Immunotherapy With Neo-adjuvant Chemotherapy for OVarian Cancer

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

October 18, 2017

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Ovarian Cancer
Interventions
DRUG

ARM A Durvalumab/chemotherapy association

"NEO-ADJUVANT Cycle 1 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV alone (day1), every 3 weeks Cycle 2 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV (day1) Cycle 3 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV (day1)~ADJUVANT :~1. If complete surgical resection at interval debulking surgery : 3 cycles of durvalumab 1125 mg IV + carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV at day1, every 3 weeks.~2. If residual tumor at interval debulking surgery : the tremelimumab 75 mg IV will be added to the durvalumab-chemotherapy combination at day 1 of cycle 2 before a salvage surgery. Durvalumab 1125 mg IV (with one cycle of tremelimumab 75 mg IV post S3) will be pursued in maintenance treatment, up to 1 year or until disease progression, unacceptable toxicity or patient withdrawn."

DRUG

ARM B Durvalumab/Tremelimumab/chemotherapy association

"NEO-ADJUVANT Cycle 1 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV alone (day1), every 3 weeks Cycle 2 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV + tremelimumab 75 mg IV (day1) Cycle 3 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV (day1)~ADJUVANT :~1. If complete surgical resection at interval debulking surgery : 3 cycles of durvalumab 1125 mg IV + carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV at day1, every 3 weeks.~2. If residual tumor at interval debulking surgery : patients will be treated according to investigator choice."

Trial Locations (11)

44202

Groupe confluent, Nantes

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

Unknown

Institut Ste Catherine, Avignon

Institut Bergonié, Bordeaux

ICM Val d'Aurelle, Montpellier

HEGP, Paris

Hôpital Cochin, Paris

Institut René Godinot, Reims

Centre Eugene Marquis, Rennes

Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy

Gustave Roussy, Villejuif

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

ARCAGY/ GINECO GROUP

OTHER