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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Malignant Melanoma

Thank you

Trial Information

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


Inclusion Criteria:



- Patients with completely resected, histologically confirmed, Stage IIC or Stage III,
cutaneous melanoma where the BRAFV600 mutation status of the current primary tumor or
involved lymph node is determined to be positive using the cobasĀ® BRAF V600 Mutation
Test. Patients with Stage IIIA disease must have at least one lymph node metastasis
measuring > 1 mm in diameter

- Patients must have been surgically rendered free of disease within 70 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 therapy for the treatment of melanoma

- 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 3 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Time Frame:

Approximately 37 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

GO27826

NCT ID:

NCT01667419

Start Date:

December 2012

Completion Date:

May 2020

Related Keywords:

  • Malignant Melanoma
  • Melanoma

Name

Location

Hinsdale, Illinois  60521
Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Louisville, Kentucky  40207
Hackensack, New Jersey  07601
Denver, Colorado  
Charlotte, North Carolina  
Eugene, Oregon  
Indianapolis, Indiana  
Charleston, South Carolina  
Charleston, West Virginia  25304
Coeur D'alene, Idaho  83814