Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.

PHASE3RecruitingINTERVENTIONAL
Enrollment

670

Participants

Timeline

Start Date

March 30, 2023

Primary Completion Date

March 1, 2028

Study Completion Date

March 1, 2030

Conditions
Metastatic MelanomaUnresectable MelanomaMelanoma
Interventions
BIOLOGICAL

Lifileucel plus Pembrolizumab

A tumor sample is resected from each patient for Lifileucel manufacturing. Patients then receive Pembrolizumab followed by the lifileucel regimen which consists of non-myeloablative lymphodepletion, lifileucel infusion followed by IL-2. Patients will then continue to receive Pembrolizumab every 6 weeks until disease progression.

BIOLOGICAL

Pembrolizumab with Optional Crossover Period

"Patient will receive Pembrolizumab monotherapy every 6 weeks until disease progression. Upon verified confirmed disease progression by the blinded independent review central committee, patients may proceed to lifileucel monotherapy during an optional crossover period if they meet eligibility criteria.~Optional crossover: A tumor sample is resected from each patient for Lifileucel manufacturing. Patients then receive the lifileucel regimen which consists of non-myeloablative lymphodepletion, lifileucel infusion followed by IL-2."

Trial Locations (72)

1011

RECRUITING

Centre Hospitalier Universitaire Vaudois Lausanne, Lausanne

1307

RECRUITING

Universitätsklinikum Carl Gustav Carus, Dresden

3000

RECRUITING

Peter MacCallum Cancer Centre, Melbourne

3080

RECRUITING

Seoul National University Hospital, Seoul

3722

RECRUITING

Severance Hospital, Yonsei University Health System, Seoul

4120

RECRUITING

Greenslopes Private Hospital, Greenslopes

5042

RECRUITING

Flinders Medical Centre, Bedford Park

6150

RECRUITING

Fiona Stanley Hospital, Murdoch

8036

RECRUITING

Hospital Clinic de Barcelona, Barcelona

8908

RECRUITING

ICO l'Hospitalet - Hospital Duran i Reynals, Barcelona

13009

RECRUITING

Institut Paoli Calmettes, Marseille

15224

RECRUITING

Allegheny Health Network, Pittsburgh

18045

RECRUITING

St. Luke's Cancer Center - Anderson, Easton

20139

RECRUITING

Istituto Europeo Di Oncologia, Milan

20251

RECRUITING

Universitätsklinikum Hamburg-Eppendorf, Hamburg

20814

RECRUITING

National Cancer Institute, Bethesda

23298

RECRUITING

Virginia Commonwealth University, Richmond

23562

RECRUITING

Universitätsklinikum Schleswig-Holstein - Campus Lübeck, Lübeck

28007

RECRUITING

Hospital General Universitario Gregorio Maranon, Madrid

28041

RECRUITING

Hospital 12 de Octubre, Madrid

28050

RECRUITING

Hospital Universitario Madrid Sanchinarro - CIOCC, Madrid

28223

RECRUITING

Hospital Universitario Quirónsalud Madrid, Madrid

29016

RECRUITING

Hospital Regional Universitario de Malaga - Hospital General, Málaga

31008

RECRUITING

Clínica Universitaria de Navarra, Pamplona

32806

RECRUITING

Orlando Health Cancer Institute, Orlando

33081

RECRUITING

Centro di Riferimento Oncologico IRCCS, Aviano

35233

RECRUITING

University of Alabama at Birmingham: The Kirklin Clinic, Birmingham

37203

RECRUITING

SCRI Oncology Partners, Nashville

37920

RECRUITING

Baptist Cancer Center, Bartlett

39008

RECRUITING

Hospital Universitario Marques de Valdecilla, Santander

40202

RECRUITING

University of Louisville - James Graham Brown Cancer Center, Louisville

41009

RECRUITING

Hospital Universitario Virgen Macarena, Seville

43201

RECRUITING

Ohio State University, Columbus

44093

RECRUITING

Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu, Nantes

45226

RECRUITING

Oncology Hematology Care, Cincinnati

46014

RECRUITING

Consorcio Hospital General Universitario de Valencia, Valencia

47014

RECRUITING

Istituto Romagnolo per lo Studio dei Tumori, Meldola

48201

RECRUITING

Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center, Detroit

48202

RECRUITING

Henry Ford Health, Detroit

52621

RECRUITING

Sheba Medical Center, Ramat Gan

56100

RECRUITING

Azienda Ospedaliero Universitaria Pisana, Pisa

60612

RECRUITING

University of Illinois Hospital & Health Sciences System, Chicago

66205

RECRUITING

University of Kansas, Kansas City

75475

RECRUITING

Hopital Saint Louis, Paris

80045

RECRUITING

University of Colorado Cancer Center, Aurora

80131

RECRUITING

Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale, Napoli

81675

RECRUITING

Klinikum Rechts der Isar der Technischen Universität München, Munich

90007

RECRUITING

USC Norris Comprehensive Cancer Center, Los Angeles

91010

RECRUITING

City of Hope, Duarte

94107

RECRUITING

California Pacific Medical Center, San Francisco

98026

RECRUITING

Swedish Cancer Institute, Edmonds

6423906

RECRUITING

Tel Aviv Sourasky Medical Center, Tel Aviv

03756

RECRUITING

Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center, Lebanon

08103

RECRUITING

MD Anderson Cancer Center at Cooper, Camden

NSW 2145

RECRUITING

Westmead Hospital, Westmead

Unknown

RECRUITING

Universitair Ziekenhuis Brussel - Oncologisch Centrum, Jette

RECRUITING

Hadassah Medical Center, Jerusalem

RECRUITING

Azienda Ospedaliera Universitaria Senese, Siena

RECRUITING

Bundang Medical Center - CHA University, Seongnam-si

RECRUITING

Hospital Universitario Ramon y Cajal, Madrid

H2L 4M1

RECRUITING

Centre hospitalier de l'Université de Montréal, Montreal

M5G

RECRUITING

Princess Margaret Cancer Centre, Toronto

1066 CX

RECRUITING

Nederlands Kanker Instituut, Amsterdam

08028

RECRUITING

Instituto Oncologico Rosell, Barcelona

08035

RECRUITING

Hospital Universitari Vall dHebron, Barcelona

SE-41346

RECRUITING

Sahlgrenska Universitetssjukhuset, Gothenburg

B15 2GW

RECRUITING

Queen Elizabeth Hospital Birmingham, Birmingham

NE7 7DN

RECRUITING

Freeman Hospital, Newcastle upon Tyne

SW3 6JJ

RECRUITING

Royal Marsden Hospital, Chelsea

G120YN

RECRUITING

Beaston West of Scotland Canter Centre, Glasgow

SE1 9RT

RECRUITING

Guy's Hospital, London

W1G 6AD

RECRUITING

Sarah Cannon Research Institute UK, London

Sponsors
All Listed Sponsors
lead

Iovance Biotherapeutics, Inc.

INDUSTRY

NCT05727904 - Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma. | Biotech Hunter | Biotech Hunter