| Titre |
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 |
| ClinicalTrials.gov ID |
NCT05217446 |
| Type(s) de cancer |
Colorectal |
| Phase |
Phase II |
| Stade |
Métastatique |
| Type étude |
Clinique |
| Médicament |
Encorafénib + cétuximab + pembrolizumab comparé à pembrolizumab en monothérapie |
| Institution |
CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
 PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX
5415 boul. de l'Assomption, Montréal, QC, H1T2M4
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Mikaël Soucisse
|
| Coordonnateur(trice) |
Samara Bloom
514-252-3400 poste 6244
|
| Statut |
 Actif en recrutement |
| Date d'activation |
12-06-2023 |
| Critètes d'éligibilité |
- 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
|
| Critètes d'exclusion |
- 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).
|
Groupe d'étude en oncologie du Québec