Study of Healthy Donor FMT (hdFMT) and Pembrolizumab in Relapsed/Refractory (R/R) PD-L1 Positive NSCLC

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Diwakar Davar
Study ID
NCT05669846
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Healthy Donor Fecal Microbiota Transplant (hdFMT) — DRUG
    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.
  • Pembrolizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 8, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2036
Completion
Dec 31, 2036

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Healthy Donor Fecal Microbiota Transplant (hdFMT) with Pembrolizumab
    The hdFMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The hdFMT is infused into the colon by performing a colonoscopy (Treatment Phase 1) and by a sigmoidoscopy or oral capsules (Treatment Phase 2). FMT will be performed 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. Pembrolizumab, 200mg, will be administered as a 30-minute IV infusion every 3 weeks starting Cycle 1 Day 1 (same day as the hdFMT), and continue on Day 1 of each 21-day cycle.

Primary Outcome Measure

Objective Response Rate (ORR) per RECIST v1.1 [ Time Frame: Up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Amy Rose, RN, BSN
[email protected]
412-647-8587
Danielle L Bednarz, RN
[email protected]
412-623-1191
Diwakar Davar, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
UPMC Hillman Cancer Center· Pittsburgh, PA

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