Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).
Completed · Phase 2
Conditions studied: Melanoma
In brief
This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-programmed cell death protein (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 Tumors (irRC-RECIST), intolerance of study treatment, or 102 weeks from the first dose of talimogene laherparepvec and/or pembrolizumab, whichever occurs first.
Key facts
- Study ID
- NCT04068181
- Run by
- Amgen
- People needed
- 72
- Starts
- 2020-01-22
- Expected to finish
- 2024-02-26
- Last updated by the study team
- 2025-01-07
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Sansum Clinic — Santa Barbara, California, United States
- Medical Oncology Hematology Consultants Helen F Graham Cancer Center — Newark, Delaware, United States
- University of Florida Health Cancer Center at Orlando Health — Orlando, Florida, United States
- University of Louisville James Graham Brown Cancer Center — Louisville, Kentucky, United States
- Allina Health Systems dba Virginia Piper Cancer Institute — Fridley, Minnesota, United States
- New York Oncology Hematology, PC — Albany, New York, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Texas Oncology Austin Central — Austin, Texas, United States
- Baylor Scott and White Research Institute — Dallas, Texas, United States
- United States Oncology Regulatory Affairs Corporate Office — The Woodlands, Texas, United States
- Melanoma Institute Australia — North Sydney, New South Wales, Australia
- Tasman Oncology Research — Southport, Queensland, Australia
- The Queen Elizabeth Hospital — Woodville South, South Australia, Australia
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
- The Alfred Hospital — Melbourne, Victoria, Australia
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada
- Jewish General Hospital — Montreal, Quebec, Canada
- CHU de Quebec-Universite Laval — Québec, Quebec, Canada
- Centre Hospitalier Universitaire de Bordeaux - Hôpital Saint André — Bordeaux, France
- Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon — Grenoble, France
- Centre Hospitalier Universitaire de Nantes, Hôpital Hôtel Dieu — Nantes, France
- Hopital Saint Louis — Paris, France
- Centre Hospitalier Lyon Sud — Pierre-Bénite, France
- Gustave Roussy — Villejuif, France
- Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden — Dresden, Germany
Full record on ClinicalTrials.gov
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