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NCT05727904 | RECRUITING | Metastatic Melanoma

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

Iovance Biotherapeutics, Inc.

Brief Summary:

This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. Participants randomized to the pembrolizumab monotherapy arm who subsequently have a blinded independent central review- verified confirmed progressive disease (PD) will be offered lifileucel monotherapy in an optional crossover period.

Condition or disease

Metastatic Melanoma

Unresectable Melanoma

Melanoma

Intervention/treatment

Lifileucel plus Pembrolizumab

Pembrolizumab with Optional Crossover Period

Phase

PHASE3

Detailed Description:

The study will enroll participants with unresectable or metastatic melanoma (Stage IIIC, IIID, or IV per the American Joint Committee on Cancer \[AJCC\] staging system) who have had no prior therapy for metastatic disease. Previous adjuvant/neoadjuvant therapy with a single line of protooncogene B-Raf (BRAF) inhibitor with or without a mitogen-activated protein kinase (MEK) inhibitor, PD-1 inhibitor, or cytotoxic T-lymphocyte-associated antigen-4 \[CTLA-4\] inhibitor is allowed, provided such treatment was completed ≥6 months before progression to metastatic disease.

Study Type : INTERVENTIONAL
Estimated Enrollment : 670 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 3, Multicenter, Randomized, Open-label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination With Pembrolizumab Compared With Pembrolizumab Monotherapy in Participants With Untreated, Unresectable or Metastatic Melanoma
Actual Study Start Date : 2023-03-30
Estimated Primary Completion Date : 2028-03-01
Estimated Study Completion Date : 2030-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
  • 2. In the investigator's assessment, the participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of \> 6 months.
  • 3. Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
  • 4. Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.
  • 5. Participants must have adequate organ function.
  • 6. Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
  • 7. Participants who are \> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
Exclusion Criteria
  • 1. Participant has melanoma of uveal/ocular origin.
  • 2. Participant has symptomatic untreated brain metastases.
  • 3. Participant received more than 1 prior line of therapy.
  • 4. Participant received prior therapy for metastatic disease
  • 5. Participants with a BRAF V600 mutation-positive tumor received prior adjuvant/neoadjuvant ICI therapy only
  • 6. Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation, such as systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
  • 7. Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
  • 8. Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or were curatively treated \>1 year ago, and in the judgment of the investigator do not pose a significant risk of recurrence.)
  • 9. Participant has a history of allogeneic cell or organ transplant.
  • Other protocol defined inclusion/exclusion criteria could apply.
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.

Location Details

NCT05727904

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

University of Alabama at Birmingham: The Kirklin Clinic

Birmingham, Albama, United States, 35233

RECRUITING

United States, California

City of Hope

Duarte, California, United States, 91010

RECRUITING

United States, California

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90007

RECRUITING

United States, California

California Pacific Medical Center

San Francisco, California, United States, 94107

RECRUITING

United States, Colorado

University of Colorado Cancer Center

Aurora, Colorado, United States, 80045

RECRUITING

United States, Florida

Orlando Health Cancer Institute

Orlando, Florida, United States, 32806

RECRUITING

United States, Illinois

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, United States, 60612

RECRUITING

United States, Kansas

University of Kansas

Kansas City, Kansas, United States, 66205

RECRUITING

United States, Kentucky

University of Louisville - James Graham Brown Cancer Center

Louisville, Kentucky, United States, 40202

RECRUITING

United States, Maryland

National Cancer Institute

Bethesda, Maryland, United States, 20814

RECRUITING

United States, Road cancer

Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center

Detroit, Road cancer, United States, 48201

RECRUITING

United States, Road cancer

Henry Ford Health

Detroit, Road cancer, United States, 48202

RECRUITING

United States, New Hampshire

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

Lebanon, New Hampshire, United States, 03756

RECRUITING

United States, New Jersey

MD Anderson Cancer Center at Cooper

Cam, New Jersey, United States, 08103

RECRUITING

United States, Ohio

Oncology Hematology Care

Cincinnati, Ohio, United States, 45226

RECRUITING

United States, Ohio

Ohio State University

Columbus, Ohio, United States, 43201

RECRUITING

United States, Pennsylvania

St. Luke's Cancer Center - Anderson

Easton, Pennsylvania, United States, 18045

RECRUITING

United States, Pennsylvania

Allegheny Health Network

Pittsburgh, Pennsylvania, United States, 15224

RECRUITING

United States, Tennessee

Baptist Cancer Center

Bartlett, Tennessee, United States, 37920

RECRUITING

United States, Tennessee

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22908

RECRUITING

United States, Virginia

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

RECRUITING

United States, Washington

Swedish Cancer Institute

Edmonds, Washington, United States, 98026

RECRUITING

Australia, Queensland

Greenslopes Private Hospital

Greenslopes, Queensland, Australia, 4120

RECRUITING

Australia, Victoria

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia, 3000

RECRUITING

Australia, Western Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia, 6150

RECRUITING

Australia,

Westmead Hospital

Westmead, Australia, NSW 2145

RECRUITING

Belgium,

University Hospital Brussels - Oncological Center

Throw, Belgium,

RECRUITING

Canada, Quebec

University of Montreal hospital center

Montréal, Quebec, Canada, H2L 4

RECRUITING

Canada,

Princess Margaret Cancer Centre

Toronto, Canada, M5g

RECRUITING

France,

Institut Paoli CALMETTES

Marseille, France, 13009

RECRUITING

France,

Nantes University Hospital Center (Nantes CHU) - Hotel -Dieu

Nantes, France, 44093

RECRUITING

France,

Saint Louis hospital

Paris, France, 75475

RECRUITING

Germany,

University Hospital Hamburg-Eppendorf

Hamburg, Germany, 20251

RECRUITING

Germany,

University Hospital Schleswig -Holstein - Lübeck campus

Lübeck, Germany, 23562

RECRUITING

Germany,

Clinic on the right of the Isar of the Technical University of Munich

Munich, Germany, 81675

RECRUITING

Israel,

Hadassah Medical Center

Jerusalem, Israel,

RECRUITING

Israel,

Sheba Medical Center

Ramat Gain, Israel, 52621

RECRUITING

Israel,

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 6423906

RECRUITING

Italy, Forlì-Cesena

Romagna Institute for the study of tumors

Meldola, Forlì-Cesena, Italy, 47014

RECRUITING

Italy, Friuli-Venezia Giulia

IRCCS Oncological Reference Center

Avian, Friuli-Venezia Giulia, Italy, 33081

RECRUITING

Italy, Tuscany

Pisan University Hospital

Pisa, Tuscany, Italy, 56100

RECRUITING

Italy,

European Institute of Oncology

Milan, Italy, 20139

RECRUITING

Italy,

National Institute for the study and treatment of tumors Giovanni Pascale Foundation

Napoli, Italy, 80131

RECRUITING

Italy,

Sienese University Hospital

Siena, Italy,

RECRUITING

Korea, Republic of, Ravy

Bundang Medical Center - CHA University

Seongnam-shi, Gyeongggi-do, Korea, Republic of,

RECRUITING

Korea, Republic of,

Seoul National University Hospital

Seoul, Korea, Republic of, 3080

RECRUITING

Korea, Republic of,

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 3722

RECRUITING

Netherlands,

Dutch Cancer Institute

Amsterdam, Netherlands, 1066 CX

RECRUITING

Spain, Sabbath

Marques de Valdecilla University Hospital

Santander, Cantabria, Spain, 39008

RECRUITING

Spain, Málaga

Regional University Hospital of Malaga - General Hospital

Malaga, Málaga, Spain, 29016

RECRUITING

Spain,

Rosell Oncological Institute

Barcelona, Spain, 08028

RECRUITING

Spain,

Vall d'Hebron University Hospital

Barcelona, Spain, 08035

RECRUITING

Spain,

Clinic Hospital in Barcelona

Barcelona, Spain, 8036

RECRUITING

Spain,

ICO L'Hospitalet - Hospital Duran i Reynals

Barcelona, Spain, 8908

RECRUITING

Spain,

Gregorio Maranon University General Hospital

Madrid, Spain, 28007

RECRUITING

Spain,

October 12 hospital

Madrid, Spain, 28041

RECRUITING

Spain,

MADRID SANCHINARRO - CIOCC UNIVERSITY HOSPITAL

Madrid, Spain, 28050

RECRUITING

Spain,

Quirónsalud Madrid University Hospital

Madrid, Spain, 28223

RECRUITING

Spain,

Ramon and Cajal University Hospital

Madrid, Spain,

RECRUITING

Spain,

Navarra University Clinic

Pamplona, Spain, 31008

RECRUITING

Spain,

Virgen Macarena University Hospital

Sevilla, Spain, 41009

RECRUITING

Spain,

Consortium General University Hospital of Valencia

Valencia, Spain, 46014

RECRUITING

Sweden, Clothing gotlands lan

Sahlgrenska University Hospital

Gothenburg, Clothing Gottlands Lan, Sweden, SE-41346

RECRUITING

Switzerland,

Vaudois University Hospital Center Lausanne

Lausanne, Switzerland, 1011

RECRUITING

United Kingdom, England

Queen Elizabeth Hospital Birmingham

Birmingham, England, United Kingdom, B15 2GW

RECRUITING

United Kingdom, England

Freeman Hospital

Newcastle upon Tyne, England, United Kingdom, Nan bosom

RECRUITING

United Kingdom, London

Royal Marsden Hospital

Chelsea, London, United Kingdom, Jaya Taj

RECRUITING

United Kingdom,

Beaston West of Scotland Canter Centre

Glasgow, United Kingdom, G120 in

RECRUITING

United Kingdom,

Guy's Hospital

London, United Kingdom, SE1 9RT

RECRUITING

United Kingdom,

Sarah Cannon Research Institute UK

London, United Kingdom, W1G 6AD