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GI Microbiota and Checkpoint Inhibition

Title Pilot study of the interaction between the GI microbiota and checkpoint inhibitors in patients with cancer
Therapeutic Area Lung Cancer, Melanoma
Principal Investigator Debra Poutsiaka
Min Age 18 Years
Gender All
Contact Debra Poutsiaka
617 636-7010


The bacteria living in the intestines (microbiota) server important roles in preserving gut and overall body health. The effect of cancer treatment on the microbiome is not known. Patients starting new therapy with a checkpoint inhibitor (anti-PDL1) will be asked to provide samples of blood, urine and stool at up to 6 time points over the course of 6 months.

Study Details

Inclusion Criteria

  • Age > 18
  • Diagnosis of cancer requiring treatment
  • Scheduled to begin a PD1/PDL1-targeting checkpoint inhibitor (pembrolizumab, nivolumab, atezolixumab, or avelumab) as new treatment

Exclusion Criteria

  • Any medical condition such as chronic diarrhea or presence of a colostomy which in the opinion of the PI/Co-I could affect generalizability of the analysis
  • Antibiotic treatment within prior one month
  • Prior exposure to a checkpoint inhibitor

Study Requirements

Up to 7 visits and up to collection of samples (blood, urine, stool)at 6 time points to coincide with routine clinic visits: baseline, before second cycle (at 2-3 weeks), after 6 weeks, after 3 months, at progression or 6 months after initiation of checkpoint inhibitor therapy (whichever is first) and int eh event of suspected gastrointestinal toxicity (no more than one visit for a suspected episode per subject). Up to 120 ml blood total collected for research.