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Brief Title: Cabozantinib and Pembrolizumab for Advanced Metastatic Melanoma
Official Title: Cabozantinib and Pembrolizumab as a Front-line Therapy for Advanced Metastatic Melanoma
Study ID: NCT03957551
Brief Summary: The study aims to evaluate the safety and preliminary efficacy of the combination of cabozantinib and pembrolizumab in advanced melanoma
Detailed Description: This is an open-label, Phase 1b/2 trial for adults with advanced melanoma. The objective of the Phase 1b portion of the study is to establish the recommended Phase 2 dose of cabozantinib in combination with pembrolizumab in patients with unresectable melanoma and assess the safety and tolerability of the combined treatments. The objective of the Phase 2 portion of the study is to evaluate the preliminary efficacy of the established dose of cabozantinib in combination with pembrolizumab as measured by best overall response rate (ORR) (complete response \[CR\] + partial response \[PR\]) with the combination of agents in patients with unresectable stage III or stage IV melanoma.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Name: Yousef Zakharia, MD
Affiliation: University of Iowa
Role: PRINCIPAL_INVESTIGATOR