Maintenance With Olaparib or Selumetinib + Durvaluma for m-PDAC Guided by BRCAness and KRAS Status.

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Study ID
NCT04348045
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Arm A - Olaparib — DRUG
    300 mg orally twice daily, for a total daily dose of 600mg Study treatment can be dose-reduced to : First step : 250 mg twice daily , for a total daily dose of 500 mg Second step: 200 mg twice daily taken twice daily, for a total daily dose of 400 mg No further dose reduction is allowed, and study treatment should be discontinued.
  • ARM B - durvalumab plus selumetinib — DRUG
    Durvalumab administered IV at a flat dose of 1500 mg on day 1 of every 28-day cycle, Selumetinib Starting Dose : 75 mg twice daily Study treatment can be dose-reduced to : Dose Level -1 : 75 mg once daily Dose Level -2 : 50 mg twice daily Dose Level -3 : 50 mg once daily
  • ARM C FOLFIRI — DRUG
    FOLFIRI every two weeks Irinotecan 180 mg/m2 Intravenous (IV) on day 1 Folinic acid 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV bolus on day 1 and 2, and 46h IV infusion of 5-FU 2400 mg/m2

Study Details

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.

Key Dates

Start date
Dec 7, 2020
Status verified
Jul 2025
Primary completion
Jun 15, 2023
Completion
Dec 31, 2025

Study Design

Enrollment
307 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ARM A - olaparib
    Olaparib tablets at 300 mg orally twice daily until PD (RECIST 1.1) or unacceptable toxicity.
  • Experimental: ARM B - durvalumab plus selumetinib
    Durvalumab plus selumetinib until PD (RECIST 1.1 and/or iRECIST), unacceptable toxicity, withdrawal of consent, or death. Durvalumab administered IV at a flat dose of 1500 mg on day 1 of every 28-day cycle, Selumetinib administered as 75 mg twice daily dose for 21 days on and 7 days off (a 28-day cycle).
  • Active Comparator: ARM C - FOLFIRI
    FOLFIRI FOLFIRI (irinotecan 180 mg/m2 IV on day 1, folinic acid 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV bolus on day 1 and 2, and 46h IV infusion of 5-FU 2400 mg/m2 every 2 weeks) until PD (RECIST 1.1) unacceptable toxicity, withdrawal of consent, or death.

Primary Outcome Measure

ARM A - Progression free survival (PFS) [ Time Frame: at 4 months ]

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