Phase II Feasibility Study of Healthy Donor FMT (hdFMT) and Pembrolizumab in Relapsed/Refractory (R/R) PD-L1 Positive NSCLC
Diwakar Davar
Summary
This study is to determine if Healthy Donor FMT (hdFMT) improves the body's ability to fight cancer in patients with relapsed/refractory PD-L1 Positive NSCLC.
Description
The study evaluating the addition of Healthy Donor FMT (hdFMT) to pembrolizumab in PD-1 R/R NSCLC will be conducted over a 104-week period. Patients with anti-PD-1 R/R NSCLC are eligible to enroll. Prior exposure to microbiome modulating therapy is exclusionary. Suitable patients will be identified at the time of progression upon PD-1 monotherapy or PD-1 containing regimens. Patients will undergo a 35-day screening evaluation consisting of systemic staging scans, tumor biopsy, stool/blood serologic studies to confirm suitability. Once enrolled, patients will be seromatched with a suitable don…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Male participants: • A male participant must agree to use a contraception as detailed per protocol of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period. * Female participants: • A female participant is eligible to participate if she is not pregnant per protocol, not breastfeeding, and at least one of the following conditions applies: * Not a woman of childbearing potential (WOCBP); OR * A WOCBP who agrees to follow the contraceptive guidance per protocol dur…
Interventions
- DrugHealthy Donor Fecal Microbiota Transplant (hdFMT)
FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by performing a colonoscopy and sigmoidoscopy, or, administered orally in the form of capsules. The FMT consists of introducing normal bacterial flora contained in the stool collected from a healthy donor into the small intestine. In this case, the hdFMT will be administered on Cycle 1 Day 1 and Cycle 3 Day 1 during Treatment Phase 1 and every 9 weeks starting with Cycle 4 Day 1 during Treatment Phase 2.
- DrugPembrolizumab
Pembrolizumab, 200mg, will be administered as a 30-minute IV infusion every 3 weeks starting Cycle 1 Day 1 (same day as the FMT), and continue on Day 1 of each 21-day cycle.
Location
- UPMC Hillman Cancer CenterPittsburgh, Pennsylvania