Why This Trial About the Study Where We're At Now Locations Researchers Partners Why This Trial In the war on cancer, we have made serious progress. However some of our best weapons, called checkpoint inhibitors, still only work for 20% to 30% of patients. In examining this problem, PICI investigator Jennifer Wargo, MD, discovered something interesting. Patients with certain types of gut bacteria and a more diverse gut microbiome overall respond better to checkpoint inhibitors, a type of immunotherapy treatment. That begged the question: could the right gut bacteria be immunotherapy’s best new ally? This study, one of the first of its kind, was designed to answer that question. This trial tested whether altering the gut microbiome of cancer patients can change – or even enhance – their ability to respond to checkpoint inhibitors. About the Study In this phase 1b, randomized, blinded clinical trial, all patients were treated with an antibiotic and then with nivolumab, an FDA-approved checkpoint inhibitor that targets the PD-1 protein. Patients then took either a placebo or SER-401, a pill that contains a mix of select bacteria found to be associated with better checkpoint inhibitor response. Researchers sequenced the gut of all patients before, during and after treatment with checkpoint inhibitors to record the types and amounts of microbes present. Researchers also took tissue and blood samples to perform additional lab and imaging tests in order to track changes in a patient’s immune system over time. Who Was Eligible Patients with metastatic or unresectable melanoma (up to 30) Treatments Tested Nivolumab SER-401 or a placebo Where We’re At Now As of March 2021, this trial is no longer enrolling patients. Locations The University of Texas MD Anderson Cancer Center (lead site) The Angeles Clinic Dana-Farber Cancer Institute Massachusetts General Hospital Memorial Sloan Kettering Cancer Center Rutgers Cancer Institute Huntsman Cancer Institute Researchers Lead Jennifer Wargo, MD, MMSc | The University of Texas MD Anderson Cancer Center Principal Investigators Genevieve Boland, MD, PhD | Massachusetts General Hospital Isabella Glitza, MD, PhD | The University of Texas MD Anderson Cancer Center Kenneth Grossman, MD, PhD | Huntsman Cancer Institute Omid Hamid, MD | The Angeles Clinic Janice Mehnert, MD | Rutgers Cancer Institute Patrick Ott, MD | Dana-Farber Cancer Center Alex Shoushtari, MD | Memorial Sloan Kettering Cancer Center Hussein Tawbi, MD, PhD | The University of Texas MD Anderson Cancer Center Partners The University of Texas MD Anderson Cancer Center Seres Therapeutics For more information on this trial (NCT03817125), visit www.clinicaltrials.gov. Related Research Update Probiotics Linked to Poorer Response to Cancer Immunotherapy in Skin Cancer Patients Partner Highlight Novel Approaches for Better Patient Responses with Immunotherapy: Seres Therapeutics Cancer Research Heroes It Takes Guts: Dr. Jennifer Wargo
Partner Highlight Novel Approaches for Better Patient Responses with Immunotherapy: Seres Therapeutics