Study design
toxicity, Cancer
ADVERSE EVENT, CANCER
This was a phase 1 single-center, open-label, single-arm, dose escalation study. There were four predefined dose levels of RRx-001: 2, 4, 8 and 16 mg while the dose of nivolumab remained fixed at 3 mg/kg given once every other week. A 3 + 3 phase 1 design was used for enrollment. Dose-limiting toxicity was defined as a combination treatment-related ≥ grade 3 toxicity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) V.4.03 not reversible to grade 2 or less within 96 hours. The protocol predefined maximum dose level to be investigated was 16 mg.