Health TrialsbyHealthPanel

Binimetinib and Imatinib for Unresectable Stage III-IV KIT-Mutant Melanoma

ConditionsMelanoma Stage IIIMelanoma Stage IV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

This phase II trial studies how well binimetinib and imatinib work in treating patients with stage III-IV KIT-mutant melanoma that cannot be removed by surgery (unresectable). Binimetinib and imatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and imatinib may help treat patients with KIT-mutant melanoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

Have histologically or cytologically confirmed melanoma

Have unresectable Stage III or Stage IV melanoma, as per American Joint Committee on Cancer 8th edition guidelines, not amenable to local therapy

Have measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria

Disqualifiers

Has received systemic anti-cancer therapies within 3 weeks of study drug start, radiation within 2 weeks, antibody therapy within 4 weeks

Has not recovered from adverse events due to prior anti-cancer therapy to =< grade 1 or baseline. Note: Stable chronic conditions (grade =< 2) that are not expected to resolve (such as neuropathy, myalgia, alopecia, prior therapy-related endocrinopathies) are exceptions and may enroll

Is currently receiving any other investigational agents or has received an investigational agent within 14 days or within 5 half-lives of investigational agent (whichever is shorter), prior to start of study drugs

Inability to swallow and retain study drugs

Trial design

Design model

Single group

Treatments tested in this trial

  • Binimetinib

    Drug

    Taken orally (PO) twice a day (BID)

  • Imatinib

    Drug

    Taken orally (PO) once a day (QD)

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Treatment (binimetinib, imatinib)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Defined as complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST v1.1). The ORR at stages 1 and 2 will be estimated using the method of Whitehead, and the p-values for testing the null hypothesis at each stage will use the method of Koyama \& Chen and 90% confidence interval will be reported.

Time frame
Up to week 16

Secondary outcomes

1

Proportion of participants with treatment-related adverse events (AE)

Proportion of participants with treatment-related AEs greater than grad2 as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 will be reported by toxicity.

Time frame
Up to 2 years
2

Median duration of response

Will estimate the probability-of-being-in-response function, assuming time to response is exponentially distributed.

Time frame
Up to 2 years
3

Progression-free survival (PFS)

Participants with an objective response will be followed for survival from initiation of study treatment until date of disease progression or death from any cause

Time frame
Up to 2 years
4

Overall survival (OS)

Participants will be followed from initiation of study treatment until date of disease progression or death from any cause and estimated using the Kaplan-Meier method to estimate the survival rate (95% CI)

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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

University of California, San Francisco

Lead sponsor

Array BioPharma

Collaborator

Source ClinicalTrials.gov
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