Evidence map›Paper›PMID 40940136›Full record

Trial reportJournal for immunotherapy of cancer2025

Analysis of treatment-free survival of patients with advanced melanoma receiving nivolumab as monotherapy or in combination with relatlimab in RELATIVITY-047.

Meredith M Regan, Paolo A Ascierto, Evan J Lipson, Jennell Palaia, Andriy Moshyk, Abraham Selvan, Christopher D Lao, Michael B Atkins, David F McDermott, Ravi Potluri and 6 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03470922 (A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 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.

NCT03470922 phase2 / phase3active not recruitingnot on this map

A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma

TypeinterventionalSponsorBristol-Myers SquibbRan2018 to 2030Enrolled714ConditionsMelanomaArmsRelatlimab, Nivolumab
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
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.

Meredith M ReganDana-Farber Cancer Institute, Boston, Massachusetts, USA mregan@jimmy.harvard.edu.ORCID http://orcid.org/0000-0002-2428-6109
Paolo A AsciertoIstituto Nazionale dei Tumori IRCCS "Fondazione G. Pascale", Naples, Italy.ORCID http://orcid.org/0000-0002-8322-475X
Evan J LipsonThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, Maryland, USA.ORCID http://orcid.org/0000-0003-2976-0911
Jennell PalaiaBristol Myers Squibb, Princeton, New Jersey, USA.
Andriy MoshykBristol Myers Squibb, Princeton, New Jersey, USA.
Abraham SelvanBristol Myers Squibb, Princeton, New Jersey, USA.
Christopher D LaoBristol Myers Squibb, Princeton, New Jersey, USA.
Michael B AtkinsGeorgetown University Lombardi Comprehensive Cancer Center, Washington, District of Columbia, USA.ORCID http://orcid.org/0000-0003-3901-9924
David F McDermottBeth Israel Deaconess Medical Center, Boston, Massachusetts, USA.ORCID http://orcid.org/0000-0002-2675-5095
Ravi PotluriPutnam Associates, New York, New York, USA.
Sandip RanjanPutnam Associates, Gurugram, Haryana, India.
Sandeep BiltharePutnam Associates, Gurugram, Haryana, India.
Georgina V LongMelanoma Institute Australia, The University of Sydney, and Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0001-8894-3545
F Stephen HodiDana-Farber Cancer Institute, Boston, Massachusetts, USA.
Hussein TawbiThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID http://orcid.org/0000-0003-1942-851X
Dirk SchadendorfUniversity of Essen and the German Cancer Consortium, Essen, Germany; National Center for Tumor Diseases, Essen, Germany; and University Alliance Ruhr, University Duisburg-Essen, Essen, Germany.ORCID http://orcid.org/0000-0003-3524-7858

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment-free survival (TFS; time spent free of systemic anticancer therapy) is increasingly used to support traditional endpoints. TFS was previously evaluated in patients with advanced melanoma treated with nivolumab plus ipilimumab. This analysis compared TFS for nivolumab plus relatlimab and nivolumab monotherapy in patients with advanced melanoma.

methodsData were from 714 patients in the phase 2/3 RELATIVITY-047 trial (ClinicalTrials.gov identifier: NCT03470922). TFS was defined as the difference in restricted mean event times between the Kaplan-Meier curves for time to protocol therapy cessation and time to subsequent systemic anticancer therapy initiation or death. TFS was further partitioned into time with and time without grade ≥3 treatment-related adverse events (TRAEs). Subgroup analysis based on tumor

resultsAt 48 months from randomization, Kaplan-Meier estimates of overall survival were 52% and 43% for patients in the nivolumab plus relatlimab and nivolumab groups, respectively; 38% and 33% of patients in these respective groups were free of subsequent systemic therapy. The 48-month mean TFS was 2.9 months (95% CI 1.0 to 4.9) longer with nivolumab plus relatlimab than with nivolumab (9.7 vs 6.8 months, respectively). Mean TFS represented 20% and 14% of the 48-month period after initiating nivolumab plus relatlimab and nivolumab, respectively. Considering only time without grade ≥3 TRAEs, the 48-month mean TFS was 2.6 months (95% CI 0.8 to 4.5) longer with nivolumab plus relatlimab than with nivolumab (9.1 vs 6.5 months, respectively). The 48-month mean total TFS was consistently longer with nivolumab plus relatlimab than with nivolumab in the

conclusionsThis analysis demonstrated TFS benefit during the 48 months since initiating nivolumab plus relatlimab compared with nivolumab alone in patients with advanced melanoma. A direct comparison between nivolumab plus relatlimab and nivolumab plus ipilimumab is needed to determine the differences between the regimens in TFS and those in traditional endpoints.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsMelanomaNivolumabAdultAgedDisease-Free SurvivalFemaleHumansMaleMiddle AgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalNivolumabrelatlimabImmune Checkpoint InhibitorImmunotherapySkin Cancer

Identifiers

PMID40940136
PMCPMC12519387

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.