Chemotherapy and Pembrolizumab, Followed by Pembrolizumab and Olaparib As Firstline Therapy in Her-2 Negative Gastric/GEJ Adenocarcinoma

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT05268510
Phase
PHASE2
Status
Completed

Conditions

  • Esophagogastric Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    400 mg Pembrolizumab day 1 Q6W (max. 18 cycles)
  • Olaparib — DRUG
    300 mg Olaparib bid. cont. day 1 to 42 (max. 16 cycles)
  • mFOLFOX-6 — DRUG
    Oxaliplatin 85 mg/m² 2h day 1, 15, 29 plus Leucovorin 400 mg/m² 2h day 1, 15, 29 plus 5-FU 400 mg/m² bolus, followed by 2.400 mg/m² 46h day 1, 15, 29; Q6W, 2 cycles
  • CapOX — DRUG
    Oxaliplatin 130 mg/m² 2h day 1,22 plus Capecitabine 1.000 mg/m² bid. day 1-14, 22-35; Q6W, 2 cycles

Study Details

This is a multicenter, single arm, prospective, open-label phase II trial investigating the clinical activity of a first-line therapy consisting of induction chemotherapy plus pembrolizumab (12 weeks of mod. FOLFOX-6 plus pembrolizumab or 12 weeks of CAPOX plus pembrolizumab) followed by pembrolizumab plus olaparib.

Key Dates

Start date
Sep 15, 2022
Status verified
Feb 2025
Primary completion
Aug 27, 2024
Completion
Jan 9, 2025

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chemotherapy plus Pembrolizumab followed by Pembrolizumab and Olaparib
    Chemotherapy plus Pembrolizumab 2 cycles à 6 weeks: Pembrolizumab+mod FOLFOX-6: * Pembrolizumab 400 mg 30 min. day 1 * Oxaliplatin 85 mg/m² 2h day 1, 15, 29 * Leucovorin 400 mg/m² 2h day 1, 15, 29 * 5-FU 400 mg/m² bolus, followed by 2.400 mg/m² 46h day 1, 15, 29 or Pembrolizumab+CapOx: * Pembrolizumab 400 mg 30 min. day 1 * Oxaliplatin 130 mg/m² 2h day 1,22 * Capecitabine 1.000 mg/m² bid. day 1-14, 22-35 Consolidation phase Pembrolizumab and Olaparib max 16 cycles à 6 weeks: * Pembrolizumab 400 mg 30 min. day 1 * Olaparib 300 mg bid. cont. day 1 to 42

Primary Outcome Measure

Overall survival (OS) rate at 1 year [ Time Frame: 1 year after enrolment ]

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