| TITRE |
(EN) A phase 2, randomized, open-label study of encorafenib and cetuximab plus pembrolizumab versus pembrolizumab alone in participants with previously untreated BRAF V600E-MUTANT, MSI H/DMMR metastatic colorectal cancer |
| PROTOCOLE ID |
SEAMARK |
| CLINICAL TRIAL.gov ID |
NCT05217446 |
| TYPE(S) DE CANCER |
Colorectal |
| PHASE |
Phase II |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
5415 boul. de l'Assomption
(514) 252-3400
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Mikaël Soucisse
|
| COORDONATEUR(RICE) |
Audrey Lamoureux
audrey.lamoureux.cemtl@ssss.gouv.qc.ca
514-252-3400 poste 6258
|
| STATUT |
Fermé
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Locally confirmed microsatellite instability-high/ deficient mismatch repair (MSI-H/dMMR) stage IV colorectal carcinoma
- Locally confirmed BRAF V600E mutation in tumor tissue or blood
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have not received prior systemic regimens for metastatic disease.
- Measurable disease per RECIST 1.1
- Adequate organ function
|
| CRITÈRES D'EXCLUSION |
(EN)
- Colorectal adenocarcinoma that is RAS mutant or for which RAS mutation status is unknown
- Known active central nervous system metastases and/or carcinomatous meningitis; leptomeningeal disease
- Immunodeficiency or active autoimmune disease requiring systemic treatment in the past 2 years
- Presence of acute or chronic pancreatitis
- Clinically significant cardiovascular diseases (eg, thromboembolic or cerebrovascular accident events ≤ 12 wks prior)
- Received a live or live-attenuated vaccine within 30 days of planned start of study medication
- Previous treatment with any selective BRAF inhibitor (eg, encorafenib, dabrafenib, vemurafenib, XL281/BMS-908662) or any epidermal growth factor receptor (EGFR) inhibitor (eg, cetuximab, panitumumab).
- Previous treatment with an immune checkpoint inhibitor (eg, anti-programmed cell death [PD-1], anti-PD-L1 or anti-PD-L2 agent); or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
|
