Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Melanoma

PHASE2CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

February 3, 2015

Primary Completion Date

April 30, 2019

Study Completion Date

April 28, 2022

Conditions
Completely Resectable Stage IIIB, IIIC, or IVM1a Melanoma
Interventions
DRUG

Talimogene Laherparepvec

Talimogene laherparepvec will be administered by intralesional injection into the injectable cutaneous, subcutaneous, and nodal tumors initially at a dose of 10\^6 plaque forming units (PFU)/mL at day 1 of week 1 followed by a dose of 10\^8 PFU/mL at day 1 (±3 days) of week 4, 6, 8, 10 and 12 or until all injectable tumors have disappeared, or intolerance of study treatment or in the opinion of the investigator, immediate surgical resection or any other treatment for melanoma is warranted, whichever occurs first.

PROCEDURE

Immediate surgical resection of melanoma lesion(s)

Surgical resection of melanoma tumor lesion(s) will be performed after randomization any time during weeks 1 to 6.

Trial Locations (46)

2060

Research Site, North Sydney

3084

Research Site, Heidelberg

5011

Research Site, Woodville South

7000

Research Site, Chur

8091

Research Site, Zurich

10029

Research Site, New York

10032

Research Site, New York

11527

Research Site, Athens

13385

Research Site, Marseille

19107

Research Site, Philadelphia

21034

Research Site, Dijon

27599

Research Site, Chapel Hill

28009

Research Site, Madrid

29010

Research Site, Málaga

31008

Research Site, Pamplona

31059

Research Site, Toulouse

32117

Research Site, Daytona Beach

32610

Research Site, Gainesville

33612

Research Site, Tampa

35249

Research Site, Birmingham

38163

Research Site, Memphis

40202

Research Site, Louisville

43210

Research Site, Columbus

68130

Research Site, Omaha

69495

Research Site, Pierre-Bénite

71110

Research Site, Heraklion - Crete

75010

Research Site, Paris

75230

Research Site, Dallas

75390

Research Site, Dallas

77030

Research Site, Houston

84112

Research Site, Salt Lake City

90404

Research Site, Santa Monica

91010

Research Site, Duarte

92868

Research Site, Orange

94115

Research Site, San Francisco

115478

Research Site, Moscow

197022

Research Site, Saint Petersburg

197758

Research Site, Saint Petersburg

01655

Research Site, Worcester

08903

Research Site, New Brunswick

88034-000

Research Site, Florianópolis

14784-400

Research Site, Barretos

20220-410

Research Site, Rio de Janeiro

60-856

Research Site, Poznan

02-781

Research Site, Warsaw

50-368

Research Site, Wroclaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY