Selected Publications

Featured publication

Fecal microbiota transplantation plus immunotherapy in metastatic renal cell carcinoma: the phase 1 PERFORM trial.

Fernandes R, Jabbarizadeh B, Rajeh A, et al. Nature Medicine, 2026.

Twenty treatment-naive patients with metastatic kidney cancer received healthy-donor FMT capsules alongside immune checkpoint inhibitors. The combination met its safety endpoint, half of evaluable patients responded, and gut microbiome engraftment patterns tracked with both response and toxicity.

Renal cell carcinomaFMTImmune checkpoint inhibitorsPhase 1Immune-related adverse events

Fecal microbiota transplantation plus immunotherapy in non-small cell lung cancer and melanoma: the phase 2 FMT-LUMINate trial.

Duttagupta S, Messaoudene M, Hunter S, et al. Nature Medicine, 2026.

A multicentre phase 2 trial of a single oral FMT before first-line immunotherapy. Response rates were 80% in lung cancer and 75% in melanoma, and responders showed a distinct post-FMT microbiome marked by loss of specific baseline bacteria.

Lung cancerMelanomaFMTPhase 2Microbiome

Improved survival in advanced melanoma patients treated with fecal microbiota transplantation using healthy donor stool in combination with anti-PD1: final results of the MIMic phase 1 trial.

Hadi DK, Baines KJ, Jabbarizadeh B, et al. Journal for ImmunoTherapy of Cancer, 2025.

Long-term follow-up of the MIMic trial after more than three years. Median progression-free survival was 29.6 months and median overall survival 52.8 months, supporting the planned ME.17 randomized phase 2 study.

MelanomaFMTAnti-PD-1SurvivalPhase 1

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

Routy B, Lenehan JG, Miller WH, et al. Nature Medicine, 2023.

The first trial of healthy-donor FMT with anti-PD-1 as first-line treatment in advanced melanoma. The combination was safe, 65% of patients responded, and responders gained immunogenic bacteria while losing deleterious ones.

MelanomaFMTAnti-PD-1First-lineMicrobiome

The gut microbiome as a target in cancer immunotherapy: opportunities and challenges for drug development.

Elkrief A, Pidgeon R, Maleki Vareki S, et al. Nature Reviews Drug Discovery, 2025.

Reviews why the gut microbiome shapes immunotherapy response and how FMT, probiotics, prebiotics and lifestyle interventions are being developed as treatments, including the hurdles to bringing them into the clinic.

Gut microbiomeDrug developmentImmunotherapyProbioticsReview

Microbial-Derived Metabolites and Their Impact on Cancer Immunotherapy.

Jeong J, Baines KJ, Maleki Vareki S. Cancer Immunology Research, 2026.

Examines four classes of bacterial metabolites, inosine, indole, bile acids and short-chain fatty acids, and their context-dependent effects on antitumor immunity and checkpoint inhibitor efficacy.

MetabolitesShort-chain fatty acidsBile acidsTumor microenvironmentReview

T Lymphocyte-Based Cancer Immunotherapeutics.

Borrie AE, Maleki Vareki S. International Review of Cell and Molecular Biology, 2018.

An overview of approved and investigational immunotherapies that act through T cells, including CAR T cells, checkpoint inhibitors and oncolytic viruses.

T cellsCAR TCheckpoint inhibitorsOncolytic virusesReview