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NCT02263508 · ClinicalTrials.gov registry record · Phase 3
Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma
A Phase 3 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 713
- Enrollment target
NCT02263508 is a Phase 3 study that was terminated before completion, run by Amgen. The registered enrollment target is 713 participants.
The verdict
NCT02263508, a Phase 3 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 713 participants
- Enrollment target
Study Summary
The primary objectives of the Phase 1b part of the study are to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with previously untreated, unresectable, stage IIIB to IVM1c melanoma. The primary objective of Phase 3 are to evaluate the efficacy of talimogene laherparepvec with pembrolizumab versus placebo with pembrolizumab, as assessed by progression-free survival (PFS) (response evaluation by blinded independent central review using modified Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) and overall survival (OS).
Interventions
- DRUG Pembrolizumab
- DRUG Placebo
- DRUG Talimogene Laherparepvec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 713 participants |
| Start Date | 2014-12-08 |
| Est. Completion | 2021-03-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02263508
The ClinicalTrials.gov registry entry for NCT02263508 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 713 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT02263508 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02263508 about?
NCT02263508 is a clinical study titled "Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma". The primary objectives of the Phase 1b part of the study are to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with previously untreated, unresectable, stage IIIB to IVM1c melanoma. The primary o...
What is the current status of trial NCT02263508?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 713 participants. The study started on 2014-12-08. Estimated completion is 2021-03-11.
What interventions are being tested in trial NCT02263508?
The interventions under investigation include: Pembrolizumab (DRUG), Placebo (DRUG), Talimogene Laherparepvec (DRUG).
Who is sponsoring clinical trial NCT02263508?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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