Evidence map›Paper›PMID 38821718›Full record

Trial reportJournal for immunotherapy of cancer2024

Nivolumab plus relatlimab in patients with previously treated microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer: the phase II CheckMate 142 study.

Michael J Overman, Fabio Gelsomino, Massimo Aglietta, Mark Wong, Maria Luisa Limon Miron, Gregory Leonard, Pilar García-Alfonso, Andrew G Hill, Antonio Cubillo Gracian, Eric Van Cutsem and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02060188 (A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite Instability High), which is not on this map. Cited by 42 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02060188 phase2completednot on this map

A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite Instability High (MSI-H) and Non-MSI-H Colon Cancer

TypeinterventionalSponsorBristol-Myers SquibbRan2014 to 2024Enrolled385ConditionsMicrosatellite Unstable Colorectal Cancer, Microsatellite Stable Colorectal Cancer, Mismatch Repair Proficient Colorectal Cancer, Mismatch Repair Deficient Colorectal CancerArmsIpilimumab, Nivolumab, Cobimetinib, Daratumumab, BMS-986016
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  8. Asthenia in cancer patients receiving immune checkpoint Inhibitors (ICIs): the MOUSEION-11 systematic review and meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Michael J OvermanDepartment of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA moverman@mdanderson.org.ORCID http://orcid.org/0000-0001-5377-135X
Fabio GelsominoDepartment of Oncology and Hematology, University Hospital Modena, Modena, Italy.
Massimo AgliettaDepartment of Medical Oncology, Istituto di Candiolo, FPO IRCCS, Candiolo, Italy.
Mark WongDepartment of Medical Oncology, Westmead Hospital The Crown Princess Mary Cancer Centre, Sydney, New South Wales, Australia.
Maria Luisa Limon MironHospital Universitario Virgen del Rocio, Sevilla, Andalucía, Spain.
Gregory LeonardMedical Oncology, University College Hospital, Galway, Ireland.
Pilar García-AlfonsoMedical Oncology Service, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Andrew G HillTasman Oncology Research, Ltd, Southport, Queensland, Australia.
Antonio Cubillo GracianHospital Universitario HM Sanchinarro, Centro Integral Oncológico Clara Campal HM CIOCC, Madrid, Spain.
Eric Van CutsemDepartment of Digestive Oncology, KU Leuven University Hospitals Leuven Gasthuisberg Campus, Leuven, Belgium.
Bassel El-RayesDepartment of Medicine, Emory University Hospital, Atlanta, Georgia, USA.
Stephen M McCraithDepartment of Translational Medicine, Bristol Myers Squibb Co, Princeton, New Jersey, USA.
Beilei HeDepartment of Translational Medicine, Bristol Myers Squibb Co, Princeton, New Jersey, USA.
Ming LeiGlobal Biostatistics and Data Science, Bristol Myers Squibb Co, Princeton, New Jersey, USA.
Sara LonardiDepartment of Oncology, Veneto Institute of Oncology IOV-IRCSS, Padova, Italy.ORCID http://orcid.org/0000-0002-7593-8138

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProgrammed death-1 (PD-1) inhibitors, including nivolumab, have demonstrated long-term survival benefit in previously treated patients with microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (CRC). PD-1 and lymphocyte-activation gene 3 (LAG-3) are distinct immune checkpoints that are often co-expressed on tumor-infiltrating lymphocytes and contribute to tumor-mediated T-cell dysfunction. Relatlimab is a LAG-3 inhibitor that has demonstrated efficacy in combination with nivolumab in patients with melanoma. Here, we present the results from patients with MSI-H/dMMR metastatic CRC treated with nivolumab plus relatlimab in the CheckMate 142 study.

methodsIn this open-label, phase II study, previously treated patients with MSI-H/dMMR metastatic CRC received nivolumab 240 mg plus relatlimab 160 mg intravenously every 2 weeks. The primary end point was investigator-assessed objective response rate (ORR).

resultsA total of 50 previously treated patients received nivolumab plus relatlimab. With median follow-up of 47.4 (range 43.9-49.2) months, investigator-assessed ORR was 50% (95% CI 36% to 65%) and disease control rate was 70% (95% CI 55% to 82%). The median time to response per investigator was 2.8 (range 1.3-33.1) months, and median duration of response was 42.7 (range 2.8-47.0+) months. The median progression-free survival per investigator was 27.5 (95% CI 5.3 to 43.7) months with a progression-free survival rate at 3 years of 38%, and median overall survival was not reached (95% CI 17.2 months to not estimable), with a 56% overall survival rate at 3 years. The most common any-grade treatment-related adverse events (TRAEs) were diarrhea (24%), asthenia (16%), and hypothyroidism (12%). Grade 3 or 4 TRAEs were reported in 14% of patients, and TRAEs of any grade leading to discontinuation were observed in 8% of patients. No treatment-related deaths were reported.

conclusionsNivolumab plus relatlimab provided durable clinical benefit and was well tolerated in previously treated patients with MSI-H/dMMR metastatic CRC. TRIAL REGISTRATION NUMBER: NCT02060188.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsMicrosatellite InstabilityNivolumabAdultAgedAged, 80 and overDNA Mismatch RepairFemaleHumansMaleMiddle AgedNeoplasm MetastasisNivolumabcolorectal cancerimmune checkpoint inhibitor

Identifiers

PMID38821718
PMCPMC11149130

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.