69
Participants
Start Date
October 18, 2017
Primary Completion Date
December 31, 2024
Study Completion Date
December 31, 2024
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will be pursued in maintenance treatment, up to 1 year or until disease progression, unacceptable toxicity or patient withdrawn."
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."
Groupe confluent, Nantes
Centre Hospitalier Lyon Sud, Pierre-Bénite
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
Collaborators (1)
AstraZeneca
INDUSTRY
ARCAGY/ GINECO GROUP
OTHER