Last updated: 02/04/2020 16:10:07

Indirect treatment comparisons of Ph3 combination studies for dabrafenib plus trametinib versus other treatments

GSK study ID
201152
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Indirect treatment comparisons of Ph3 combination studies for dabrafenib plus trametinib versus other treatments
Trial description: In order to meet the requirements of reimbursement agencies there is a need to perform a systematic review and quantitative analysis of any new drug treatments compared to current treatments being used in that particular indication/setting. A recent systematic literature review of the medical literature (randomized and non-randomized controlled studies), including quantitative analysis (indirect/mixed treatment comparisons where feasible) directly and indirectly compared relevant clinical outcomes of BRAF inhibitor (dabrafenib) and MEK inhibitor (trametinib) versus other treatments used for BRAF+ advanced or metastatic melanoma (e.g. dacarbazine, ipilimumab, vemurafenib). The objective of this study is to undertake an updated quantitative analysis (indirect/mixed treatment comparisons where feasible) based on newer data from combination studies of dabrafenib plus trametinib versus other treatments used for BRAF+ advanced or metastatic melanoma (e.g. dacarbazine, ipilimumab, vemurafenib).(dabrafenib). The data source for this study includes the results of published studies in the medical literature. The study designs of interest to this review are randomized controlled trials (RCTs), non-randomized controlled trials (non-RCTs), single-arm studies, and observational studies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Safety outcomes

Timeframe: 12, 18, 24, etc. months

Efficacy outcomes

Timeframe: 12, 18, 24, etc. months

Tolerability outcomes

Timeframe: 12, 18, 24, etc. months

Secondary outcomes:
Not applicable
Interventions:
  • Drug: dabrafenib
  • Drug: trametinib
  • Drug: dacarbazine
  • Drug: fotemustine
  • Drug: ipilimumab
  • Drug: Placebo/supportive care
  • Drug: Chemotherapy/immunotherapy
  • Drug: vemurafenib
    • Enrollment:
    0
    Primary completion date:
    2014-05-06
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Melanoma
    Product
    GSK3377370, GSK507260, dabrafenib, dabrafenib/trametinib, dacarbazine, fotemustine, ipilimumab, trametinib, vemurafenib
    Collaborators
    Not applicable
    Study date(s)
    November 2013 to June 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Adult subjects of any race and gender.
    • Subjects with advanced or metastatic malignant melanoma (MMM)
    • Studies enrolling children or adolescents
    • Subjects with other types of skin cancers (non-melanoma skin cancers) such as basal cell and squamous cell cancers, Kaposi sarcoma, and lymphoma of the skin
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Adult subjects of any race and gender.
    • Subjects with advanced or metastatic malignant melanoma (MMM)
    • Studies which enroll a mixed population of MMM and other skin cancers will only be included if there is a subgroup analysis on the MMM patient population.
    • Only subjects with unresectable advanced or metastatic malignant melanoma (stage III or IV) will be included in the review.
    • Studies which enroll a mixed population of stage I, II, III, and IV melanoma will only be included if there is a sub-group analysis on the stage III or IV patient population.
    • The line of therapy will be applicable only for metastatic disease stage.
    • Subjects who are either treatment naïve or have received up to one line of prior therapy for metastatic melanoma (receiving either first-line or second-line therapy in the trial setting) will be considered in this review. Included studies will be classified according to line of therapy during the screening of the full publication.
    • This systematic review will focus on pharmacological treatments for metastatic melanoma.
    • The review will include studies that assess the use of approved interventions or investigational therapies (dabrafenib and trametinib) for the treatment of metastatic melanoma.
    • A list of interventions of interest to this review includes dabrafenib, trametinib, ipilimumab, vemurafenib, dacarbazine, and fotemustine.
    • Comparators
    • The study must compare one of the included interventions to one of the following comparators: another included intervention (i.e. head-to-head trials of included interventions), placebo/best supportive care, any chemotherapy/immunotherapy
    • Only studies with the full-text in English will be included.
    • In order to get the evidence from all the available data, all studies meeting the inclusion criteria irrespective of publication date will be included
    Exclusion criteria:
    • Studies enrolling children or adolescents
    • Subjects with other types of skin cancers (non-melanoma skin cancers) such as basal cell and squamous cell cancers, Kaposi sarcoma, and lymphoma of the skin
    • Subjects with stage I or stage II melanoma
    • Studies assessing subjects receiving further line of therapies i.e. third or further line for the treatment of advanced or metastatic melanoma in the trial
    • Studies with an English abstract where the full-text is non-English
    • Pharmacokinetic studies
    • Studies which do not provide subgroup data for the population of interest

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2014-05-06
    Actual study completion date
    2014-05-06

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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