A Multi-arm Phase I Safety Study of Nivolumab in Combination with Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects with Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)
Trial Purpose and Description
Study Assessments and Primary Endpoint: The primary objective is safety and tolerability of nivolumab in combination with chemotherapy, targeted therapy, and ipilimumab or as monotherapy. The primary objective will be measured by: 1) Frequency of adverse events occurring up to 100 days after the last dose of study drug 2) Frequency of serious adverse events occurring up to 100 days after the last dose of study drug 3) Frequency of clinical laboratory test by worst toxicity grade (as assessed at screening, Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycle 2+). Secondary Endpoints: The secondary objective (efficacy) will be measured by objective response rate (ORR) and Progression free survival rate (PFSR) at 24 weeks based on RECIST 1.1. For subjects treated in arms A, B, C and D, tumor response will be based on tumor assessment at screening, Cycle 4 Day 1 (C4D1, week 10), every 6 weeks until Cycle 8 Day 1 (C8D1, Week 22), and then every 3 months thereafter until progression or end of treatment for subjects discontinued due to other reasons. In arm E, F, K, L and M, O, P, Q, R and S tumor response will be based on tumor assessment at screening, cycle 6 Day 1 (C6D1, Week 11), cycle 9 Day 1 (C9D1, Week 17), cycle 12 Day 1 (C12D1, Week 23) and then every 3 months thereafter until progression. In arms G, H, I, J and N, tumor response will be assessed at Cycle 4 Day 1 (C4D1, Week 10), Cycle 7 Day 1 (C7D1, Week 17), Cycle 10 Day 1 (C10D1, Week 23) and then every 3 months thereafter until disease progression is noted.
- Bristol-Myers Squibb Company
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