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

Description

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.

Conditions

Metastatic Melanoma, Unresectable Melanoma, Melanoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Metastatic Melanoma
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham: The Kirklin Clinic, Birmingham, Alabama, United States, 35233

Duarte

City of Hope, Duarte, California, United States, 91010

Los Angeles

USC Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90007

San Francisco

California Pacific Medical Center, San Francisco, California, United States, 94107

Orlando

Orlando Health Cancer Institute, Orlando, Florida, United States, 32806

Chicago

University of Illinois Hospital & Health Sciences System, Chicago, Illinois, United States, 60612

Kansas City

University of Kansas, Kansas City, Kansas, United States, 66205

Louisville

University of Louisville - James Graham Brown Cancer Center, Louisville, Kentucky, United States, 40202

Bethesda

National Cancer Institute, Bethesda, Maryland, United States, 20814

Detroit

Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center, Detroit, Michigan, United States, 48201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Iovance Biotherapeutics, Inc.,

Iovance Biotherapeutics Study Team, STUDY_DIRECTOR, Iovance Biotherapeutics

Study Record Dates

2030-03-01