Two Combination Treatment Regimens of Nivolumab and Ipilimumab in Patients With dMMR and / or MSI mCRC.

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Study ID
NCT04730544
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Colorectal Cancer Metastatic
  • MSI-H Colorectal Cancer

Eligibility Criteria

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

Interventions

Study Details

NIPISAFE is open-label, phase II study to identify a combination scheme of nivolumab and ipilimumab with a high level of clinical activity, but with a lower toxicity in MSI/dMMR metastatic colorectal cancer patients.

Key Dates

Start date
May 21, 2021
Status verified
Jun 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

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

Arms

  • Experimental: Experimental Arm A
    Treatment for 108 weeks (one cycle = 12 weeks; 9 cycles): Nivolumab 480 mg every 4 weeks (27 infusions) and ipilimumab 1 mg/kg every 6 weeks (18 infusions) for a total of 24 months of treatment (or less in case of RECIST progression (PD) or limiting toxicity, whichever occurs first).
  • Active Comparator: Control Arm B
    Induction of 12 weeks (one cycle = 3 weeks; 4 cycles): Nivolumab 240 mg and ipilimumab 1 mg/kg every 3 weeks for 4 dosing cycles (4 infusions of nivolumab and ipilimumab), Maintenance of 96 weeks (one cycle = 4 weeks; 24 cycles): Nivolumab 480 mg every 4 weeks for 24 dosing cycles (24 infusions) for a total of 24 months of treatment (or less in case of RECIST progression (PD) or limiting toxicity, whichever occurs first).

Primary Outcome Measure

Number of adverse events grade 3 or 4 at week 24 for two combination schemes. [ Time Frame: At week 24 ]

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