A Study of Carboplatin and Paclitaxel Chemotherapy With Nivolumab With or Without Ipilimumab in Patients With Ovarian Cancer

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 4, 2017

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
High Grade Serous OvarianFallopian TubePrimary Peritoneal Cancer
Interventions
DRUG

Carboplatin and Paclitaxel

Paclitaxel 80mg/m2 will be administered over approximately 1 hour as an IV infusion on Days 1,8, and 15 of each 21-day cycle. Carboplatin AUC6 will be administered as approximately a 30 minute IV infusion, following paclitaxel administration on Day 1 of each 21-day cycle.

DRUG

Nivolumab

Nivolumab 360mg will be infused IV over approximately 30 min on Day 1 of Cycles 1-6 (to 8) of each 21 day cycle. During the maintenance phase, Nivolumab 480mg will be infused IV over approximately 30 min on day 1 of each 28 day cycle, for up to 12 months. During the maintenance period, each cycle is 4 weeks

PROCEDURE

Cytoreductive surgery

Cytoreductive surgery

DRUG

Ipilimumab

Ipilimumab 1mg/kg every 6 weeks x 3-6 cycles in the neoadjuvant setting (maximum 2 doses of ipilimumab)

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT03245892 - A Study of Carboplatin and Paclitaxel Chemotherapy With Nivolumab With or Without Ipilimumab in Patients With Ovarian Cancer | Biotech Hunter | Biotech Hunter