Colorectal Cancer Metastatic Clinical Trial
Official title:
National French Cohort Evaluating Predictive Factors of Resistance to Immunotherapy in Patients With MSI Metastatic Colorectal Cancer
The Keynote 117 phase III trial demonstrated the superiority of pembrolizumab (anti-PD1 monoclonal antibody) versus chemotherapy +/- targeted therapy in first-line treatment of dMMR/MSI metastatic colorectal cancer (mCRC). However, primary resistance to pembrolizumab was observed in approximately 20-30% of patients treated in the Keynote 177 study. Therefore, the identification of biomarkers predictive of resistance to immunotherapy for dMMR/MSI mCRC is necessary to better select patients who benefit the most from immunotherapy, and those for whom other therapeutic approaches should be favored.
The primary endpoint is the identification of predictive factors of resistance to pembrolizumab in first-line treatment of MSI and/or dMMR metastatic colorectal cancer CORESIM is a retrospective and prospective multicenter national French cohort. National recruitment will be carried out in all French centers, including the FFCD, AGEO, GERCOR, and UNICANCER, representing more than 150 centers and most French sites, public and private hospitals. In France, pembrolizumab for first-line treatment of patients with MSI mCRC was accessible via its compassionate use in February 2021, then its reimbursement was effective in June 2023 Patients treated with pembrolizumab will be included prospectively on the start date of the study, i.e. on February 2024; patients treated since February 2021 via compassionate use of pembrolizumab will be included retrospectively A total of 600 patients are expected. The theoretical duration of inclusion is set at 2 years. All patients will be followed up for 3 years. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03941080 -
Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer
|
||
Completed |
NCT03213314 -
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
|
N/A | |
Completed |
NCT03647839 -
Modulation Of The Tumour Microenvironment Using Either Vascular Disrupting Agents or STAT3 Inhibition in Order to Synergise With PD1 Inhibition in Microsatellite Stable, Refractory Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT05057052 -
Cryoablation Combined With Sintilimab Plus Regorafenib In Previously Treated Colorectal Cancer Liver Metastasis
|
Phase 2 | |
Terminated |
NCT02316496 -
Rechallenge of Cetuximab Combined With Irinotecan as Third-line Chemotherapy in Patients With Metastatic Colorectal Cancer - Phase II Study
|
Phase 2 | |
Completed |
NCT03251612 -
Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
Completed |
NCT02380443 -
AlloStim® Immunotherapy Dosing Alone or in Combination With Cryoablation in Metastatic Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT02149784 -
Effectiveness Study of Resection of Primary Tumor in Stage IV Colorectal Cancer Patients
|
Phase 3 | |
Recruiting |
NCT01959061 -
Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases
|
Phase 4 | |
Terminated |
NCT01668680 -
Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma
|
Phase 2 | |
Recruiting |
NCT05068531 -
Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients
|
||
Not yet recruiting |
NCT04525807 -
Precision Medicine for Colorectal Cancer Liver Metastasis Guided by Multi-omics Data Under the Umbrella Theory
|
||
Completed |
NCT04482608 -
The mCRC Patients With pMMR/MSS or dMMR/MSI-H Status Received Palliative Chemotherapy Efficacy and Survival
|
||
Recruiting |
NCT03193710 -
The Effects of General Anesthetics on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and Mechanism Involved
|
N/A | |
Recruiting |
NCT04854213 -
PRELUDE-1 (Prospective Evaluation of Radiotherapy-induced Biologic Effects in Colorectal Cancer Oligometastatic Patients With LUng-limited Disease: Evolution of Cancer Genetics and Regulatory Immune Cells)
|
N/A | |
Suspended |
NCT04108481 -
Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03144804 -
A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer
|
Phase 2 | |
Completed |
NCT03142516 -
FOLFIRI + Panitumumab First-line Treatment in Elderly Patients With Unresectable Metastatic Colorectal Cancer, RAS/BRAF Wild-type and Good Performance Status
|
Phase 2 | |
Active, not recruiting |
NCT01910610 -
Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer
|
Phase 3 | |
Recruiting |
NCT05759728 -
A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer
|
Phase 1/Phase 2 |