A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma (BRIM8)
|ClinicalTrials.gov Identifier: NCT01667419|
Recruitment Status : Active, not recruiting
First Posted : August 17, 2012
Last Update Posted : December 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Vemurafenib Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||475 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Vemurafenib (RO5185426) Adjuvant Therapy in Patients With Surgically Resected, Cutaneous BRAF-Mutant Melanoma at High Risk for Recurrence|
|Actual Study Start Date :||September 24, 2012|
|Primary Completion Date :||June 23, 2017|
|Estimated Study Completion Date :||October 14, 2020|
Participants will receive vemurafenib tablets, 960 milligrams (mg) twice daily (BID) orally in 28-day cycles for up to 52 weeks.
4 tablets of vemurafenib 240 mg each (total 960 mg) will be administered orally as per the schedule specified in the respective arm.
Other Name: RO5185426/F17, Zelboraf
Placebo Comparator: Placebo
Participants will receive placebo tablets matching to vemurafenib, BID orally in 28-day cycles for up to 52 weeks.
Placebo matching to vemurafenib will be administered orally as per the schedule specified in the respective arm.
- Disease-Free Survival (DFS) as Assessed Using Contrast-Enhanced Magnetic Resonance Imaging (MRI) or Contrast Enhanced Computed Tomography (CT) [ Time Frame: From randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause (up to approximately 5 years) ]
- Overall Survival (OS) [ Time Frame: From randomization until the date of death from any cause (up to approximately 6 years) ]
- Distant Metastasis-Free Survival (DMFS) as Assessed Using Contrast-Enhanced MRI or Contrast Enhanced CT [ Time Frame: From randomization until the date of diagnosis of distant (i.e., non-locoregional) metastases or death from any cause (up to approximately 5 years) ]
- Percentage of Participants With Adverse Events [ Time Frame: From randomization up to end of study (up to approximately 6 years) ]
- European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score [ Time Frame: Days 1 and 15 of Cycles 1 and 2; Day 1 of Cycles 3-13; at end of treatment (up to 13 months); every 13 weeks thereafter until recurrence or occurrence of a new primary melanoma (up to approximately 5 years) ]
- Plasma Concentration of Vemurafenib [ Time Frame: Pre-morning dose (0 hour [hr]) and 1 to 4 hrs post-dose on Days 1, 8, 15, and 22 of Cycle 1; pre-morning dose (0 hr) on Days 1 and 15 of Cycle 2; pre-morning dose (0 hr) on Day 1 of Cycles 3-13; at end of treatment (up to 13 months) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667419
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|Study Director:||Clinical Trials||Hoffmann-La Roche|