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

NCT04038619 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2018-0663NCI-2019-02660
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colitis; Diarrhea; Malignant Genitourinary System Neoplasm; Melanoma; Lung Cancer; Ovarian Cancer; Uterine Cancer; Breast Cancer; Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Recurrent immune-related diarrhea/colitis within 3 months post-FMT after initially achieving clinical remission/response

  Up to 3 months post-FMT

Other Outcomes (5)

• Endoscopic remission (Mayo Clinic sub-score 0-1) of immune-related diarrhea/colitis

  At 4 weeks and 8 weeks post-FMT

• Histological remission (resolution of active inflammation) of immune-related diarrhea/colitis

  At 8 weeks post-FMT

• Recurrent immune-related diarrhea/colitis following FMT and immune checkpoint inhibitors (ICPI) resumption within 6 months of ICPI resumption

  Up to 6 months after restarting ICPI

Study Arms (1)

Treatment (loperamide, colonoscopy, FMT)

EXPERIMENTAL

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

Procedure: Fecal Microbiota Transplantation; Drug: Loperamide

Interventions

Fecal Microbiota Transplantation PROCEDURE

Undergo FMT via colonoscopy

Also known as: Fecal Material Transplantation, Fecal Transplantation, FMT, Poo Transplant, Poop Transplant, Stool Transplant

Treatment (loperamide, colonoscopy, FMT)

Loperamide DRUG

Given PO

Treatment (loperamide, colonoscopy, FMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Treatment with any ICPI agent(s)
• 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
• 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
• 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)
• 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
• 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
• Ability to understand and willingness to sign an informed consent form
• Life expectancy \> 6 months

You may not qualify if:

• Age younger than 18 years
• Participants with persistent GI infection confirmed with positive stool test(s) despite completing 5 days of antibiotics prior to initiation of protocol therapy
• History of inflammatory bowel disease, and/or radiation enteritis or colitis with active disease status at the time of study treatment initiation
• Pregnant and breastfeeding women
• 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
• Immunosuppressive treatment at onset of ICPI-induced diarrhea/colitis
• 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.
• Participants who develop concurrent non-GI toxicity at the time of study treatment
• Donors at risk for monkeypox infection and/ or exposure as determined by a questionnaire

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Colitis; Diarrhea; Urogenital Neoplasms; Melanoma; Lung Neoplasms; Ovarian Neoplasms; Uterine Neoplasms; Breast Neoplasms; Uterine Cervical Neoplasms

Interventions

Fecal Microbiota Transplantation; Loperamide

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Diseases; Breast Diseases; Uterine Cervical Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yinghong Wang

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yinghong Wang

CONTACT

281-221-9138; ywang59@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 31, 2019
• Study Start: February 1, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

US (1)