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. 2024 Jan 1;3(1):e156. doi: 10.1002/imt2.156

Table 2.

Strategies to modulate gut microbiota in cancer immunotherapy and the corresponding clinical trials.

ClinicalTrials.gov Identifier

Study title Cancer types Intervention Objective Status
NCT04645680

Diet and Immune Effects Trial: DIET—A Randomized Double Blinded Dietary

Intervention Study in Patients With Metastatic Melanoma Receiving

Immunotherapy

Melanoma Dietary Intervention: Two different diets vary in fiber content To assess effect of high‐in‐fiber diet on efficacy and toxicity of immunotherapy drugs pembrolizumab or nivolumab Recruiting
NCT04866810 The Effect of Diet and Exercise on Immunotherapy and the Microbiome (EDEN) Melanoma Dietary Intervention: A plant‐based, high‐fiber diet and a change for high intensity exercise To see if nutritional intake and physical activity change the gut microbiota in people with melanoma receiving relatlimab and nivolumab immunotherapy Not Applicable
NCT05251389 FMT to Convert Response to Immunotherapy Melanoma Procedure; Fecal Microbial Transplantation To investigate the influence of FMT on efficacy and toxicity of immunotherapy Recruiting
NCT04163289

Preventing Toxicity in Renal Cancer Patients Treated With

Immunotherapy Using Fecal Microbiota Transplantation (PERFORM)

Renal Cell Carcinoma Drug: Fecal Microbiota Transplant To study the safety of FMT combination treatment with ipilimumab and nivolumab, and whether reduce incidence of immune‐related toxicities in patients Recruiting
NCT04056026 A Single Dose FMT Infusion as an Adjunct to Keytruda for Metastatic Mesothelioma Mesothelio‐ma Biological: Fecal Microbiota Transplant To see if FMT can increase efficacy of an immunotherapy drug Keytruda Completed
NCT04116775 Fecal Microbiota Transplant and Pembrolizumab for Men With Metastatic Castration Resistant Prostate Cancer Prostate Cancer Biological: Fecal Microbiota Transplant To evaluate anticancer effect of FMT in pembrolizumab treatment Recruiting
NCT05303493 Camu‐Camu Prebiotic and Immune Checkpoint Inhibition in Patients With Nonsmall Cell Lung Cancer and Melanoma Advanced NSCLC Stage IV and Melanoma Stage IV

Probiotics drug:

Camu Camu Capsules

To evaluate the safety and tolerability of Camu Camu prebiotic in addition to ICI in patients with NSCLC and melanoma Recruiting
NCT05220124 A Study of Probiotics Administration in the Immunotherapy of Urothelial Bladder Carcinoma Bladder Urothelial Carcinoma Probiotics drug: Live Combined (Bifidobacterium, Lac‐tobacillus, and Enterococcus Capsules) To evaluate clinical benefits of probiotics in immunotherapy Recruiting
NCT04699721 Clinical Study of Neoadjuvant Chemotherapy and Immunotherapy Combined With Probiotics in Patients With Potential/Resectable NSCLC Nonsmall Cell Lung Cancer Stage III

Probiotics drug:

Bifidobacterium trifidum live powder

To evaluate safety and effect of neoadjuvant chemotherapy and immunotherapy combined with probiotics Recruiting

Abbreviations: CAR‐T, chimeric antigen receptor T‐cell; CTLA‐4, cytotoxic T lymphocyte‐associated antigen 4; DC, dendritic cell; GI cancer, gastrointestinal cancer; ICI, immune checkpoint inhibitor; NSCLC, nonsmall cell lung cancer; PD‐1, programmed cell death protein 1; PD‐L1, programmed cell death ligand 1; RCC, renal cell cancer; SCFAs, short‐chain fatty acids; TME, tumor microenvironment.