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 First-Line or in Switch Maintenance in Subjects with Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC).
To evaluate the safety and tolerability of using Nivolumab in combination with 1 of 3 platinum based doublet chemotherapy regimens (cisplat/gemcitabine; ciplat/pemetrexed; carboplatin/paxlitaxel), with Ipilimumab or alone in chemonaive patients or Erlotinib in patients with EGFR mutation gene,or with Bevacizumab as a maintence therapy in patients with Stage IIIB/IV NSCLC; to determine overall response rate, disease control rate of Nivolumab with different chemotherapy backbones for NSCLC ; to assess pharmacokinetics of Nivolumab in subjects with Stage IIIB/IV NSCLC and to explore exposure-response relationship.
Chemonaive patients greater than 18 years old, with histologically confirmed NSCLC stages IIIB/ or IV, with good performance score (ECOG PS 0-1), and with measureable disease. There are a number of exclusions related to autoimmune, cardiovascular, hepatic or infectious diseases.
Patients will have histologically and RECIST measured disease confirming advanced stage IIIB or IV NSCLC. Eligible patients will receive study drug Nivolumab (an anti PD-1 monoclonal antibody) along with 1 of 3 randomized platinum doublet chemotherapy treatment regimens for 4 cycles (each cycle equal to 21 day)followed by Nivolumab alone once every 3 weeks until disease progression, or with Bevacizumab as a maintenance, or with daily Erlotinib , or with Ipilimumab for 4 cycles (every 3 weeks) followed by Nivolumab alone (every 2 weeks), or Nivolumab alone (every 2 weeks) as a maintenance or for untreated brain metastasis until unacceptable toxicities or withdrawal of consent. There are weekly visits and labs during the first cycle. Frequency of visits during subsequent cycles depends on the arm of chemotherapy.
05/24/2013 04:02 AM