Phase 3
N=3,219
A Study of Vemurafenib in Participants With Metastatic Melanoma
Malignant Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01307397 ↗Enrolled (actual)
3,219
Serious AEs
34.6%
Results posted
Dec 2017
Primary outcome: Primary: Percentage of Participants Experiencing Any Grade 3 or 4 Adverse Events (AEs) as Determined by National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0 — 52.8 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vemurafenib (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Any Grade 3 or 4 Adverse Events (AEs) as Determined by National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0 |
52.8 | — |
| PRIMARY Percentage of Participants With at Least 1 AE Leading to Study Drug Interruption or Drug Discontinuation |
7.0; 34.0 | — |
| PRIMARY Percentage of Participants With AEs of Special Interest |
42.3; 47.9; 28.4; 36.8; 14.6; 0.1 | — |
| PRIMARY Mean Cumulative Dose of Vemurafenib |
501.283 | — |
| PRIMARY Duration of Vemurafenib Treatment |
9.383; 9.724 | — |
| PRIMARY Mean Total Vemurafenib Dose Per Day |
1.802; 1.732 | — |
| PRIMARY Dose Intensity of Vemurafenib |
90.21 | — |
| SECONDARY Percentage of Participants With Improvement in Eastern Cooperative Group (ECOG) Performance Status |
24.7; 9.9 | — |
| SECONDARY Percentage of Participants Who Received Any Concomitant Medications |
93.8 | — |
| SECONDARY Percentage of Participants With Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR), as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) |
33.4 | — |
| SECONDARY Duration of Response |
7.4 | — |
| SECONDARY Time to Response |
1.84 | — |
| SECONDARY Percentage of Participants With PD Assessed According to RECIST v1.1 or Death |
87.3 | — |
| SECONDARY Progression Free Survival (PFS) |
5.6 | — |
| SECONDARY Percentage of Participants Who Died |
63.8 | — |
| SECONDARY Overall Survival (OS) |
12.1 | — |
Summary
This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer [AJCC]) metastatic melanoma.
Eligibility Criteria
Inclusion Criteria
- Participants with Histologically confirmed metastatic melanoma (surgically incurable and unresectable Stage IIIC or Stage IV; AJCC) with BRAF V 600 mutation determined by Cobas 4800 BRAF Mutation Test. Unresectable Stage IIIC disease must have had confirmation from a surgical oncologist
- Participants with either measurable or non-measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
- Participants may or may not have received prior systemic therapy for metastatic melanoma
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 to 2
- Adequate hematologic, renal and liver function
Exclusion Criteria
- Evidence of symptomatic central nervous system (CNS) lesions, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of vemurafenib
- Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
- Concurrent administration of any anti-cancer therapies other than those administered in the study
- Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
- Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption
Data sourced from ClinicalTrials.gov (NCT01307397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.