A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma (BRIM8)
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|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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667419
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|Study Director:||Clinical Trials||Hoffmann-La Roche|