Multi-Site Disease Site

Complexity Level: 2

Eligibility: Patients with recurrent, unresectable, locally advanced or metastatic rare tumours: vascular sarcomas (non-pediatric); clear cell carcinomas of ovary, endometrium; medullary thyroid carcinoma; non-pancreatic neuroendocrine tumours: pheochromocytoma, paragangliomas; adrenocortical carcinoma; thymic carcinoma; fibrolamellar hepatocellular carcinoma; rare tumours with somatic mutations in VEGFR, PDGFR, KIT, RET; rare tumours arising from known/suspected germline mutations in PTEN, TS, LKB1, NF1/2. Unidimensionally measurable disease. Archival tissue or fresh biopsy required at study entry. No limit on prior chemotherapy or radiation therapy, although no prior treatment with mTOR inhibitor (for temsirolimus) or VEGFR, PDGFR, RET or KIT inhibitor (for sunitinib) permitted. No uncontrolled hypertension, therapeutic doses of coumadin-derivative anticoagulants, or certain CYP3A4 inhibitors/inducers permitted on sunitinib arm.

Objectives: To assess the efficacy (objective response rate) of sunitinib given orally daily for 4 weeks every 6 weeks and temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent rare tumours. To assess the adverse events, time to progression and response duration of sunitinib orally and temsirolimus given IV weekly in patients with rare tumours. To assess time to first and second progression for patients who receive sunitinib and temsirolimus in sequence. To explore the relationship between genetic alterations in the genome in archival and/or fresh tumour tissue and blood samples from patients on this trial and their objective response to therapy. To assess the consistency of diagnosis of rare tumours through central review of pathology specimens.

NCT Registration ID (from clinicaltrials.gov): NCT01396408
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: July 14, 2011 Closing Date: February 05, 2015

Complexity Level: 1

Eligibility: Patients with histologically confirmed, unresectable locally advanced/metastatic solid tumour (Phase I - Esophogeal/GEJ/gastric, NSCLC and breast, fallopian tube, bladder, adenocystic, anal, melanoma, periampullary, renal, liver, vulvar and ovarian). Tumour must be MAGE-A3 positive. Patient must have have at least one additional tumour mass amenable to core or excisional biopsy and must consent and be willing to undergo at least 2 core biopsies. Patients must have had a least one prior standard first line therapy for advanced/metastatic disease with adequate wash-out period since last dose. Patients must have measurable disease per RECIST 1.1 and adequate organ function. At least 4 weeks since major surgery or radiation therapy. ECOG 0-1. Age >= 18 years.

Objectives: Phase I-To determine the recommended phase II dose/schedule and maximum tolerated dose of MG1MA3 alone, AdMA3 alone and in combination. To determine the safety, tolerability, pharmacokinetics (PK) including viral shedding, viral delivery and replication in the tumour cells and anti-tumour activity. Phase II-To assess the anti-tumour activity as evidenced by response rates and further explore the safety profile, PK, cellular and immune response, changes in tumour biomarkers and evaluate overall survival, time to progression by tumour type.

NCT Registration ID (from clinicaltrials.gov): NCT02285816
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: October 31, 2014 Closing Date: April 11, 2019

Chair: (Canada) Dr. Derek Jonker, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70168

Complexity Level: 1

NCT Registration ID (from clinicaltrials.gov): NCT02537418
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: October 01, 2015 Closing Date: September 06, 2017

Chair: (Canada) Dr. Rosalyn Anne Juergens, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9711 Ext. 64604, (Canada) Dr. Desiree Hao, Tom Baker Cancer Centre, (403) 521-3706

Complexity Level: 2

Eligibility: Clinically and/or radiologically documented disease, with at least one measurable lesion as defined by RECIST 1.1; >=16 years of age; ECOG 0 or 1; no limit on number of prior chemo; No therapy with PD-1/PD-L1 or CTLA-4 inhibitors. No prior autoimmune or inflammatory disorders ie inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome , etc., within the past 3 years prior to the start of treatment. No history of primary immunodeficiency, allogenic organ transplant that requires therapeutic use of IO agents within 28 days. No attenuated vaccination administered within 30 days. No untreated symptomatic brain mets or in whom radiation or surgery is indicated. NO pts with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.

Objectives: To evaluate the objective response rate of the combination of durvalumab and tremelimumab given by IV every 4 weeks in patients with rare tumours. To explore the correlation between anti-tumour activity and PD-L1 expression, presence of tumour infiltrating lymphocytes (TILs) and T cell subsets within the tumour. To explore the correlation between anti-tumour activity and genomic alterations in tumour. To assess the consistency of histopathological diagnosis of rare tumours through central review of pathology specimens. To explore the correlation between anti-tumour activity and toxicity with blood based biomarkers. To evaluate the tolerability and safety of durvalumab and tremelimumab combination. To evaluate the effect of durvalumab and tremelimumab combination including time to progression, progression free survival and response duration.

NCT Registration ID (from clinicaltrials.gov): NCT02879162
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: October 19, 2016 Closing Date: January 21, 2020

Chair: (Canada) Dr. Abha Gupta, Hospital for Sick Children, (416) 946-2252

Complexity Level: 1

Eligibility: Must live in Canada & received durvalumab +/- tremelimumab, with or without chemo/targeted therapy. Patients who received other PD-1/PD-L1 agents +/- anti-CTLA agents may be eligible, contact CCTG. Had a G3 irAEs that required study drug discontinuation per protocol, selected G4 irAEs, & prolonged G1-2 irAEs where physician/patient wanted to discontinue therapy due to poor tolerability. irAE must have resolved to <= grade 1 or baseline. Completed steroid therapy & have documented CR, PR, or prolonged SD to initial IO therapy. Prior adjuvant/neoadjuvant/consolidation IO is eligible provided a >= 6 mo. treatment free interval prior to enrollment and >= 1 standard of care chemo in the palliative setting (discuss with CCTG if chemo is not SOC or indicated or patient refusal/not eligible). Ineligible if prior G4 non-hematological, non-endocrine irAE, or if required biologic agents to manage irAE, had PD as best response to initial IO, or symptomatic or uncontrolled brain mets.

Objectives: Primary: To determine the safety and toxicity profile of rechallenging with durvalumab in patients who previously discontinued immunotherapy due to irAE. Secondary: To determine the objective response rate (RECIST 1.1 and iRECIST); To evaluate the efficacy of corticosteroids in preventing recurrent or new grade 2 or higher irAEs. Tertiary: To explore PFS and iPFS on rechallenge with durvalumab after progression on initial immunotherapy; To explore blood-based and stool-based biomarkers for irAEs; PD-L1 expression.

NCT Registration ID (from clinicaltrials.gov): NCT03847649
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: June 07, 2019

Chair: (Canada) Dr. Peter Ellis, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495, (Canada) Dr. Sara Taylor, BCCA - Cancer Centre for the Southern Interior, (250) 712-3996

Complexity Level: 1

Eligibility: Patients (>=18yrs old, ECOG PS0-1), life expectancy >=3 mo., must have advanced/metastatic/recurrent or unresectable cancer, with no curable therapy. All reversible prior toxicity related to prior therapies must have recovered to grade =<1 and have adequate washout. Measurable disease per RECIST 1.1. Consent to release of tissue block and biopsies. Women/men of childbearing potential must have agreed to use an effective contraceptive method. No history of other malignancies or uncontrolled /serious illnesses which would not permit the patient to be managed per protocol. Hypersensitivity to any of the study drug components. No CNS metastases. No pts who are unable to swallow oral meds/have impairment of GI function. No history of non-compliance. Met additional cohort specific eligibility criteria.

Objectives: Primary: To determine the response rate of RP-6306 in patients with selected cancers receiving standard agents. Secondary: To determine the safety and tolerability of RP-6306 in patients with selected cancers receiving standard agents; To explore the recommended dose of RP-6306, if indicated. Tertiary: To assess potential biomarkers of response, including but not limited to such as PP2R1A, FBXW7 mutations or CCNE1 amplification / overexpression; To assess efficacy of RP-6306 + FOLFIRI in patients harboring KRAS/TP53/FBXW7 triple mutation; To correlate changes in ctDNA with response.clinical outcomes; To summarize progression-free survival.

NCT Registration ID (from clinicaltrials.gov): NCT05605509
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: April 17, 2023

Chair: (Canada) Dr. Stephanie Lheureux, University Health Network, (416) 946-4501 Ext. 2415, (Canada) Dr. Eric (Xueyu) Chen, University Health Network, (416) 946-2263, (Canada) Dr. Yvette Drew, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 4831

Complexity Level: 1

Eligibility: Patients with incurable metastatic solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma (NHL - excluding CLL, SLL and HCL), who have no standard treatment options known to prolong life (or may have refused such option(s)), and have an "actionable" genomic variant known to be a target of a Health Canada-approved anticancer drug or to predict sensitivity to a Health Canada- approved anticancer drug.

Objectives: PRIMARY: To evaluate the objective response rate (based on disease-appropriate objective criteria) of targeted drugs matched to pre-specified molecular aberrations (at the level of the gene) within a tumor type, among patients with incurable metastatic solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma (NHL) with an "actionable" genomic variant known to be a target of a Health Canada-approved anticancer drug or to predict sensitivity to a Health Canada- approved anticancer drug. SECONDARY: (1) To evaluate the safety of commercially available anticancer agents in patients enrolled on CAPTUR; (2) To evaluate progression free survival (PFS) based on disease-appropriate objective criteria.

NCT Registration ID (from clinicaltrials.gov): NCT03297606
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: October 06, 2017

Chair: (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2911, (Canada) Dr. Daniel John Renouf, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 672357

Complexity Level: 3

Eligibility: Patients with incurable metastatic solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma (NHL - excluding CLL, SLL and HCL), who have no standard treatment options known to prolong life (or may have refused such option(s)), and will haveundergone standard testing as indicated by local/provincial practice for diagnosis Medical oncologists must be QIs or SIs active on the PM.1 Participants List and must be from a site which is participating on the PM.1/CAPTUR trial..

Objectives: Primary Objective 1. To determine how Canadian oncologists, from academic cancer centres, use Next-Generation Sequencing (NGS) tests to evaluate patients with metastatic disease who have already undergone standard of care diagnostic testing and inform treatment recommendations, pre- and post-testing. Secondary Objectives 1. To determine patient's satisfaction with their decision-making using a validated tool, pre- and post-NGS testing 2. To obtain feedback from oncologists on the decision impact of NGS and requirements to increase the usage of precision medicine

NCT Registration ID (from clinicaltrials.gov): no NCT
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: June 08, 2020 Closing Date: May 31, 2022

Chair: (Canada) Dr. Philippe Bedard, University Health Network, (416) 946-4501 Ext. 4534

Complexity Level: 2

Eligibility: CAN-IMPACT-IO is a standalone study of the CCTG, to be performed in collaboration with the Marathon of Hope Cancer Centres Network (MOHCCN) and Princess Margaret Cancer Consortium (PM2C), to perform fresh tumor biopsies for whole genome and transcriptome sequencing (WGTS) analysis for patients enrolled in a specified list of immuno-oncology (IO) therapeutic trials with immune checkpoint inhibitors targeting PD1/PDL1 as single agents or in combination currently active in CCTG.

Objectives: Primary Objective -To profile human bodily material (HBM) from patients treated in a specified list of IO therapeutic trials currently active in CCTG, using WGTS either before treatment, during treatment or at time of disease progression with IO to uncover prognostic biomarkers as well as predictive biomarkers of response or resistance. Secondary Objectives -To contribute clinically annotated WGTS data to a unique MOHCCN cohort of 15,000 Canadian cancer patients via PM2C-led Pan-Canadian projects. Tertiary Objectives -To evaluate immune cell populations present in tumoral areas and in the tumor microenvironment (TME) using multiplexed immunohistochemistry (IHC) in a subset of patients treated in a specified list of IO therapeutic trials currently active in CCTG.

NCT Registration ID (from clinicaltrials.gov): NCT06630273
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: October 08, 2024

Chair: (Canada) Dr. Anna Spreafico, University Health Network, (416) 946-4501 Ext. 4012, (Canada) Dr. Philippe Bedard, University Health Network, (416) 946-4501 Ext. 4534