OncoMatch/Clinical Trials/NCT05310643
Nivolumab and Ipilimumab in Anti-PD1-Resistant dMMR/MSI mCRC
Is NCT05310643 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nivolumab and Ipilimumab for metastatic colorectal cancer.
Treatment: Nivolumab · Ipilimumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MLH1 loss of expression
Required: MSH2 loss of expression
Required: MSH6 loss of expression
Required: PMS2 loss of expression
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-PD-1 therapy — monotherapy
Disease progression per iRECIST criteria (i.e., iCPD: immune confirmed PD) during monotherapy with anti-PD1 monoclonal antibody or less than 6 months after the discontinuation of anti-PD1 monoclonal antibody
Must have received: fluoropyrimidine — metastatic
approved standard therapies for the metastatic disease, which must include at least: • Fluoropyrimidine, oxaliplatin, and irinotecan
Must have received: oxaliplatin — metastatic
approved standard therapies for the metastatic disease, which must include at least: • Fluoropyrimidine, oxaliplatin, and irinotecan
Must have received: irinotecan — metastatic
approved standard therapies for the metastatic disease, which must include at least: • Fluoropyrimidine, oxaliplatin, and irinotecan
Must have received: anti-EGFR therapy — metastatic
Anti-EGFR therapy if wild-type RAS
Must have received: anti-VEGF therapy — metastatic
Anti-VEGF therapy
Cannot have received: anti-LAG-3 antibody
Prior treatment with an anti-LAG-3, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents, except anti-PD1 antibodies
Cannot have received: anti-CTLA-4 antibody
Prior treatment with an anti-LAG-3, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents, except anti-PD1 antibodies
Lab requirements
Blood counts
White blood cell > 2000/μL; Neutrophils > 1500/μL; Platelets > 100,000/μL; Hemoglobin > 10.0 g/dL
Kidney function
Serum creatinine level < 120 μM; Clearance > 50 ml/min (MDRD or Cockcroft and Gault)
Liver function
Serum bilirubin ≤ 1.5 x ULN; ALP ≤ 3.0 x ULN; ALT ≤ 3.0 x ULN; AST ≤ 3.0 x ULN
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 7 days prior inclusion: - Adequate hematological status (White blood cell > 2000/μL; o Neutrophils > 1500/μL; Platelets > 100.000/μL; Hemoglobin > 10.0 g/dL; - Adequate renal function: Serum creatinine level < 120 μM; Clearance > 50 ml/min (Modification of the Diet in Renal Disease [MDRD] or Cockcroft and Gault, - Adequate liver function: Serum bilirubin ≤ 1.5 x upper normal limit (ULN); Alkaline phosphatase (ALP) ≤ 3.0 x ULN; Alanine aminotransferase (ALT) ≤ 3.0 x ULN; Aspartate aminotransferase (AST) ≤ 3.0 x ULN; Hemostasis: Prothrombin time (PT)/International normalized ratio (INR) and activated partial PT (aPTT) ≤ 1.5 x ULN unless participants are receiving anticoagulant therapy and their INR is stable and within the recommended range for the desired level of anticoagulation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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