A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF VEMURAFENIB VERSUS VEMURAFENIB PLUS GDC-0973 IN PREVIOUSLY UNTREATED BRAFV600-MUTATION POSITIVE PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA

Phase 3

Completed

Conditions: Skin cancer
10040900

Registration Number: NL-OMON44115

Lead Sponsor: Hoffmann-La Roche

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

1. Patients with histologically confirmed melanoma, either unresectable stage IIIc or stage IV metastatic melanoma, as defined by the American Joint Committee on Cancer 7th edition. Unresectability of stage IIIc disease must have confirmation from a surgical oncologist.
2. Patients must be naïve to treatment for locally advanced unresectable or metastatic disease (i.e., NO prior systemic anti-cancer therapy for advanced disease; stage IIIc and IV). Prior adjuvant immunotherapy (including ipilimumab) is allowed.
3. Documentation of BRAFV600 mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples) using the cobas 4800 BRAF V600 mutation test.
4. Male or female patient aged * 18 years.
5. Life expectancy * 12 weeks.

Exclusion Criteria

1. History of prior RAF or MEK pathway inhibitor treatment.
2. Palliative radiotherapy within 14 days prior to the first dose of study treatment.
3. Major surgery or traumatic injury within 14 days prior to first dose of study treatment.
4. Active malignancy other than melanoma that could potentially interfere with the interpretation of efficacy measures. Patients with a previous malignancy within the past 3 years are excluded except for patients with resected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin, melanoma in-situ, carcinoma in-situ of the cervix, and carcinoma in-situ of the breast.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure for this study is as follows:<br /><br>* PFS, defined as the time from randomization to the first occurrence of<br /><br>disease progression, as determined by the investigator using RECIST v1.1, or<br /><br>death from any cause, whichever comes first. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measures are as follows:<br /><br>* Overall survival, defined as the time from randomization to death from any<br /><br>cause<br /><br>* Objective response rate for patients with measurable disease at baseline,<br /><br>defined as complete or partial response as assessed by investigator according<br /><br>to RECIST v1.1<br /><br>* Duration of response for patients with measurable disease at baseline,<br /><br>defined as the time from first occurrence of a documented objective response<br /><br>until the time of disease progression, as determined by investigator review of<br /><br>tumor assessments using RECIST v1.1, or death from any cause during the study<br /><br>(i.e., within 30 days after the last dose of study treatment)<br /><br>* progression-free survival (PFS)</p><br>