Evidence map›Paper›PMID 37414899›Full record

ArticleNature medicine2023

Fecal microbiota transplantation plus anti-PD-1 immunotherapy in advanced melanoma: a phase I trial.

Bertrand Routy, John G Lenehan, Wilson H Miller, Rahima Jamal, Meriem Messaoudene, Brendan A Daisley, Cecilia Hes, Kait F Al, Laura Martinez-Gili, Michal Punčochář and 27 more

Erratum issued 2 registry-linked trialsAbstract readClinical Trial, Phase IMulticenter Study
PubMed Publisher
In one paragraph

Article in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 345 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
345citing papers in PubMed, 7 pooled it
62.5field-weighted citation impact, top 1% of its field
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.

NCT03772899 phase1active not recruitingnot on this map

Fecal Microbial Transplantation in Combination With Immunotherapy in Melanoma Patients (MIMic)

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2019 to 2026Enrolled20ConditionsMelanomaArmsFecal Microbial Transplantation
NCT06661044 completednot on this mapstarted 2024, after this paper: background citation

Exploiting Human Microbiota-associated in Vivo Models for Mechanistic Studies to Understand the Benefits of Dietary Fibre Supplementation in Patients With Prostate Cancer

TypeobservationalSponsorUniversity of AberdeenRan2024 to 2025Enrolled6ConditionsProstate Cancer (Adenocarcinoma)
3 · Its place in the literature

Who cites it

345 citing papers in PubMed, 7 syntheses or guidelines pooled it, 407 citations in OpenAlex.

  1. Pooled it
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  4. Worldwide research trends on theFrontiers in immunology · 2026
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  5. [Fecal Microbiota Transplantation: A Promising Avenue for Lung Cancer Therapy].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2025
    Pooled it
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  19. Oncoimmunology · 2026
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285 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

37 authors at 10 institutions in 4 countries.

Bertrand Routy *Research Center of the Centre Hospitalier de l'Université de Montréal, Montréal (CRCHUM), Montreal, Quebec, Canada.ORCID http://orcid.org/0000-0003-1955-9149
John G Lenehan *Department of Oncology, Western University, London, Ontario, Canada.
Wilson H MillerLady Davis Institute of the Jewish General Hospital, Segal Cancer Centre, Montreal, Quebec, Canada.
Rahima JamalResearch Center of the Centre Hospitalier de l'Université de Montréal, Montréal (CRCHUM), Montreal, Quebec, Canada.
Meriem MessaoudeneResearch Center of the Centre Hospitalier de l'Université de Montréal, Montréal (CRCHUM), Montreal, Quebec, Canada.
Brendan A DaisleyDepartment of Microbiology & Immunology, Western University, London, Ontario, Canada.ORCID http://orcid.org/0000-0001-5999-5792
Cecilia HesResearch Center of the Centre Hospitalier de l'Université de Montréal, Montréal (CRCHUM), Montreal, Quebec, Canada.ORCID http://orcid.org/0000-0002-4828-3260
Kait F AlLawson Health Research Institute, London, Ontario, Canada.ORCID http://orcid.org/0000-0002-5905-6581
Laura Martinez-GiliDivision of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, St Mary's Hospital Campus, Imperial College London, London, UK.ORCID http://orcid.org/0000-0001-5271-9672
Michal PunčochářDepartment of Computational, Cellular and Integrative Biology, University of Trento, Trento, Italy.ORCID http://orcid.org/0000-0002-1915-9391
Scott ErnstDepartment of Oncology, Western University, London, Ontario, Canada.
Diane LoganDepartment of Oncology, Western University, London, Ontario, Canada.
Karl BelangerResearch Center of the Centre Hospitalier de l'Université de Montréal, Montréal (CRCHUM), Montreal, Quebec, Canada.
Khashayar EsfahaniLady Davis Institute of the Jewish General Hospital, Segal Cancer Centre, Montreal, Quebec, Canada.
Corentin RichardResearch Center of the Centre Hospitalier de l'Université de Montréal, Montréal (CRCHUM), Montreal, Quebec, Canada.
Marina NinkovDepartment of Microbiology & Immunology, Western University, London, Ontario, Canada.
Gianmarco PiccinnoDepartment of Computational, Cellular and Integrative Biology, University of Trento, Trento, Italy.
Federica ArmaniniDepartment of Computational, Cellular and Integrative Biology, University of Trento, Trento, Italy.
Federica PintoDepartment of Computational, Cellular and Integrative Biology, University of Trento, Trento, Italy.ORCID http://orcid.org/0000-0002-4539-4811
Mithunah KrishnamoorthyDepartment of Pathology and Laboratory Medicine, Western University, London, Ontario, Canada.
Rene FigueredoDepartment of Oncology, Western University, London, Ontario, Canada.
Pamela ThebaultResearch Center of the Centre Hospitalier de l'Université de Montréal, Montréal (CRCHUM), Montreal, Quebec, Canada.
Panteleimon TakisDepartment of Metabolism, Digestion and Reproduction, Faculty of Medicine, National Phenome Centre, Imperial College London, London, UK.ORCID http://orcid.org/0000-0002-7224-0412
Jamie MagrillRosalind and Morris Goodman Cancer Institute, McGill University, Montréal, Quebec, Canada.
LeeAnn RamsayRosalind and Morris Goodman Cancer Institute, McGill University, Montréal, Quebec, Canada.
Lisa DerosaGustave Roussy Cancer Campus, Villejuif, France.ORCID http://orcid.org/0000-0003-0527-2964
Julian R MarchesiDivision of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, St Mary's Hospital Campus, Imperial College London, London, UK.
Seema Nair ParvathyDepartment of Medicine, Division of Infectious Diseases, Western University, London, Ontario, Canada.
Arielle ElkriefResearch Center of the Centre Hospitalier de l'Université de Montréal, Montréal (CRCHUM), Montreal, Quebec, Canada.
Ian R WatsonRosalind and Morris Goodman Cancer Institute, McGill University, Montréal, Quebec, Canada.ORCID http://orcid.org/0000-0002-6025-3080
Rejean LapointeResearch Center of the Centre Hospitalier de l'Université de Montréal, Montréal (CRCHUM), Montreal, Quebec, Canada.
Nicola SegataDepartment of Computational, Cellular and Integrative Biology, University of Trento, Trento, Italy.
S M Mansour HaeryfarLawson Health Research Institute, London, Ontario, Canada.ORCID http://orcid.org/0000-0002-1125-8176
Benjamin H MullishDivision of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, St Mary's Hospital Campus, Imperial College London, London, UK.ORCID http://orcid.org/0000-0001-6300-3100
Michael S SilvermanLawson Health Research Institute, London, Ontario, Canada.
Jeremy P BurtonLawson Health Research Institute, London, Ontario, Canada.ORCID http://orcid.org/0000-0002-3591-6436
Saman Maleki VarekiDepartment of Oncology, Western University, London, Ontario, Canada. saman.malekivareki@lhsc.on.ca.ORCID http://orcid.org/0000-0002-9615-7779
Western University · CACentre Hospitalier de l’Université de Montréal · CAUniversity of Trento · ITJewish General Hospital · CAMcGill University · CASt Mary's Hospital · GBImperial College Healthcare NHS Trust · GBImperial College London · GBInserm · FROntario Institute for Cancer Research · CA

Funding

CIHR MOP 389137CIHR PJT – 156295CIHR PJT-178341Medical Research Council MC_PC_12025
6 · The paper itself

Abstract

Fecal microbiota transplantation (FMT) represents a potential strategy to overcome resistance to immune checkpoint inhibitors in patients with refractory melanoma; however, the role of FMT in first-line treatment settings has not been evaluated. We conducted a multicenter phase I trial combining healthy donor FMT with the PD-1 inhibitors nivolumab or pembrolizumab in 20 previously untreated patients with advanced melanoma. The primary end point was safety. No grade 3 adverse events were reported from FMT alone. Five patients (25%) experienced grade 3 immune-related adverse events from combination therapy. Key secondary end points were objective response rate, changes in gut microbiome composition and systemic immune and metabolomics analyses. The objective response rate was 65% (13 of 20), including four (20%) complete responses. Longitudinal microbiome profiling revealed that all patients engrafted strains from their respective donors; however, the acquired similarity between donor and patient microbiomes only increased over time in responders. Responders experienced an enrichment of immunogenic and a loss of deleterious bacteria following FMT. Avatar mouse models confirmed the role of healthy donor feces in increasing anti-PD-1 efficacy. Our results show that FMT from healthy donors is safe in the first-line setting and warrants further investigation in combination with immune checkpoint inhibitors. ClinicalTrials.gov identifier NCT03772899 .

Indexed as

Fecal Microbiota TransplantationMelanomaFecesHumansImmune Checkpoint InhibitorsImmunotherapyTreatment OutcomeImmune Checkpoint Inhibitors

Identifiers

PMID37414899
OpenAlexW4383341159

What Socratic holds

Textmetadata
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 Socratic graph.