Evidence map›Paper›PMID 40389373›Full record

Trial reportJournal for immunotherapy of cancer2025

Interplay between sarcopenia, GDF-15, and the efficacy of nivolumab plus ipilimumab in patients with mismatch repair deficient metastatic colorectal cancer: final survival analysis of the phase II GERCOR NIPICOL study.

Leonard Depotte, Paula Nay, Christophe Borg, Aurélia Meurisse, Julie Henriques, Jaafar Bennouna, Christelle De La Fouchardière, David Tougeron, Thibault Mazard, Benoist Chibaudel and 5 more

Registry-linked trialAbstract readClinical 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 NCT03350126 (Interest of iRECIST Radiological Assessment for Disease Control Rate), which is not on this map. Cited by 3 papers.

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

NCT03350126 phase2active not recruitingnot on this map

Interest of iRECIST Radiological Assessment for Disease Control Rate (DCR) for Evaluation of Patients With Metastatic Colorectal Cancer dMMR and/or MSI Treated With Nivolumab and Ipilimumab. A GERCOR Open-label Phase II Study NIPICOL C17-01

TypeinterventionalSponsorGERCOR - Multidisciplinary Oncology Cooperative GroupRan2017 to 2025Enrolled57ConditionsMetastatic Cancer ColorectalArmsIpilimumab 200 MG in 40 ML Injection, Nivolumab 10 MG/ML
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
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.

Leonard DepotteDepartment of Medical Oncology, Univ Paris Est Creteil, INSERM, IMRB, AP-HP, Hopital Henri Mondor, Creteil, Île-de-France, France.
Paula NayDepartment of Medical Oncology, Hôpital Saint-Antoine, Paris, Île-de-France, France.
Christophe BorgMedical Oncology, Hôpital Jean Minjoz, Besancon, France.
Aurélia MeurisseEFS, INSERM, UMR RIGHT, University of Franche-Comté, Besancon, Bourgogne-Franche-Comté, France.
Julie HenriquesEFS, INSERM, UMR RIGHT, University of Franche-Comté, Besancon, Bourgogne-Franche-Comté, France.
Jaafar BennounaDepartment of Digestive Oncology, University Hospital Centre Nantes, Nantes, Pays de la Loire, France.
Christelle De La FouchardièreMedical Oncology, Centre Leon Berard, Lyon, Rhône-Alpes, France.
David TougeronDepartment of Hepato-Gastroenterology, CHU Poitiers, Poitiers, France.ORCID http://orcid.org/0000-0002-8065-9635
Thibault MazardDepartment of Medical Oncology, Institut de Recherche en Cancérologie de Montpellier, Montpellier, Languedoc-Roussillon, France.
Benoist ChibaudelDepartment of Medical Oncology, Hospital Franco-Britannique, Fondation Cognacq-Jay, Paris, France.
Christophe TournigandDepartment of Medical Oncology, Univ Paris Est Creteil, INSERM, IMRB, AP-HP, Hopital Henri Mondor, Creteil, Île-de-France, France.
Dewi VernereyEFS, INSERM, UMR RIGHT, University of Franche-Comté, Besancon, Bourgogne-Franche-Comté, France.
Frédéric PigneurDepartment of Radiology, University Hospital of Henri Mondor, Créteil, France.
Thierry AndreGERCOR, Paris, France.ORCID http://orcid.org/0000-0002-5103-7095
Romain CohenGERCOR, Paris, France romain.cohen@aphp.fr.ORCID http://orcid.org/0000-0001-9602-5162

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSarcopenia and growth differentiation factor 15 (GDF-15) are linked to poor cancer survival. In this exploratory analysis, we evaluated their interaction with nivolumab-ipilimumab efficacy in chemoresistant metastatic colorectal cancer (mCRC) harboring microsatellite instability and/or mismatch-repair deficiency (MSI/dMMR), based on the final survival analysis of the NIPICOL phase II trial. PATIENTS AND

methods57 patients with MSI/dMMR chemoresistant mCRC received nivolumab-ipilimumab for 3 months (3M), then, nivolumab alone for 9M. Skeletal muscle mass index (SMI) was evaluated by CT scan at baseline and 12M to assess sarcopenia. GDF-15 levels were assessed at baseline and 3M. Main endpoints were overall survival (OS) and immune Response Evaluation Criteria In Solid Tumors progression-free survival (iPFS).

resultsAfter excluding three patients not confirmed as MSI/dMMR by central review, the overall median follow-up was 60.4 months. The 3-year and 5 year iPFS rates were 72.0% and 65.3%, with OS rates of 77.5% and 73.3%, respectively. Among 49 patients with evaluable GDF-15, high-baseline GDF-15 was associated with poorer survival: 3-year iPFS rate of 56.3% for GDF-15≥2500 versus 81.7% for GDF-15<2500 (PFS HR=2.45, 95% CI 0.91 to 6.55), 3-year OS rates of 61.4% versus 84.5% (OS HR=2.08, 95% CI 0.70 to 6.22). Of the 48 evaluable patients for SMI, 31 (65.0%) displayed sarcopenia at baseline. 11 out of 20 (55%) patients with baseline sarcopenia and assessed for SMI at 12M, reversed sarcopenia by 12M. They had higher baseline GDF-15 levels and greater GDF-15 decrease by 3M (delta mean change: -69.8% vs -40.3%) compared with patients who remained sarcopenic.

conclusion1-year nivolumab-ipilimumab demonstrates consistent efficacy after 5-year follow-up in an MSI/dMMR chemoresistant mCRC population. GDF-15 confirms to be a promising biomarker for sarcopenia and survival. TRIAL REGISTRATION NUMBER: NCT03350126.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsGrowth Differentiation Factor 15IpilimumabNivolumabSarcopeniaAdultAgedDNA Mismatch RepairFemaleHumansMaleMiddle AgedSurvival AnalysisGDF15 protein, humanGrowth Differentiation Factor 15IpilimumabNivolumabColorectal CancerImmune Checkpoint InhibitorImmunotherapyMicrosatellite

Identifiers

PMID40389373
PMCPMC12090849

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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.