| Titre |
A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma |
| Protocole ID |
MK-3475-966 (KEYNOTE-966) |
| ClinicalTrials.gov ID |
NCT04003636 |
| Type(s) de cancer |
Pancréas |
| Phase |
Phase III |
| Stade |
Maladie avancée ou métastatique |
| Type étude |
Traitement |
| Médicament |
Pembrolizumab + Gemcitabine/Cisplatine vs placebo + Gemcitabine/Cisplatine |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Jamil Asselah
|
| Coordonnateur(trice) |
Selmane Boubendir
514-934-1934 poste 44328
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
- Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer).
- Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the site investigator.
- Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria.
- Provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion.
- Have a life expectancy of greater than 3 months.
- Have adequate organ function.
|
| Critètes d'exclusion |
- Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer), with the exception of adjuvant therapy which is allowed.
- Has ampullary cancer.
- Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma and/or Mucinous cystic neoplasms.
- Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti- programmed cell death ligand 1 or 2 (anti-PD-L1, anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
- Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis, as assessed by local site investigator.
- Has had an allogenic tissue/solid organ transplant.
|
Groupe d'étude en oncologie du Québec