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A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma (BRIM8)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01667419
First Posted: August 17, 2012
Last Update Posted: September 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Melanoma Drug: Vemurafenib Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 475
Actual Study Start Date: September 24, 2012
Estimated Study Completion Date: October 14, 2020
Primary Completion Date: June 23, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vemurafenib
Participants will receive vemurafenib tablets, 960 milligrams (mg) twice daily (BID) orally in 28-day cycles for up to 52 weeks.
Drug: Vemurafenib
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.
Drug: Placebo
Placebo matching to vemurafenib will be administered orally as per the schedule specified in the respective arm.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Information from the National Library of Medicine

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


  Show 207 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01667419     History of Changes
Other Study ID Numbers: GO27826
2011-004011-24 ( EudraCT Number )
First Submitted: August 15, 2012
First Posted: August 17, 2012
Last Update Posted: September 27, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Vemurafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action