Cabozantinib and Pembrolizumab for Advanced Metastatic Melanoma

Phase 1

Recruiting

• Conditions: Advanced Metastatic Melanoma
• Interventions: Drug: Cabozantinib; Drug: Pembrolizumab

• Registration Number: NCT03957551
• Lead Sponsor: Yousef Zakharia

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.

Study Timeline

• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-21
• Study Start: 2019-08-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-14
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cabozantinib and pembrolizumab	Cabozantinib	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.
Cabozantinib and pembrolizumab	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.

Primary Outcome Measures

Name	Time	Method
Phase 1: Incidence of dose limiting toxicities using CTCAE, Version 4.03	Initiation of treatment up to 2 years	All adverse events (AEs )will be considered in DLT assessment unless an event is clearly unrelated to trial treatment. The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 will be used.
Phase 2: Best overall response rate (ORR) (complete response (CR) + partial response (PR)) per RECIST v1.1	Initiation of treatment up to 2 years	Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 will be used to determine ORR.

Secondary Outcome Measures

Name	Time	Method
Determine disease control rate (DCR) according to RECIST v1.1 criteria	Initiation of treatment up to 2 years	DCR defined as the percentage of patients achieving CR+PR +SD
Radiologic progression-free survival (PFS) per RECIST v1.1	Initiation of treatment up to 2 years	PFS is defined as the time between the first dose of study therapy and the earliest date of progression or death (participants who have neither progressed nor died will be censored at the most recent last-known-alive date).
Summarize overall survival (OS) with the method of Kaplan-Meier	Initiation of treatment up to 2 years	OS is defined as defined as the time between the first dose of study therapy and death (participants who have not died will be censored at the most recent last-known-alive date).

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States