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NCT02818023 · ClinicalTrials.gov registry record · Phase 1
Dose-seeking Study of Pembrolizumab Plus Vemurafenib and Cobimetinib Advanced Melanoma
A Phase 1 study, sponsored by Yana Najjar.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT02818023 is a Phase 1 study that was terminated before completion, run by Yana Najjar. The registered enrollment target is 9 participants.
The verdict
NCT02818023, a Phase 1 study, was terminated before completion, sponsored by Yana Najjar.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
The study plans to treat patients with pembrolizumab and thus blocking the PD-1/PD-L1 axis would render tumor-infiltrating lymphocytes (TILs) in the tumor parenchyma more functional as a consequence of BRAF inhibition, such that T cell activation by BRAFi would not be dampened by the PD-1/PD-L1 interaction. This combination would reverse dysfunction among T cells in the tumor parenchyma, maximizing T cell mediated immune anti-tumor efficacy. Progression free survival (PFS) with pembrolizumab in KEYNOTE-001 was 57% at 6 months, and 46.4% in the more recently reported phase III trial. PFS with vemurafenib treatment in BRIM-3 was \~50% at 6 months. Combined treatment with pembrolizumab, cobimetinib and vemurafenib for BRAF mutant melanoma is hypothesized to be safe and to improve the PFS compared to these recent historical controls. Because this combination has not yet been tested, and because the primary objective is to assess safety, the investigators are staging accrual in the first phase of the trial. The study aims to accrue up to 30 patients to the mTPI design of this study with the expectation that there will be at least 30 patients treated at RP2D. In case there are less than 30 patients on the RP2D, additional patients will be accrued. Patients will continue to receive treatment with pembrolizumab, vemurafenib and cobimetinib until disease progression or dose limiting toxicity. Patients with treatment response and no dose limiting toxicity may receive treatment with pembrolizumab for up to 24 months.
Interventions
- DRUG Pembrolizumab
- DRUG Vemurafenib
- DRUG Cobimetinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2016-07-13 |
| Est. Completion | 2021-04-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02818023
The ClinicalTrials.gov registry entry for NCT02818023 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yana Najjar, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT02818023 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02818023 about?
NCT02818023 is a clinical study titled "Dose-seeking Study of Pembrolizumab Plus Vemurafenib and Cobimetinib Advanced Melanoma". The study plans to treat patients with pembrolizumab and thus blocking the PD-1/PD-L1 axis would render tumor-infiltrating lymphocytes (TILs) in the tumor parenchyma more functional as a consequence of BRAF inhibition, such that T cell activation by BRAFi would not be dampened by the PD-1/PD-L1 inte...
What is the current status of trial NCT02818023?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2016-07-13. Estimated completion is 2021-04-23.
What interventions are being tested in trial NCT02818023?
The interventions under investigation include: Pembrolizumab (DRUG), Vemurafenib (DRUG), Cobimetinib (DRUG).
Who is sponsoring clinical trial NCT02818023?
This trial is sponsored by Yana Najjar, which has 8 total clinical trials registered on ClinicalTrials.gov.
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