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

Hanmi Pharmaceutical

Status and phase

Enrolling

Phase 2

Conditions

Advanced or Metastatic Melanoma

Treatments

Drug: Belvarafenib

Combination Product: Cobimetinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT07449754

HM-RAFI-201

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Have histologically, cytologically confirmed locally advanced or metastatic melanoma for which no adequate standard of care exists, or for which standard of care has failed or is not tolerated.
Have NRAS mutation.
Have at least one measurable lesion at baseline per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Age of 19 years or older
Adequate renal, hematologic and liver function.

Key Exclusion Criteria:

Have a history of prior treatment with RAF, MEK, or ERK inhibitor.
Have past history or ongoing retinal pathology that is considered a risk factor for retinopathy or RVO.
Have past history or ongoing cardiac function-related disorders.
Had hemorrhage or bleeding corresponding to CTCAE Grade ≥3 within 4 weeks prior to the first dose of study drug treatment (Cycle 1 Day 1).