MAZEPPA: Phase II PRODIGE-GERCOR Study to Evaluate MAintenance Therapy With Olaparib or Selumetinib Plus Durvalumab According to BRCAness and KRAS Somatic Status Personalized in Metastatic Pancreatic Adenocarcinoma Patients

NCT04348045 Phase 2 ACTIVE_NOT_RECRUITING

MAZEPPA is open-label, phase II study to assess the efficacy of a genomic-driven maintenance therapy in terms of PFS in Pancreatic ductal adenocarcinoma (PDAC) patients with disease controlled after 4 months of mFOLFIRINOX chemotherapy as following: Patients with a BRCAness somatic profile: olaparib Arm A. Patients with no BRCAness profile and with KRAS mutation randomization between durvalumab plus selumetinib Arm B, versus FOLFIRI Arm C.

Details

Lead sponsor	GERCOR - Multidisciplinary Oncology Cooperative Group
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	307
Start date	2020-12-07
Completion	2025-12

Conditions

• Metastatic Pancreatic Adenocarcinoma

Interventions

• Arm A - Olaparib
• ARM B - durvalumab plus selumetinib
• ARM C FOLFIRI

Primary outcomes

• ARM A - Progression free survival (PFS) — at 4 months
  PFS rate at 4 months is defined by the number of patients alive at 4 months from inclusion without PD divided by the total number of patients evaluable at 4 months (dead during 4 months or alive at 4 months with a progressive status available).
• ARM B/ C - PFS — Assessed up to 36 months
  PFS is defined as time from randomization into arm B/C to the date of first documented PD RECIST 1.1 and/or iRECIST for arm B and PD RECIST1.1 for arm C or death.

Countries

France