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HEALTH PROFESSIONAL · SOURCE READING

Nivolumab and ipilimumab

Source: Rectal Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.

Source updated: February 12, 2025 · Captured 2026-09-09.

Selected source text with whitespace normalised. This Triangle page is not an NCI PDQ summary. Independent clinical review is pending.

Context: Treatment of Stage IV and Recurrent Rectal Cancer / Treatment Options for Stage IV and Recurrent Rectal Cancer / Immunotherapy / Second-line immunotherapy

Evidence (nivolumab and ipilimumab):

CheckMate-142 (NCT02060188) was a multicenter, open-label, phase II trial with a cohort for patients with recurrent or metastatic dMMR and/or MSI-H colorectal cancer who had progressed on, were intolerant of, or declined at least one line of chemotherapy (including 5-FU and oxaliplatin and/or irinotecan). The trial enrolled 119 patients who received four doses of nivolumab (3 mg/kg) and ipilimumab (1 mg/kg) every 3 weeks (induction), then nivolumab (3 mg/kg IV) every 2 weeks (maintenance). The primary end point was objective response rate.[72]

Source links and citations

CheckMate-142 (NCT02060188) was a multicenter, open-label, phase II trial with a cohort for patients with recurrent or metastatic dMMR and/or MSI-H colorectal cancer who had progressed on, were intolerant of, or declined at least one line of chemotherapy (including 5-FU and oxaliplatin and/or irinotecan). The trial enrolled 119 patients who received four doses of nivolumab (3 mg/kg) and ipilimumab (1 mg/kg) every 3 weeks (induction), then nivolumab (3 mg/kg IV) every 2 weeks (maintenance). The primary end point was objective response rate.[72]

The objective response rate was 55% (95% CI, 45.2%–63.8%).

CheckMate-142 (NCT02060188) was a multicenter, open-label, phase II trial with a cohort for patients with recurrent or metastatic dMMR and/or MSI-H colorectal cancer who had progressed on, were intolerant of, or declined at least one line of chemotherapy (including 5-FU and oxaliplatin and/or irinotecan). The trial enrolled 119 patients who received four doses of nivolumab (3 mg/kg) and ipilimumab (1 mg/kg) every 3 weeks (induction), then nivolumab (3 mg/kg IV) every 2 weeks (maintenance). The primary end point was objective response rate.[72]

Among patients experiencing a response, 83% had responses lasting more than 6 months.

CheckMate-142 (NCT02060188) was a multicenter, open-label, phase II trial with a cohort for patients with recurrent or metastatic dMMR and/or MSI-H colorectal cancer who had progressed on, were intolerant of, or declined at least one line of chemotherapy (including 5-FU and oxaliplatin and/or irinotecan). The trial enrolled 119 patients who received four doses of nivolumab (3 mg/kg) and ipilimumab (1 mg/kg) every 3 weeks (induction), then nivolumab (3 mg/kg IV) every 2 weeks (maintenance). The primary end point was objective response rate.[72]

Grade 3 to 4 treatment-related adverse events occurred in 32% of patients.

Studies cited in this source section

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Preserved source evidence · Independent clinical review pending · Not medical advice