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

COMPLETEDPHASE2

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

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

NCT04068181•Amgen

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years with histologically confirmed diagnosis of stage IIIB to IVM1d melanoma and for whom surgery is not recommended. Subjects with stage IVM1d disease may be enrolled with up to 3 cerebral metastases, provided that all lesions have been adequately treated with stereotactic radiation therapy, craniotomy, or gamma knife therapy, with no evidence of progression and not requiring steroids for at least 2 months prior to enrollment.
•Subjects must have measurable disease and be a candidate for intralesional therapy administration into cutaneous, subcutaneous, or nodal lesions.

Exclusion Criteria

•ECOG performance status of 0 or 1.
•Adequate hematologic, renal, hepatic, and coagulation function.
•Subjects considered by the investigator to have rapid clinical progression due to melanoma
•Subjects with prior treatment and disease progression on more than 1 line of anti-PD-1 therapy
•Stage IVM1d subjects must not have greater than 3 cerebral melanoma metastases, or clinically active cerebral melanoma metastases requiring therapy, and/or carcinomatous meningitis regardless of clinical stability.
•Primary uveal or mucosal melanoma, history or evidence of melanoma associated with immunodeficiency states or history of other malignancy within the past 3 years.
•Subjects must not have history or evidence of symptomatic autoimmune glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, or active autoimmune disease or syndrome requiring systemic treatment in the past 2 years (ie, with use of disease modifying agents, steroids or immunosuppressive agents) except vitiligo or resolved childhood asthma/atopy, or evidence of clinically significant immunosuppression.
•Subjects may not have been previously treated with talimogene laherparepvec or any other oncolytic virus.
•Subjects must not have active herpetic skin lesions or prior complications of herpetic infection and must not require intermittent or chronic treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use.

Locations (46)

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

Key Dates

Start Date

January 22, 2020

Primary Completion Date

August 19, 2021

Completion Date

February 26, 2024

Last Updated

January 7, 2025

Enrollment

ACTUAL participants

Conditions

Melanoma

Interventions

Talimogene laherparepvec

DRUG

Pembrolizumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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