Why This Trial About the Study Where We're At Now Locations Researchers Partners Why This Trial Checkpoint inhibitor treatments release the brakes on the immune system so it can attack tumors more freely. While they have extended the lives of many patients, these blockbuster drugs do not always work for everyone. PICI investigators aim to uncover why checkpoint inhibitors shrink tumors in some patients and not others – and whether two checkpoint therapies could help patients who did not initially respond to one checkpoint inhibitor alone. To do that, they will hunt for “biomarkers for response” – tell-tale, measurable signs in the body that correlate to how well a patient may do on a given therapy. About the Study This phase 2 randomized trial was designed for patients with advanced melanoma whose tumors did not respond, or continued to grow, after treatment with checkpoint therapy targeting the protein PD-1. Some patients received a single checkpoint inhibitor, ipilimumab, which targets the protein CTLA-4. Other patients were treated with a combination of ipilimumab and nivolumab, a checkpoint inhibitor that targets the PD-1 protein. Different samples from each patient were collected throughout the study. As part of the analysis, the researchers will look for potential biomarkers that can predict which patients will respond to one or both treatments. Who’s Eligible Patients with inoperable, metastatic melanoma whose tumors did not respond or continued to grow after treatment with anti-PD-1 checkpoint inhibitors. Treatments Tested Ipilimumab Ipilimumab and nivolumab Where We’re At Now PICI researchers are in the process of analyzing biological samples to study the impact of the immunotherapies on the patients’ biology and tumors. The study completed enrollment in July 2018 and closed in August 2019. Locations Memorial Sloan Kettering Cancer Center (lead site) University of California, Los Angeles University of California, San Francisco University of Pennsylvania The University of Texas MD Anderson Cancer Center Researchers Lead Jedd Wolchok, MD, PhD | Memorial Sloan Kettering Cancer Center Principal Investigators Claire Friedman, MD | Memorial Sloan Kettering Cancer Center Tara C. Mitchell, MD | University of Pennsylvania Antoni Ribas, MD, PhD | University of California, Los Angeles Hussein Tawbi, MD, PhD | The University of Texas MD Anderson Cancer Center Katy Tsai, MD | University of California, San Francisco Partners Bristol-Myers Squibb For more information on this trial (NCT02731729), visit www.clinicaltrials.gov. Related Partner Highlight A Win-Win in Cancer Research: Bristol-Myers Squibb Research Update Brain Cancer Breakthrough with Immunotherapy Points to New Hope for Patients Point of View PICI Catalyzes Scientific Innovation