A phase 1b/2 study of cabozantinib in combination with pembrolizumab in advanced cutaneous melanoma.

ABSTRACT:

Background

Pembrolizumab is approved for advanced cutaneous melanoma (aCM). Cabozantinib, an oral multi-tyrosine kinase inhibitor, has demonstrated antitumor activity as monotherapy or in combination with anti-PD-1 therapy in malignancies. The objective of this study was to determine the safety and efficacy of cabozantinib and pembrolizumab for patients with aCM.

Methods

This phase 1b/2 study enrolled 28 patients with unresectable aCM. In phase 1b, escalating dose levels of cabozantinib (20 mg, 40 mg, and 60 mg) were administered concurrently with pembrolizumab 200 mg intravenously every 3 weeks using a 3 + 3 design to determine recommended phase 2 dose (RP2D). In phase 2, patients received cabozantinib at RP2D in combination with pembrolizumab using a Simon 2 stage design.

SUBMITTER: Zakharia Y 

PROVIDER: S-EPMC12912253 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature