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Belvarafenib

Phase 1

Melanoma | Small molecule | Oncology |Roche Holding AG|Last Updated: Jul 1, 2026

Target and mechanism

Molecular targetRAF1, BRAF, ARAF
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

Clinical trial landscape

Belvarafenib · 1 trial · 1 indication

Phase 1 1
NCT04835805A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-mutant Advanced Melanoma.Melanoma
ACTIVE NOT_RECRUITING65 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-mutant Advanced Melanoma.
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Dose Limiting Toxicity (DLTs)
28 Days from Cycle 1, Day 1
Percentage of Participants With Adverse Events
From Cycle 1, Day 1 Up to 4 Years

Severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0

Secondary Endpoints

Objective response rate (ORR) according to RECIST v1.1
Up to Approximately 4 Years
Progression free survival (PFS) according to RECIST v1.1
Up to Approximately 4 Years
Duration of response (DOR) according to RECIST v1.1
Up to Approximately 4 Years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Belvarafenib MonotherapyEXPERIMENTALTwice daily (BID), continuous dosing.
Belvarafenib Plus CobimetinibEXPERIMENTALRecommended dose (RD) and schedule of belvarafenib and cobimetinib selected based on the safety data, tolerability, pharmacokinetics, and anti-tumor activity tested in dose-finding phase followed by an expansion phase.
Belvarafenib Plus Cobimetinib Plus NivolumabEXPERIMENTALRecommended dose (RD) and schedule of belvarafenib and cobimetinib plus nivolumab IV infusion every 4 weeks (Q4W) in a run-in phase followed by an expansion phase

Interventions

NameTypeDescription
BelvarafenibDRUGTwice daily (BID), continuous dosing
CobimetinibDRUGOnce daily (QD) or three times weekly (TIW) for 21 days, 7 days off
NivolumabDRUGOnce every 4 weeks (Q4W)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * ECOG Performance Status of 0 or 1 * Histologically confirmed, metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage III) cutaneous melanoma, that has progressed on or after treatment with anti-PD-1 or anti-PD-L1 therapy. Patients may have received ...

Countries:United StatesAustraliaCanadaGermanySouth Korea
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Frequently asked questions about Belvarafenib

What is Belvarafenib used for?

Belvarafenib is an investigational small molecule being studied for the treatment of melanoma. It is currently in Phase 1 clinical development for this indication. The drug is being evaluated in patients with NRAS-mutant advanced melanoma, as detailed in an ongoing clinical trial.

What does Belvarafenib target?

Belvarafenib is a kinase inhibitor, as indicated by its '-nib' suffix. It targets kinases, which are enzymes involved in cell signaling and growth. By inhibiting these kinases, Belvarafenib aims to interfere with cancer cell proliferation in melanoma.

Who makes Belvarafenib?

Belvarafenib is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY. The company is conducting clinical trials to evaluate the safety and activity of Belvarafenib in melanoma patients.

What phase is Belvarafenib in?

Belvarafenib is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is evaluating its safety and activity in patients with NRAS-mutant advanced melanoma.

What clinical trials is Belvarafenib in?

Belvarafenib is being studied in a Phase 1 clinical trial with the identifier NCT04835805. This trial evaluates Belvarafenib as a single agent and in combination with either cobimetinib or cobimetinib plus nivolumab in patients with NRAS-mutant advanced melanoma. The trial is active but not recruiting participants.

Is Belvarafenib the same as any other drug?

Belvarafenib is a distinct investigational drug and is not known to be the same as any other approved medication. It is being studied under its own name in clinical trials for melanoma. No alternative names for Belvarafenib have been established in the available information.