A Phase 1 Study to Evaluate the Safety and Tolerability of Anti-PD-L1, MEDI4736, in Combination with Tremelimumab in Subjects With Advanced Solid Tumors

This is an open label Phase 1 study of a MEDI4736 and tremelimumab combination, utilizing a 3+3 dose-escalation phase, with doses of MEDI4736 0.3, 1, 3 and 10 mg/kg and tremelimumab 1, 3 and 10 mg/kg (see Figure 2: Dose-escalation Schema), followed by an expansion phase with 6 disease-specific cohorts in subjects with ovarian cancer, colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck cancer, cervical cancer and renal cell carcinoma (RCC), who are not eligible for, declined or failed standard treatment, treated at the identified MTD (MTD or maximum dose tested).MEDI4736 will be administered every 2 weeks (Q2W) for 13 cycles. Tremelimumab will be administered every 4 weeks (Q4W) for the first 6 cycles and then at cycle 7, 10 and 13 (every 12 weeks (Q12W)).

Study Number: 

I 243813

Principal Investigator: 
ClinicalTrials.Gov ID: 

To inquire about participating in these studies, call 1-877-ASK-RPCI (1-877-275-7724) or e-mail askrpci@roswellpark.org.