NCT03957551

Cabozantinib and Pembrolizumab for Advanced Metastatic Melanoma

Cabozantinib and Pembrolizumab as a Front-line Therapy for Advanced Metastatic Melanoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: John Rieth · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Cabozantinib	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.
DRUG	Pembrolizumab	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.

Timeline

• Start date: 2019-08-27
• Primary completion: 2024-06-10
• Completion: 2025-10-17
• First posted: 2019-05-21
• Last updated: 2026-01-29
• Results posted: 2025-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study