Actively Recruiting
Nivolumab and Ipilimumab in Anti-PD1-Resistant dMMR/MSI mCRC
Led by GERCOR - Multidisciplinary Oncology Cooperative Group · Updated on 2025-07-01
30
Participants Needed
9
Research Sites
277 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nivolumab and Ipilimumab in Anti-PD1-Resistant dMMR/MSI mCRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willingness to follow study procedures
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Confirmed colorectal adenocarcinoma
- Metastatic disease not suitable for complete surgical removal
- Disease progression during or within 6 months after anti-PD1 monotherapy
- Prior treatment with fluoropyrimidine, oxaliplatin, irinotecan, anti-EGFR (if wild-type RAS), and anti-VEGF therapies
- At least one measurable lesion by CT or MRI for repeated assessments
- Tumor with dMMR and/or MSI status confirmed by immunohistochemistry and/or pentaplex PCR
- New biopsy to obtain anti-PD1 resistant tumor tissue before treatment
- Archival tumor tissue available from before anti-PD1 therapy
- Adequate blood counts and organ function based on recent lab tests
- Negative pregnancy test for women of childbearing potential
- Use of effective contraception during treatment and for 5 months after
- Registered in a national health care system
You will not qualify if you...
- Known brain or leptomeningeal metastases
- Ongoing toxicities from prior treatments above grade 1, except certain specified conditions
- Stopped anti-PD1 due to severe treatment-related adverse events
- Previous treatment with anti-LAG-3, anti-CTLA-4, or other immune checkpoint therapies except anti-PD1
- Receiving other unplanned cancer treatments
- Major surgery within 4 weeks before starting study treatment
- Use of other investigational drugs within 21 days before treatment
- Active or suspected autoimmune diseases requiring systemic treatment, with some exceptions
- History of interstitial lung disease or pneumonitis
- Need for systemic corticosteroids or immunosuppressive drugs above allowed doses within 14 days
- Recent active malignancy within 3 years, with some exceptions
- Active hepatitis B, hepatitis C, or HIV infections
- Previous bone marrow or organ transplantation
- Serious medical conditions that increase risk or interfere with study
- Allergy to study drugs
- Recent live vaccine administration
- Legal or mental incapacity to consent
- Inability to attend medical follow-up due to social, geographic, or psychiatric reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
CHU Jean Minjoz
Besançon, France
Actively Recruiting
2
Institute Bergonie
Bordeaux, France
Actively Recruiting
3
CHRU Lille
Lille, France
Actively Recruiting
4
CHU Dupuytren
Limoges, France
Actively Recruiting
5
Centre Léon Bérard
Lyon, France
Actively Recruiting
6
ICM Val d'Aurelle
Montpellier, France
Actively Recruiting
7
Centre Antoine Lacassagne
Nice, France
Actively Recruiting
8
Hôpital Saint Antoine
Paris, France
Actively Recruiting
9
CHU Poitiers
Poitiers, France
Actively Recruiting
Research Team
M
Marie Line GARCIA LARNICOL, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here