Trial Title:
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
NCT ID:
NCT05727904
Condition:
Metastatic Melanoma
Unresectable Melanoma
Melanoma
Conditions: Official terms:
Melanoma
Pembrolizumab
Conditions: Keywords:
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
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Lifileucel plus Pembrolizumab
Description:
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.
Arm group label:
Arm A
Other name:
LN-144
Other name:
Pembrolizumab
Intervention type:
Biological
Intervention name:
Pembrolizumab with Optional Crossover Period
Description:
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.
Arm group label:
Arm B
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.
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama at Birmingham: The Kirklin Clinic
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
USC Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90007
Country:
United States
Status:
Recruiting
Facility:
Name:
California Pacific Medical Center
Address:
City:
San Francisco
Zip:
94107
Country:
United States
Status:
Recruiting
Facility:
Name:
Orlando Health Cancer Institute
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Illinois Hospital & Health Sciences System
Address:
City:
Chicago
Zip:
60612
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Kansas
Address:
City:
Kansas City
Zip:
66205
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Louisville - James Graham Brown Cancer Center
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Facility:
Name:
National Cancer Institute
Address:
City:
Bethesda
Zip:
20814
Country:
United States
Status:
Recruiting
Facility:
Name:
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center at Cooper
Address:
City:
Camden
Zip:
08103
Country:
United States
Status:
Recruiting
Facility:
Name:
St. Luke's Cancer Center - Anderson
Address:
City:
Easton
Zip:
18045
Country:
United States
Status:
Recruiting
Facility:
Name:
Allegheny Health Network
Address:
City:
Pittsburgh
Zip:
15224
Country:
United States
Status:
Recruiting
Facility:
Name:
Baptist Cancer Center
Address:
City:
Bartlett
Zip:
37920
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Virginia
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Commonwealth University
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Recruiting
Facility:
Name:
Greenslopes Private Hospital
Address:
City:
Greenslopes
Zip:
4120
Country:
Australia
Status:
Recruiting
Facility:
Name:
Peter MacCallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Fiona Stanley Hospital
Address:
City:
Murdoch
Zip:
6150
Country:
Australia
Status:
Recruiting
Facility:
Name:
Westmead Hospital
Address:
City:
Westmead
Zip:
NSW 2145
Country:
Australia
Status:
Recruiting
Facility:
Name:
Centre hospitalier de l'Université de Montréal
Address:
City:
Montréal
Zip:
H2L 4M1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G
Country:
Canada
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
Address:
City:
Nantes
Zip:
44093
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Saint Louis
Address:
City:
Paris
Zip:
75475
Country:
France
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Hamburg-Eppendorf
Address:
City:
Hamburg
Zip:
20251
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Address:
City:
Lübeck
Zip:
23562
Country:
Germany
Status:
Recruiting
Facility:
Name:
Istituto Romagnolo per lo Studio dei Tumori
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliero Universitaria Pisana
Address:
City:
Pisa
Zip:
56100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Europeo Di Oncologia
Address:
City:
Milan
Zip:
20139
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera Universitaria Senese
Address:
City:
Siena
Country:
Italy
Status:
Recruiting
Facility:
Name:
Nederlands Kanker Instituut
Address:
City:
Amsterdam
Zip:
1066 CX
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Hospital Universitario Marques de Valdecilla
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Regional Universitario de Malaga - Hospital General
Address:
City:
Malaga
Zip:
29016
Country:
Spain
Status:
Recruiting
Facility:
Name:
Instituto Oncologico Rosell
Address:
City:
Barcelona
Zip:
08028
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall dHebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinic de Barcelona
Address:
City:
Barcelona
Zip:
8036
Country:
Spain
Status:
Recruiting
Facility:
Name:
ICO l'Hospitalet - Hospital Duran i Reynals
Address:
City:
Barcelona
Zip:
8908
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario Gregorio Maranon
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Madrid Sanchinarro - CIOCC
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Quirónsalud Madrid
Address:
City:
Madrid
Zip:
28223
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clínica Universitaria de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen Macarena
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Consorcio Hospital General Universitario de Valencia
Address:
City:
Valencia
Zip:
46014
Country:
Spain
Status:
Recruiting
Facility:
Name:
Sahlgrenska Universitetssjukhuset
Address:
City:
Göteborg
Zip:
SE-41346
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Universitaire Vaudois Lausanne
Address:
City:
Lausanne
Zip:
1011
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
Royal Marsden Hospital
Address:
City:
Chelsea
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Start date:
March 30, 2023
Completion date:
March 1, 2030
Lead sponsor:
Agency:
Iovance Biotherapeutics, Inc.
Agency class:
Industry
Source:
Iovance Biotherapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05727904
