OSE2101+FOLFIRI, or FOLFIRI Maintenance After FOLFIRINOX-based Induction Therapy in Advanced or Metastatic PDAC

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Study ID
NCT03806309
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • FOLFIRI — DRUG
    Intravenous (IV); folinic acid 400 mg/m\^2, irinotecan 180 mg/m\^2, 5-FU bolus 400 mg/m\^2 and continuous infusion 2,400 mg/m\^2
  • OSE2101 — DRUG
    subcutaneous injection on days 1 and 15, every 4 weeks for 6 doses then every 8 weeks until month 12 and then every 12 weeks for a maximum treatment duration of 24 months

Study Details

TEDOPAM is a randomized (1.1.1) non-comparative phase II study. This study will assess the efficacy and safety of OSE2101 alone or in combination with nivolumab followed by FOLFIRI reintroduction, versus FOLFIRI as maintenance therapy in patients with advanced PDAC after induction therapy with FOLFIRINOX.

Key Dates

Start date
Apr 10, 2021
Status verified
Jul 2025
Primary completion
Dec 9, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
106 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A : maintenance with FOLFIRI
    FOLFIRI (IV; folinic acid 400 mg/m\^2, irinotecan 180 mg/m\^2, 5-FU bolus 400 mg/m\^2 and continuous infusion 2,400 mg/m\^2/46h (dose adjustment will be accepted).
  • Experimental: Arm B : maintenance with OSE2101 plus FOLFIRI
    OSE2101 - subcutaneous injection on day 1 and day 15, every 4 weeks for 6 doses then every 8 weeks until month 12 then every 12 weeks up to 24 months. FOLFIRI - schedules as in Arm A until disease progression on unacceptable toxicity

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: At 12 months ]

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