Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 3 study, sponsored by Amgen.
NCT02263508 is a Phase 3 study that was terminated before completion, run by Amgen. The registered enrollment target is 713 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
A DLT was defined as any toxicity related to study drug which met any of the following criteria based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0: * Grade 4 non-hematologic toxicity. * Grade 3 or higher pneumonitis. * Grade 3 non-hematologic toxicity lasting \> 3 days despite optimal supportive care, excluding grade 3 fatigue. * Any grade 3 or higher non-hematologic laboratory value if medical intervention was required, or the abnormality lead to hospitalization, or th
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 |
Why NCT02263508 stopped before completion
NCT02263508 is an interventional study that assigns participants to a tested intervention. The registered 713 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT02263508 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02263508's enrollment target sits among peer trials
713 499th of 2000 higher than 1,502 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05208762 · 714 participants · Phase 1
A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
- NCT06758401 · 714 participants · Phase 3
This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.
- NCT04680000 · 716 participants · NA
Chronic Pain Management In Primary Care Using Behavioral Health Consultants
- NCT06179160 · 710 participants · Phase 1
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI