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).
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 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.
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There are 46 Locations for this study
Santa Barbara California, 93105, United States
Newark Delaware, 19713, United States
Orlando Florida, 32806, United States
Louisville Kentucky, 40202, United States
Fridley Minnesota, 55432, United States
Albany New York, 12208, United States
Cleveland Ohio, 44195, United States
Austin Texas, 78731, United States
Dallas Texas, 75246, United States
The Woodlands Texas, 77380, United States
North Sydney New South Wales, 2060, Australia
Southport Queensland, 4215, Australia
Woodville South South Australia, 5011, Australia
Melbourne Victoria, 3000, Australia
Melbourne Victoria, 3004, Australia
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H3T 1, Canada
Quebec , G1R 2, Canada
Bordeaux , 33075, France
Grenoble Cedex 9 , 38043, France
Nantes Cedex 1 , 44093, France
Paris , 75010, France
Pierre Benite Cedex , 69495, France
Villejuif , 94805, France
Dresden , 01307, Germany
Hannover , 30625, Germany
Regensburg , 93053, Germany
TÃ¼bingen , 72076, Germany
Athens , 11527, Greece
Ioannina , 45500, Greece
Thessaloniki , 546 2, Greece
Bergamo , 24127, Italy
Meldola FC , 47014, Italy
Milano , 20141, Italy
Amsterdam , 1066 , Netherlands
Rotterdam , 3015 , Netherlands
Gdansk , 80-21, Poland
Poznan , 60-78, Poland
Warszawa , 02-78, Poland
Malaga AndalucÃ-a, 29010, Spain
San Sebastian PaÃ-s Vasco, 20014, Spain
Barcelona , 08035, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
London , SE1 9, United Kingdom
London , SW3 6, United Kingdom
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