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A Phase III, Randomised, Open-label Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to the BRAF Inhibitor Vemurafenib in Subjects With Unresectable (Stage IIIc) or Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Melanoma

Thank you

Trial Information

A Phase III, Randomised, Open-label Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to the BRAF Inhibitor Vemurafenib in Subjects With Unresectable (Stage IIIc) or Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma


Inclusion Criteria:



- >= 18 years of age

- Stage IIIc or Stage IV BRAF V600E/K cutaneous melanoma

- Measurable disease according to RECIST 1.1

- Women of childbearing potential with negative serum pregnancy test prior to
randomisation

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Adequate baseline organ function

Exclusion Criteria:

- Any prior use of a BRAF or MEK inhibitor

- Prior systemic anti-cancer treatment in the advanced or metastatic setting; prior
systemic treatment in the adjuvant setting is allowed

- History of another malignancy (except subjects who have been disease free for 3 years
or with a history of completely resected non-melanoma skin cancer)

- Known HIV, HBV, HCV infection (except chronic or cleared HBV and HCV infection which
will be allowed)

- Brain metastases (except if all known lesions were previously treated with surgery or
stereotactic radiosurgery and lesions, if still present, are confirmed stable for >=
12 weeks prior to randomisation or if no longer present are confirmed no evidence of
disease for >= 12 weeks, and are asymptomatic with no corticosteroid requirements for
>= 4 weeks prior to randomisation, and no enzyme inducing anticonvulsants for >= 4
weeks prior to randomisation

- History or evidence of cardiovascular risk (LVEF < LLN; QTcB >= 480 msec; blood
pressure or systolic >=140 mmHg or diastolic >= 90 mmHg which cannot be controlled by
anti-hypertensive therapy)

- History or current evidence/risk of retinal vein occlusion (RVO) or central serous
retinopathy (CSR)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

time from randomisation until death due to any cause

Outcome Time Frame:

approx. 20 months

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Australia: Human Research Ethics Committee

Study ID:

116513

NCT ID:

NCT01597908

Start Date:

June 2012

Completion Date:

June 2015

Related Keywords:

  • Melanoma
  • BRAF inhibitor
  • Metastatic Melanoma
  • Cancer
  • MEK inhibitor
  • Melanoma
  • Skin Neoplasms

Name

Location

GSK Investigational Site Phoenix, Arizona  85013 - 4496
GSK Investigational Site Bakersfield, California  93309
GSK Investigational Site Gainesville, Florida  32610
GSK Investigational Site Duluth, Minnesota  55805
GSK Investigational Site St. Louis, Missouri  63141
GSK Investigational Site Raleigh, North Carolina  27609
GSK Investigational Site Akron, Ohio  44304
GSK Investigational Site Fort Worth, Texas  76104
GSK Investigational Site Green Bay, Wisconsin  54301
GSK Investigational Site Savannah, Georgia  31405
GSK Investigational Site Royal Oak, Michigan  48073
GSK Investigational Site Columbia, South Carolina  29210
GSK Investigational Site Germantown, Tennessee  38138
GSK Investigational Site Salem, Virginia  24153
GSK Investigational Site New York, New York  10021
GSK Investigational Site Birmingham, Alabama  35209
GSK Investigational Site Aurora, Colorado  80012
GSK Investigational Site Henderson, Nevada  89014
GSK Investigational Site Edison, New Jersey  08837
GSK Investigational Site Oregon City, Oregon  97045
GSK Investigational Site Salt Lake City, Utah  84107
GSK Investigational Site South Burlington, Vermont  05403