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Protein Kinase Inhibitor

Triple Drug Therapy for Melanoma

Phase 1
Waitlist Available
Led By Zeynep Eroglu, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have cytologically or histologically-confirmed unresectable melanoma that harbors a BRAF V600 mutation determined by pyrosequencing assay or equivalent genotyping assay in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory, meeting specific AJCC staging criteria.
Must have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
Must not have
HIV-positive patients on combination antiretroviral therapy.
History of malabsorption or other condition that would interfere with absorption of study drugs.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat melanoma. The goal is to find the best dose of the new drugs while monitoring for side effects.

Who is the study for?
Adults with unresectable BRAF V600 mutated melanoma can join this trial. They must have a performance status indicating they are relatively active, agree to use contraception, and not be pregnant or nursing. Prior treatments for cancer are okay if side effects have settled, but no past use of BRAF, MEK or HSP90 inhibitors is allowed. Participants need functioning major organs and cannot have untreated brain metastases or certain serious health conditions.
What is being tested?
The study aims to find the highest dose of XL888 that's safe when taken with vemurafenib and cobimetinib in patients with advanced melanoma. It will also assess how well participants tolerate this drug combination.
What are the potential side effects?
Potential side effects include issues related to liver, kidney or bone marrow function; digestive problems; skin reactions from the drugs; fatigue; vision changes due to retinal complications; and possible heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My melanoma cannot be surgically removed and has a BRAF V600 mutation.
Select...
I can take care of myself but might not be able to do heavy physical work.
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I have not taken BRAF, MEK, or HSP90 inhibitors for my condition.
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My liver, kidneys, and bone marrow are functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am HIV-positive and on antiretroviral therapy.
Select...
I do not have a condition that affects how my body absorbs medication.
Select...
I have a history of serious heart problems.
Select...
I have been treated with BRAF, MEK, or HSP90 inhibitors.
Select...
I have a history of eye conditions that could lead to serious retinal problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose (MTD)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose EscalationExperimental Treatment3 Interventions
Escalating Doses of XL888 with Vemurafenib plus Cobimetinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XL888
2017
Completed Phase 1
~70
Vemurafenib
2015
Completed Phase 3
~3550
Cobimetinib
2017
Completed Phase 3
~3300

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
561 Previous Clinical Trials
144,655 Total Patients Enrolled
43 Trials studying Melanoma
3,267 Patients Enrolled for Melanoma
ExelixisIndustry Sponsor
120 Previous Clinical Trials
20,104 Total Patients Enrolled
5 Trials studying Melanoma
260 Patients Enrolled for Melanoma
Genentech, Inc.Industry Sponsor
1,556 Previous Clinical Trials
569,367 Total Patients Enrolled
34 Trials studying Melanoma
1,691 Patients Enrolled for Melanoma

Media Library

Cobimetinib (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02721459 — Phase 1
Melanoma Research Study Groups: Dose Escalation
Melanoma Clinical Trial 2023: Cobimetinib Highlights & Side Effects. Trial Name: NCT02721459 — Phase 1
Cobimetinib (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02721459 — Phase 1
~3 spots leftby Nov 2025
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