Last updated: 11/03/2018 18:14:09
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

COMBI-AD: A phase III randomized double blind study of dabrafenib (GSK2118436) in COMBInation with trametinib (GSK1120212) versus two placebos in the ADjuvant treatment of high-risk BRAF V600 mutation-positive melanoma after surgical resectionCOMBI-AD

GSK study ID
115532
Clinicaltrials.gov ID
NCT01682083
EudraCT ID
2012-001266-15
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: COMBI-AD: A phase III randomized double blind study of dabrafenib (GSK2118436) in COMBInation with trametinib (GSK1120212) versus two placebos in the ADjuvant treatment of high-risk BRAF V600 mutation-positive melanoma after surgical resection
Trial description: This is a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] cutaneous melanoma will be screened for eligibility. Subjects will be randomized to receive either dabrafenib (150 milligram (mg) twice daily [BID]) and trametinib (2 mg once daily [QD]) combination therapy or two placebos for 12 months.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Relapse-free survival (RFS)

Timeframe: Approximately 32 months

Secondary outcomes:

Overall survival (OS) of dabrafenib and trametinib as a combination therapy versus placebo

Timeframe: approximately 5 years

Distant metastasis-free survival (DMFS) of dabrafenib and trametinib as a combination therapy versus placebo

Timeframe: approximately 32 months

Freedom from relapse (FFR) of dabrafenib and trametinib as a combination therapy versus placebo

Timeframe: approximately 32 months

Safety of dabrafenib and trametinib as a combination therapy in the overall study population

Timeframe: approximately 5 years

Interventions:
  • Drug: Placebos
  • Drug: Dabrafenib
  • Drug: Trametinib
    • Enrollment:
    852
    Primary completion date:
    2016-13-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Melanoma
    Product
    dabrafenib, dabrafenib/trametinib, trametinib
    Collaborators
    Not applicable
    Study date(s)
    January 2013 to June 2018
    Type
    Interventional
    Phase
    2/3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Completely resected histologically confirmed high-risk [Stage IIIa (LN metastasis more than 1 mm), IIIb or IIIc cutaneous melanoma determined to be V600E/K mutation positive by a central laboratory. Patients presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma are eligible.
    • Surgically rendered free of disease no more than 12 weeks before randomization.
    • Known mucosal or ocular melanoma or the presence of unresectable in-transit metastases.
    • Evidence of distant metastatic disease.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Completely resected histologically confirmed high-risk [Stage IIIa (LN metastasis more than 1 mm), IIIb or IIIc cutaneous melanoma determined to be V600E/K mutation positive by a central laboratory. Patients presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma are eligible.
    • Surgically rendered free of disease no more than 12 weeks before randomization.
    • Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains).
    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
    • Adequate hematologic, hepatic, renal and cardiac function.
    Exclusion criteria:
    • Known mucosal or ocular melanoma or the presence of unresectable in-transit metastases.
    • Evidence of distant metastatic disease.
    • Prior systemic anti-cancer treatment and radiotherapy for melanoma; prior surgery for melanoma is allowed.
    • History of another malignancy or concurrent malignancy including prior malignant melanoma. Exceptions to this include: Patients who have been disease-free for 5 years or patients with a history completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ, multiple primary melanomas, or other malignancies for which the patient has been disease free for > 5 years.
    • History or current evidence of cardiovascular risk.
    • History or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR)

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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