Melanoma Clinical Trial
Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma
Summary
The primary objectives of the Phase 1b part of the study are to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with previously untreated, unresectable, stage IIIB to IVM1c melanoma.
The primary objective of Phase 3 are to evaluate the efficacy of talimogene laherparepvec with pembrolizumab versus placebo with pembrolizumab, as assessed by progression-free survival (PFS) (response evaluation by blinded independent central review using modified Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and overall survival (OS).
Eligibility Criteria
Key Inclusion Criteria:
Age ≥ 18 years with histologically confirmed diagnosis of melanoma and stage IIIB to IVM1c for whom surgery is not recommended.
Subjects must have measurable disease and be a candidate for intralesional therapy administration into cutaneous, subcutaneous, or nodal lesions.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate hematologic, hepatic, renal, and coagulation function.
Subjects with serine/threonine protein kinase B-Raf V600 (BRAFV600) wild-type tumors must not have received any prior systemic anticancer treatment consisting of chemotherapy, immunotherapy, or targeted therapy given in a non-adjuvant setting for unresectable stage IIIB to IVM1c melanoma.
Subjects with B-Raf V600 (BRAFV600) mutated tumors who have received prior BRAF inhibitor therapy either alone or in combination with mitogen-activated protein kinase kinase (MEK) inhibitor as their only prior systemic therapy are eligible.
Subjects who received prior adjuvant therapy for melanoma will not be excluded (including, but not limited to, interferon, ipilimumab, limb infusion/perfusion, or use of investigational agents in the adjuvant setting) with the exception that prior adjuvant therapy with inhibitors of programmed cell death-1 (PD-1) or programmed cell death ligand 1 (PD-L1) is not allowed. However, if the subject received adjuvant therapy, the subject must have completed therapy at least 28 days prior to enrollment.
Subjects must have a tumor sample that is adequate for PD-L1 assessment prior to randomization.
Key Exclusion Criteria:
Subjects must not have clinically active cerebral metastases.
Subjects must not have 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 may not have been previously treated with talimogene laherparepvec, any other oncolytic virus, pembrolizumab, or any other inhibitor of PD-1, PD-L1, or PD-L2.
Subjects must not have history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, other symptomatic autoimmune disease, documented history of 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 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 161 Locations for this study
Birmingham Alabama, 35243, United States
Mobile Alabama, 36608, United States
Beverly Hills California, 90211, United States
Duarte California, 91010, United States
Encinitas California, 92024, United States
La Jolla California, 92037, United States
Los Angeles California, 90024, United States
Los Angeles California, 90025, United States
Riverside California, 92505, United States
San Francisco California, 94115, United States
San Francisco California, 94117, United States
Santa Monica California, 90404, United States
Miami Beach Florida, 33140, United States
Miami Florida, 33136, United States
Orlando Florida, 32806, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21237, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Fridley Minnesota, 55432, United States
Saint Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
Buffalo New York, 14263, United States
New York New York, 10016, United States
New York New York, 10032, United States
New York New York, 10065, United States
Cincinnati Ohio, 45209, United States
Cleveland Ohio, 44195, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15232, United States
Germantown Tennessee, 38138, United States
Knoxville Tennessee, 37920, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75246, United States
Murray Utah, 84107, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98109, United States
North Sydney New South Wales, 2060, Australia
Waratah New South Wales, 2298, Australia
Wollongong New South Wales, 2500, Australia
Southport Queensland, 4215, Australia
Woolloongabba Queensland, 4102, Australia
Woodville South South Australia, 5011, Australia
Geelong Victoria, 3220, Australia
Heidelberg Victoria, 3084, Australia
Melbourne Victoria, 3000, Australia
Prahran Victoria, 3181, Australia
Murdoch Western Australia, 6150, Australia
Graz , 8036, Austria
Innsbruck , 6020, Austria
Salzburg , 5020, Austria
Wien , 1090, Austria
Bruxelles , 1200, Belgium
Liege , 4000, Belgium
Edmonton Alberta, T6G 1, Canada
Kingston Ontario, K7L 2, Canada
London Ontario, N6A 4, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H3T 1, Canada
Quebec , G1R 2, Canada
Brno , 656 5, Czechia
Olomouc , 775 2, Czechia
Ostrava-Poruba , 708 5, Czechia
Praha 10 , 100 3, Czechia
Praha 2 , 128 0, Czechia
Praha 8 , 180 8, Czechia
Helsinki , 00290, Finland
Bordeaux Cedex , 33075, France
Grenoble Cedex 9 , 38043, France
Lille , 59037, France
Lyon cedex 08 , 69373, France
Marseille cedex 05 , 13385, France
Nantes Cedex 1 , 44093, France
Paris , 75010, France
Pierre Benite Cedex , 69495, France
Toulouse cedex 9 , 31059, France
Vandoeuvre les Nancy , 54511, France
Berlin , 10117, Germany
Dresden , 01307, Germany
Erlangen , 91054, Germany
Essen , 45147, Germany
Hannover , 30625, Germany
Heidelberg , 69120, Germany
Kiel , 24105, Germany
Leipzig , 04103, Germany
Mainz , 55131, Germany
Mannheim , 68167, Germany
München , 80337, Germany
Regensburg , 93053, Germany
Tübingen , 72076, Germany
Würzburg , 97080, Germany
Athens , 11527, Greece
Athens , 18547, Greece
Heraklion - Crete , 71110, Greece
Ioannina , 45500, Greece
Thessaloniki , 54622, Greece
Budapest , 1122, Hungary
Pecs , 7632, Hungary
Szeged , 6720, Hungary
Bergamo , 24127, Italy
Brescia , 25123, Italy
Meldola FC , 47014, Italy
Milano , 20133, Italy
Milano , 20141, Italy
Siena , 53100, Italy
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Amsterdam , 1066 , Netherlands
Amsterdam , 1081 , Netherlands
Groningen , 9713 , Netherlands
Nijmegen , 6525 , Netherlands
Bielsko-Biala , 43-30, Poland
Bydgoszcz , 85-79, Poland
Gdansk , 80-95, Poland
Konin , 62-50, Poland
Krakow , 31-50, Poland
Poznan , 60-84, Poland
Poznan , 61-86, Poland
Szczecin , 71-73, Poland
Warszawa , 02-78, Poland
Wroclaw , 50-36, Poland
Almada , 2801-, Portugal
Lisboa , 1099-, Portugal
Lisboa , 1649-, Portugal
Porto , 4200-, Portugal
Moscow , 11547, Russian Federation
Saint-Petersburg , 19775, Russian Federation
Groenkloof Gauteng, 0181, South Africa
Johannesburg Gauteng, 2196, South Africa
Parktown Gauteng, 2193, South Africa
Kraaifontein , 7570, South Africa
Pretoria , 0002, South Africa
Pretoria , 0081, South Africa
Badalona Cataluña, 08916, Spain
Barcelona Cataluña, 08036, Spain
Valencia Comunidad Valenciana, 46014, Spain
Pamplona Navarra, 31008, Spain
San Sebastian PaÃs Vasco, 20014, Spain
Madrid , 28009, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Bellinzona , 6500, Switzerland
Bern , 3010, Switzerland
Geneva 14 , 1211, Switzerland
Lausanne , 1011, Switzerland
Zürich , 8091, Switzerland
Birmingham , B15 2, United Kingdom
Guildford , GU2 7, United Kingdom
Leeds , LS9 7, United Kingdom
Leicester , LE1 5, United Kingdom
London , SE1 9, United Kingdom
London , SW3 6, United Kingdom
Manchester , M20 4, United Kingdom
Oxford , OX3 7, United Kingdom
Preston , PR2 9, United Kingdom
Southampton , SO16 , United Kingdom
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