Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).

Official Title

Phase 2 Study of Talimogene Laherparepvec in Combination With Pembrolizumab in Subjects With Unresectable/Metastatic Stage IIIB-IVM1d Melanoma Who Have Progressed on Prior Anti PD-1 Based Therapy

Summary:

This is a phase 2, open-label, single-arm, multicentre clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-PD-1 therapy in unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting. Subjects will be treated with talimogene laherparepvec and pembrolizumab until confirmed complete response, disappearance of all injectable lesions, documented confirmed disease progression per modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumours (irRC-RECIST), intolerance of study treatment, or 102 weeks from the first dose of talimogene laherparepvec and/or pembrolizumab, whichever occurs first.

Trial Description

Primary Outcome:

  • Overall response (Complete Response [CR] plus partial response [PR] by investigator assessment using modified Response Evaluation Criteria in Solid Tumour [RECIST v1.1])
Secondary Outcome:
  • Complete Response by investigator assessment using modified Response Evaluation Criteria in Solid Tumour (RECIST v1.1) and modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumours (irRC-RECIST).
  • Best Overall Response (BOR) by investigator assessment using modified Response Evaluation Criteria in Solid Tumour (RECIST v1.1) and modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumours (irRC-RECIST).
  • Durable Response by investigator assessment using modified Response Evaluation Criteria in Solid Tumour (RECIST v1.1) and modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumours (irRC-RECIST).
  • Duration Of Response (DOR) by investigator assessment using modified Response Evaluation Criteria in Solid Tumour (RECIST v1.1) and modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumours (irRC-RECIST).
  • Disease Control by investigator assessment using modified Response Evaluation Criteria in Solid Tumour (RECIST v1.1) and modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumours (irRC-RECIST).
  • Overall Response by investigator assessment using modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumours (irRC-RECIST).
  • Progression Free Survival (PFS) by investigator assessment using modified Response Evaluation Criteria in Solid Tumour (RECIST) v1.1 and modified immune-related Response Criteria simulating Response evaluation criteria in Solid Tumours (irRC-RECIST).
  • Overall Survival (OS)
  • Incidence of treatment-emergent adverse events.
  • Incidence of treatment related adverse events.
  • Incidence of abnormal laboratory tests.
  • Time to subsequent anti-cancer therapy.

View this trial on ClinicalTrials.gov

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Resources

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