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

NCT04730544 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-06-13

No results posted yet for this study

Summary

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.

Conditions

  • Colorectal Cancer Metastatic
  • MSI-H Colorectal Cancer

Interventions

DRUG

Nivolumab 480mg + Ipilimumab

Nivolumab 480 mg q4w + Ipilimumab 1 mg/kg q6w

DRUG

Nivolumab 240 mg + Ipilimumab

induction phase : Nivolumab 240 mg q3w + Ipilimumab 1 mg/kg q3w and then maintenance : Nivolumab 480 mg q4w

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • GERCOR - Multidisciplinary Oncology Cooperative Group

    lead OTHER

Principal Investigators

  • Romain COHEN, MD · Saint Antoine Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2027-04-30
Completion
2028-04-30

Countries

  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04730544 on ClinicalTrials.gov