Clinical trialPhase 2Active not recruiting
Maintenance With Olaparib or Selumetinib + Durvaluma for m-PDAC Guided by BRCAness and KRAS Status.
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
- Outcome
- Ongoing
- Phase
- Phase 2
- Status
- Active not recruiting
- Study type
- Interventional
- Start
- 7 December 2020
- Expected end
- December 2025
- Enrollment
- 307 participants
- Sites
- 29
- Primary outcomes
- ARM A - Progression free survival (PFS); ARM B/ C - PFS
- Sponsor
- Other
- Results posted
- No
- Last update
- 25 July 2025
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
Searching for efficient maintenance therapies in metastatic PDAC patients whose disease has been controlled using an induction chemotherapy is crucial for two main reasons: 1. Patients may stop IV toxic chemotherapy while their tumor remains under control. Although up to 70% of PDAC patients achieve tumor control when treated during induction with mFOLFIRINOX, toxicity of this regimen, particularly neuropathy and fatigue, remains a key concern. 2. Tumor control may be extended, which might improve quality of life (QoL) and survival. Patients are included in MAZEPPA study based on the genetic profile of their tumor. * If a BRCA gene mutation is present in the tumor, treatment with the drug olaparib will be proposed (arm A), regardless of the status of the other genes analyzed. * In the absence of a mutation in the BRCA gene and in the presence of a mutation in the KRAS gene, a treatment combining immunotherapy and targeted therapy (durvalumab and selumetinib - Arm B) or chemotherapy by FOLFIRI (arm C) will be proposed.