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NCT02027961 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Safety and Tolerability of MEDI4736 in Combination With Dabrafenib and Trametinib or With Trametinib Alone
A Phase 1 study of Melanoma, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
- 11
- Study locations
NCT02027961: Completed Phase 1 study of Melanoma, sponsored by MedImmune.
NCT02027961 is a Phase 1 study of Melanoma that has completed, run by MedImmune. The registered enrollment target is 68 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (90% lower). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02027961, a Phase 1 study of Melanoma, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this study is to determine the maximum tolerated dose and characterize the safety profile of durvalumab (MEDI4736) in combination with dabrafenib and trametinib or with trametinib alone in participants with metastatic or unresectable melanoma with BRAF-mutation positive or wild-type (WT) BRAF, respectively.
Primary Outcome
Dose limiting toxicities are defined as any Grade 3 or higher treatment-related (related to any study drug) toxicity that occurs during the DLT evaluation period. Number of participants with DLTs are reported.
Conditions Studied
Interventions
- BIOLOGICAL Durvalumab
- DRUG Trametinib
- DRUG Dabrafenib
Study Locations (11)
California
- Research Site - Los Angeles
- Research Site - San Francisco
Other
- Research Site - Villejuif
- Research Site - Naples
Arizona
- Research Site - Scottsdale
Florida
- Research Site - Miami Beach
Illinois
- Research Site - Chicago
Massachusetts
- Research Site - Boston
Missouri
- Research Site - St Louis
Ontario
- Research Site - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2013-12-20 |
| Est. Completion | 2018-04-24 |
| Phase | Phase 1 |
What the finished NCT02027961 record still lists
NCT02027961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Durvalumab is the first listed.
NCT02027961 lists 11 locations in 9 states (California, Other, Arizona).
Frequently Asked Questions
What is clinical trial NCT02027961 about?
NCT02027961 is a clinical study titled "Phase 1 Safety and Tolerability of MEDI4736 in Combination With Dabrafenib and Trametinib or With Trametinib Alone". The purpose of this study is to determine the maximum tolerated dose and characterize the safety profile of durvalumab (MEDI4736) in combination with dabrafenib and trametinib or with trametinib alone in participants with metastatic or unresectable melanoma with BRAF-mutation positive or wild-type (...
What is the current status of trial NCT02027961?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2013-12-20. Estimated completion is 2018-04-24.
What conditions does trial NCT02027961 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT02027961?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Trametinib (DRUG), Dabrafenib (DRUG).
Who is sponsoring clinical trial NCT02027961?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02027961 being conducted?
This trial has 11 study locations across Arizona, California, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02027961's enrollment target sits among peer trials
68 142nd of 266 higher than 125 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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