CIMAvax Vaccine, Nivolumab, and Pembrolizumab in Treating Patients With Advanced Non-small Cell Lung Cancer or Squamous Head and Neck Cancer

Description

PRIMARY OBJECTIVES:

* I. To identify the maximum dose of CIMAvax in combination with nivolumab based on dose limiting toxicities (DLTs) as assessed by Common Terminology Criteria for Adverse Events version 4.03 (CTCAE version [v] 4.03). (Phase I)
* II. To evaluate the 12-month overall survival of CIMAvax combined with nivolumab in patients with advanced non-small cell lung cancer (NSCLC). (Phase II-Study A)
* III. To evaluate the 6-month progression free survival (PFS) of CIMAvax combined with nivolumab in patients with advanced recurrent squamous cell carcinoma of the head and neck. (Phase II-Study B)
* IV. To evaluate the objective response rate of pembrolizumab in combination with CIMAvax as first-line therapy in patients with advanced NSCLC (PD-L1 expression >= 50%). (Phase II-Study C)
* V. To evaluate the 12-month PFS of pembrolizumab in combination with CIMAvax as maintenance therapy in patients with advanced squamous NSCLC (PD-L1 expression < 50%) (Phase II-Study D)
* VI. To evaluate the 12-month PFS of pembrolizumab in combination with CIMAvax as maintenance therapy in patients with advanced NON-squamous NSCLC without EGFR/ALK/ROS-1/KRAS mutations (PD-L1 expression = 50%). (Phase II-Study C)
* VI. To evaluate the PFS and overall survival of CIMAvax in combination with pembrolizumab as maintenance therapy in patients with advanced squamous NSCLC (PD-L1 expression < 50%). (Phase iI- Study D)
* VII. To evaluate the PFS and overall survival of CIMAvax in combination with pembrolizumab as maintenance treatment in non-squamous NSCLC patients without EGFR/ALK/ROS-1/KRAS mutations after induction chemoimmunotherapy (PD-L1 expression = 1:4000 at the end of the loading phase may receive CIMAvax IM every 8 or 12 weeks during the maintenance phase.

PHASE II STUDY C: Patients with PD-L1expression >= 50% receive CIMAvax IM and pembrolizumab IV over 30 minutes. Treatment with CIMAvax repeats every 2 weeks for 4 doses during the loading phase and every 4 weeks during the maintenance phase in the absence of disease progression or unacceptable toxicity. Courses for pembrolizumab repeat every 2 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

PHASE II STUDY D: Patients with PD-L1 expression < 50% after 4 cycles of induction chemotherapy with pembrolizumab, receive CIMAvax IM and pembrolizumab IV over 30 minutes. Treatment repeats every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity

After completion of study treatment, patients are followed up every 30 days for 120 days.