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RECRUITING
NCT07449754
PHASE2

Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma

Sponsor: Hanmi Pharmaceutical Company Limited

View on ClinicalTrials.gov

Summary

This is a Phase 2 open-label, multicenter, single-arm study evaluating the combination of Belvarafenib and Cobimetinib in patients with locally advanced or metastatic melanoma with NRAS mutations. The study plans to assess ORR, DCR, DOR, TTP, PFS, OS and safety of the participating subjects. Treatment cycles for all subjects will be 28 days in duration and Belvarafenib and Cobimetinib will be administered orally in combination.

Official title: A Phase 2, Multicenter, Single-Arm Study of Belvarafenib (HM95573) in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-02-12

Completion Date

2030-03

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DRUG

Belvarafenib

Belvarafenib will be taken twice daily (BID) on Days 1-28 of each cycle

COMBINATION_PRODUCT

Cobimetinib

Cobimetinib will be taken on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle (three times weekly, TIW), followed by a drug holiday through Day 28

Locations (10)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Dong-A University Medical Center

Busan, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Chungnam National University Hospital

Daejeon, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea