A Study of Vemurafenib (RO5185426) in Comparison With Placebo as Adjuvant Therapy in Previously Untreated Patients With Adequately Resected Melanoma (BRIM 8)

Phase 1

• Conditions: Melanoma (patients with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma or patients with Stage IIIC cutaneous melanoma); MedDRA version: 19.1Level: PTClassification code 10025670Term: Malignant melanoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.1Level: PTClassification code 10025669Term: Malignant melanoma stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004011-24-BE
• Lead Sponsor: F. Hoffman-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-18
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 475

Inclusion Criteria

•Male or female patients age = 18 years
•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 cobas® BRAF V600 Mutation Test. Patients with Stage IIIA disease must have at least one lymph node metastasis measuring > 1 mm in diameter
•ECOG performance status of 0 or 1
•Life expectancy of at least 5 years
•Adequate hematologic, liver, and renal function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 373
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 102

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 radiotherapy for the treatment of melanoma
•Invasive malignancy other than melanoma at the time of enrollment or within 5 years prior to first study drug administration except for adequately treated (with curative intent) basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, in situ ductal adenocarcinoma of the breast, in situ prostate cancer, or limited stage bladder cancer. This requires that the patient pathology evaluation of the screening Papanicolaou (Pap) smear, and of any polyps resected at the screening coloscopy, is negative for invasive malignancy.
•Known personal history of more than three (>3) adenomatous colorectal polyps or a personal history of adenomatous colorectal polyp(s) > 2 cm in size. This also applies to the screening colonoscopy for select patients.
•History of or current clinical, radiographic, or pathologic evidence of in-transit metastases, satellite, or microsatellite lesions or recurrent lymph node involvement after resection of a primary melanoma with lymph node involvement at any time in the past
•History or current radiographic or pathologic evidence of distant metastases
•History of clinically significant cardiac dysfunction including serious arrhythmias requiring treatment (except for atrial fibrillation and paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months prior to randomization, and history of congenital long QT syndrome or QTc interval > 450 ms at baseline
•Current, recent (within 28 days prior to randomization) or planned use of any investigational product outside of this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified