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NCT01689519 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma
A Phase 3 study of Malignant Melanoma, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 495
- Enrollment target
- 20
- Study locations
NCT01689519 is a Phase 3 study of Malignant Melanoma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 495 participants, above the 166-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (198% higher). The trial reports 20 study locations across 14 states.
The verdict
NCT01689519, a Phase 3 study of Malignant Melanoma, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 495 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Vemurafenib
- DRUG Cobimetinib
Study Locations (20)
California
- The Angeles Clinic and Research Institute - W LA Office - Los Angeles
- University of California Davis Health System - Sacramento
- Sutter Pacific Medical Foundation - Santa Rosa
Florida
- Florida Cancer Specialists - Broadway - Fort Myers
- Mount Sinai Medical Center - Miami Beach
- Orlando Health Inc. - Orlando
Pennsylvania
- St. Luke's University Health network - Bethlehem
- Thomas Jefferson University Hospital - Philadelphia
- University of Pittsburgh - Pittsburgh
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- University Of Colorado - Aurora
Illinois
- Northwestern Center For Clinical Research - Chicago
Kansas
- Uni of Kansas Medical Center; Dept of Neurology - Kansas City
Kentucky
- U of L - Physicians Pulmonology; Dept of Neuroradiology and Dept of Diagnostic Radiology - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 495 participants |
| Start Date | 2013-01-08 |
| Est. Completion | 2019-07-21 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01689519
The ClinicalTrials.gov registry entry for NCT01689519 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 495 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 166-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (198% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Malignant Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01689519 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01689519 about?
NCT01689519 is a clinical study titled "A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma". To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed ...
What is the current status of trial NCT01689519?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 495 participants. The study started on 2013-01-08. Estimated completion is 2019-07-21.
What conditions does trial NCT01689519 study?
This clinical trial studies the following conditions: Malignant Melanoma.
What interventions are being tested in trial NCT01689519?
The interventions under investigation include: Placebo (DRUG), Vemurafenib (DRUG), Cobimetinib (DRUG).
Who is sponsoring clinical trial NCT01689519?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01689519 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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