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Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, phase 2 study
Open accessAbstract
Background Metastatic DNA mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) colorectal cancer has a poor prognosis after treatment with conventional chemotherapy and exhibits high levels of tumour neoantigens, tumour-infiltrating lymphocytes, and checkpoint regulators. All of these features are associated with the response to PD-1 blockade in other tumour types. Therefore, we aimed to study nivolumab, a PD-1 immune checkpoint inhibitor, in patients with dMMR/MSI-H metastatic colorectal cancer.Methods In this ongoing, multicentre, open-label, phase 2 trial, we enrolled adults (aged ≥18 years) with histologically confirmed recurrent or metastatic colorectal cancer locally assessed as dMMR/MSI-H from 31 sites (academic centres and hospitals) in eight countries (Australia, Belgium, Canada, France, Ireland, Italy, Spain, and the USA). Eligible patients had progressed on or after, or been intolerant of, at least one previous line of treatment, including a fluoropyrimidine and oxaliplatin or irinotecan. Patients were given 3 mg/kg nivolumab every 2 weeks until disease progression, death, unacceptable toxic effects, or withdrawal from study. The primary endpoint was investigator-assessed objective response as per Response Evaluation Criteria in Solid Tumors (version 1.1). All patients who received at least one dose of study drug were included in all analyses. This trial is registered with ClinicalTrials.gov, number NCT02060188.Findings Of the 74 patients who were enrolled between March 12, 2014, and March 16, 2016, 40 (54%) had received three or more previous treatments. At a median follow-up of 12·0 months (IQR 8·6-18·0), 23 (31·1%, 95% CI 20·8-42·9) of 74 patients achieved an investigator-assessed objective response and 51 (69%, 57-79) patients had disease control for 12 weeks or longer. Median duration of response was not yet reached; all responders were alive, and eight had responses lasting 12 months or longer (Kaplan-Meier 12-month estimate 86%, 95% CI 62-95). The most common grade 3 or 4 drug-related adverse events were increased concentrations of lipase (six [8%]) and amylase (two [3%]). 23 (31%) patients died during the study; none of these deaths were deemed to be treatment related by the investigator.Interpretation Nivolumab provided durable responses and disease control in pre-treated patients with dMMR/MSI-H metastatic colorectal cancer, and could be a new treatment option for these patients.Funding Bristol-Myers Squibb.
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In the citing paper
“Initial results demonstrated a 31% objective response rate and 69% demonstrated at least 12 weeks of stable disease [78].”
From Update on Targeted Therapy and Immunotherapy for Metastatic Colorectal Cancer (2024) · cites this paper as [78]
In the citing paper
“The Checkmate-142 phase II study demonstrated the effectiveness of nivolumab in previously treated MSI-H mCRC patients [84].”
From RAS Mutations in Advanced Colorectal Cancer: Mechanisms, Clinical Implications, and Novel Therapeutic Approaches (2025) · cites this paper as [84]
In the citing paper
“Upon examining the subgroup analysis of this study, it was observed that patients without RAS or BRAF mutations achieved a 41% objective response rate with nivolumab. In comparison, the rate was 27% in RAS mutant patients.”
From RAS Mutations in Advanced Colorectal Cancer: Mechanisms, Clinical Implications, and Novel Therapeutic Approaches (2025) · cites this paper as [84]
In the citing paper
“Additionally, the efficacy of ICIs in phase II studies with dMMR/MSI and BRAFV600E tumors versus dMMR/MSI and BRAF wild type was similar [53,54,55,56].”
From Current and Future Trends of Colorectal Cancer Treatment: Exploring Advances in Immunotherapy (2024) · cites this paper as [54]
In the citing paper
“Recently, a combination of nivolumab and ipilimumab, a CTLA-4 inhibitor, gained approval from the FDA for the treatment of previously treated MSI-H/dMMR mCRC [54,131].”
From Current and Future Trends of Colorectal Cancer Treatment: Exploring Advances in Immunotherapy (2024) · cites this paper as [54]
In the citing paper
“Nivolumab, an anti-PD1 monoclonal antibody (moAb), has been utilized since 1 August 2017, for MSI-H/dMMR mCRC, as evidenced by the CheckMate 142 study [54].”
From Current and Future Trends of Colorectal Cancer Treatment: Exploring Advances in Immunotherapy (2024) · cites this paper as [54]
In the citing paper
“The CHECKMATE 142 study reported that Nivolumab could provide a durable response in patients with dMMR/MSI-H metastatic colorectal cancer, proposing Nivolumab as a new treatment option in these patients [117].”
From Immune Checkpoint Inhibitors in Cancer Therapy (2022) · cites this paper as [117]
In the citing paper
“Response rates range from 15 to 30% (in most solid tumors) to 45–60% (in melanoma and MSI-H tumors).”
From Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors (2019) · cites this paper as [8]
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Metadata
- Authors
- Overman, M. J., McDermott, R., Leach, J. L., Lonardi, S., Lenz, H.-J., Morse, M. A., Desai, J., Hill, A., Axelson, M., Moss, R. A., Goldberg, M. V., Cao, Z. A., Ledeine, J.-M., Maglinte, G. A., Kopetz, S., & André, T.
- Affiliations
- The University of Texas MD Anderson Cancer Center (US)
- Cancer Trials Ireland (IE)
- Allina Health (US)
- Istituto Oncologico Veneto (IT)
- USC Norris Comprehensive Cancer Center (US)
- Duke Medical Center (US)
- The Royal Melbourne Hospital (AU)
- Bristol-Myers Squibb (United States) (US)
- Bristol-Myers Squibb (Belgium) (BE)
- Sorbonne Université (FR)
- Corresponding author
- Overman, Michael J
- ORCID
- Venue
- The Lancet Oncology
- Publisher
- Elsevier BV
- Published
- 2017-09
- Volume
- 18
- Issue
- 9
- Pages
- 1182-1191
- ISSN
- 1470-2045 (ISSN-L)
- PMC
- PMC6207072
- OpenAlex
- W2739132742
- Cited by
- 2,836
- References
- 37
- Citations by year
- 2026: 185 · 2025: 242 · 2024: 302 · 2023: 382 · 2022: 377 · 2021: 438 · 2020: 361 · 2019: 288 · 2018: 223 · 2017: 31
- FWCI
- 108.88
- Type
- journal article
- Language
- en
- Update notices
- erratum (2017-09-01)
- Open access
- green
- europepmc.org
- Locations
- The Lancet Oncology (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Health Research Board (ICORG-2016-1)
- National Institutes of Health (UL1TR000371)
- National Cancer Institute (P30CA016672)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Pathology and Forensic Medicine › Genetic factors in colorectal cancer
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Keywords
- nivolumab, metastatic colorectal cancer, mismatch repair deficiency, microsatellite instability-high, PD-1 inhibitors, immune checkpoint blockade, objective response rate, disease control rate, progression-free survival, overall survival, treatment toxicity, first-line therapy, second-line therapy, third-line therapy, neoantigens, tumor-infiltrating lymphocytes
- MeSH terms
- Nivolumab, Adult, Antibodies, Monoclonal, Antineoplastic Agents, Carcinoma, Female, Humans, Male, Middle Aged, Colorectal Neoplasms, Treatment Outcome, Disease-Free Survival, Microsatellite Instability, DNA Mismatch Repair, Programmed Cell Death 1 Receptor
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