Melanoma Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Key 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.
Subjects must have had prior treatment (for at least 2 to 3 consecutive cycles within an 8 week period) with a PD-1 inhibitor and have confirmed disease progression (as defined by RECIST v1.1 criteria). The anti-PD-1 therapy must be the immediate prior line of therapy before enrollment and subjects with disease progression on more than 1 line of anti-PD-1 therapy are not eligible.
ECOG performance status of 0 or 1.
Adequate hematologic, renal, hepatic, and coagulation function.

Key Exclusion Criteria:

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.

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

72

Study ID:

NCT04068181

Recruitment Status:

Completed

Sponsor:

Amgen

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There are 46 Locations for this study

See Locations Near You

Sansum Clinic
Santa Barbara California, 93105, United States
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark Delaware, 19713, United States
University of Florida Health Cancer Center at Orlando Health
Orlando Florida, 32806, United States
University of Louisville James Graham Brown Cancer Center
Louisville Kentucky, 40202, United States
Allina Health Systems dba Virginia Piper Cancer Institute
Fridley Minnesota, 55432, United States
New York Oncology Hematology, PC
Albany New York, 12208, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Texas Oncology Austin Central
Austin Texas, 78731, United States
Baylor Scott and White Research Institute
Dallas Texas, 75246, United States
United States Oncology Regulatory Affairs Corporate Office
The Woodlands Texas, 77380, United States
Melanoma Institute Australia
North Sydney New South Wales, 2060, Australia
Tasman Oncology Research
Southport Queensland, 4215, Australia
The Queen Elizabeth Hospital
Woodville South South Australia, 5011, Australia
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
CHU de Quebec-Universite Laval
Quebec , G1R 2, Canada
Centre Hospitalier Universitaire de Bordeaux - Hôpital Saint André
Bordeaux , 33075, France
Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
Grenoble Cedex 9 , 38043, France
Centre Hospitalier Universitaire de Nantes, Hôpital Hôtel Dieu
Nantes Cedex 1 , 44093, France
Hopital Saint Louis
Paris , 75010, France
Centre Hospitalier Lyon Sud
Pierre Benite Cedex , 69495, France
Gustave Roussy
Villejuif , 94805, France
Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden
Dresden , 01307, Germany
Medizinische Hochschule Hannover
Hannover , 30625, Germany
Universitätsklinikum Regensburg
Regensburg , 93053, Germany
Universitätsklinikum Tübingen
Tübingen , 72076, Germany
General Hospital of Athens Laiko
Athens , 11527, Greece
University Hospital of Ioannina
Ioannina , 45500, Greece
Bioclinic of Thessaloniki
Thessaloniki , 546 2, Greece
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo , 24127, Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola FC , 47014, Italy
IRCCS Istituto Europeo di Oncologia
Milano , 20141, Italy
Nederlands Kanker Instituut, Antoni van Leeuwenhoekziekenhuis
Amsterdam , 1066 , Netherlands
Erasmus Medisch Centrum
Rotterdam , 3015 , Netherlands
Uniwersyteckie Centrum Kliniczne Centrum Medycyny Nieinwazyjnej
Gdansk , 80-21, Poland
Szpital Kliniczny im Heliodora Swiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Pozn
Poznan , 60-78, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy
Warszawa , 02-78, Poland
Hospital Clinico Universitario Virgen de la Victoria
Malaga AndalucÃ-a, 29010, Spain
Onkologikoa
San Sebastian PaÃ-s Vasco, 20014, Spain
Hospital Universitari Vall d Hebron
Barcelona , 08035, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Universitario Madrid Sanchinarro
Madrid , 28050, Spain
Guys Hospital
London , SE1 9, United Kingdom
Royal Marsden Hospital
London , SW3 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

72

Study ID:

NCT04068181

Recruitment Status:

Completed

Sponsor:


Amgen

How clear is this clinincal trial information?

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