Evidence map›Paper›PMID 33542131›Full record

Trial reportScience (New York, N.Y.)2021

Fecal microbiota transplant overcomes resistance to anti-PD-1 therapy in melanoma patients.

Diwakar Davar, Amiran K Dzutsev, John A McCulloch, Richard R Rodrigues, Joe-Marc Chauvin, Robert M Morrison, Richelle N Deblasio, Carmine Menna, Quanquan Ding, Ornella Pagliano and 22 more

3 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Science (New York, N.Y.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 1,092 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,092citing papers in PubMed, 9 pooled it
72.2field-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.

NCT03341143 phase2completednot on this map

Phase II Feasibility Study of Fecal Microbiota Transplant (FMT) in Advanced Melanoma Patients Not Responding to PD-1 Blockade

TypeinterventionalSponsorZarour, Hassane, MDRan2018 to 2024Enrolled20ConditionsMelanomaArmsFecal Microbiota Transplant with Pembrolizumab
NCT04758507 phase1 / phase2completednot on this map

Targeting Gut Microbiota to Improve Efficacy of Immune Checkpoint Inhibitors in Patients With Advanced Renal Cell Carcinoma

TypeinterventionalSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCSRan2021 to 2025Enrolled50ConditionsRenal Cell CarcinomaArmsdonor FMT, Placebo FMT
NCT05502913 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

Fecal Microbiota Transplantation to Improve Efficacy of Immune Checkpoint Inhibitors in Metastatic Lung Cancer

TypeinterventionalSponsorSoroka University Medical CenterRan2023 to 2028Enrolled80ConditionsMetastatic Lung CancerArmsAntibiotics, FMT (Fecal Microbiota Transplantation)
3 · Its place in the literature

Who cites it

1,092 citing papers in PubMed, 9 syntheses or guidelines pooled it, 1,511 citations in OpenAlex.

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1,032 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

32 authors at 6 institutions in 1 country.

Diwakar Davar *Department of Medicine and UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA 15213, USA.ORCID https://orcid.org/0000-0002-7846-8055
Amiran K Dzutsev *Laboratory of Integrative Cancer Immunology, Center for Cancer Research, National Cancer Institute, Bethesda, MD 20892, USA.
John A McCullochLaboratory of Integrative Cancer Immunology, Center for Cancer Research, National Cancer Institute, Bethesda, MD 20892, USA.ORCID https://orcid.org/0000-0001-7107-6561
Richard R RodriguesLaboratory of Integrative Cancer Immunology, Center for Cancer Research, National Cancer Institute, Bethesda, MD 20892, USA.ORCID https://orcid.org/0000-0003-3985-3003
Joe-Marc ChauvinDepartment of Medicine and UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA 15213, USA.ORCID https://orcid.org/0000-0002-5294-8632
Robert M MorrisonDepartment of Medicine and UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA 15213, USA.ORCID https://orcid.org/0000-0002-8421-8183
Richelle N DeblasioDepartment of Medicine and UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA 15213, USA.
Carmine MennaDepartment of Medicine and UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA 15213, USA.
Quanquan DingDepartment of Medicine and UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA 15213, USA.
Ornella PaglianoDepartment of Medicine and UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA 15213, USA.ORCID https://orcid.org/0000-0001-6745-1744
Bochra ZidiDepartment of Medicine and UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA 15213, USA.
Shuowen ZhangDepartment of Medicine and UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA 15213, USA.ORCID https://orcid.org/0000-0002-1466-1788
Jonathan H BadgerLaboratory of Integrative Cancer Immunology, Center for Cancer Research, National Cancer Institute, Bethesda, MD 20892, USA.ORCID https://orcid.org/0000-0002-5662-423X
Marie VetizouLaboratory of Integrative Cancer Immunology, Center for Cancer Research, National Cancer Institute, Bethesda, MD 20892, USA.ORCID https://orcid.org/0000-0003-4125-9652
Alicia M ColeLaboratory of Integrative Cancer Immunology, Center for Cancer Research, National Cancer Institute, Bethesda, MD 20892, USA.ORCID https://orcid.org/0000-0002-7792-2543
Miriam R FernandesLaboratory of Integrative Cancer Immunology, Center for Cancer Research, National Cancer Institute, Bethesda, MD 20892, USA.ORCID https://orcid.org/0000-0001-6570-0946
Stephanie PrescottLaboratory of Integrative Cancer Immunology, Center for Cancer Research, National Cancer Institute, Bethesda, MD 20892, USA.ORCID https://orcid.org/0000-0002-0469-5255
Raquel G F CostaLaboratory of Integrative Cancer Immunology, Center for Cancer Research, National Cancer Institute, Bethesda, MD 20892, USA.ORCID https://orcid.org/0000-0001-7602-7945
Ascharya K BalajiLaboratory of Integrative Cancer Immunology, Center for Cancer Research, National Cancer Institute, Bethesda, MD 20892, USA.ORCID https://orcid.org/0000-0003-1382-5864
Andrey MorgunCollege of Pharmacy, Oregon State University, Corvallis, OR 97331, USA.ORCID https://orcid.org/0000-0002-8924-6108
Ivan Vujkovic-CvijinLaboratory of Immune System Biology, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Bethesda, MD 20892, USA.ORCID https://orcid.org/0000-0002-8611-4900
Hong WangBiostatistics Facility, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA 15213, USA.ORCID https://orcid.org/0000-0003-0477-2908
Amir A BorhaniDivision of Abdominal Imaging, Department of Radiology, University of Pittsburgh, Pittsburgh, PA 15213, USA.ORCID https://orcid.org/0000-0001-8963-2984
Marc B SchwartzDivision of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh, Pittsburgh, PA 15213, USA.ORCID https://orcid.org/0000-0002-2646-380X
Howard M DubnerDivision of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh, Pittsburgh, PA 15213, USA.ORCID https://orcid.org/0000-0003-4510-5677
Scarlett J ErnstDepartment of Medicine and UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA 15213, USA.
Amy RoseDepartment of Medicine and UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA 15213, USA.
Yana G NajjarDepartment of Medicine and UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA 15213, USA.ORCID https://orcid.org/0000-0002-0138-1664
Yasmine BelkaidLaboratory of Immune System Biology, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Bethesda, MD 20892, USA.ORCID https://orcid.org/0000-0001-9962-3571
John M KirkwoodDepartment of Medicine and UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA 15213, USA.ORCID https://orcid.org/0000-0002-3570-4476
Giorgio Trinchieri *Laboratory of Integrative Cancer Immunology, Center for Cancer Research, National Cancer Institute, Bethesda, MD 20892, USA. zarourhm@upmc.edu trinchig@mail.nih.gov.ORCID https://orcid.org/0000-0001-5892-7464
Hassane M Zarour *Department of Medicine and UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA 15213, USA. zarourhm@upmc.edu trinchig@mail.nih.gov.ORCID https://orcid.org/0000-0003-2525-2688
UPMC Hillman Cancer Center · USNational Cancer Institute · USUniversity of Pittsburgh · USNational Institute of Allergy and Infectious Diseases · USFrederick National Laboratory for Cancer Research · USOregon State University · US

Funding

VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI JOHN C. BYRD · 1988 to 2026
$158.0M
LICI Microbiome and Genetics CoreZICBC011237 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI OHUIGIN, COLM · 2009 to 2025
$28.3M
Role of the microbiota in immunityZIAAI001115 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI BELKAID, YASMINE · 2009 to 2025
$22.4M
Role of mouse microbiome in cancer and inflammationZIABC011153 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI TRINCHIERI, GIORGIO · 2009 to 2025
$22.0M
NIAID Microbiome ProgramZICAI001233 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI MOUTSOPOULOS, NIKI · 2018 to 2025
$18.9M
Fecal Microbiota Transplant and PD-1 blockade in MelanomaR01CA222203 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI ZAROUR, HASSANE M · 2018 to 2022
$2.5M
Targeting TIGIT and PD-1 in MelanomaR01CA228181 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI ZAROUR, HASSANE M · 2018 to 2022
$1.8M
NCI NIH HHS P30 CA047904NCI NIH HHS R01 CA222203NCI NIH HHS R01 CA228181
6 · The paper itself

Abstract

Anti-programmed cell death protein 1 (PD-1) therapy provides long-term clinical benefits to patients with advanced melanoma. The composition of the gut microbiota correlates with anti-PD-1 efficacy in preclinical models and cancer patients. To investigate whether resistance to anti-PD-1 can be overcome by changing the gut microbiota, this clinical trial evaluated the safety and efficacy of responder-derived fecal microbiota transplantation (FMT) together with anti-PD-1 in patients with PD-1-refractory melanoma. This combination was well tolerated, provided clinical benefit in 6 of 15 patients, and induced rapid and durable microbiota perturbation. Responders exhibited increased abundance of taxa that were previously shown to be associated with response to anti-PD-1, increased CD8

Indexed as

Drug Resistance, NeoplasmFecal Microbiota TransplantationAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCD8-Positive T-LymphocytesGastrointestinal MicrobiomeHumansInterleukin-8Lymphocyte ActivationLymphocytes, Tumor-InfiltratingMelanomaMyeloid CellsProgrammed Cell Death 1 ReceptorSkin NeoplasmsTumor MicroenvironmentAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalInterleukin-8pembrolizumabProgrammed Cell Death 1 Receptor

Identifiers

PMID33542131
PMCPMC8097968
OpenAlexW3126208996

What OpenQuestion holds

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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.