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Phase 1 Safety and Tolerability of MEDI4736 in Combination With Dabrafenib and Trametinib or With Trametinib Alone
NCT02027961 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02027961
The ClinicalTrials.gov registry entry for NCT02027961 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MedImmune, which has 55 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02027961 reports 11 study locations spanning 9 distinct geographic areas — top geographies include California, Other, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02027961?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Trametinib (DRUG), Dabrafenib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02027961?
This trial is sponsored by MedImmune, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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