Fecal Microbiota Transplant + Anti-PD-1 Therapy for Metastatic Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial studies the effect of fecal microbiota transplant and re-introduction of anti-PD-1 therapy (pembrolizumab or nivolumab) in treating anti-PD-1 non-responders with colorectal cancer that has spread to other places in the body (metastatic). Fecal microbiota transplants contain the normal bacteria and viruses found in fecal (stool) material. Immunotherapy with monoclonal antibodies, such as pembrolizumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab or nivolumab with fecal microbiota transplants may help to control the disease.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have received any systemic anti-cancer therapy within 2 weeks of starting the study treatment, except for ongoing nivolumab or pembrolizumab therapy.
Is Fecal Microbiota Transplant plus Anti-PD-1 Therapy safe for humans?
How is the treatment of Fecal Microbiota Transplant + Anti-PD-1 Therapy for Metastatic Colorectal Cancer different from other treatments?
This treatment is unique because it combines fecal microbiota transplantation (FMT), which involves transferring healthy gut bacteria from a donor, with anti-PD-1 therapy, a type of immunotherapy that helps the immune system attack cancer cells. This combination aims to enhance the effectiveness of immunotherapy by improving the gut microbiome, which can influence the body's response to cancer treatment.13467
What data supports the effectiveness of the treatment Fecal Microbiota Transplantation combined with anti-PD-1 therapy for metastatic colorectal cancer?
Research shows that combining fecal microbiota transplantation (FMT) with anti-PD-1 therapy has been effective in treating melanoma, with some patients experiencing complete responses. This suggests potential benefits for other cancers, like colorectal cancer, by enhancing the immune response and overcoming resistance to treatment.13458
Who Is on the Research Team?
Michael J Overman, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with metastatic colorectal cancer that didn't respond to anti-PD-1 therapy. They must have a certain type of tumor (dMMR or MSI-H), good kidney and liver function, no severe allergies to pembrolizumab or nivolumab, not be pregnant, and agree to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Treatment
Patients receive metronidazole, vancomycin, and neomycin prior to colonoscopic FMT
Treatment
Patients undergo colonoscopic FMT and receive pembrolizumab or nivolumab with fecal microbiota transplantation capsules
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fecal Microbiota Transplantation
- Nivolumab
- Pembrolizumab
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator