BRIM8: A Study of Vemurafenib Adjuvant Therapy in Patients With Resected Cutaneous BRAF Mutant Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01667419
First received: August 15, 2012
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

This multi-center, randomized, double-blind, placebo-controlled study will evalu ate the efficacy and safety of vemurafenib in patients with completely resected, cutaneous BRAF-mutation positive melanoma at high risk for recurrence. Patient s will be randomized to receive oral doses of vemurafenib 960 mg twice daily or matching placebo. The anticipated time on study treatment is 52 weeks.


Condition Intervention Phase
Malignant Melanoma
Drug: Placebo
Drug: vemurafenib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 [ Time Frame: Approximately 37 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Approximately 7 years ] [ Designated as safety issue: No ]
  • Distant metastases-free survival [ Time Frame: Approximately 37 months ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics: plasma concentration of vemurafenib [ Time Frame: Cycle 1: Day 1, 8, 15, 22; Cycle 2: Day 1, 15; cycles thereafter: Day 1, and end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 725
Study Start Date: September 2012
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Arm Drug: Placebo
Oral doses twice daily for 52 weeks
Experimental: Vemurafenib Arm Drug: vemurafenib
Oral doses of 960 mg twice daily for 52 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients should have histologically confirmed melanoma of cutaneous origin
  • Patients must have been surgically rendered free of disease within 90 days of randomization
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Life expectancy of at least 5 years
  • Patients must have 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 colon cancer syndromes
  • History of clinically significant cardiac or pulmonary dysfunction
  • Major surgical procedure within 4 weeks prior to first dose of study treatment
  • Infection with human immunodeficiency virus, hepatitis B or hepatitis C virus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667419

Contacts
Contact: Reference Study ID Number: GO27826 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 202 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01667419     History of Changes
Other Study ID Numbers: GO27826, 2011-004011-24
Study First Received: August 15, 2012
Last Updated: October 13, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014