Evidence Map / Solid Tumor Immuno-oncology / Apr 2026

The gut microbiome
and anti–PD-1 response.

A curated map of eleven foundational and validating studies, five completed interventional trials, and the patent families claiming rights on the bacteria they identify.

11 papers 5 trials 5 patent assignees 4 themes Smart Citations via Scite
Year
Study type
11 / 11 visible

Completed trials referenced

  • NCT03341143
    FMT + pembrolizumab in PD-1–refractory melanoma. Phase II, UPMC/Merck. n=18. Completed Sept 2024.
    → Davar 2021, Science
  • NCT04116775
    FMT + pembro + enzalutamide in mCRPC. Phase II, Portland VA. n=32 anticipated. Completed Oct 2023.
  • NCT04729322
    FMT + pembro/nivo re-challenge in MSI-H mCRC. Phase II, MD Anderson/NCI. Completed Dec 2024.
  • NCT04951583
    FMT + ICI in NSCLC / melanoma / uveal. Phase II, CHUM Canada (Routy group). Completed Sept 2025.
  • NCT03829111
    CBM588 + nivo/ipi in mRCC. Phase I, City of Hope. n=30. Completed June 2024.
    → Dizman 2022, Nature Medicine. PFS 12.7 vs 2.5 mo (HR 0.15). Microbiome 1° endpoint not met.

Patent assignees & key filings

  • Gustave Roussy
    Zitvogel lab, 7+ families.
    WO 2018/115519 · US 2019/0282632 · US 2022/0370514 · US 2024/0288449 · US 2024/0398876 · WO 2020/064997 (via Everimmune / INSERM / Paris-Saclay)
  • Evelo
    Bacterial EVs & membrane preps (dissolved 2024).
    US 12,109,243 · US 2022/0118030 · US 2022/0296654 · US 2021/0052669
  • 4D Pharma
    Roseburia franchise via GT Biologics / Armistice Capital.
    US 11,266,698 (R. hominis) · US 11,414,463 (R. flagellin)
  • U. Chicago
    Gajewski — foundational Bifidobacterium + ICI IP.
    US 9,855,302 · inventors Gajewski, Sivan, Corrales
  • MD Anderson
    Wargo / Gopalakrishnan, cross-assigned with Zitvogel.
    US 2022/0016188 (via Board of Regents, UT System)