RecruitingPhase 2NCT05310643

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

Nivolumab and Ipilimumab in Patients With dMMR and/or MSI Metastatic Colorectal Cancer Resistant to Anti-PD1 Monotherapy: An Open-label Phase II GERCOR Trial (NIPIRESCUE)


Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Enrollment

30 participants

Start Date

May 5, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two immunotherapy drugs — nivolumab and ipilimumab — in patients with metastatic colorectal cancer whose cancer has a specific DNA repair defect (called dMMR or MSI-high) but stopped responding to anti-PD1 immunotherapy alone. **You may be eligible if...** - You are 18 or older with metastatic colorectal cancer confirmed by biopsy - Your tumor has a DNA mismatch repair defect (dMMR) or is microsatellite instability-high (MSI-H) - Your cancer progressed during or within 6 months of stopping a PD-1 immunotherapy drug - You have received prior standard chemotherapy treatments (including fluorouracil-based regimens and oxaliplatin) **You may NOT be eligible if...** - You are able to have all your metastases surgically removed - You have active autoimmune disease or are on high-dose steroids - You have serious heart, liver, kidney, or lung problems - You have untreated brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab

Induction therapy with nivolumab 240 mg; 4 infusions, every 3 weeks. Maintenance therapy with nivolumab 480 mg; 21 infusions, every 4 weeks.

DRUGIpilimumab

Induction therapy with ipilimumab 1 mg/kg; 4 infusions, every 3 weeks.


Locations(9)

CHU Jean Minjoz

Besançon, France

Institute Bergonie

Bordeaux, France

CHRU Lille

Lille, France

CHU Dupuytren

Limoges, France

Centre Léon Bérard

Lyon, France

ICM Val d'Aurelle

Montpellier, France

Centre Antoine Lacassagne

Nice, France

Hôpital Saint Antoine

Paris, France

CHU Poitiers

Poitiers, France

View Full Details on ClinicalTrials.gov

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NCT05310643


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