biostudies-literatureVo HHSupport was provided in part by the National Institutes of Health/National Cancer InstituteSupported in part by donor funds from Mr. and Mrs. Steven McKenzie, Mr. and Mrs. Zane W. Arrott, and Jamie’s Hope for Dr. Tsimberidou’s Personalized Medicine ProgramSupported in part by donor funds from Mr. and Mrs. Steven McKenzie, Mr. and Mrs. Zane W. Arrott, and Jamie's Hope for Dr. Tsimberidou's Personalized Medicine ProgramThe study was primarily supported by Sumitomo Dainippon Pharma Oncology, Cambridge, Massachusetts, USA1330https://www.ebi.ac.uk/biostudies/studies/S-EPMC8909492biostudies-literatureUnknown14(5)<b>Background</b>: BBI608 is an investigational reactive oxygen species generator that affects several molecular pathways. We investigated BBI608 combined with immune checkpoint inhibitors in patients with advanced cancers. <b>Methods</b>: BBI608 (orally twice daily) was combined with ipilimumab (3 mg/kg IV every 3 weeks); pembrolizumab (2 mg/kg IV every 3 weeks); or nivolumab (3 mg/kg IV every 4 weeks). We assessed the safety, antitumor activity and the pharmacokinetic profile of BBI combined with immunotherapy. <b>Results:</b> From 1/2017 to 3/2017, 12 patients were treated (median age, 54 years; range, 31-78; 6 men). Treatment was overall well tolerated. No dose-limiting toxicity was observed. The most common adverse events were diarrhea (5 patients: grade (G)1-2, <i>n</i> = 3; G3, <i>nCancersIpilimumab, Pembrolizumab, or Nivolumab in Combination with BBI608 in Patients with Advanced Cancers Treated at MD Anderson Cancer Center.PMC8909492N/AP30CA016672Cartwright CXie YHitron MSong IWKarol MVining DVo HHTsimberidou AMNogueras Gonzalez GMKarp DDfalseIpilimumab, Pembrolizumab, or Nivolumab in Combination with BBI608 in Patients with Advanced Cancers Treated at MD Anderson Cancer Center.<b>Background</b>: BBI608 is an investigational reactive oxygen species generator that affects several molecular pathways. We investigated BBI608 combined with immune checkpoint inhibitors in patients with advanced cancers. <b>Methods</b>: BBI608 (orally twice daily) was combined with ipilimumab (3 mg/kg IV every 3 weeks); pembrolizumab (2 mg/kg IV every 3 weeks); or nivolumab (3 mg/kg IV every 4 weeks). We assessed the safety, antitumor activity and the pharmacokinetic profile of BBI combined with immunotherapy. <b>Results:</b> From 1/2017 to 3/2017, 12 patients were treated (median age, 54 years; range, 31-78; 6 men). Treatment was overall well tolerated. No dose-limiting toxicity was observed. The most common adverse events were diarrhea (5 patients: grade (G)1-2, <i>n</i> = 3; G3, <i>n2022-01-01T00:00:00Z2022 Mar2026-04-08T17:50:55.015Z2025-04-04T19:30:39.192ZS-EPMC89094923526763810.3390/cancers14051330