Evidence map›Paper›PMID 39889250›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025

Nivolumab With or Without Ipilimumab in Patients With Recurrent or Metastatic Merkel Cell Carcinoma: A Nonrandomized, Open-Label, International, Multicenter Phase I/II Study.

Shailender Bhatia, Suzanne L Topalian, William Sharfman, Tim Meyer, Neil Steven, Christopher D Lao, Lorena Fariñas-Madrid, Lot A Devriese, Kathleen Moore, Robert L Ferris and 6 more

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

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02488759 (Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab Monotherapy and Nivolumab Combination Therapy in Subjects With Virus-Positive and Virus-Negative Solid Tumors), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 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.

NCT02488759 phase1 / phase2completednot on this map

Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab Monotherapy and Nivolumab Combination Therapy in Subjects With Virus-Positive and Virus-Negative Solid Tumors

TypeinterventionalSponsorBristol-Myers SquibbRan2015 to 2022Enrolled578ConditionsVarious Advanced CancerArmsNivolumab, Ipilimumab, Relatlimab, Daratumumab
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

16 authors.

Shailender BhatiaDivision of Hematology-Oncology, University of Washington and Fred Hutchinson Cancer Center, Seattle, WA.ORCID 0000-0002-3816-2238
Suzanne L TopalianJohns Hopkins Bloomberg-Kimmel Institute for Cancer Immunotherapy and Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.ORCID 0000-0002-0821-8587
William SharfmanJohns Hopkins Bloomberg-Kimmel Institute for Cancer Immunotherapy and Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD.ORCID 0000-0001-7766-249X
Tim MeyerDepartment of Oncology, University College London Cancer Institute, London, United Kingdom.ORCID 0000-0003-0782-8647
Neil StevenInstitute of Immunology and Immunotherapy, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom.ORCID 0000-0002-0571-5043
Christopher D LaoMichigan Medicine, Rogel Cancer Center, Ann Arbor, MI.
Lorena Fariñas-MadridVall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
Lot A DevrieseDepartment of Medical Oncology, Cancer Center, University Medical Center Utrecht, Utrecht, the Netherlands.
Kathleen MooreDepartment of Obstetrics and Gynecology, Stephenson Cancer Center at the University of Oklahoma HSC, Oklahoma City, OK.ORCID 0000-0002-5803-0718
Robert L FerrisLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC.ORCID 0000-0001-6605-2071
Yoshitaka HonmaDepartment of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0002-4209-4493
Ileana EliasBristol Myers Squibb, Princeton, NJ.
Anjaiah SrirangamBristol Myers Squibb, Princeton, NJ.
Charlie Garnett-BensonBristol Myers Squibb, Princeton, NJ.ORCID 0000-0002-0238-3303
Michelle LeeBristol Myers Squibb, Princeton, NJ.
Paul NghiemUniversity of Washington Medical Center, Seattle, WA.ORCID 0000-0003-2784-963X

Funding

Understand & overcome resistance to PD-1P01CA225517 · NCI · UNIVERSITY OF WASHINGTON · PI PAUL NGHIEM · 2019 to 2026
$22.7M
NCI NIH HHS P01 CA225517
6 · The paper itself

Abstract

purposeApproximately 50% of patients with advanced Merkel cell carcinoma (MCC) have primary or acquired resistance to PD-(L)1 blockade, which may be overcome using combination immune checkpoint inhibition (ICI) with anti-cytotoxic T lymphocyte antigen-4 antibody. We present results from the recurrent/metastatic MCC cohort in CheckMate 358, a nonrandomized, multicohort, phase I/II study of nivolumab (NIVO) with or without ipilimumab (IPI) in virus-associated cancers (ClinicalTrials.gov identifier: NCT02488759).

methodsICI-naïve patients with recurrent/metastatic MCC and 0-2 previous systemic therapies were administered NIVO monotherapy at 240 mg once every 2 weeks or combination therapy with NIVO 3 mg/kg once every 2 weeks + IPI 1 mg/kg once every 6 weeks. The primary end point was objective response. Secondary end points included duration of response (DOR), progression-free survival (PFS), and overall survival (OS).

resultsSixty-eight patients received NIVO (n = 25) or NIVO + IPI (n = 43). The objective response rate (95% CI) and median DOR (95% CI), respectively, were 60% (38.7 to 78.9) and 60.6 months (16.7 to not applicable [NA]) with NIVO and 58% (42.1 to 73) and 25.9 months (10.4 to NA) with NIVO + IPI. The median PFS (95% CI) and OS (95% CI), respectively, were 21.3 (9.2 to 62.5) and 80.7 (23.3 to NA) months with NIVO and 8.4 (3.7 to 24.3) and 29.8 (8.5 to 48.3) months with NIVO + IPI. The incidence of grade 3/4 treatment-related adverse events was 28% with NIVO and 47% with the combination.

conclusionThis nonrandomized study showed frequent and durable responses with both NIVO and NIVO + IPI in patients with ICI-naïve advanced MCC. However, it did not show improvement in efficacy with the combination, thus contradicting previous study reports that had suggested clinical benefit with combination ICI. A randomized trial of NIVO + IPI versus NIVO monotherapy is warranted.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Merkel CellIpilimumabNeoplasm Recurrence, LocalNivolumabSkin NeoplasmsAdultAgedAged, 80 and overFemaleHumansImmune Checkpoint InhibitorsMaleMiddle AgedProgression-Free SurvivalImmune Checkpoint InhibitorsIpilimumabNivolumab

Identifiers

PMID39889250
PMCPMC11908902

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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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 Socratic graph.