Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes (COMBI-APlus)
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|ClinicalTrials.gov Identifier: NCT03551626|
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : April 16, 2019
This is an open-label Phase IIIb study of dabrafenib in combination with trametinib in the adjuvant treatment of melanoma after complete resection to evaluate the impact on pyrexia related outcomes of an adapted pyrexia AE-management algorithm, as well as safety, efficacy and health-related outcomes.
Approximately 600 subjects will be enrolled to receive dabrafenib (150 mg BID) and trametinib (2 mg once daily) combination therapy for 12 months. At enrollment, subjects will be instructed on the pyrexia management algorithm.
This study consists of two Periods for Enrolled subjects:
- Treatment Period - subjects will receive up to 12 months of treatment.
- Follow-up Period - subjects will be followed through 24 months from their first dose date for relapse, and through end of study for overall survival. Follow-up will start once treatment is complete or is prematurely discontinued and continue through the end of the study, regardless of disease recurrence.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Melanoma||Drug: Dabrafenib Drug: Trametinib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||COMBI-APlus: Open-label, Phase IIIb Study of Dabrafenib in COMBInation With Trametinib in the Adjuvant Treatment of Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes of an Adapted Pyrexia AE-management Algorithm (Plus)|
|Actual Study Start Date :||January 25, 2018|
|Estimated Primary Completion Date :||March 16, 2021|
|Estimated Study Completion Date :||October 22, 2021|
Experimental: Dabrafenib and trametinib combination therapy
Subjects will receive dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
Supplied as dabrafenib 50 mg, 75 mg Capsules for oral use
supplied as trametinib 0.5mg, 2.0mg tablets for oral use
- Change from baseline in composite rate of pyrexia related events [ Time Frame: Baseline up to 12 months ]The composite rate of grade 3/4 pyrexia, ospitalization due to pyrexia, or permanent treatment discontinuation due to pyrexia by 12 months in overall treated subjects
- Relapse free survival (RFS) from the first dose to disease recurrence or death from any cause [ Time Frame: Baseline up to approximately 24 months ]RFS is defined as the time from the date of first dose of the study medication to the date of disease recurrence or death due to any cause.
- Overall Survival (OS) from the first dose to date of death due to any cause [ Time Frame: Baseline up to approximately 24 months ]OS is defined as the time from date of the first dose of study medication to date of death due to any cause.
- Percentage of patients who require management of pyrexia [ Time Frame: Baseline up to 12 months ]Percentage of patients who experienced pyrexia and required intervention
- The percentage of participants who permanently discontinued treatment due to any Adverse event [ Time Frame: Baseline up to 12 months ]Participants who permanently discontinued treatment due to any Adverse event during treatment
- Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M MS) [ Time Frame: Baseline up to 24 months ]QoL assessed using Function Assessment Cancer Therapy-melanoma (FACT-M) assessment tool. This includes the FACT-Melanoma subscale (FACT-M MS) questionnaire -specific subscale consists of 16 questions for Melanoma Subscale (MS) and 8 questions for Melanoma Surgery Scale (MSS).Each of these questions could have a response of Not at all, a little bit, somewhat, quite a bit and very much. The responses were given a value between 0 and 4 with 4 being best response. The FACT-M Total Score (FACT-M TS) ranges from 0 to 172 and is derived as follows: FACT-M TS= PWB Score + SWB Score + EWB Score + FWB Score + MS Score. Higher scores represent a better quality of life.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551626
|Contact: Novartis Pharmaceuticalsfirstname.lastname@example.org|
|Contact: Novartis Pharmaceuticals||+81337978748|
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