Pembrolizumab With or Without Talimogene Laherparepvec or Talimogene Laherparepvec Placebo in Unresected Melanoma (KEYNOTE-034)

Official Title

A Phase 1b/3, Multicentre, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable Stage IIIB to IVM1c Melanoma (MASTERKEY-265/KEYNOTE-034)

Summary:

Phase 1b Subjects will be treated with talimogene laherparepvec until all injectable tumours have disappeared, disease progression per modified Immune-Related Response Criteria (irRC), or intolerance of study treatment, up to a maximum of 24 months of study treatment. Subjects will be treated with MK-3475 (pembrolizumab) until complete response (CR) disease progression per irRC, or intolerance of study treatment, up to a maximum of 24 months of study treatment. In Phase 3, Subjects will be treated with talimogene laherparepvec plus pembrolizumab(arm 1) or placebo plus pembrolizumab (arm 2) until 24 months from the date of the first dose of pembrolizumab or end of treatment due to disappearance of injectable lesions, complete response, disease progression per irRC-RECIST or intolerance of study treatment.

Trial Description

Primary Outcome:

  • Incidence of dose limiting toxicities (DLT)
  • Progression Free Survival (PFS) (response evaluation by blinded central review assessed modified RECIST 1.1)
  • Overall Survival
Secondary Outcome:
  • Incidence of adverse events (AEs)
  • Objective Response Rate (ORR)
  • Best overall response (BOR)
  • Durable response rate (DRR) defined as rate of objective responses for a duration of 6 months or longer
  • Duration of response (DOR)
  • Disease Control Rate (DCR)
  • Overall survival (OS)
  • As assessed by the QLQ-C30 subject questionnaires
  • Complete response rate (CRR)

View this trial on ClinicalTrials.gov

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Resources

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