Health TrialsbyHealthPanel

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

ConditionAdvanced or Metastatic Melanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorHanmi Pharmaceutical Company Limited

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Belvarafenib

    Drug

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

  • Cobimetinib

    Combination product

    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

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Belvarafenib + CobimetinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

ORR will be measured as the proportion of subjects with a confirmed response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Independent Central Review (ICR)

Time frame
Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)

Secondary outcomes

1

Disease Control Rate (DCR)

DCR will be measured as the proportion of subject with confirmed CR, PR, or Stable Disease (SD) as per RECIST v1.1 by Independent Central Review (ICR)

Time frame
Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)
2

Duration of response (DOR)

DOR will be measured as the time from initial onset of CR or PR to first radiographic progression as per RECIST v1.1 by Independent Central Review (ICR) or death from any cause, whichever occurs first.

Time frame
Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)
3

Progression-free survival (PFS)

PFS will be measured from date of first treatment until date of radiographic progression as per RECIST v1.1 by Independent Central Review (ICR) or until death from any cause, whichever occurs first

Time frame
Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)
4

Time to progression (TTP)

TTI will be measured from date of first treatment until date of rediographic progression as per RECIST v1.1 by Independent Central Review (ICR)

Time frame
Throughout the study until disease progression (up to approximately 3 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hanmi Pharmaceutical Company Limited

Lead sponsor

Source ClinicalTrials.gov
Apply now