Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Melanoma

In brief

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).

Key facts

Study ID
NCT02263508
Run by
Amgen
People needed
713
Starts
2014-12-08
Expected to finish
2021-03-11
Last updated by the study team
2022-11-14

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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