Cabozantinib and Pembrolizumab for Advanced Metastatic Melanoma

Conditions

Cabozantinib — DRUG
Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form, at three dose levels: 40, 20 and 60 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle.
Pembrolizumab — DRUG
Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.

The study aims to evaluate the safety and preliminary efficacy of the combination of cabozantinib and pembrolizumab in advanced melanoma

Experimental: Cabozantinib and pembrolizumab
Cabozantinib will be administered in the tablet form, at three dose levels: 40, 20 and 60 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks.

Phase I: Number of Participants With a Dose Limiting Toxicity (DLT) Using CTCAE, Version 4.03 [ Time Frame: Up to 21 days ]

Facility	City	State	ZIP	Site coordinators
University of Iowa Hospitals and Clinics	Iowa City	Iowa	52242	-

By research site