Clin2
NCT03819296Possibly a fitRecruiting

Fecal transplant to treat cancer immunotherapy bowel side effects

Clinical Stage 0 Cutaneous Melanoma AJCC v8Clinical Stage I Cutaneous Melanoma AJCC v8Clinical Stage IA Cutaneous Melanoma AJCC v8Clinical Stage IB Cutaneous Melanoma AJCC v8Clinical Stage II Cutaneous Melanoma AJCC v8Clinical Stage IIA Cutaneous Melanoma AJCC v8Clinical Stage IIB Cutaneous Melanoma AJCC v8Clinical Stage IIC Cutaneous Melanoma AJCC v8

Treatments studied

Part of Cancer, Digestive system, Kidney & urinary, Lungs & breathing, Women’s health & pregnancy clinical trials.

This early-phase study tests whether changing your gut bacteria with a fecal transplant can improve diarrhea or colitis caused by cancer immunotherapy. It may help people whose symptoms have not fully settled with standard treatments like steroids and other immune-blocking medicines.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1
Enrollment
800 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have cancer such as melanoma, non-small cell lung cancer, or certain urinary/gyn cancers, or you fit any cancer type in another part of the study
  • You are currently (or were recently) taking an immunotherapy medicine called an immune checkpoint inhibitor (ICPI)
  • You have had significant immunotherapy-related diarrhea and/or colitis (grade 2 or higher), treated with standard immune-suppressing medicines
  • Your diarrhea/colitis must be timed around the transplant (generally within 45 days before the fecal transplant)
  • Infections in the stool must be ruled out before starting the transplant (or your doctor has cleared you if infection risk is known)
  • You must be at least 18 years old and able to understand and sign consent and complete questionnaires

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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