Phase 1/2, open-label study of oral bacterial supplementation (EDP1503) plus pembrolizumab in participants with advanced or metastatic microsatellite-stable colorectal cancer, triple-negative breast cancer, and checkpoint inhibitor–relapsed tumors

Ethics approval and consent to participate

The study protocol and its amendments were approved by the appropriate local or national ethics committee or institutional review board for each participating center. All participants provided written informed consent. The study was conducted in accordance with the Good Clinical Practice requirements and the ethical principles described in the Declaration of Helsinki.

Consent for publication

Not applicable.

Competing interests

Judy S Wang: has served in a consulting role for Fusion Pharma; has received research funding to the institution from AbbVie, Accutar Biotech, Adagene, Agenus, Allorion Therapeutics, Alterome Therapeutics, Apollo, Artios, Astellas Pharma, Bayer, Beigene, Bicycle Therapeutics, BioNTech SE, Biostar, BioTheryX, Blueprint Medicines, BMS GmbH & Co. KG, Boehringer Ingelheim, C4 Therapeutics, Celgene/Bristol Myers Squibb, Centessa Pharmaceuticals, Circle Pharma, Compass Therapeutics, Compugen, Cullinan Oncology, Conjupro Biotherapeutics, Cyteir, D3 Bio, Daiichi Sankyo/UCB Japan, DualityBio, Edgewood Oncology, Ellipses Pharma, Erasca Inc, Forty Seven, Genentech/Roche, GenMab, Georgiamune, GlaxoSmithKline, Hotspot Therapeutics, IgM Biosciences, Immunitas, Immunogen, Immuno-Onc, Janssen, Jazz Pharmaceuticals, Kineta, Klus Pharma, Kumquat, Kura Oncology, Kymab, Loxo/Lilly, LSK Global, MabSpace Biosciences, Macrogenics, MBQ Pharma, Medikine, MediLink Therapeutics, Menarini, Merck KGaA, Mersana, Moderna Therapeutics, NGM Biopharmaceuticals, Novartis, Nurix, Olema Oncology, OnCusp Therapeutics, Pfizer, Phoenix Molecular Designs, Prelude Therapeutics, PureTech, Pyxis, Qilu Puget Sound Biotherapeutics, Quanta Therapeutics, Relay Therapeutics, Revolution Medicines, Ribon Therapeutics, Sanofi, Seven and Eight Biopharmaceuticals, Step Pharma, Syndax, Tango Therapeutics, TeneoBio, Treadwell Therapeutics, Vividion Therapeutics, Xencor, Zai Lab, and Zymeworks; and has received travel, accommodations, and expenses support from NGM Biopharmaceuticals. Edward R Arrowsmith: has received research funding to the institution from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Calistoga Pharmaceuticals, Celgene, Cephalon, Chorus, Eisai, EMD Serono, Evelo Biosciences, Exelixis, Genentech, Gilead Sciences, Incyte, Merck KGaA, Millennium, Modra, Novartis, Oncogenex, Onyx, Peloton Therapeutics, Pfizer, Sarah Cannon Research Institute, Takeda, Clovis Oncology, Lilly, Infinity Pharmaceuticals, Janssen Research & Development, Leap Therapeutics, F. Hoffmann LaRoche, Loxo, Tolmar, Dana-Farber Cancer Institute, AbbVie, and G1 Therapeutics. J Thaddeus Beck: has received research funding to the institution from Merck & Co., Inc., Rahway, NJ, USA, Bristol Myers Squibb, Lilly, DSI, Novartis, Gilead, AbbVie, Stemline, Arvenist, Pfizer, Johnson and Johnson, and AstraZeneca. Jennifer Friedmann: nothing to disclose. Rahima Jamal: has received honoraria from Pfizer, BMS GmbH & Co. KG, Merck KGaA, and Novartis; has served in a consulting or advisory role for Bristol Myers Squibb, Medison Pharma, Pfizer, Merck KGaA, and Novartis; and has received research funding to the institution from MSD, Bristol Myers Squibb, Iovance Biotherapeutics, Pfizer, BioNTech SE, Astellas Pharma, Pacylex, Novartis, VelsoBio/Merck, Alkermes, Surface Oncology, Boerhinger Ingelheim, Immunocore, Evelo Biosciences, AstraZeneca/MedImmune, Roche/Genentech, and Takeda. Duncan McHale: former employee of Evelo Biosciences, Cambridge, MA, USA. Humphrey Gardner: nothing to disclose. Michael J Chisamore: employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, who may own stock and/or hold stock options in Merck & Co., Inc., Rahway, NJ, USA. Susanna V Ulahannan: has served on an advisory board for Eisai, AstraZeneca, and IGM Biosciences; and has received research funding to the institution from AbbVie, Inc, Adlai Nortye, Artios Pharma, ArQule, Inc, AstraZeneca, Atreca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene Corporation, Ciclomed LLC, Eisai, Erasca, Evelo Biosciences, Inc, Exelexis, Exthera, G1 Therapeutics, Inc, GSK, IGM Biosciences, Immunitas Therapeutics, Incyte, Isofol, Jazz Pharmaceuticals, Klus Pharma, Inc, Macrogenics, Merck & Co., Inc., Rahway, NJ, USA, Mersana Therapeutics, Omega Therapeutics, OncoMed Pharmaceuticals, Inc, Pfizer, Purple Biotech, Qurgen, Regeneron Pharmaceuticals, Inc, Revolution Medicines, Inc, Sapience Therapeutics, Inc, Synermore Biologics Co, Takeda, Tarveda Therapeutics, Tesaro, Tempest Therapeutics, Theradex, Totos Medicines, Inc, Tvardi Therapeutics, and Vigeo Therapeutics Inc.

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