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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01667419
Registration number
NCT01667419
Ethics application status
Date submitted
15/08/2012
Date registered
17/08/2012
Date last updated
23/07/2019
Titles & IDs
Public title
A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma
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Scientific 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
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Secondary ID [1]
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2011-004011-24
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Secondary ID [2]
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GO27826
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Universal Trial Number (UTN)
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Trial acronym
BRIM8
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Vemurafenib
Treatment: Drugs - Placebo
Experimental: Cohort 1 Vemurafenib - Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 milligrams (mg) twice daily, in 28-day cycles, for up to 52 weeks
Placebo comparator: Cohort 1 Placebo - Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Experimental: Cohort 2 Vemurafenib - Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Placebo comparator: Cohort 2 Placebo - Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Treatment: Drugs: Vemurafenib
4 tablets of vemurafenib 240 mg each (total 960 mg) were administered orally as per the schedule specified in the respective arm.
Treatment: Drugs: Placebo
Placebo matching to vemurafenib were administered orally as per the schedule specified in the respective arm.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disease-Free Survival (DFS) as Assessed Using Contrast-Enhanced Magnetic Resonance Imaging (MRI) or Contrast Enhanced Computed Tomography (CT)
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Assessment method [1]
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DFS was defined as the time from randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause.
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Timepoint [1]
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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 the April 17, 2017 data cut-off, approximately 4.5 years)
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Secondary outcome [1]
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Distant Metastasis-Free Survival (DMFS) as Assessed Using Contrast-Enhanced MRI or Contrast Enhanced CT
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Assessment method [1]
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DMFS was defined as the time from randomization until the date of diagnosis of distant (i.e. non-locoregional) metastases or death from any cause.
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Timepoint [1]
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From randomization until the date of diagnosis of distant (i.e., non-locoregional) metastases or death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as the time from randomization until the date of death from any cause.
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Timepoint [2]
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From randomization until the date of death from any cause (up until 13-July-2018, approximately 6 years)
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Secondary outcome [3]
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Percentage of Participants With Adverse Events
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Assessment method [3]
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An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
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Timepoint [3]
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From randomization up to study completion or discontinuation (up until 13-July-2018, approximately 6 years)
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Secondary outcome [4]
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Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score
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Assessment method [4]
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European Organisation for Research and Treatment of Cancer 30-Item Quality of Life Questionnaire assesses 8 symptoms, function, financial difficulties, and a global health status/health-related quality of life (HRQoL). Most questions use a 4-point scale (1 'Not at all' to 4 'Very much';2 questions use a 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to a 0-100 scale. Higher scores for the function and HRQoL represent higher levels of functioning and HRQoL, higher scores for the symptom represent higher levels of symptoms/problems, higher score for financial difficulty represent higher level of perceived financial burden of treatment. Changes of 5-10 points are considered to represent a minimally important difference to participants. A positive value means an increase, and negative value means a decrease in score at the indicated time-point relative to the score at baseline (Cycle 1 Day 1).
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Timepoint [4]
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Day 1, Day 8, Day 15, Day 22 of Cycle 1;Day 1, Day 15 of Cycle 2;Day 1 Cycles 3-13;end of treatment(up to 13 months);every 13 weeks thereafter until recurrence or occurrence of a new primary melanoma (up to 17-Apr-17 data cut-off,approximately 4.5 years)
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Secondary outcome [5]
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Plasma Concentration of Vemurafenib
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Assessment method [5]
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Timepoint [5]
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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)
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Eligibility
Key inclusion criteria
* Histologically confirmed melanoma of cutaneous origin
* Participants with BRAFV600 mutation-positive, cutaneous melanoma (either pathologic Stage IIC or Stage III according to AJCC Staging Criteria version 7 that has been completely resected
* BRAF V600 mutation status of the current primary tumor or involved lymph node determined to be positive using the cobas BRAF V600 mutation test
* Surgically rendered free of disease within 90 days of randomization
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of at least 5 years
* Fully recovered from the effects of any major surgery or significant traumatic injury prior to the first dose of study treatment
* Adequate hematologic, hepatic, and renal function
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* History of any systemic or local therapy (e.g., chemotherapy, biologic or targeted therapy, hormonal therapy, or photodynamic therapy) for the treatment or prevention of melanoma, including interferon alpha-2b and pegylated interferon alpha-2b
* History of limb perfusion therapy
* History of radiotherapy for the treatment of melanoma
* Invasive malignancy other than melanoma at the time of enrollment or within 5 years prior to first dose of study treatment
* Family history of inherited colon cancer syndromes
* Known personal history of >3 adenomatous colorectal polyps or a personal history of adenomatous colorectal polyp(s) >2 centimeters (cm) in size
* History of or current clinical, radiographic, or pathologic evidence of in-transit metastases, satellite, or microsatellite lesions
* History of or current clinical, radiographic, or pathologic evidence of recurrent lymph node involvement after resection of a primary melanoma with lymph node involvement at any time in the past
* History of local and/or regional and/or distant melanoma recurrence
* History or current radiographic or pathologic evidence of distant metastases
* History of clinically significant cardiac or pulmonary dysfunction
* Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study treatment
* Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/09/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/07/2018
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Sample size
Target
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Accrual to date
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Final
498
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Chris O'Brien Lifehouse - Camperdown
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Melanoma Institute Australia - North Sydney
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Calvary Mater Newcastle - Waratah
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Border Medical Oncology - Wodonga
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Southern Medical Day Care Centre - Wollongong
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Cairns Base Hospital - Cairns
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The Townsville Hospital; Townsville Cancer Centre - Townsville
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Recruitment hospital [8]
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Royal Adelaide Hospital; Hepatology - Adelaide
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Recruitment hospital [9]
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Queen Elizabeth Hospital - Woodville
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Launceston General Hospital; Gastroenterology Research - Launceston
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Recruitment hospital [11]
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Box Hill Hospital - Box Hill
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Peninsula Oncology Centre; Frankston Private - Frankston
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Peter Maccallum Cancer Centre - Melbourne
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Alfred Hospital - Melbourne
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Recruitment hospital [15]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2050 - Camperdown
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2060 - North Sydney
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2298 - Waratah
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Recruitment postcode(s) [4]
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3690 - Wodonga
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Recruitment postcode(s) [5]
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2500 - Wollongong
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Recruitment postcode(s) [6]
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4870 - Cairns
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Recruitment postcode(s) [7]
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4812 - Townsville
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Recruitment postcode(s) [8]
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5000 - Adelaide
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Recruitment postcode(s) [9]
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5011 - Woodville
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Recruitment postcode(s) [10]
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7250 - Launceston
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Recruitment postcode(s) [11]
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3128 - Box Hill
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Recruitment postcode(s) [12]
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3199 - Frankston
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Recruitment postcode(s) [13]
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3000 - Melbourne
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Recruitment postcode(s) [14]
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3004 - Melbourne
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Recruitment postcode(s) [15]
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6150 - Murdoch
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Recruitment outside Australia
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California
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Colorado
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New York
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North Carolina
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Cork
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Israel
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Israel
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Petach Tikva
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Ramat Gan
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Israel
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Italy
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Wolverhampton
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Funding & Sponsors
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Hoffmann-La Roche
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Summary
Brief summary
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than \[\>\] 1 millimeter \[mm\] in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period.
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Trial website
https://clinicaltrials.gov/study/NCT01667419
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Trial related presentations / publications
Ascierto PA, Lewis KD, Di Giacomo AM, Demidov L, Mandala M, Bondarenko I, Herbert C, Mackiewicz A, Rutkowski P, Guminski A, Simmons B, Ye C, Hooper G, Wongchenko MJ, Goodman GR, Yan Y, Schadendorf D. Prognostic impact of baseline tumour immune infiltrate on disease-free survival in patients with completely resected, BRAFv600 mutation-positive melanoma receiving adjuvant vemurafenib. Ann Oncol. 2020 Jan;31(1):153-159. doi: 10.1016/j.annonc.2019.10.002. Maio M, Lewis K, Demidov L, Mandala M, Bondarenko I, Ascierto PA, Herbert C, Mackiewicz A, Rutkowski P, Guminski A, Goodman GR, Simmons B, Ye C, Yan Y, Schadendorf D; BRIM8 Investigators. Adjuvant vemurafenib in resected, BRAFV600 mutation-positive melanoma (BRIM8): a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):510-520. doi: 10.1016/S1470-2045(18)30106-2. Epub 2018 Feb 21. Erratum In: Lancet Oncol. 2018 Apr;19(4):e184. doi: 10.1016/S1470-2045(18)30209-2.
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Contacts
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Hoffmann-La Roche
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/19/NCT01667419/Prot_001.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/19/NCT01667419/SAP_002.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01667419
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