Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma (COMBI-v)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01597908
First received: May 10, 2012
Last updated: December 4, 2014
Last verified: December 2014
Results First Received: December 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Melanoma
Interventions: Drug: Dabrafenib
Drug: Vemurafenib
Drug: Trametinib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants (par.) were stratified for lactate dehydrogenase (LDH) and BRAF mutation (V600E versus V600K). Par. were randomized in a 1:1 ratio to receive either dabrafenib and trametinib combination therapy or vemurafenib until disease progression, death, or withdrawal.

Reporting Groups
  Description
Dabrafenib Plus Trametinib Participants received dabrafenib 150 milligrams (mg) orally twice daily (BID) and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
Vemurafenib Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.

Participant Flow:   Overall Study
    Dabrafenib Plus Trametinib     Vemurafenib  
STARTED     352     352  
Ongoing     236     202  
COMPLETED     0     0  
NOT COMPLETED     352     352  
Death                 100                 122  
Lost to Follow-up                 4                 9  
Physician Decision                 2                 1  
Withdrawal by Subject                 10                 18  
Ongoing                 236                 202  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dabrafenib Plus Trametinib Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
Vemurafenib Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
Total Total of all reporting groups

Baseline Measures
    Dabrafenib Plus Trametinib     Vemurafenib     Total  
Number of Participants  
[units: participants]
  352     352     704  
Age  
[units: Years]
Median (Full Range)
  55.0    (18 to 91)     54.0    (18 to 88)     54.5    (18 to 91)  
Gender  
[units: Participants]
     
Female     144     172     316  
Male     208     180     388  
Race/Ethnicity, Customized  
[units: Participants]
     
Asian - East Asian Heritage     8     8     16  
White - Arabic/North African Heritage     4     2     6  
White - White/Caucasian/European Heritage     339     339     678  
White - Mixed Race     1     0     1  
Mixed Race     0     1     1  
African American/African Heritage     0     1     1  
American Indian or Alaskan Native     0     1     1  



  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: From randomization until death due to any cause (up to Study Week 92) ]

2.  Secondary:   Progression-free Survival, as Assessed by the Investigator   [ Time Frame: From randomization to the first documented occurrence of disease progression or death due to any cause (up to Study Week 80) ]

3.  Secondary:   Overall Response, as Assessed by the Investigator   [ Time Frame: Screening, Week 8 and every 8 weeks thereafter through Week 56, and then every 12 weeks ]

4.  Secondary:   Duration of Response, as Assessed by the Investigator   [ Time Frame: From the first documented evidence of a CR or PR until the earliest date of disease progression or death due to any cause (up to Study Week 80) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01597908     History of Changes
Other Study ID Numbers: 116513
Study First Received: May 10, 2012
Results First Received: December 1, 2014
Last Updated: December 4, 2014
Health Authority: Australia: Human Research Ethics Committee
United States: Food and Drug Administration