First-Line Nivolumab Plus Low-Dose Ipilimumab for Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer: The Phase II CheckMate 142 Study
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PURPOSE: Nivolumab received US Food and Drug Administration approval as a single agent or in combination with ipilimumab in patients with microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC) that progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan based on CheckMate 142. Presented are results of nivolumab plus low-dose ipilimumab in the first-line therapy cohort from the phase II CheckMate 142 study. PATIENTS AND METHODS: Patients with no prior treatment in the metastatic setting for MSI-H/dMMR CRC were treated with nivolumab every 2 weeks plus low-dose ipilimumab every 6 weeks until disease progression. The primary end point was objective response rate (investigator assessment; RECIST v1.1). RESULTS: Median age of treated patients was 66 years (N = 45). Median follow-up was 29.0 months. Objective response rate and disease control rate were 69% (95% CI, 53 to 82) and 84% (95% CI, 70.5 to 93.5), respectively, with 13% complete response rate. Median duration of response was not reached; 74% of responders had ongoing responses at data cutoff. Median progression-free survival and median overall survival were not reached with minimum follow-up of 24.2 months (24-month rates, 74% and 79%, respectively). Clinical benefit was observed regardless of baseline demographic and tumor characteristics, including BRAF or KRAS mutation status. In a post hoc analysis, of 14 patients who discontinued treatment and did not receive subsequent therapy, 10 remained progression-free. Patient-reported outcomes were stable over the treatment period. Grade 3-4 treatment-related adverse events occurred in 22% of patients; 13% discontinued because of any-grade treatment-related adverse events. CONCLUSION: Nivolumab plus low-dose ipilimumab demonstrated robust and durable clinical benefit and was well tolerated as a first-line treatment for MSI-H/dMMR mCRC. Based on these promising data, randomized studies are warranted.
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In the most recent iteration of CheckMate 142, nivolumab plus ipilimumab among patients with no prior treatments had an objective response rate of 69%, disease control rate of 84%, and complete response rate of 13%; median progression-free survival and overall survival had not been met at 24.2 months.
“The objective response rate was 69%, and the disease control rate was 84%; there was a 13% complete response rate. Median progression-free survival and overall survival had not been met at 24.2 months.”
From Update on Targeted Therapy and Immunotherapy for Metastatic Colorectal Cancer (2024) · cites this paper as [80]
Dual ICB is already established as effective in primary dMMR/MSI-H and second or later line treatment of dMMR/MSI-H mCRC.
“in addition to the already established effectiveness of this combination in primary dMMR/MSI-H and second or later line treatment of dMMR/MSI-H mCRC.105 106”
From Current and emerging concepts for systemic treatment of metastatic colorectal cancer (2025) · cites this paper as [106]
Despite high rates of durable responses, a fraction of dMMR/MSI-H colorectal cancer patients treated with ICIs develop immune resistance, approximately 15-29%.
“However, despite the high rate of durable responses, a fraction of them will develop immune resistance that can outweigh prolonged survival outcomes (approximately 15–29%) [12,15,16].”
From Current and Future Trends of Colorectal Cancer Treatment: Exploring Advances in Immunotherapy (2024) · cites this paper as [16]
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- Authors
- Lenz, H.-J., Van Cutsem, E., Luisa Limon, M., Wong, K. Y. M., Hendlisz, A., Aglietta, M., García-Alfonso, P., Neyns, B., Luppi, G., Cardin, D. B., Dragovich, T., Shah, U., Abdullaev, S., Gricar, J., Ledeine, J.-M., Overman, M. J., & Lonardi, S.
- Affiliations
- USC Norris Comprehensive Cancer Center (US)
- University Hospitals Gasthuisberg/Leuven and KU Leuven, Leuven, Belgium
- Hospital Universitario Virgen del Rocio, Sevilla, Spain
- Westmead Hospital (AU)
- Institut Jules Bordet (BE)
- Candiolo Cancer Institute (IT)
- Hospital General Universitario Gregorio Marañón (ES)
- Universitair Ziekenhuis Brussel (BE)
- University of Modena and Reggio Emilia (IT)
- Vanderbilt University (US)
- Banner MD Anderson Cancer Center (US)
- Lehigh Valley Cancer Institute, Allentown, PA
- Bristol-Myers Squibb (United States) (US)
- The University of Texas MD Anderson Cancer Center (US)
- Istituto Oncologico Veneto (IT)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2022-01-10
- Volume
- 40
- Issue
- 2
- Pages
- 161-170
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W3206775306
- Semantic Scholar
- 2e81a9ea94ac646baf31c284ca8497f8b3df6f0e
- Cited by
- 728
- References
- 30
- Citations by year
- 2026: 125 · 2025: 148 · 2024: 182 · 2023: 173 · 2022: 93 · 2021: 5
- FWCI
- 41.26
- Type
- journal article
- Language
- en
- Open access
- green
- biblio.vub.ac.be
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- Lirias (submittedVersion)
- Funders
- Bristol-Myers Squibb
- Agilent Technologies (PD-L1 IHC 28-8)
- Ono Pharmaceutical
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Health Sciences › Medicine › Pathology and Forensic Medicine › Genetic factors in colorectal cancer
- Keywords
- nivolumab, ipilimumab, metastatic colorectal cancer, microsatellite instability-high, mismatch repair deficiency, first-line therapy, immune checkpoint inhibitors, combination immunotherapy, objective response rate, progression-free survival, treatment-related adverse events
- MeSH terms
- Ipilimumab, Nivolumab, Progression-Free Survival, Immune Checkpoint Inhibitors, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Female, Humans, Male, Middle Aged, Neoplasm Metastasis, Time Factors, Colorectal Neoplasms, Disease Progression, Microsatellite Instability, DNA Mismatch Repair, Young Adult
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