Study aimed at evaluating the efficacy and safety of the lifileucel regimen in combination with pembrolizumab compared to pembrolizumab monotherapy in participants with untreated advanced melanoma
Summary description of the study
The main objective of the study is to determine whether the lifileucel + pembrolizumab treatment is more effective than pembrolizumab alone in reducing the size of a patient's tumor and possibly eliminating it completely. The investigator physician will also examine the patient's lifespan until the tumor develops and their lifespan after treatment. Another objective of the study is to determine whether the study drugs are safe. Approximately 670 patients distributed across approximately 100 centers worldwide will participate in the study. All patients will be assigned to one of the 2 treatment arms: Arm A (lifileucel + pembrolizumab) or Arm B (pembrolizumab alone). All patients will have a 1 in 2 chance of being part of one of these arms. The study will consist of 3 periods: selection period, during which the investigator physician will check if each patient meets the criteria to participate in the study, treatment and evaluation period, and follow-up period, during which the investigator physician will continue to monitor the health and evaluate the ongoing care of each patient for their tumor, through phone calls until the end of the study. The duration of the study will vary for each patient. Only those in Arm A will undergo a surgical intervention to remove a piece of tumor, used to manufacture lifileucel. Patients in Arm B may have the opportunity to receive the regimen with lifileucel if their melanoma worsens or recurs while they are taking pembrolizumab. This is the optional arm switch from Arm B. Various medical procedures will be performed: imaging examinations, ECG, pulmonary function tests, tumor sample collections, and frequent blood and urine samples. Patients will complete questionnaires on quality of life and report observed changes in health status to the investigator physician/study staff.
(BASEC)
Intervention under investigation
Lifileucel plus pembrolizumab regimen. Lifileucel is a new type of immunotherapy that uses the body's immune system to destroy cancer cells. Lifileucel is also referred to as treatment with "tumor infiltrating lymphocytes" (TIL). It consists of a type of white blood cells called T-lymphocytes or T-cells, which are taken from a piece of the patient's tumor and transformed into millions of cells in the laboratory. These T-cells are effective at detecting and attacking the patient's tumor. Pembrolizumab is a commercially available immunotherapy drug that works by binding to a specific protein on T-cells. This allows T-cells to find hidden cancer cells and destroy them. Researchers believe that lifileucel combined with pembrolizumab may help treat advanced melanoma that has never been treated before. The term "study drug(s)" refers to the regimen with lifileucel and/or pembrolizumab.
(BASEC)
Disease under investigation
Melanoma is a type of skin cancer. It begins in the cells that give skin its color (called melanocytes). Unresectable melanoma is a skin cancer that cannot be cured by surgical operation. Metastatic melanoma is a skin cancer that has spread to other parts of the body. Melanoma can develop anywhere on the body where the cells that give skin its color become cancerous. In this summary, the term "advanced melanoma" refers to unresectable or metastatic melanoma.
(BASEC)
Patients may participate in the study if they: • are between 18 and 70 years old; • have melanoma at a specific stage; • have at least one melanoma tumor that can be partially removed by surgical operation; • have at least one melanoma tumor that can be measured during the study; • have sufficiently good kidney, liver, heart, and lung function. (BASEC)
Exclusion criteria
Patients cannot participate in the study if they: • have ocular melanoma; • have an untreated tumor that has spread to the brain; • have received more than one therapy to treat their advanced melanoma; • are not mentally fit, in the opinion of the investigator physician; • have tested positive for infections such as AIDS or have undergone an organ transplant. (BASEC)
Trial sites
Lausanne
(BASEC)
Sponsor
PPD Switzerland GmbH c/o Dufour Treuhand AG
(BASEC)
Contact
Contact Person Switzerland
SOFIYA BEDO LATIFYAN
(+41) 79 556 2698
Sofiya.latifyan@clutterchuv.chUniversity Hospital Lausanne (CHUV)
(BASEC)
Scientific Information
Iovance Biotherapeutics,
1-844-845-4682
Sofiya.latifyan@clutterchuv.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
06.09.2024
(BASEC)
ICTRP Trial ID
NCT05727904 (ICTRP)
Official title (approved by ethics committee)
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 TILVANCE-301 (BASEC)
Academic 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 (ICTRP)
Public title
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma. (ICTRP)
Disease under investigation
Metastatic MelanomaUnresectable MelanomaMelanoma (ICTRP)
Intervention under investigation
Biological: Lifileucel plus PembrolizumabBiological: Pembrolizumab with Optional Crossover Period (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion 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. (ICTRP)
not available
Primary and secondary end points
Objective Response Rate and Progression Free Survival (ICTRP)
Overall Survival;Complete Response Rate, Duration of Response and Event Free Survival;Objective Response Rate, Progression Free Survival, Complete Response Rate, Duration of Responses, Event Free Survival and PFS2;Adverse Events (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Iovance Biotherapeutics Study Team;Iovance Biotherapeutics https://www.tilvance-301.com, Clinical.Inquiries@iovance.com, 1-844-845-4682, Iovance Biotherapeutics, (ICTRP)
Secondary trial IDs
TILVANCE-301, TILVANCE, IOV-MEL-301 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05727904 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available