Titre |
A Phase 3, Randomized, Double-blind, Multicenter Study of Dostarlimab (TSR-042) Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Patients With Recurrent or Primary Advanced Endometrial Cancer |
Protocole ID |
RUBY/ENGOT-EN6 |
ClinicalTrials.gov ID |
NCT03981796 |
Type(s) de cancer |
Endomètre |
Phase |
Phase III |
Stade |
Maladie avancée ou métastatique |
Type étude |
Traitement |
Médicament |
Dostarlimab + carboplatine-paclltaxel vs placebo + carboplatine-paclitaxel |
Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
L'HOTEL-DIEU DE QUEBEC ET CRCEO
11 Côte du Palais, Québec, QC, G1R 2J6
|
Ville |
Québec |
Investigateur(trice) principal(e) |
Dre Marie Plante
|
Coordonnateur(trice) |
Maryse Gingras
418-691-5781
|
Statut |
Fermé |
Critètes d'éligibilité |
- Female subject is at least 18 years of age.
- Subject has histologically or cytologically proven endometrial cancer with recurrent or advanced disease.
- Subject must have primary Stage III or Stage IV disease or first recurrent endometrial cancer with a low potential for cure by radiation therapy or surgery alone or in combination.
- Subject has an ECOG performance status of 0 or 1.
- Subject has adequate organ function.
|
Critètes d'exclusion |
- Subject has received neo-adjuvant/adjuvant systemic chemotherapy for primary Stage III or IV disease and:
- has not had a recurrence or PD prior to entering the study OR
- has had a recurrence or PD within 6 months of completing chemotherapy treatment prior to entering the study
- Subject has had > 1 recurrence of endometrial cancer.
- Subject has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Subject has received prior anticancer therapy within 21 days or < 5 times the half-life of the most recent therapy prior to Study Day 1, whichever is shorter.
- Subject has a concomitant malignancy, or subject has a prior non-endometrial invasive malignancy who has been disease-free for < 3 years or who received any active treatment in the last 3 years for that malignancy.
- Subject has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
- Subject has a known history of human immunodeficiency virus.
- Subject has known active hepatitis B or hepatitis C.
- Subject has an active autoimmune disease that has required systemic treatment in the past 2 years.
- Subject has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- Subject has not recovered from cytotoxic therapy-induced AEs.
- Subject has not recovered adequately from AEs or complications from any major surgery prior to starting therapy.
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