Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma
(COMBI-v Trial)
Recruiting in Palo Alto (17 mi)
+187 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Novartis Pharmaceuticals
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.
Research Team
NP
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Eligibility Criteria
Inclusion Criteria
>= 18 years of age
Stage IIIc or Stage IV BRAF V600E/K cutaneous melanoma
Measurable disease according to RECIST 1.1
See 4 more
Treatment Details
Interventions
- Dabrafenib (Kinase Inhibitor)
- Trametinib (Kinase Inhibitor)
- Vemurafenib (Kinase Inhibitor)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Dabrafenib plus TrametinibExperimental Treatment2 Interventions
BRAF inhibitor plus MEK inhibitor
Group II: VemurafenibActive Control1 Intervention
BRAF inhibitor
Dabrafenib is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Tafinlar for:
- Unresectable or metastatic melanoma with a BRAF V600 mutation
- Adjuvant treatment of melanoma with a BRAF V600 mutation
🇺🇸 Approved in United States as Tafinlar for:
- Unresectable or metastatic melanoma with a BRAF V600E mutation
- Adjuvant treatment of melanoma with a BRAF V600E or V600K mutation
- Metastatic non-small cell lung cancer with a BRAF V600E mutation
🇨🇦 Approved in Canada as Tafinlar for:
- Unresectable or metastatic melanoma with a BRAF V600 mutation
- Adjuvant treatment of melanoma with a BRAF V600 mutation
🇯🇵 Approved in Japan as Tafinlar for:
- Unresectable or metastatic melanoma with a BRAF V600 mutation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Novartis Investigative SiteAnn Arbor, MI
Novartis Investigative SiteSaint Louis, MO
Novartis Investigative SiteNew Brunswick, NJ
Novartis Investigative SiteChapel Hill, NC
More Trial Locations
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Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Trials
2963
Patients Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
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