Nivolumab and Ipilimumab in Anti-PD1-Resistant dMMR/MSI mCRC

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Study ID
NCT05310643
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Induction therapy with nivolumab 240 mg; 4 infusions, every 3 weeks. Maintenance therapy with nivolumab 480 mg; 21 infusions, every 4 weeks.
  • Ipilimumab — DRUG
    Induction therapy with ipilimumab 1 mg/kg; 4 infusions, every 3 weeks.

Study Details

NIPIRESCUE evaluates nivolumab and ipilimumab in patients with MSI/dMMR mCRC resistant to anti-PD1 monotherapy and previously treated with fluoropyrimidine, oxaliplatine, irinotecan, and anti- vascular endothelial growth factor (VEGF) or anti- epidermal growth factor receptor (EGFR) therapy.

Key Dates

Start date
May 5, 2022
Status verified
Jun 2025
Primary completion
Sep 30, 2025
Completion
Sep 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment phase
    Induction therapy: Nivolumab 240 mg + ipilimumab 1 mg/kg every 3 weeks for 4 dosing cycles (4 infusions of nivolumab and ipilimumab). Maintenance therapy: Nivolumab 480 mg every 4 weeks (21 infusions).

Primary Outcome Measure

Objective response rate (ORR) by RECIST 1.1 [ Time Frame: At week 24 (6 months) ]

Central Contacts

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