FMT With Nivolumab in Patients With Advanced Solid Cancers Who Have Progressed During Anti-PD-(L)1 Therapy

NCT05533983 | Recruiting DMC

• 1 other identifier: 2022-0761
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, Phase 2 study to evaluate the efficacy and safety of FMT with nivolumab in patients with advanced, unresectable, or metastatic solid cancer who have progressed during anti-PD-(L)1 therapy.

Conditions

Solid Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  ˙ To evaluate the anti-tumor activity (objective response rate \[ORR\]) of fecal microbiota transplantation (FMT) in combination with nivolumab in patients with advanced solid cancers who have progressed on prior anti-PD-(L)1 based therapy (as monotherapy or combination)

  5year

Study Arms (1)

Preparation of Frozen Stool Suspensions for FMT

EXPERIMENTAL

The study will enroll patients with advanced, unresectable, or metastatic solid cancer who have progressed during anti-PD-(L)1 therapy.

Other: fecal microbiota transplantation with Nivolumab

Interventions

fecal microbiota transplantation with Nivolumab OTHER

This is a single-center, open-label, Phase 2 study to evaluate the efficacy and safety of FMT with nivolumab in patients with advanced, unresectable, or metastatic solid cancer who have progressed during anti-PD-(L)1 therapy.

Also known as: FMT, Nivolumab

Preparation of Frozen Stool Suspensions for FMT

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sex: Male or female
• Age (at the time of informed consent): 19 years and older
• Subjects with histologically- or cytologically-confirmed solid cancer In case of hepatocellular carcinoma, clinically confirmed diagnosis as per the American Association for the Study of Liver Diseases (AASLD) is allowed.1
• Patients who currently maintain a CR, PR or SD per RECIST v1.12 for at least 6 months with anti-PD-(L)1 monotherapy for solid cancer

You may not qualify if:

• Having taken antimicrobials (antibiotics, antivirals antifungals) in the 4 weeks prior to donation
• Positive result for any pathogen tests during the screening period (Table 3)
• Current gastrointestinal symptoms including diarrhea, nausea, or vomiting
• History of chronic gastrointestinal disease including inflammatory bowel disease, celiac disease, or irritable bowel syndrome
• History of systemic autoimmune disease (e.g., multiple sclerosis, connective tissue disorder, type I diabetes mellitus)
• History of significant neurological (except for chemotherapy-induced neuropathy), neurodegenerative, neurodevelopmental, or psychiatric disorders
• History or risk behaviors for infectious disease:
• History of HIV, syphilis, human T-lymphotropic virus I and II
• Current systemic infection
• Enteric pathogen infection in the last 8 weeks
• Vaccination with a live attenuated virus in the last 8 weeks
• Previous tissue/organ transplant
• Recent travel (3 months) to tropical countries, countries with endemic diarrheal diseases or high risk of traveler's diarrhea (Africa, Southeast Asia, Mexico, Central America, South America, Caribbean)
• Having provided written consent before participation in the study, patients must fulfill all of the following criteria to be eligible for this study:
• Sex: Male or female

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Interventions

Fecal Microbiota Transplantation; Nivolumab

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Sook Ryun Park, M.D, Ph D

  Asan Medical Center, Ulsan University of College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sook Ryun Park, M.D, Ph D

CONTACT

+82-2-3010-3210; srpark@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a single-center, open-label, Phase 2 study to evaluate the efficacy and safety of FMT with nivolumab in patients with advanced, unresectable, or metastatic solid cancer who have progressed during anti-PD-(L)1 therapy.

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: March 8, 2023
• Primary Completion (Estimated): August 19, 2026
• Study Completion (Estimated): August 19, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)