phases":288,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":296,"locationsCount":297},"100488506","phase-2-adjuvant-therapy-in-pole-mutated-and-p53-wildtypensmp-early-stage-endometrial-cancer-rainbo-blue--taper-100488506","NCT05640999","Adjuvant Therapy in POLE-Mutated and p53-Wildtype\u002FNSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER","A Phase II Study of Tailored Adjuvant Therapy in POLE-Mutated and p53-Wildtype\u002FNSMP Early Stage Endormetrial Cancer (RAINBO BLUE & TAPER)","Inclusion Criteria:\n\n* Patients must have had surgery consisting of hysterectomy and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards. There must be no macroscopic residual disease after surgery.\n* Patients must have histologically confirmed Stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un\u002Fdedifferentiated, carcinosarcoma or mixed.\n* Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Patients' age must be ≥ 18 years.\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements.\n* Patient is able (i.e. sufficiently fluent) and willing to complete the patient-reported outcomes (PRO) questionnaires in either English, French or a validated language\n* Patients must be accessible for treatment and follow-up. Patients enrolled on this trial must be treated and followed at the participating centre\n* Protocol treatment is to begin within 10 weeks of hysterectomy\u002Fbilateral salpingo-oophorectomy\n\nExclusion Criteria:\n\n* Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.\n* Prior pelvic radiation.\n* Patients with a history of other malignancies, except: carcinoma in-situ without evidence of invasive disease when resected, adequately treated non-melanoma skin cancer, or other tumours curatively treated with no evidence of disease for ≥ 5 years.\n* Clinical evidence of distant metastasis as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan)\n* Patients with a documented positive surgical margin.\n* Patients with a documented positive peritoneal washings, if performed.","FEMALE",{"count":287,"type":21},393,[100],"This protocol tests de-escalated adjuvant treatment in patients with POLE-mutated or p53wt\u002FNSMP (p53 wildtype\u002Fno specific molecular profile) early-stage endometrial cancer (EC). Patients may be enrolled in one of two sub-studies\n\n* EN10.A\u002FRAINBO BLUE: POLE-mutated EC\n* EN10.B\u002FTAPER: p53 wildtype \u002F NSMP EC",[291],"Endometrial Cancer",{"date":130,"type":30},{"date":294,"type":30},"2022-12-19",{"date":87,"type":21},{"name":36,"class":37},110,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":48,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":318},"100473908","phase-3-spect-ct-guided-elective-contralateral-neck-treatment-for-patients-with-lateralized-oropharyngeal-cancer-100473908","NCT05451004","SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer","SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer. A Phase III Randomized Controlled Trial","SELECT","Inclusion Criteria:\n\n* Patients with pathologically proven diagnosis of lateralized OPC (tonsil, tongue base, soft palate, or pharyngeal wall) not involving or crossing midline.\n* HPV positive or negative (by p16 immunohistochemistry).\n* Clinical stage T1-3 M0 (UICC\u002FAJCC TNM 8th Edition). Nodal involvement may include no nodes or single or multiple ipsilateral lymph nodes (largest ≤6cm in maximum diameter)\n* Radiological investigations within 8 weeks of registration:\n\n  * CT or MRI of the neck (with head imaging as indicated);\n  * PET-CT scan\n  * Chest CT scan\n* Planned definitive RT or CRT with bilateral neck RT (patients planned for unilateral neck RT are excluded).\n* Intent to deliver concurrent chemotherapy or not must be known at the time of randomization. As this is a pragmatic trial, even patients who are not candidates for systemic therapy will be eligible for participation.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n* Willing to complete the quality of life and\u002For health utility questionnaire, if sufficiently fluent in available language(s).\n* Informed consent prior to registration\n* Accessible for treatment and follow-up.\n* Commencement of definitive RT within 28 days (+ 14 days) of randomization.\n* Injection procedure for lymphatic mapping may be performed in the nuclear medicine, ambulatory clinic, or operating room setting\n* Women\u002Fmen of childbearing potential must have agreed to use a highly effective contraceptive method\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patient must consent to provision of, and investigator(s) must confirm location and commitment to obtain a representation of formalin fixed paraffin block of non-cytology tumour tissue in order that the specific correlative marker assays\n\nExclusion Criteria:\n\n* T1-T2 cancers isolated to the tonsil fossa (i.e. without any soft palate, tongue base, posterior pharyngeal wall or posterior tonsil pillar involvement) with no involved lymph nodes or with a single ipsilateral node \\\u003C 3 cm without extranodal extension.\n* Tonsil or tongue base primary cancer who have previously undergone diagnostic palatine or lingual tonsillectomy with either complete excision or with no clinically apparent residual disease\n* Previous head and neck cancer or multiple synchronous primary head and neck cancers\n* Previous induction or neo-adjuvant chemotherapy.\n* Previous radiation therapy to the head and neck or comprehensive neck dissection of at least 3 levels on either side (due to potential for disrupted lymphatic channels and drainage pathways). Patients who have had excisional biopsies of involved lymph nodes are eligible\n* Radiotracer allergy\n* Severe, active co-morbidity including any of the following:\n\n  * Chronic Obstructive Pulmonary Disease or other pulmonary illness requiring hospitalization within 30 days of registration\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the 30 days of registration\n  * Acute myocardial infarction within 30 days of study registration\n  * Diseases precluding RT (e.g. scleroderma)",{"count":307,"type":21},510,[78],"This study is being done to answer the following question:\n\nIs the chance of cancer spreading or returning the same if radiotherapy to the neck is guided, by using a special imaging study called lymph node mapping (lymphatic mapping) Single Photon Emission Computed Tomography (SPECT-CT), compared to the usual treatment when radiotherapy is given to both sides of the neck?",[311],"Oropharyngeal Cancer",{"date":130,"type":30},{"date":314,"type":30},"2023-02-10",{"date":316,"type":21},"2031-08-30",{"name":36,"class":37},36,{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":48,"phases":327,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":337},"100369655","phase-2-study-of-ctdna-response-adaptive-immuno-chemotherapy-in-lung-cancer-100369655","NCT04093167","Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer","A Biomarker-Directed, Multi-Centre Phase II\u002FIII Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic NSCLC. Patients with stage III disease are eligible if they are not candidates for surgical resection or definitive chemoradiation. Patients with Large Cell Neuroendocrine Carcinoma (LCNEC) are not eligible.\n* Confirmed EGFR and ALK mutation-negative disease based on testing consistent with local guidelines.\n* Patients must have a PD-L1 test result from a certified laboratory indicating PD-L1 expression Tumour Proportion Score (TPS) ≥ 50%. Patients with lower PD-L1 TPS scores treated with single agent pembrolizumab consistent with local guidelines and regulatory approvals may be eligible following discussion with CCTG.\n* Patients are to be registered prior to starting immunotherapy. Screening ctDNA is to be drawn following registration prior to starting immunotherapy and after not more than 2 cycles of the 200mg or 2mg\u002Fkg IV Q3W dose\u002Fschedule of pembrolizumab, or at least and not more than 1 cycle of 400mg or 4mg\u002Fkg IV Q6W dose\u002Fschedule of pembrolizumab as first-line systemic immunotherapy for advanced metastatic NSCLC at the time of. Eligible patients with detectable ctDNA at 6 weeks may proceed to enrollment and randomization.\n* Prior chemotherapy or immunotherapy for non-metastatic disease (e.g. adjuvant and or neoadjuvant therapy) is allowed if at least 6 months have elapsed between the completion of prior therapy and start of pembrolizumab as first-line treatment for metastatic disease. Local therapy, e.g. palliative extra-cranial radiation, is allowed as long as a period of 2 weeks has passed since completion and screening as ctDNA levels may be altered by radiotherapy. There is no requirement for delay for patients who have received brain radiation.\n* Patients must have recovered to ≤ grade 1 from all reversible toxicity related to prior systemic or radiation therapy.\n* Previous major surgery is permitted provided that surgery occurred at least 14 days prior to screening of ctDNA and 28 days prior to patient enrollment and that wound healing has occurred.\n* Eligible and suitable to receive continued treatment with pembrolizumab OR the addition of chemotherapy to pembrolizumab at the time of registration and again at the time of enrollment and randomization. Patients should be clinically stable without evidence of clinical progression or symptomatic deterioration that requires change in cancer treatment. Reimbursement of pembrolizumab may not be uniform across all sites. In the event that the site\u002Finvestigator is unable to provide access to the drug, the patient will not be eligible for this trial.\n* Must be ≥ 18 years of age.\n* ECOG performance status 0-2.\n* Clinically and\u002For radiologically documented and evaluable disease. Measurable disease as defined by RECIST is not required.\n* Imaging investigations including CT of the chest, abdomen and pelvis and MRI\u002FCT of the brain (if known brain metastases) or other scans as necessary to document all sites of disease must be done within 14 days prior to randomization to ensure patients do not have clinical progression requiring change in systemic treatment. Patients must have non-progression of disease to be randomized. Patients who are clinically stable with PD such that in the opinion of the investigator they could continue with single agent immunotherapy may be eligible for enrollment and randomization following discussion with CCTG.\n* Patients must have RECIST non-PD or clinically stable PD documented prior to enrollment that can continue on IO therapy if randomized to that arm.\n* Detectable ctDNA on screening at 6 weeks is required for subsequent enrollment and randomization.\n* Adequate hematology and organ function to continue immunotherapy or receive standard platinum combination therapy (must be done prior to registration for ctDNA testing) and prior to enrollment and randomization).\n\n  * White Blood Cells ≥ 2.0 x 10\\^9\u002FL (2000\u002FμL)\n  * Absolute neutrophils ≥ 1.5 x 10\\^9\u002FL (1500\u002FμL)\n  * Platelets ≥ 100 x 10\\^9\u002FL (100 x 10\\^3\u002FμL)\n  * Bilirubin ≤ 1.5 x ULN (upper limit of normal)\\*\n  * AST and\u002For ALT ≤ 3 x ULN, \\\u003C 5 x ULN for patients with liver metastases\n  * Serum creatinine or Creatinine clearance ≤ 1.5 x ULN OR ≥ 40 mL\u002Fmin\n* Patients must consent to the provision of, and investigator must agree to submit, a representative archival formalin-fixed paraffin block of tumour tissue for correlative analyses when tumour tissue is available.\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to registration to the trial to document their willingness to the collection of liquid biopsy (blood) samples for ctDNA analysis by CLIA central laboratory and for correlative analysis by a research central laboratory, and to subsequent enrollment and randomization to continued pembrolizumab or the addition of chemotherapy to pembrolizumab if ctDNA is detected.\n* Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, collection of blood samples, response assessments and follow-up. Patients must agree to return to their primary care facility for response assessments as well as any adverse events which may occur through the course of the trial.\n* In accordance with CCTG policy, protocol treatment is to begin within 5 working days of patient randomization.\n* Women\u002Fmen of childbearing potential must have agreed to use a highly effective contraceptive method during protocol treatment and for at least 6 months after the last dose of the protocol treatment. Participants of childbearing potential will have a pregnancy test to determine eligibility as part of the Pre-Study Evaluation. Male participants with partners of childbearing potential must agree to use condoms (with spermicide, if available) in combination with an additional highly effective contraceptive method used by their partner, during treatment period and for at least 6 months after the last dose of the investigational product.\n\nExclusion Criteria:\n\n* Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the protocol treatment regimens are eligible for this trial.\n* Patients with symptomatic central nervous system (CNS) metastases and\u002For CNS metastases requiring immunosuppressive doses of systemic corticosteroids (\\>10 mg\u002Fday prednisone equivalents). Patients with known central nervous system metastases who are asymptomatic and on a stable dose of corticosteroids ≤ 10 mg\u002Fday prednisone equivalents are eligible.\n* Patients who are not suitable candidates for treatment with pembrolizumab as a single agent or in combination with standard platinum combination chemotherapy according to the current guidance\u002Findications described in the Product Monograph (Canada) or Drug Label (U.S.) and practice guidelines including but not limited to patients with active infection, autoimmune disease, conditions that require systemic immunosuppressive therapy (such as transplant patients) and patients with a history of severe immune-mediated adverse reactions, or known hypersensitivity to pembrolizumab or its components. Patients with pre-existing conditions such as colitis, hepatic impairment, respiratory or endocrine disorders (such as hypo or hyperthyroidism or diabetes mellitus), can be considered for enrollment to this study provided pembrolizumab is administered with caution and patients are closely monitored. Patients should not have contraindications to platinum combination chemotherapy.\n* History of significant neurologic or psychiatric disorder that would impair the ability to obtain consent or limit compliance with study requirements.\n* Concurrent treatment with other anti-cancer therapy or other investigational anti-cancer agents\n* Pregnant or lactating women.",{"count":227,"type":21},[100,78],"The standard or usual treatment for this disease is pembrolizumab given by needle into the veins (IV).\n\nSome cancers shed DNA (circulating tumour DNA or ctDNA) or genes (biomarkers) into the blood, and levels of these biomarkers may be able to tell researchers how people respond to treatment with pembrolizumab before they feel worse, or the cancer is worse on imaging tests. Researchers are studying how levels of these biomarkers can show how cancers are responding to treatment and whether adding chemotherapy to pembrolizumab based on detection of ctDNA can offer better results.",[330],"Lung Cancer",{"date":130,"type":30},{"date":333,"type":30},"2020-05-26",{"date":335,"type":21},"2027-07-30",{"name":36,"class":37},11,{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":48,"phases":347,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":355,"locationsCount":356},"100327995","phase-3-stereotactic-radiosurgery-compared-with-hippocampal-avoidant-whole-brain-radiotherapy-ha-wbrt-plus-memantine-for-5-or-more-brain-metastases-100327995","NCT03550391","Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases","A Phase III Trial of Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases","Inclusion Criteria:\n\n* Patients must have 5 or more brain metastases as counted on a T1 contrast enhanced MRI obtained ≤ 30 days from randomization (maximum 15 brain metastases).\n* Patients must have a pathological diagnosis (cytological or histological) of a non-hematopoietic malignancy.\n* The largest brain metastasis must measure \\\u003C2.5 cm in maximal diameter.\n* Centre must have the ability to treat patients with either a Gamma Knife, Cyberknife, or a linear accelerator-based radiosurgery system.\n* Patient must be \\> 18 years of age.\n* Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French either alone or with assistance.\n* ECOG performance status 0, 1, or 2.\n* Creatinine clearance must be ≥ 30 ml\u002Fmin within 28 days prior to registration.\n* The Neurocognitive Testing examiner must have credentialing confirming completion of the neurocognitive testing training.\n* Facility is credentialed by IROC to perform SRS and HA-WBRT. The treating centre must have completed stereotactic radiosurgery credentialing of the specific system(s) to be used in study patients. The treating centre must have completed IMRT credintialing of this specific IMRT systems to be used in study patients for the purposes of HA-WBRT.\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate.\n* A similar process must be followed for sites outside of Canada as per their respective cooperative group's procedures.\n* Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.\n* In accordance with CCTG policy, protocol treatment is to begin within 14 days of patient enrolment.\n* Women\u002Fmen of childbearing potential must have agreed to use a highly effective contraceptive method.\n\nExclusion Criteria:\n\n* Pregnant or nursing women.\n* Men or women of childbearing potential who are unwilling to employ adequate contraception.\n* Inability to complete a brain MRI.\n* Known allergy to gadolinium.\n* Prior cranial radiation therapy.\n* Planned cytotoxic chemotherapy within 48 hours prior or after the SRS or HA-WBRT.\n* Primary germ cell tumour, small cell carcinoma, or lymphoma.\n* Widespread definitive leptomeningeal metastasis. This includes cranial nerve palsy, leptomeningeal carcinomatosis, ependymal involvement, cranial nerve involvement on imaging, suspicious linear meningeal enhancement, or cerebrospinal fluid (CSF) positive for tumour cells.\n* A brain metastasis that is located ≤ 5 mm of the optic chiasm or either optic nerve.\n* Surgical resection of a brain metastasis (stereotactic biopsies will be allowed).\n* More than 15 brain metastases on a volumetric T1 contrast MRI (voxels of 1mm or smaller) performed within the past 14 days, or more than 10 metastases in the case of a non-volumetric MRI.\n* Prior allergic reaction to memantine.\n* Current alcohol or drug abuse.\n* Current use of NMDA antagonists, such as amantadine, ketamine, or dextromethorphan.\n* Diagnosis of chronic liver disease\u002Fcirrhosis of the liver (e.g. Child-Pugh class B or C).\n* Patients with architectural distortion of lateral ventricular systems, which, in the opinion of the local investigator, makes hippocampal delineation challenging",{"count":346,"type":21},206,[78],"Stereotactic radiosurgery (SRS) is a commonly used treatment for brain tumors. It is a one-day (or in some cases two day), out-patient procedure during which a high dose of radiation is delivered to small spots in the brain while excluding the surrounding normal brain.\n\nWhole brain radiation therapy with hippocampal avoidance (HA-WBRT) is when radiation therapy is given to the whole brain, while trying to decrease the amount of radiation that is delivered to the area of the hippocampus. The hippocampus is a brain structure that is important for memory. Memantine is a drug that is given to help relieve symptoms that can be caused by WBRT, including problems with memory and other mental symptoms.\n\nHealth Canada, the regulatory body that oversees the use of drugs in Canada, has not approved the sale or use of memantine in combination with WBRT to treat this kind of cancer, although they have allowed its use in this study.",[350],"Brain Metastases",{"date":130,"type":30},{"date":353,"type":30},"2018-11-22",{"date":34,"type":21},{"name":36,"class":37},86,{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":48,"phases":367,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":377},"100272046","phase-3-duration-of-anti-pd-1-therapy-in-metastatic-melanoma-100272046","NCT02821013","Duration of Anti-PD-1 Therapy in Metastatic Melanoma","A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic Melanoma","STOP-GAP","Minimum age 18 or as specified in the Product Monograph and eligible for public funding.\n\nInclusion Criteria:\n\n* Histologically confirmed melanoma that is unresectable \u002F metastatic (stage III or stage IV).\n* Eligible to receive treatment with a government approved and publically-funded PD-1 inhibitor, according to the guidance \u002F indications described in the Product Monograph \u002F Provincial Formulary.\n* Patients must have evidence of unresectable \u002F metastatic disease, that is considered evaluable by the investigator and can be followed, but measurable disease is not mandatory.\n* Patients with brain metastases are allowed, provided they are stable according to the following definitions:\n\n  1. Without evidence of progression for at least four weeks prior to randomization and have no evidence of new or enlarging brain metastases.\n  2. Treated with surgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases.\n  3. Treated with stereotactic radiosurgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases.\n* Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and health utility questionnaires in either English or French. The baseline assessment must be completed within required timelines, prior to randomization. Inability (lack of comprehension in English or French, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible.\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.\n* Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.\n* Patients must be randomized prior to the start of, or within 16 weeks from, the initiation of PD-1 inhibitor treatment. For patients who are being randomized before the start of treatment, the PD-1 inhibitor should be started within 5 working days after randomization. Patients who initiate treatment with combination anti-PD-1 and anti-CTLA-4 therapies who experience toxicity may be randomized at the time prior to starting single-agent PD-1 inhibitor. Repeat imaging must be done within 50 days prior to randomization to ensure the patient has no evidence of disease progression\n\nExclusion Criteria:\n\n* Patients not willing to stop anti-PD-1 therapy, if randomized to the intermittent arm.\n* Patients with any contraindications to PD-1 inhibitors, as described in the Product Monograph or Provincial Formulary, and\u002For not eligible to receive anti-PD-1 therapy.",{"count":366,"type":21},614,[78],"The purpose of this study is to compare the effects on patients with metastatic melanoma of taking a government approved and paid-for PD-1 inhibitor intermittently, with taking the same type of agent continuously. Researchers want to see if the two ways of giving this type of treatment work equally well in extending the life of patients with melanoma, or not.",[370],"Unresectable\u002FMetastatic Melanoma",{"date":130,"type":30},{"date":373,"type":30},"2016-10-31",{"date":375,"type":21},"2029-12-31",{"name":36,"class":37},30,{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":17,"minAge":385,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":48,"phases":387,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":396,"completionDateStruct":397,"leadSponsor":399,"locationsCount":400},"100615827","phase-1-gcar1-a-chimeric-antigen-receptor-car-t-cell-therapy-for-relapsedrefractory-gpnmb-expressing-solid-tumours-100615827","NCT07297667","GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed\u002FRefractory GPNMB-Expressing Solid Tumours","A Phase I Study of GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Participants With Selected Relapsed\u002FRefractory GPNMB-Expressing Solid Tumours","Inclusion Criteria:\n\n* Archival tumour specimen must be positive for GPNMB with high expression by immunohistochemistry (central laboratory testing).\n* Histologically and\u002For cytologically confirmed diagnosis of one of the following tumours that is advanced\u002F metastatic\u002F recurrent or unresectable, for which no curative therapy exists.\n* alveolar soft part sarcoma\n* renal cell carcinoma (excluding clear cell)\n* triple negative breast cancer (ER, PR and HER-2 negative as defined by ASCO\u002FCAP criteria)\n* Must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block.\n* Presence of radiologically documented disease.\n* Measurable disease as defined by RECIST 1.1.\n* ASPS participants ≥ 15 years of age.\n* TNBC and RCC participants ≥ 18 years of age.\n* ECOG performance status of 0 or 1 or Karnofsky or Lansky \\> 60.\n* Anticipated life expectancy of ≥ 6 months.\n* Must have received prior systemic therapy as shown below;\n* ASPS - completed all systemic therapy available that has been shown to improve survival (unless contraindicated).\n* TNBC\n\n  1. Progressive disease following at least one line of systemic treatment for metastatic disease which must include an ADC (all participants) and an ICI (participants whose tumours express PD-L1).\n  2. ≤3 lines of treatment for metastatic disease.\n  3. Must have had at least 1 prior line of cytotoxic chemotherapy for breast cancer, in any setting, which must have included an anthracycline and a taxane (unless contraindicated).\n* RCC - must have progressive disease following at least one line of systemic treatment for metastatic disease that must have included an ICI and a VEGFR targeted agent (unless contraindicated).\n* Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior therapies.\n* Adequate washout must be followed per protocol.\n* Previous major surgery is permitted ≥21 days prior to enrollment\n* Prior external beam radiation is permitted ≥28 prior to enrollment. Concurrent radiotherapy is not permitted.\n* Adequate hematologic and biochemical parameters.\n* Consent and assent, when applicable, must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant or their parent\u002F legal guardian (if applicable) must sign a consent form prior to screening onto the trial to document their willingness to participate.\n* Fit for leukapheresis and has adequate venous access for cell collection.\n* Must be accessible for treatment and follow up at the participating centre for a minimum of 12 months or for as long as is deemed necessary by the treating physician.\n* Participants of childbearing potential must have agreed to use a highly effective contraceptive method.\n\nExclusion criteria\n\n* Participants on active anticancer therapy for other advanced or metastatic malignancies.\n* Concurrent treatment with other anti-cancer therapy\n* Prior therapy with a gene therapy product or any adoptive T cell therapy or prior GPNMB targeting therapy.\n* Live attenuated vaccination administered within 30 days prior to or planned within 30 days after GCAR1 therapy.\n* Primary immunodeficiency or history of severe autoimmune disease (including: Crohn's disease, rheumatoid arthritis, systemic lupus) requiring immunosuppressive agents\u002F systemic disease modifying agents within 2 years of enrollment.\n* Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the participant to be managed according to the protocol including but not limited to:\n* Hepatitis B or C virus (HBV or HCV). For participants with previous HBV or HCV infection who are currently on treatment, they are eligible if they have an undetectable viral load via quantitative PCR and\u002For nucleic acid testing\n* HIV positive by serology and PCR\n* Uncontrolled fungal, bacterial, viral or other infection\n* Current infection with HTLV-1\n* Tuberculosis\n* Syphilis\n* West Nile Virus\n* Untreated and\u002For uncontrolled cardiovascular conditions and\u002For symptomatic cardiac dysfunction (including cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects) or unstable angina congestive heart failure or myocardial infarction within the previous year.\n* Known sensitivity or allergy to fludarabine, cyclophosphamide or any of their components, or to GCAR1 or any of its components.\n* Active intracerebral metastases or leptomeningeal disease. Participants who have received definitive treatment, are clinically stable and do not require corticosteroids are eligible to participate in the trial.\n* Pregnant or breastfeeding women.","15 Years",{"count":377,"type":21},[388],"PHASE1","Only enrolling in Canada.\n\nThe purpose of this study is to identify the highest dose of GCAR1, a chimeric antigen receptor (CAR-T) cell therapy, that can be tolerated without causing very severe side effects, and to see what effects GCAR1 has on selected cancers",[391,392,393],"Alveolar Soft Part Sarcoma","Renal Cell Carcinoma","Triple Negative Breast Cancer","2026-06-04",{"date":150,"type":30},{"date":29,"type":21},{"date":398,"type":21},"2033-09-01",{"name":36,"class":37},1,{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":48,"phases":410,"briefSummary":411,"conditions":412,"keywords":414,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":424,"leadSponsor":425,"locationsCount":426},"100619174","phase-2-sonrotoclax-plus-zanubrutinib-in-patients-with-relapsedrefractory-mantle-cell-lymphoma-planned-for-standard-of-care-car-t-cell-therapy-100619174","NCT07341191","Sonrotoclax Plus Zanubrutinib in Patients With Relapsed\u002FRefractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy","A Phase II Study of Sonrotoclax Plus Zanubrutinib in Patients With Relapsed\u002FRefractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy","Inclusion Criteria:\n\n* Have histologically confirmed mantle cell lymphoma that is relapsed or refractory after at least one prior line of systemic therapy\n* Eligible for and planned to receive Health Canada approved CAR-T.\n* Have a formalin fixed paraffin embedded tumour tissue block available and must have provided informed consent for the release of the block.\n* Presence of radiologically documented disease.\n* Measurable disease (one site bidimensionally measurable).\n* Age ≥ 18 years.\n* Have an ECOG performance status of 0, 1 or 2\n* Anticipated life expectancy of ≥ 6 months\n* Adequate hematologic and biochemical parameters\n* Must have received prior systemic therapy as shown below;\n* At least one line of systemic therapy including a Bruton's Tyrosine Kinase inhibitor (BTKi).\n* Participants who have previously received venetoclax, sonrotoclax, or any other BCL2 inhibitor (BCL2i) are eligible as long as progressive disease did not occur within 6 months of the last dose of BCL2i. Participants with progressive disease during BCL2i therapy or within 6 months of last dose are not eligible.\n* Participants must enter the study while on a BTKi or enroll to a substudy of the protocol to receive zanubrutinib for a minimum duration prior to enrolling to the main study.\n* Participants previously exposed to zanubrutinib are eligible irrespective of response to treatment.\n* Participants entering the study while on a BTKi must have their BTKi switched to zanubrutinib supplied through the study.\n* Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior therapies.\n* Adequate washout must be followed per protocol.\n* Prior high-dose myelosuppresive radiation is permitted ≥28 prior to enrollment.\n* Previous major surgery is permitted ≥28 days prior to enrollment. Participants of childbearing potential must have agreed to use a highly effective contraceptive method.\n\nExclusion Criteria\n\n* • Participants on active anticancer therapy for other advanced or metastatic malignancies.\n* Concurrent treatment with other anti-cancer therapy\n* Serious illnesses or medical conditions which would not permit the participant to be managed according to the protocol.\n* Known hypersensitivity to the study drug(s) or their components.\n* Prior CD19-directed CAR-T at any time, autologous hematopoietic cell transplantation within 6 weeks, or allogeneic hematopoietic cell transplantation within 3 months. Allogeneic hematopoietic cell transplantation recipients must be free of clinically-significant graft-versus-host disease (GvHD) and must be off immunosuppression for GvHD for at least 4 weeks before enrollment.\n* Untreated and\u002For uncontrolled cardiovascular conditions and\u002For symptomatic cardiac dysfunction (including cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects) or unstable angina congestive heart failure or myocardial infarction within the previous year.\n* Active, uncontrolled bacterial, fungal, or viral infection within 14 days prior to enrollment\n* Pregnant or breastfeeding women.\n* Inability to discontinue use of moderate or strong CYP3A inducers or inhibitors during the ramp-up treatment period with sonrotoclax.\n* Live vaccination within 4 weeks prior to enrollment or who plan to receive a live vaccine during treatment or within 90 days post last dose.\n* Inability to swallow capsules or tablets or have any diseases significantly affecting GI function\n* Active central nervous system (CNS) disease; Participants with stable CNS disease are eligible.\n* Growth factors within 28 days prior to enrollment.",{"count":409,"type":21},40,[100],"The purpose of this study is to evaluate the effects of adding two oral medications (sonrotoclax plus zanubrutinib) to standard of care chimeric antigen receptor (CAR-T) cell therapy in participants with mantle cell lymphoma.",[413],"Mantle Cell Lymphoma",[415,416,417,418,419],"CAR-T","Relapsed","Refractory","BTK inhibitor","BCL2 inhibitor","2026-05-11",{"date":422,"type":30},"2026-05-14",{"date":29,"type":21},{"date":196,"type":21},{"name":36,"class":37},2,{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":48,"phases":437,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":444,"leadSponsor":445,"locationsCount":446},"100563999","phase-2-lnd101-for-fecal-microbiota-transplantation-in-combination-with-immune-checkpoint-blockade-in-advanced-melanoma-100563999","NCT06623461","LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Advanced Melanoma","A Phase II Randomized Trial of LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Patients With Advanced Melanoma","Canbiome2","Inclusion Criteria:\n\n* Participants must have a confirmed histological diagnosis of cutaneous melanoma or melanoma of unknown primary.\n* Participants must have stage IV or advanced unresectable disease.\n* No prior ICB treatment for advanced unresectable or metastatic disease. Participants may have received adjuvant or neoadjuvant ICB if last dose was given ≥ 6 months prior to enrollment\n* Prior targeted therapy with BRAF\u002FMEK inhibition in the adjuvant or advanced \u002F metastatic setting is permitted if at least 2 weeks have elapsed between the last dose and study enrollment. Participants must have recovered to ≤ grade 1 from all toxicity related to BRAF\u002FMEK inhibition\n* Prior radiation therapy is permitted if at least 7 days have elapsed between the last fraction and study enrollment. Participants must have recovered to ≤ grade 1 from all toxicity related to prior radiotherapy.\n* Previous major surgery is permitted provided that surgery occurred ≥ 14 days prior to participant enrollment and that wound healing has occurred.\n* Participants must have measurable disease as per RECIST 1.1\u002F iRECIST.\n* Participants must be at least 18 years of age.\n* Participants must have an ECOG performance status of 0, 1, or 2.\n* The participant's standard-of-care ICB regimen must be selected prior to enrollment and must stay the same, regardless of arm assignment, post-enrollment\n* Participants must demonstrate adequate organ function Participants must be able to ingest capsules.\n* Participants must consent to provision of samples of blood and stool for correlative marker analysis.\n* Participants must consent to provision of, and investigator must agree to submit, a representative archival formalin fixed paraffin block of tumour tissue for correlative analyses when tumour tissue is available.\n* Participants must have access to provincially-funded standard-of-care ICB treatment.\n* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate.\n* Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.\n* Protocol ICB treatment must begin within 14 calendar days after participant enrollment.\n* Participants of childbearing potential must have agreed to use a highly effective contraceptive method.\n\nExclusion Criteria:\n\n* Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n* Participants who have received antibiotics within 14 days of enrollment.\n* Participants with systemic prednisone use \\> 10mg per day or equivalent dose.\n* Participants with concurrent treatment with other anti-cancer therapy.\n* Participants that have received live attenuated vaccination administered within 30 days prior to randomization. Note: Seasonal vaccines for influenza and COVID-19 are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and not allowed.\n* For participants with history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with absolute contraindications to FMT including: a) Toxic megacolon; b) Inflammatory bowel disease; c) Severe dietary allergies\n* Participants with hypersensitivity to PegLyte®\n* Participants with symptomatic brain metastases unless brain lesions are shown to be stable, according to the following definitions:\n\n  1. without evidence of progression for at least four weeks prior to randomization and have no evidence of new or enlarging brain metastases; or\n  2. treated with surgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases; or\n  3. treated with stereotactic radiosurgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases.\n  4. asymptomatic or minimally symptomatic active metastases, with controlled steriod use and no imminent CNS complications.\n* Participants with leptomeningeal disease.\n* Participants with any uncontrolled autoimmune disease that requires active immunosuppressive agents.\n* Participants who are solid organ transplantation recipients or likely to receive solid organ transplants in the future.\n* Participants living with HIV.\n* Participants with active infection. Participants may be eligible following recovery. Participants requiring antibiotics require 2-week washout period prior to enrollment.\n* Participants that are pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial.",{"count":436,"type":21},128,[100],"This study is being done to answer the following question: Can the chance of melanoma growing or spreading be lowered by receiving a treatment called LND101 for Fecal Microbiota Transplant (FMT) in addition to the usual immunotherapy treatment called Immune Checkpoint Blockade (ICB)? FMT treatment changes the bacteria in your gut called the microbiome.",[440],"Melanoma",{"date":442,"type":30},"2026-05-12",{"date":214,"type":30},{"date":375,"type":21},{"name":36,"class":37},14,{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":285,"minAge":18,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":48,"phases":457,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":461,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":337},"100543638","stratification-of-vulvar-scc-by-hpv-and-p53-status-to-guide-excision-100543638","NCT06358469","STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision","STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision","STRIVE","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of vulvar squamous cell carcinoma (VSCC)\n* Surgically staged FIGO I-II VSCC as per FIGO 2021 guidelines\n* Vulvar resection according to standard of care guidelines\n* Post-operative margin assessment of tumour clearance, dVIN and p53 status.\n* Participants' age must be ≥ 18 years old\n* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and\u002For health utility questionnaires in either English or French\n* Participant's consent must be appropriately obtained in accordance with applicable local and regulatory requirements\n\nExclusion Criteria:\n\n* Recurrent vulvar squamous cell carcinoma\n* Non-squamous cell carcinoma histotypes\n* Participants referred for\u002Freceiving\u002For previously received adjuvant vulvar radiation or chemotherapy\n* Primary tumour HPV-I p53 wild-type VSCC\n* Surgical margins positive for invasive cancer.\n* Participants with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years\n* Lymph node positive VSCC or lymph nodes with isolated tumour cells.",{"count":456,"type":21},249,[50],"This study is being done to answer the following question: Are there types of early-stage vulvar cancer that require either less or more treatment than the usual approach?",[460],"Vulvar Squamous Cell Carcinoma",{"date":442,"type":30},{"date":463,"type":30},"2024-12-10",{"date":465,"type":21},"2031-11-30",{"name":36,"class":37},{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":48,"phases":476,"briefSummary":477,"conditions":478,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":480,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":486},"100530130","phase-3-fixed-duration-vs-continuous-anti-cd38-antibody-therapy-among-transplant-ineligible-older-adults-with-newly-diagnosed-multiple-myeloma-100530130","NCT06182774","Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma","A Phase III Non-Inferiority Randomized Controlled Trial of Fixed Duration Versus Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma","Inclusion Criteria:\n\n* Participants with newly diagnosed multiple myeloma that are transplant-ineligible\n* Measurable disease at the time of diagnosis, as defined by at least one of the following criteria: Serum monoclonal protein (M-protein) ≥ 5 g\u002FL; Urine M-protein ≥ 200 mg\u002F24 hours; Involved serum free light chain measurement ≥ 100 mg\u002FL, provided serum FLC ration is abnormal; For IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin ≥ 750 mg\u002FdL\n* Completed 18-20 cycles of daratumumab-lenalidomide-dexamethasone or isatuximab-lenalidomide-dexamethasone.\n* Obtained at least a partial response per the standard 2016 IMWG criteria\n* ECOG performance status 0-3\n* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and\u002For health utility questionnaires in English, French, or a provided validated language.\n* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements.\n* Participants must be accessible for treatment and follow-up.\n* In accordance with CCTG policy, protocol treatment is to begin within 2 working days of participant enrollment.\n* Participants of childbearing potential must have agreed to use a highly effective contraceptive method.\n\nExclusion Criteria:\n\n* Known history of concurrent amyloid light chain amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), and Waldenstrom's macroglobulinemia.\n* Patients receiving concurrent treatment with other anti-cancer therapy that would impact the ability to comply with protocol treatment are ineligible. Note: Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of protocol treatment are eligible for this trial\n* Active, uncontrolled bacterial, fungal, or viral infection within 7 days prior to enrollment.\n* Known human immunodeficiency virus (HIV) with CD4 count \\\u003C 350 cells\u002Fmicroliter. Note that patients who are HIV positive are eligible, provided:\n\n  * They are under treatment with antiretroviral therapy for at least 4 weeks prior to enrollment, with acceptable pharmacokinetic interactions and minimal overlapping toxicity with protocol therapy AND\n  * HIV viral load must be \\\u003C 400 copies\u002Fml within 16 weeks prior to enrollment AND\n  * No history of opportunistic infections within the past year.",{"count":475,"type":21},570,[78],"Currently, daratumumab or isatuximab are given continuously (non-stop), along side lenalidomide, and dexamethasone as part of multiple myeloma treatment. are given continuously (non-stop). Recent observations suggest that stopping daratumumab or isatuximb after about a year and a half of treatment may work just as well as giving them continuously with lenalidomide and dexamethasone. Sometimes, bortezomib is also given. This study is being done to answer the question: is less daratumumab or isatuximab treatment as good as more?",[479],"Multiple Myeloma",{"date":442,"type":30},{"date":482,"type":30},"2024-04-10",{"date":484,"type":21},"2032-07-31",{"name":36,"class":37},28,{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":285,"minAge":18,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":48,"phases":496,"briefSummary":497,"conditions":498,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":500,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":504,"locationsCount":66},"100432982","phase-2-immunotherapy-platform-study-in-platinum-resistant-high-grade-serous-ovarian-cancer-100432982","NCT04918186","Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer","An Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer","IPROC","Inclusion Criteria:\n\n* This study will enroll women with platinum resistant high grade serous ovarian cancer.\n* This study is open to minorities as appropriate but is not designed to measure differences in intervention effects.\n* All patients must be registered for screening prior to study enrollment, however, if biomarker testing results are not required prior to enrollment to a substudy, then enrollment can proceed immediately. CCTG will advise sites when biomarker testing results are required prior to substudy enrollment.\n\nAdditional Criteria To Be Met Prior To Sub-study Enrollment All patients must fulfill all of the following criteria to be eligible for enrollment to the study. Additional eligibility criteria and relevant timings that are specific to a substudy are listed in each substudy specific protocol.\n\n* Patients must have platinum resistant high grade serous carcinoma of ovarian, fallopian tube or peritoneal origin defined as progression within 6 months of last platinum containing chemotherapy. Histological confirmation of the original primary tumour is required.\n* All patients must have measurable disease as defined by RECIST 1.1. The criteria for defining measurable disease are as follows:\n\n  * Chest x-ray ≥ 20 mm\n  * CT scan (with slice thickness of 5 mm) ≥ 10 mm - longest diameter\n  * Physical exam (using calipers) ≥ 10 mm\n  * Lymph nodes by CT scan ≥ 15 mm - measured in short axis\n* Patients must have at least one disease site amendable to pre and on-treatment biopsies and must consent to undergo these tumour biopsies.\n* Prior surgery is permitted provided that a minimum of at least 28 days have elapsed between any major surgical procedure and date of enrollment, and that wound healing has occurred.\n* Systemic Therapy:\n\n  * There is no limit to the number of prior regimens for platinum-sensitive disease. However, patients may not have received more than one cytotoxic chemotherapy regimen for platinum-resistant disease.\n  * Patients may have received non-cytotoxic therapies (excluding agents targeted by the planned substudy). Refer to each substudy protocol for exclusions.\n  * Prior treatment with an immune checkpoint inhibitor (ICI) is permissible providing the ICI was not discontinued for severe or recurrent severe toxicity (including myocarditis, or other myocardiotoxicity, encephalitis, colitis, diarrhea, pancreatitis, hypo\u002Fhyper thyroidism, hypopituitarism, adrenal insufficiency, rash, autonomic neuropathy, myasthenia gravis, Guillain-Barre, myositis\u002Fpolymyositis, hepatitis, nephritis, Type 1 diabetes, thrombocytopenia)\n  * A minimum of 4 weeks must have elapsed between last dose of prior therapy and enrollment.\n  * All reversible prior toxicity must have recovered to grade ≤ 1 (consult CCTG in the case of irreversible toxicity)\n* Other Therapy:\n\n  • Radiation, endocrine therapy, or other non-anti-cancer investigational agents are permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose and enrollment. Exceptions may be made for low-dose, non-myelosuppressive radiotherapy after consultation with CCTG.\n* ECOG performance status 0 or 1 and have a life expectancy ≥ 3 months.\n* Patients must be ≥ 18 years of age.\n* All patients must have consented to:\n\n  1. Release of tumour block from their primary or metastatic tumour, if available. If archival tissue is unavailable, a tumour biopsy is required during screening. The centre\u002Fpathologist must have agreed to the submission of the specimen(s).\n  2. Pre and on treatment tumour biopsies:\n* Core needle (a minimum of 6 core samples are required) or excisional biopsies or resected tissue specimens are required.\n* CCTG will advise sites when biomarker testing results are required prior to enrollment\n* Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the trial.\n* Patients must have adequate organ and marrow function measured within 7 days prior to enrollment including;\n* Absolute neutrophils ≥ 1.5 x 10\\^9\u002FL (1500\u002FµL)\n* Platelets ≥ 100 x 10\\^9\u002FL (100 x 103\u002FµL)\n* Hemoglobin ≥90g\u002FL\\* (10.0 g\u002FdL) with no blood transfusions in the past 28 days.\n* Bilirubin ≤ 1.5 x ULN (upper limit of normal)\\*\\*\n* AST \\& ALT ≤ 2.5 x ULN; if patient has liver metastases ≤ 5.0 x ULN\n* Serum creatinine or: Creatinine clearance ≤ 1.5 x ULN \u002F \\>50 mL\u002Fmin\n* Albumin \\>35 g\u002FL (3.5 g\u002FdL)\n* INR\u002FPTT INR \\\u003C 1.7 or PTT \\\u003C 4 seconds above control\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.\n* Patients must be accessible for treatment and follow up. Patients enrolled on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial.\n* Patient must agree to return to their primary care facility for any adverse events, response assessments and follow-up, which may occur through the course of the trial.\n* In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient enrollment.\n* Women of childbearing potential will have a pregnancy test to determine eligibility as part of the Pre-Study Evaluation\n\nExclusion Criteria:\n\n* Patients with a history of other malignancy may be eligible if curatively treated and\u002For the malignancy does not affect the determination of safety or efficacy of the investigational regimen (must be confirmed with CCTG prior to enrollment).\n* Patients with uncontrolled or serious illnesses, or medical conditions which could cause unacceptable safety risks or would not permit the patient to be managed according to the protocol or substudy. This includes but is not limited to:\n\n  * history of intra-abdominal abscess within 3 months prior to starting treatment;\n  * other active infection or chronic liver disease requiring systemic therapy;\n  * active or known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection on antiviral treatment or with detectable viral load;\n  * history of interstitial lung disease, non-infectious pneumonitis or severe pulmonary disease exacerbated by pneumonitis or uncontrolled diseases, including pulmonary fibrosis, acute lung disease, etc.\n  * clinically significant pleural, pericardial, and\u002For peritoneal effusion (e.g., effusion affecting normal organ function and\u002For requiring percutaneous drainage or diuretic control);\n  * autoimmune disease requiring chronic steroid use;\n  * prior history of a stroke or transient ischemic attack within the last 6 months;\n  * history of significant cardiac disease within 6 months prior to starting treatment such as myocardial infarction, unstable angina, cardiomyopathy, congestive heart failure;\n  * prior allogeneic stem cell transplantation or organ transplantation.\n* Central nervous system metastases\n\n  * Symptomatic uncontrolled brain metastases requiring corticosteroid treatment.\n  * History of spinal cord compression unless after definitive treatment the patient has clinically stable disease (SD) for at least 28 days prior to starting investigational agent(s).\n* Pregnant or lactating (breastfeeding) women.\n* Patients receiving concurrent treatment with other anti-cancer therapy or other investigational anti-cancer agents.\n* Active or prior documented autoimmune or inflammatory disorders, including: inflammatory bowel disease (e.g. colitis or Crohn's disease), diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea, systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome (granulomatosis with polyangiitis), rheumatoid arthritis, hypophysitis, uveitis, etc., within the past 3 years prior to the start of treatment.\n* Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune conditions only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions considered to be of low risk for recurrence are permitted to enroll.\n* Patients must not have been administered a live vaccine ≤ 4 weeks before enrollment.\n\nNote: Seasonal vaccines for influenza are general inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and not allowed.\n\n* QTc (using the Fridericia correction calculation) \\>470 msec or \\>450 msec if history of additional risk factors for Torsade de Pointe (e.g. heart failure, hypokalemia, family history of Long QT Syndrome) or use of concomitant medications that prolong the QT\u002FQTc interval.",{"count":98,"type":21},[100],"This study is being done to answer the following question: What are the effects of a new drug or drugs on ovarian cancer? The pre-study screening may be done to test a sample of tissue for biomarkers to determine participation in the study.",[499],"Ovarian Cancer",{"date":442,"type":30},{"date":502,"type":30},"2022-05-03",{"date":64,"type":21},{"name":36,"class":37},{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":48,"phases":514,"briefSummary":515,"conditions":516,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":526},"100485466","phase-2-liquid-biopsy-informed-platform-trial-to-evaluate-cdk46-inhibitor-resistant-erher2--metastatic-breast-cancer-100485466","NCT05601440","Liquid-biopsy Informed Platform Trial to Evaluate CDK4\u002F6-inhibitor Resistant ER+\u002FHER2- Metastatic Breast Cancer","A Liquid-biopsy Informed Platform Trial to Evaluate Treatment in CDK4\u002F6-inhibitor Resistant ER+\u002FHER2- Metastatic Breast Cancer","Inclusion Criteria:\n\n* Patients must have histologically and\u002For cytologically confirmed, advanced \u002F metastatic breast cancer, ER \\>10% and not HER2 overexpressing\u002Famplified as per ASCO\u002FCAP criteria. Patients with locally advanced or inflammatory disease without distant metastases that is potentially resectable or treatable with curative intent are not eligible\n* All patients must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block\n* Patients must have had objective disease progression demonstrated on (defined as while taking or within 8 weeks of the last dose) first line CDK4\u002F6i + ET for MBC. Patients who discontinued CDK4\u002F6i + ET without disease progression more than 8 weeks prior to objective disease progression (toxicity, patient request) are not eligible. Patients must have received at least 24 weeks of first line CDK4\u002F6i + ET therapy\n* Presence of clinically and\u002For radiologically documented disease. All radiology studies must be performed within 21 days prior to enrollment (within 28 days if negative). All patients must have measurable disease as defined by RECIST 1.1.\n* The criteria for defining measurable disease are as follows:\n\n  * Chest x-ray ≥ 20 mm\n  * CT scan (with slice thickness of 5 mm) ≥ 10 mm: longest diameter\n  * Physical exam (using calipers) ≥ 10 mm\n  * Lymph nodes by CT scan ≥ 15 mm: measured in short axis\n* Patients must be ≥ 18 years of age\n* Patients must have an ECOG performance status 0 or 1\n* Patients must have a life expectancy ≥ 3 months.\n* Hemoglobin ≥90 g\u002FL\\*\n* Absolute neutrophils ≥ 1.5 x 10\\^9\u002FL (1500\u002FµL)\n* Platelets ≥ 100 x 109\u002FL (100 x 10\\^3\u002FµL)\n* Bilirubin ≤ 1.5 x ULN (upper limit of normal)\\*\\*\n* AST \\& ALT ≤ 2.5 x ULN\n* ≤ 5.0 x ULN if patient has liver metastases\n* Serum creatinine ≤ 1.5 x ULN, Creatinine clearance ≥50 mL\u002Fmin\n* All patients must have received at least 24 weeks of prior CDK4\u002F6i in combination with first line ET for advanced or metastatic disease and have had disease progression on or within 8 weeks of the last dose of CDK4\u002F6i. Patients who have progressed on, or within 12 months of completion of adjuvant therapy with an aromatase inhibitor who are treated with fulvestrant instead of an aromatase inhibitor combined with CDK4\u002F6 inhibitor are only eligible for non fulvestrant containing substudies.\n\nIn addition, the following systemic therapies may have been given after CDK4\u002F6i \u002F ET prior to screening \u002F enrollment to this study:\n\n* For enrollment to \"second line\" substudies:\n\n  \\- An additional single agent non-fulvestrant\u002FSERD endocrine therapy in the palliative setting is permitted provided patient remains eligible for and can access fulvestrant treatment. Patients who have received prior fulvestrant\u002FSERD are not eligible for fulvestrant containing substudies. Contact CCTG in case of any other prior endocrine therapy other than an aromatase inhibitor or tamoxifen.\n* For enrollment to \"third line\" substudies:\n\n  * Non-SERD endocrine therapy and targeted agents (for example, PI3K\u002FAKT\u002FPTEN inhibitors unless excluded in substudy-specific eligibility criteria) alone or in combination.\n  * Patients who have received a prior targeted agent may not be eligible for substudies that contain the same class of agent. Please refer to substudy-specific eligibility criteria.\n  * Note: if a patient has not had fulvrestrant\u002FSERD prior to enrollment to \"third line: substudy, single agent fulvestrant\u002FSERD must be given prior to enrollment (unless not possible for reasons such as fulvestrant\u002FSERD not standard of care \u002F not funded in province, patient cannot receive intramuscular injection; contact CCTG for other scenarios).\n* Patients may also have received adjuvant\u002Fneoadjuvant systemic therapies; however cytotoxic chemotherapy or antibody drug conjugates (ADC) in the palliative setting are not permissible.\n* Patients receiving LHRH agonists (for example premenopausal patients) may continue on the LHRH agonist, but may not start a LHRH agonist within 12 weeks prior to enrollment.\n* Consult CCTG for other scenarios (for example where short course of other ET is given prior to CDKi + ET, patients who have received investigational drugs, vaccines or immunotherapies) as certain patients may be eligible.\n* All reversible prior toxicity related to prior therapies must have recovered to grade ≤ 1 (consult CCTG in the case of irreversible toxicity) and have adequate washout as follows (screening may occur during the washout period): Longest of the following (for questions or any proposed variance, please discuss with CCTG prior to patient enrollment): Two weeks; 5 half-lives for investigational agents; standard cycle length of standard therapies\n* Patients must not have received a transfusion (platelets or red blood cells) or colony stimulating factors ≤ 4 weeks prior to initiating treatment substudy therapy.\n* Surgery: Prior surgery is permitted provided that a minimum of at least 28 days have elapsed between any major surgical procedure and date of enrollment, and that wound healing has occurred.\n* Radiation: Prior external beam radiation is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and date of enrollment. Exceptions may be made for low-dose, non-myelosuppressive radiotherapy after consultation with CCTG. Concurrent radiotherapy is not permitted.\n* Patients must be registered and provide consent prior to blood collection for screening. The screening blood sample cannot be sent for analysis prior to screening registration.\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to both screening registration as well as enrollment to a specific substudy to document their willingness to participate.\n* Patients must be accessible for treatment and follow up. Patients enrolled on this trial must be treated and followed at the participating centre\n* In accordance with CCTG policy, substudy treatment is to begin within 2 working days of patient enrollment.\n* Women\u002Fmen of childbearing potential must have agreed to use a highly effective contraceptive method.\n\nExclusion Criteria:\n\n* Patients with a history of other malignancies, including Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML) except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other malignancies curatively treated with no evidence of disease for ˃ 2 years and which do not require ongoing treatment.\n* Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to protocol.\n\n  * Infection includes but is not limited to active infection requiring systemic therapy and active or known human immunodeficiency virus (HIV) with detectable viral load, known hepatitis B surface antigen or positive hepatitis C antibody\n  * Pneumonitis or any history of pneumonitis requiring steroids (any dose)\n  * Participant has received a live attenuated vaccine within 30 days of planned start of study therapy. Note: Seasonal vaccines for influenze are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and not allowed.\n  * Known primary immunodeficiency\n* Patients with recent clinically significant cardiac disease, including:\n\n  * Angina pectoris, symptomatic pericarditis, coronary artery bypass grafting, coronary angioplasty, or stenting, or myocardial infarction in the previous 12 months;\n  * History of documented congestive heart failure (New York Heart Association functional classification III-IV) or cardiomyopathy\n  * Uncontrolled hypertension (per Canadian guidelines)\n* All patients should have a LVEF ≥ 50%.\n* Patients with HER2 positive breast cancer (based on the most recent assessment, according to ASCO\u002FCAP criteria).\n* History of hypersensitivity to any of the study drugs or their components.\n* Patients may not receive concurrent treatment with other anti-cancer therapy (other than bone-targeted therapy, if already taking and stable) or investigational agents while on protocol therapy.\n* Patients with prior allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n* Pregnant or breastfeeding women (including within 1 month following last dose of protocol therapy).\n* Patients with history of central nervous system metastases or spinal cord compression unless they have received definitive treatment such as resection or radiation, are clinically stable and do not require corticosteroids; corticosteroids must have been discontinued at least 7 days prior to enrollment.\n* Patients who are unable to swallow oral medication and\u002For have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g. Crohn's disease, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, active bowel inflammation (e.g. diverticulitis) or small bowel resection), unless agreed with CCTG (exceptions may be given if a parenteral treatment substudy is available\u002Fappropriate).\n* Patients with a history of non-compliance to medical regimens.\n* See Section 7.3 and individual treatment substudies for a list of concomitant medications that are not permitted.\n* Many substudies include drugs that have a risk for thrombocytopenia; therefore, participants should be advised to use caution when taking oral anticoagulants (e.g. warfarin) and antiplatelet drugs (e.g. aspirin). Patients with history of deep vein thrombosis or pulmonary embolus who are being treated with therapeutic doses of low molecular weight heparin, direct factor Xa inhibitors or prophylactic dose anticoagulants may be enrolled, but the use of warfarin should be avoided.",{"count":513,"type":21},484,[100],"This study is being done to answer the following question: Can testing breast cancer for DNA abnormalities or \"biomarkers\" help predict which patients are most likely to be helped by certain treatments? The pre-study screening is being done to test a sample of blood (or tumour tissue) for biomarkers to see if patients can participate in the study",[517],"Breast Cancer","2026-05-06",{"date":520,"type":30},"2026-05-07",{"date":522,"type":30},"2023-06-13",{"date":524,"type":21},"2028-06-30",{"name":36,"class":37},10,{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":536,"conditions":537,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":218},"100467825","economic-analysis-of-early-vs-delayed-therapy-in-newly-diagnosed-asymptomatic-high-risk-patients-with-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-100467825","NCT05371808","Economic Analysis of Early vs Delayed Therapy in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma:","An Economic Analysis of Early vs Delayed Therapy in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma: A Companion Analysis to CCTG CLC.3\u002FSWOG 1925 Randomized Phase III Clinical Trial","Inclusion Criteria:\n\n* Patient must be eligible for the core CLC3\u002FS1925 protocol.\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.\n* Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and\u002For health utility questionnaires in either English or French. The baseline assessment must be completed within required timelines, prior to enrollment. Inability (lack of comprehension in English or French, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible.\n* Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.",{"count":535,"type":21},247,"Utilization data will be collected from all patients entered on the trial at Canadian centres from the time of registration until death, removal from study, or completion of 10 years of follow-up.\n\nProtocol-specified health care utilization will be collected within trial case report forms, and will include study visits, radiographic assessments, laboratory investigations, and treatment administration.\n\nResource utilization data collection will be supplemented by a self-administered resource utilization form (Stanford SMRC) to document non-protocol specified utilization. This will include hospitalizations (including days in hospital), emergency room visits, and non-protocol specified ambulatory visits.",[538,539],"Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","2026-05-05",{"date":518,"type":30},{"date":543,"type":30},"2023-01-27",{"date":545,"type":21},"2028-10-01",{"name":36,"class":37},""]