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A Phase 1B/2 Open-Label Study to Evaluate Safety, Clinical Activity, Pharmacokinetics and Pharmacodynamics of Avelumab (MSB00100718C) in Combination with Other Cancer Immunotherapies in Patients with Advanced Malignancies
The purpose of this research study is to learn about the effects of the study treatment, avelumab/MSB0010718C when given with other cancer immunotherapies to find the best treatment combination for various cancer types. The study will begin by looking for the best dose of PF-05082566 in the combination.
Primary Objectives - Phase 1b lead-in: To assess safety and tolerability of avelumab in combination with increasing dose levels of other immune modulators in combination with a single dose level of avelumab in patients with advanced solid tumors in order to select the Recommended Phase 2 Dose(s) (RP2D)/schedule for the combination. Phase 2: To assess objective response (OR) of avelumab in combination with other immune modulators in patients with locally advanced or metastatic cancer [i.e., non-small cell lung cancer (NSCLC), melanoma, or squamous cell carcinoma of the head and neck(SCCHN)]. Secondary Objectives - To assess the overall safety and tolerability of avelumab and other immune modulators when given in combination; To characterize the pharmacokinetics of avelumab and other immune modulators when given in combination; To evaluate the immunogenicity of avelumab and other immune modulators when given in combination; To assess the antitumor activity of avelumab and other immune modulators when given in combination in patients with locally advanced or metastatic NSCLC, melanoma, and/or SCCHN; To evaluate candidate predictive biomarkers of sensitivity or resistance to avelumab in combination with other immune modulators in pre-treatment tumor tissue that may aid in the identification of patient subpopulations most likely to benefit from treatment.