FMT + Immunotherapy for Non-Small Cell Lung Cancer or FMT + Immunotherapy for Melanoma
(FMT-LUMINATE Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byArielle Elkrief, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This study is evaluating whether fecal microbiota transplantation (FMT) can be used to treat cancer.

Eligibility Criteria

Adults over 18 with certain types of advanced melanoma or non-small cell lung cancer (NSCLC) that haven't been treated with anti-PD1 drugs. They must understand the risks of fecal microbial transplantation (FMT), not have autoimmune diseases, active infections, severe heart conditions, or be pregnant. Participants should not be on high-dose steroids and must agree to effective contraception.

Inclusion Criteria

My condition is at stage IV or cannot be surgically removed.

I have never received anti-PD1 treatment.

My melanoma returned more than 6 months after my last immunotherapy.

+12 more

Exclusion Criteria

I have an active inflammatory bowel condition.

I have not taken antibiotics in the last 2 weeks.

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

+20 more

Participant Groups

The trial is testing the combination of FMT and immune checkpoint inhibitors (ICI) as a treatment for advanced melanoma and NSCLC. It aims to see if adding FMT can boost the anti-tumor effects of ICI therapy in patients who meet specific health criteria.

1Treatment groups

Experimental Treatment

Group I: Immune checkpoint inhibitor (ICI) therapy in combination with fecal microbial transplantation (FMT).Experimental Treatment1 Intervention

Metastatic or advanced NSCLC: Single-agent Pembrolizumab (2 mg/kg or 200 mg every 3 weeks) in combination with investigational FMT capsules as follows: Full FMT at least 7 days prior to first cycle of Pembrolizumab. Metastatic melanoma and uveal melanoma: Combination therapy of Ipilimumab plus Nivolumab (Ipilimumab 3 mg/kg every 3 weeks and Nivolumab 1 mg/kg every 3 weeks x 4 doses, followed by Nivolumab 3 mg/kg or 240mg every 2 weeks or 6 mg/kg or 480mg every 4 weeks) in combination with investigational FMT capsules as follows: full FMT at least 7 days prior to first treatment with Ipilimumab plus Nivolumab, followed by supportive FMT within 7 days of the second cycle with combination Ipilimumab plus Nivolumab, followed by supportive FMT within 7 days of the third cycle of Ipilimumab plus Nivolumab.