Last updated: 02/04/2020 16:30:04
HO-14-15482 - Indirect treatment comparisons of trametinib versus vemurafenib in metastatic melanoma
GSK study ID
201925
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: HO-14-15482 - Indirect treatment comparisons of trametinib versus vemurafenib in metastatic melanoma
Trial description: In order to meet the requirements of the German reimbursement agency there is a need to perform a systematic review and quantitative analysis of any new drug treatments compared to other relevant treatments being used in that particular indication/setting. The treatment of interest in this particular case is trametinib for the treatment of BRAF V600 mutation-positive advanced or metastatic melanoma which was compared against chemotherapy in the METRIC study. The relevant comparator for the German reimbursement agency is vemurafenib which was compared against chemotherapy in the BRIM-3 study in a similar patient population. A systematic review and quantitative analyses (etrack 117254) has been previously performed and reported. Given the availability of updated clinical trial data the objective of this study was to conduct indirect treatment comparison (ITC) analyses of trametinib against vemurafenib, based on the updated data from METRIC and BRIM-3 studies, respectively to support the German reimbursement dossier.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Efficacy outcomes
Timeframe: Varies by study
Tolerability and Safety outcomes
Timeframe: Varies by study
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
0
Primary completion date:
2015-05-03
Observational study model:
Other
Time perspective:
Other
Clinical publications:
Not applicable
Medical condition
Melanoma
Product
trametinib, vemurafenib
Collaborators
Not applicable
Study date(s)
October 2014 to March 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Adult patients of any race or gender
- Patients with advanced or metastatic malignant melanoma
- Studies focusing on children or adolescents
- Patients 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 patients of any race or gender
- Patients with advanced or metastatic malignant melanoma
- Patients with unresectable advanced or metastatic malignant melanoma (stage III or IV)
- Patients who are either treatment-naive or have received up to one one line of prior therapy for metastatic melanoma (receiving either first-line or second-line therapy in the trial setting)
Exclusion criteria:
- Studies focusing on children or adolescents
- Patients 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
- Patients with stage I or stage II melanoma
- Studies assessing patients receiving further line of therapies, i.e. third or further line for the treatment of advanced or metastatic melanoma in the trial
- 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
No study documents available.
Results overview
No study documents available
Recruitment status
Study complete
Actual primary completion date
2015-05-03
Actual study completion date
2015-05-03
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website