Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients

Fecal Microbiota Transplantation (FMT) for Immune-Checkpoint Inhibitor Induced-Diarrhea/Colitis in Genitourinary Cancer Patients

This trial studies how well fecal microbiota transplantation works in treating diarrhea or colitis (inflammation of the intestines) that is caused by certain types of medications (called immune-checkpoint inhibitors) in patients with genitourinary cancer. Fecal microbiota transplantation may effectively reduce the incidence of immune checkpoint inhibitor-induced diarrhea/colitis.

Study Overview

• Status: Recruiting
• Conditions: Melanoma; Cervical Cancer; Breast Cancer; Diarrhea; Ovarian Cancer; Lung Cancer; Colitis; Uterine Cancer; Malignant Genitourinary System Neoplasm
• Intervention / Treatment: Drug: Loperamide; Procedure: Fecal Microbiota Transplantation

Detailed Description

PRIMARY OBJECTIVES:

• To assess the safety and tolerability of fecal microbiota transplantation (FMT).
• To assess the efficacy of FMT for clinical remission/response of immune-related diarrhea/colitis.

SECONDARY OBJECTIVES:

- To measure the recurrence rate after achieving clinical remission/response of immune-related diarrhea/colitis.

EXPLORATORY OBJECTIVES:

• To assess the efficacy of FMT to achieve endoscopic remission of immune-related diarrhea/colitis.
• To assess the efficacy of FMT to achieve histological remission of immune-related diarrhea/colitis.
• To assess the efficacy of FMT on recurrence of immune-related diarrhea/colitis after resumption of immune checkpoint inhibitors (ICPI).
• To assess immunological, molecular and microbiome changes in tissue/blood/stool.

To study the efficacy and/ or benefit of PuraStat gel in the healing of mucosal ulcers and its hemostatic effect on bleeding lesions

OUTLINE:

Patients receive loperamide orally (PO). After 4 hours, patients undergo FMT via colonoscopy over 15-30 minutes.

After completion of study treatment, patients are followed up at 2, 4, and 8 weeks, and then at 3 months.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yinghong Wang; Phone Number: 281-221-9138; Email: ywang59@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Principal Investigator: Yinghong Wang
      • Contact: Yinghong Wang; Phone Number: 713-792-7672

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of any type of genitourinary (kidney, bladder and prostate), melanoma, non-melanoma skin cancer, lung, head & neck, sarcoma/lymphoma, gastrointestinal system (luminal GI, hepatobiliary, pancreas), gynecology system (ovarian, uterine, cervical), and breast malignancies
2. Treatment with any ICPI agent(s)
3. Participants with new onset of ≥ grade 2 ICPI-induced diarrhea and/or colitis symptoms based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5 within 45 days prior to date of FMT treatment without involvement of non- GI toxicity
4. Participants with a history of steroid use before FMT can be allowed if last dose was > 30 days prior to FMT treatment or treatment duration was for <7 days beyond one week prior to FMT treatment
5. Participants with a history of immunosuppressant (Infliximab, Vedolizumab etc) use before FMT can be allowed if last dose was administered ≥ 3 months prior to FMT treatment when used for the treatment of conditions other than for ICI- induced GI toxicities (e.g., Infliximab is used in the treatment of Crohn's disease, rheumatoid arthritis, plaque psoriasis, and Vedolizumab is used in treating ulcerative colitis)
6. No concern for active concomitant GI infection at the time of initiation of protocol therapy as confirmed by stool tests or as per the treating physician based on clinical presentation
7. Patient has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g., lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of protocol therapy and/ or imaging (e.g. CXR, CT CAP etc) confirms the absence of active infections (e.g. TB) within 60 days prior to initiation of protocol therapy
8. Ability to understand and willingness to sign an informed consent form
9. Life expectancy > 6 months

Exclusion Criteria

1. Age younger than 18 years
2. Participants with persistent GI infection confirmed with positive stool test(s) despite completing 5 days of antibiotics prior to initiation of protocol therapy
3. History of inflammatory bowel disease, and/or radiation enteritis or colitis with active disease status at the time of study treatment initiation
4. Pregnant and breastfeeding women
5. Women who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was > 1 year prior to consent and/ or clear documentation states that participant is peri- or post-menopausal or there has been recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment
6. Immunosuppressive treatment at onset of ICPI-induced diarrhea/colitis
7. Any medical conditions (e.g. severe heart failure, brain hemorrhage, septic shock, etc.) that are high risk for colonoscopy procedure by the assessment of the study PI or Co-PIs.
8. Participants who develop concurrent non-GI toxicity at the time of study treatment
9. Donors at risk for monkeypox infection and/ or exposure as determined by a questionnaire

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (loperamide, colonoscopy, FMT); Patients receive loperamide PO. After 4 hours, patients undergo FMT via colonoscopy over 15-30 minutes.	Drug: Loperamide; Given PO; Procedure: Fecal Microbiota Transplantation; Undergo FMT via colonoscopy; Other Names: Fecal Material Transplantation; Fecal Transplantation; FMT; Poo Transplant; Poop Transplant; Stool Transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of fecal microbiota transplantation (FMT)-related adverse events	Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5. All events are recorded with grade and attribution to FMT.	Up to 3 months post-FMT
Clinical response/remission of immune-related diarrhea/colitis	Clinical remission of immune related events defined as improvement of symptoms of grade 1 or lower within 2 weeks post-FMT. Clinical partial response of immune related diarrhea/colitis defined as improvement of diarrhea/colitis to a lower grade than the initial presentation but not meeting criteria of clinical remission at 2 week post-FMT time point.	At 2 weeks post-FMT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent immune-related diarrhea/colitis within 3 months post-FMT after initially achieving clinical remission/response	Recurrent immune-related diarrhea colitis events occurring post-FMT are recorded throughout the follow-up period.	Up to 3 months post-FMT

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic remission (Mayo Clinic sub-score 0-1) of immune-related diarrhea/colitis	Endoscopic remission is defined as Mayo Clinic endoscopic subscore 0 or 1 (absence of ulcers, with or without mild erythema, friability and decreased vascular pattern).	At 4 weeks and 8 weeks post-FMT
Histological remission (resolution of active inflammation) of immune-related diarrhea/colitis	Histological remission is defined resolution of active inflammation on biopsy sample.	At 8 weeks post-FMT
Recurrent immune-related diarrhea/colitis following FMT and immune checkpoint inhibitors (ICPI) resumption within 6 months of ICPI resumption	Recurrent immune-related diarrhea colitis events occurring post-FMT will be recorded throughout the follow-up period.	Up to 6 months after restarting ICPI
Measure immunological measures (including levels of cytokines (IL-6, 17, TNF, etc.) in tissue/blood/stool samples	Blood, stool, and colon tissues will be collected from at each scheduled time point. Markers of interest for immunological and biological profiles include levels of cytokines (IL-6, 17, TNF, etc). Special attention will focus on Bacteroidetes, Akkermansia, and Blautia.	Up to 3 months
Frequencies of immune cells (CD4/8 T cells, regulatory T cells [Treg], macrophages, etc.) in tissue/blood/stool samples	Blood, stool, and colon tissues will be collected from at each scheduled time point. Markers of interest for immunological and biological profiles include frequencies of immune cells (CD4/8 T cells, Treg, macrophages, etc). Special attention will focus on Bacteroidetes, Akkermansia, and Blautia.	Up to 3 months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Yinghong Wang, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Signs and Symptoms, Digestive; Intestinal Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Digestive System Diseases; Gastrointestinal Diseases; Uterine Diseases; Genital Diseases, Female; Lung Diseases; Endocrine Gland Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Skin Diseases; Gastroenteritis; Breast Diseases; Uterine Cervical Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Lung Neoplasms; Ovarian Neoplasms; Colitis; Breast Neoplasms; Uterine Cervical Neoplasms; Melanoma; Urogenital Neoplasms; Uterine Neoplasms; Diarrhea; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Piperidines; Biological Therapy; Loperamide; Fecal Microbiota Transplantation
• Other Study ID Numbers: 2018-0663 (Other Identifier: M D Anderson Cancer Center); NCI-2019-02660 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No