The DOI matches its Crossref record; 34 of the 37 references it cites were found in a registry or an index.
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.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
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]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)
Eisenhauer, E. A., Therasse, P., Bogaerts, J., Schwartz, L. H., Sargent, D., Ford, R., Dancey, J., Arbuck, S., Gwyther, S., Mooney, M., et al. (2009) · European Journal of Cancer · doi:10.1016/j.ejca.2008.10.026 · Cited by 29,534
Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., Filiberti, A., Flechtner, H., Fleishman, S. B., Haes, J. C. J. M. D., et al. (1993) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/85.5.365 · Cited by 16,005
EuroQol: a new facility for the measurement of health-related quality of life
(1990) · Health Policy · doi:10.1016/0168-8510(90)90421-9 · Cited by 15,736
PD-1 Blockade in Tumors with Mismatch-Repair Deficiency
Le, D. T., Uram, J. N., Wang, H., Bartlett, B. R., Kemberling, H., Eyring, A. D., Skora, A. D., Luber, B. S., Azad, N. S., Laheru, D., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1500596 · Cited by 9,377
Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck
Ferris, R. L., Blumenschein, G., Fayette, J., Guigay, J., Colevas, A. D., Licitra, L., Harrington, K., Kasper, S., Vokes, E. E., Even, C., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1602252 · Cited by 5,101
Interpreting the significance of changes in health-related quality-of-life scores.
Osoba, D., Rodrigues, G., Myles, J., Zee, B. C.-Y., & Pater, J. L. (1998) · Journal of Clinical Oncology · doi:10.1200/jco.1998.16.1.139 · Cited by 3,016
Brahmer, J. R., Drake, C. G., WOLLNER, I. S., Powderly, J. D., Picus, J., Sharfman, W. H., Stankevich, E., Pons, A., Salay, T. M., McMiller, T. L., et al. (2010) · Journal of Clinical Oncology · doi:10.1200/jco.2009.26.7609 · Cited by 2,967
Grothey, A., Cutsem, E. V., Sobrero, A., Siena, S., Falcone, A., Ychou, M., Humblet, Y., Bouché, O., Mineur, L., Barone, C., et al. (2013) · The Lancet · doi:10.1016/s0140-6736(12)61900-x · Cited by 2,895
Self-citationDe Roock, W., Claes, B., Bernasconi, D., De Schutter, J., Biesmans, B., Fountzilas, G., Kalogeras, K. T., Kotoula, V., Papamichael, D., Laurent-Puig, P., et al. (2010) · The Lancet Oncology · doi:10.1016/s1470-2045(10)70130-3 · Cited by 2,144
Wild-Type BRAF Is Required for Response to Panitumumab or Cetuximab in Metastatic Colorectal Cancer
Di Nicolantonio, F., Martini, M., Molinari, F., Sartore-Bianchi, A., Arena, S., Saletti, P., De Dosso, S., Mazzucchelli, L., Frattini, M., Siena, S., et al. (2008) · Journal of Clinical Oncology · doi:10.1200/jco.2008.18.0786 · Cited by 1,591
Llosa, N. J., Cruise, M., Tam, A., Wicks, E. C., Hechenbleikner, E. M., Taube, J. M., Blosser, R. L., Fan, H., Wang, H., Luber, B. S., et al. (2015) · Cancer Discovery · doi:10.1158/2159-8290.cd-14-0863 · Cited by 1,487
Randomized Trial of TAS-102 for Refractory Metastatic Colorectal Cancer
Mayer, R. J., Van Cutsem, E., Falcone, A., Yoshino, T., Garcia-Carbonero, R., Mizunuma, N., Yamazaki, K., Shimada, Y., Tabernero, J., Komatsu, Y., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1414325 · Cited by 1,431
Self-citationAntonia, S. J., López-Martin, J. A., Bendell, J., Ott, P. A., Taylor, M., Eder, J. P., Jäger, D., Pietanza, M. C., Le, D. T., de Braud, F., et al. (2016) · The Lancet Oncology · doi:10.1016/s1470-2045(16)30098-5 · Cited by 1,244
Self-citationGenomic Correlates of Immune-Cell Infiltrates in Colorectal Carcinoma
Giannakis, M., Mu, X. J., Shukla, S. A., Qian, Z. R., Cohen, O., Nishihara, R., Bahl, S., Cao, Y., Amin‐Mansour, A., Yamauchi, M., et al. (2016) · Cell Reports · doi:10.1016/j.celrep.2016.03.075 · Cited by 924
Tran, B., Kopetz, S., Tie, J., Gibbs, P., Jiang, Z., Lieu, C. H., Agarwal, A., Maru, D. M., Sieber, O. M., & Desai, J. (2011) · Cancer · doi:10.1002/cncr.26086 · Cited by 812
Self-citationSelf-Reported Population Health: An International Perspective based on EQ-5D
Szende, Á., Hita, J. M. C., & Janssen, B. (2013) · Springer eBooks · doi:10.1007/978-94-007-7596-1 · Cited by 811
Venderbosch, S., Nagtegaal, I. D., Maughan, T. S., Smith, C. G., Cheadle, J. P., Fisher, D., Kaplan, R., Quirke, P., Seymour, M. T., Richman, S. D., et al. (2014) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-14-0332 · Cited by 772
Engstrom, P. F., Arnoletti, J. P., Benson, A. B., Chen, Y., Choti, M. A., Cooper, H. S., Covey, A. M., Dilawari, R. A., Early, D. S., Enzinger, P. C., et al. (2009) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2009.0056 · Cited by 683
Deficient mismatch repair system in patients with sporadic advanced colorectal cancer
Koopman, M., Kortman, G. A. M., Mekenkamp, L. J., Ligtenberg, M. J. L., Hoogerbrugge, N., Antonini, N. F., Punt, C. J. A., & van Krieken, J. H. (2009) · British Journal of Cancer · doi:10.1038/sj.bjc.6604867 · Cited by 521
Kopetz, S., Guthrie, K. A., Morris, V. K., Lenz, H., Magliocco, A. M., Maru, D. M., Yan, Y., Lanman, R. B., Manyam, G. C., Hong, D. S., et al. (2020) · Journal of Clinical Oncology · doi:10.1200/jco.20.01994 · Cited by 390
Self-citationSchwitalle, Y., Kloor, M., Eiermann, S., Linnebacher, M., Kienle, P., Knaebel, H. P., Tariverdian, M., Benner, A., & Doeberitz, M. V. K. (2008) · Gastroenterology · doi:10.1053/j.gastro.2008.01.015 · Cited by 386
Goldstein, J., Tran, B., Ensor, J., Gibbs, P., Wong, H. L., Wong, S. F., Vilar, E., Tie, J., Broaddus, R., Kopetz, S., et al. (2014) · Annals of Oncology · doi:10.1093/annonc/mdu100 · Cited by 288
Self-citationSæterdal, I., Bjørheim, J., Lislerud, K., Klemp, M., Bukholm, I. K., Olsen, O. C., Nesland, J. M., Eriksen, J. A., Møller, M., Lindblom, A., et al. (2001) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.231326898 · Cited by 285
Population Norms for the EQ-5D
Janssen, B., & Szende, Á. (2013) · Springer eBooks · doi:10.1007/978-94-007-7596-1_3 · Cited by 258
Domingo, E., Niessen, R. C., Oliveíra, C., Alhopuro, P., Moutinho, C., Espín, E., Armengol, M., Sijmons, R. H., Kleibeuker, J. H., Seruca, R., et al. (2005) · Oncogene · doi:10.1038/sj.onc.1208569 · Cited by 176
Programmed death-1 blockade in mismatch repair deficient colorectal cancer.
Le, D. T., Uram, J. N., Wang, H., Bartlett, B. R., Kemberling, H., Eyring, A. D., Azad, N. S., Laheru, D. A., Donehower, R. C., Crocenzi, T. S., et al. (2016) · Journal of Clinical Oncology · doi:10.1200/jco.2016.34.15_suppl.103 · Cited by 106
Kopetz, S., McDonough, S. L., Morris, V. K., Lenz, H., Magliocco, A. M., Atreya, C. E., Diaz, L. A., Allegra, C. J., Wang, S. E., Lieu, C. H., et al. (2017) · Journal of Clinical Oncology · doi:10.1200/jco.2017.35.4_suppl.520 · Cited by 102
Self-citationGeyer, C. E., O’Shaughnessy, J., Untch, M., Sikov, W. M., Rugo, H. S., McKee, M. D., Huober, J., Golshan, M. A., Giranda, V. L., von Minckwitz, G., et al. (2017) · Journal of Clinical Oncology · doi:10.1200/jco.2017.35.15_suppl.520 · Cited by 75
PD-1 blockade in mismatch repair deficient non-colorectal gastrointestinal cancers.
Le, D. T., Uram, J. N., Wang, H., Kemberling, H., Eyring, A. D., Bartlett, B. R., Goldberg, R. M., Crocenzi, T. S., Fisher, G. A., Lee, J. J., et al. (2016) · Journal of Clinical Oncology · doi:10.1200/jco.2016.34.4_suppl.195 · Cited by 64
Sueda, T., Sakai, D., Kudo, T., Sugiura, T., Takahashi, H., Haraguchi, N., Nishimura, J., Hata, T., Hayashi, T., Mizushima, T., et al. (2016) · PubMed · Cited by 51
Corcoran, R. B., André, T., Yoshino, T., Bendell, J. C., Atreya, C. E., Schellens, J. H. M., Ducreux, M. P., McRee, A. J., Siena, S., Middleton, G., et al. (2016) · Annals of Oncology · doi:10.1093/annonc/mdw370.04 · Cited by 46
Self-citationLonardi, S., André, T., Wong, K. Y. M., Morse, M. A., McDermott, R., Hill, A., Hendlisz, A., Lenz, H., Leach, J. W., Moss, R. A., et al. (2017) · Annals of Oncology · doi:10.1093/annonc/mdx422.001 · Cited by 33
Self-citationAndré, T., Lonardi, S., Wong, K. Y. M., Morse, M. A., McDermott, R., Hill, A. G., Hendlisz, A., Lenz, H., Leach, J. W., Moss, R. A., et al. (2017) · Journal of Clinical Oncology · doi:10.1200/jco.2017.35.15_suppl.3531 · Cited by 27
Self-citationBRAF Mutations in Colorectal Cancer: Clinical Relevance and Role in Targeted Therapy
Yaeger, R., & Saltz, L. (2012) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2012.0148 · Cited by 18
Cited by
Sorted by citations
Dekker, E., Tanis, P. J., Vleugels, J. L. A., Kasi, P. M., & Wallace, M. B. (2019) · The Lancet · doi:10.1016/s0140-6736(19)32319-0 · Cited by 5,313
A guide to cancer immunotherapy: from T cell basic science to clinical practice
Waldman, A. D., Fritz, J. M., & Lenardo, M. J. (2020) · Nature Reviews Immunology · doi:10.1038/s41577-020-0306-5 · Cited by 4,154
Pembrolizumab in Microsatellite-Instability-High Advanced Colorectal Cancer
André, T., Shiu, K.-K., Kim, T. W., Jensen, B. V., Jensen, L. H., Punt, C., Smith, D., Garcia-Carbonero, R., Benavides, M., Gibbs, P., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2017699 · Cited by 3,099
Self-citationFundamental Mechanisms of Immune Checkpoint Blockade Therapy
Wei, S. C., Duffy, C. R., & Allison, J. P. (2018) · Cancer Discovery · doi:10.1158/2159-8290.cd-18-0367 · Cited by 3,088
Marabelle, A., Le, D. T., Ascierto, P. A., Giacomo, A. M. D., Jesus‐Acosta, A. D., Delord, J., Geva, R., Gottfried, M., Penel, N., Hansen, A. R., et al. (2019) · Journal of Clinical Oncology · doi:10.1200/jco.19.02105 · Cited by 3,122
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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
