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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: Completed Phase 3 study of Malignant Melanoma, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Progression-free survival was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using Response Evaluation Criteria in Solid Tumors v1.1, or death from any cause, whichever came first. Disease progression was defined as: (1) at least a 20% increase in the sum (the increase in the sum must be at least 5 mm) of diameters of target lesions, taking as reference the smallest sum during the study; (2) unequivocal progression of exis
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 |
What the finished NCT01689519 record still lists
NCT01689519 is an interventional study that assigns participants to a tested intervention. The registered 495 participants enrollment target is mid-sized for trials with a published cap, above the 166-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (198% higher).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01689519's enrollment target sits among peer trials
495 4th of 28 higher than 25 of 28 other Malignant Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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