RECRUITING

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

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Conditions

Metastatic MelanomaUnresectable MelanomaMelanomaTumor Infiltrating LymphocytesTILCell TherapyCellular Immuno-therapyIL-2Non-myeloablative lymphodepletion (NMALD)Check point inhibitorLifileucelStage III MelanomaStage IV MelanomaSkin cancerSkin cancer typesMalignant melanomaAutologous Adoptive Cell TherapyAutologous Adoptive Cell TransferLN-144PembrolizumabPembroAdjuvant/Neo-adjuvantBRAF/MEKICIBRAF v600Immune checkpoint inhibitorTumor infiltrating T-cellsTILVANCETILVANCE-301

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2023-03-30
Study Completion:2030-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05727904

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
  2. 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. 3. Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
  4. 4. Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.
  5. 5. Participants must have adequate organ function.
  6. 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. 7. Participants who are \> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
  1. 1. Participant has melanoma of uveal/ocular origin.
  2. 2. Participant has symptomatic untreated brain metastases.
  3. 3. Participant received more than 1 prior line of therapy.
  4. 4. Participant received prior therapy for metastatic disease
  5. 5. Participants with a BRAF V600 mutation-positive tumor received prior adjuvant/neoadjuvant ICI therapy only
  6. 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. 7. Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
  8. 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. 9. Participant has a history of allogeneic cell or organ transplant.

Contacts and Locations

Study Contact

Iovance Biotherapeutics https://www.tilvance-301.com
CONTACT
1-844-845-4682
Clinical.Inquiries@iovance.com
Iovance Biotherapeutics Study Team
CONTACT
1-844-845-4682
Clinical.Inquiries@iovance.com

Principal Investigator

Iovance Biotherapeutics Study Team
STUDY_DIRECTOR
Iovance Biotherapeutics

Study Locations (Sites)

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
California Pacific Medical Center
San Francisco, California, 94107
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
Henry Ford Health
Detroit, Michigan, 48202
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
Swedish Cancer Institute
Edmonds, Washington, 98026
United States

Collaborators and Investigators

Sponsor: Iovance Biotherapeutics, Inc.

  • Iovance Biotherapeutics Study Team, STUDY_DIRECTOR, Iovance Biotherapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-30
Study Completion Date2030-03-01

Study Record Updates

Study Start Date2023-03-30
Study Completion Date2030-03-01

Terms related to this study

Keywords Provided by Researchers

  • Tumor Infiltrating Lymphocytes
  • TIL
  • Metastatic Melanoma
  • Unresectable Melanoma
  • Cell Therapy
  • Cellular Immuno-therapy
  • IL-2
  • Non-myeloablative lymphodepletion (NMALD)
  • Check point inhibitor
  • Melanoma
  • Lifileucel
  • Stage III Melanoma
  • Stage IV Melanoma
  • Skin cancer
  • Skin cancer types
  • Malignant melanoma
  • Autologous Adoptive Cell Therapy
  • Autologous Adoptive Cell Transfer
  • LN-144
  • Pembrolizumab
  • Pembro
  • Adjuvant/Neo-adjuvant
  • BRAF/MEK
  • ICI
  • BRAF v600
  • Immune checkpoint inhibitor
  • Tumor infiltrating T-cells
  • TILVANCE
  • TILVANCE-301

Additional Relevant MeSH Terms

  • Metastatic Melanoma
  • Unresectable Melanoma
  • Melanoma