Melanoma Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
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.
Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.
Participants must have adequate organ function.
Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
Participants who are > 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.

Exclusion Criteria:

Participant has melanoma of uveal/ocular origin.
Participant has symptomatic untreated brain metastases.
Participant received more than 1 prior line of therapy.
Participant received prior therapy for metastatic disease
Participants with a BRAF V600 mutation-positive tumor received prior adjuvant/neoadjuvant ICI therapy only
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.
Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
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.)
Participant has a history of allogeneic cell or organ transplant.

Other protocol defined inclusion/exclusion criteria could apply.

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

670

Study ID:

NCT05727904

Recruitment Status:

Recruiting

Sponsor:

Iovance Biotherapeutics, Inc.

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There are 33 Locations for this study

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University of Alabama at Birmingham: The Kirklin Clinic
Birmingham Alabama, 35233, United States
City of Hope
Duarte California, 91010, United States
USC Norris Comprehensive Cancer Center
Los Angeles California, 90007, United States
Orlando Health Cancer Institute
Orlando Florida, 32806, United States
University of Illinois Hospital & Health Sciences System
Chicago Illinois, 60612, United States
University of Kansas
Kansas City Kansas, 66205, United States
University of Louisville - James Graham Brown Cancer Center
Louisville Kentucky, 40202, United States
National Cancer Institute
Bethesda Maryland, 20814, United States
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center
Detroit Michigan, 48201, United States
MD Anderson Cancer Center at Cooper
Camden New Jersey, 08103, United States
St. Luke's Cancer Center - Anderson
Easton Pennsylvania, 18045, United States
Allegheny Health Network
Pittsburgh Pennsylvania, 15224, United States
Baptist Cancer Center
Bartlett Tennessee, 37920, United States
University of Virginia
Charlottesville Virginia, 22908, United States
Virginia Commonwealth University
Richmond Virginia, 23298, United States
Greenslopes Private Hospital
Greenslopes Queensland, 4120, Australia
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia
Fiona Stanley Hospital
Murdoch Western Australia, 6150, Australia
Centre hospitalier de l'Université de Montréal
Montréal Quebec, H2L 4, Canada
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
Nantes , 44093, France
Istituto Romagnolo per lo Studio dei Tumori
Meldola Forlì-Cesena, 47014, Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Napoli , 80131, Italy
Nederlands Kanker Instituut
Amsterdam , 1066 , Netherlands
Hospital Universitario Marques de Valdecilla
Santander Cantabria, 39008, Spain
Hospital Regional Universitario de Malaga - Hospital General
Malaga Málaga, 29016, Spain
Instituto Oncologico Rosell
Barcelona , 08028, Spain
Hospital Universitari Vall dHebron
Barcelona , 08035, Spain
Hospital 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario Madrid Sanchinarro - CIOCC
Madrid , 28050, Spain
Hospital Universitario Quirónsalud Madrid
Madrid , 28223, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain
Consorcio Hospital General Universitario de Valencia
Valencia , 46014, Spain
Sahlgrenska Universitetssjukhuset
Göteborg Vastra Gotalands Lan, SE-41, Sweden

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

670

Study ID:

NCT05727904

Recruitment Status:

Recruiting

Sponsor:


Iovance Biotherapeutics, Inc.

How clear is this clinincal trial information?

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