A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma
Public ClinicalTrials.gov record NCT01667419. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than \[\>\] 1 millimeter \[mm\] in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period.
Study identification
- NCT ID
- NCT01667419
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 498 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 24, 2012 (Actual)
- Primary completion
- Jun 23, 2017 (Actual)
- Completion
- Jul 13, 2018 (Actual)
- Last update posted
- Jul 23, 2019
2012 – 2018
United States locations
- U.S. sites
- 47
- U.S. states
- 17
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| UCLA Department of Medicine; Division of Hematology / Oncology | California City | California | 90095 | — |
| Kaiser Permanente - Hayward | Hayward | California | 94545 | — |
| UCLA Hematology Oncology - Irvine | Irvine | California | 92604 | — |
| UCSD Moores Cancer Center | La Jolla | California | 92093 | — |
| The Angeles Clinic and Research Institute - W LA Office | Los Angeles | California | 90025 | — |
| Cancer Center Of Santa Barbara; Network Clinical Research Specialist | Los Angeles | California | 90095 | — |
| TRIO-US Network Administration; Network Clinical Research Specialist | Los Angeles | California | 90095 | — |
| Kaiser Foundation Hospital - Oakland (W. MacArthur) | Oakland | California | 94611 | — |
| Kaiser Permanente - Oakland | Oakland | California | 94611 | — |
| UCLA Healthcare/Pasadena Oncology | Pasadena | California | 91105 | — |
| Kaiser Permanente - Roseville | Roseville | California | 95661 | — |
| Kaiser Permanente Sacramento Medical Center | Sacramento | California | 95814 | — |
| Kaiser Permanente | San Francisco | California | 94115 | — |
| K. Permanente - San Jose | San Jose | California | 95119 | — |
| Coastal Integrative Cancer Care | San Luis Obispo | California | 93401 | — |
| Kaiser Permanente - Santa Clara | Santa Clara | California | 95051 | — |
| Kaiser Permanente - South San Francisco | South San Francisco | California | 94080 | — |
| Stanford University School of Medicine; Stanford Hospital Pharmacy | Stanford | California | 94305 | — |
| UCLA Cancer Center Hema/Oncol | Valencia | California | 91355 | — |
| Kaiser Permanente - Vallejo | Vallejo | California | 94589 | — |
| Kaiser Permanente - Walnut Creek | Walnut Creek | California | 94596 | — |
| UCLA Hematology Oncology - Westlake | Westlake Village | California | 91361 | — |
| University Of Colorado | Aurora | Colorado | 80045 | — |
| St. Mary's Hospital Regional Cancer Center | Grand Junction | Colorado | 81501 | — |
| Florida Cancer Specialists - Broadway | Fort Myers | Florida | 33901 | — |
| Memorial Healthcare System | Hollywood | Florida | 33021 | — |
| GulfCoast Oncology | Sarasota | Florida | 34232 | — |
| Oncology Specialists, S.C. | Park Ridge | Illinois | 60068 | — |
| Indiana University Health; Goshen Center for Cancer Care | Goshen | Indiana | 46526 | — |
| Indiana University Department of Medicine; Division of Infectious Diseases | Indianapolis | Indiana | 46202 | — |
| U of L - Physicians Pulmonology; Dept of Neuroradiology and Dept of Diagnostic Radiology | Louisville | Kentucky | 40202 | — |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| St. Luke's Hospital | Kansas City | Missouri | 64111 | — |
| University of Kansas Medical Center; Cancer Center | Kansas City | Missouri | 64131 | — |
| Washington University; Dept of Medicine/Div of Medical Oncology | St Louis | Missouri | 63110 | — |
| Atlantic Health Systems; Pediatrics | Randolph Township | New Jersey | 07869 | — |
| New York University Medical Center PRIME; NYU Clinical Cancer Center | New York | New York | 10016 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Duke University Medical Center; Oncology | Durham | North Carolina | 27710 | — |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | — |
| MUSC Hollings Cancer Center/cannon Park Place; Attn: Tamara Saunders | Charleston | South Carolina | 29425 | — |
| West Clinic | Germantown | Tennessee | 38138 | — |
| Tennessee Oncology PLLC - Nashville (20th Ave) | Nashville | Tennessee | 37203 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Mary Babb Randolph Cancer Center | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 160 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01667419, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 23, 2019 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01667419 live on ClinicalTrials.gov.