Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05727904 | Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma. | PHASE3 | RECRUITING | 670 | — | — | Mar 30, 2023 | Mar 1, 2030 | Apr 3, 2026 | 75 | United States, Australia +12 |
| NCT02360579 | Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma | PHASE2 | COMPLETED | 220 | — | — | Sep 24, 2015 | Oct 24, 2024 | Mar 25, 2026 | 57 | United States, France +6 |
| NCT05640193 | A Study of LN-144 in People With Metastatic Melanoma to the Brain | PHASE1 | ACTIVE NOT_RECRUITING | 10 | — | — | Nov 25, 2022 | Nov 1, 2026 | Sep 12, 2025 | 1 | United States |
To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured by objective response rate (ORR) and progression-free survival (PFS) assessed by the blinded independent review committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Evaluate the efficacy of LN-144 in patients with unresectable or metastatic melanoma using the objective response rate (ORR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for Cohorts 1 \& 3 and as assessed by Independent Review Committee (IRC) per RECIST Version 1.1 for Cohorts 2 \& 4
measured by the number of patients who undergo surgery and successfully undergo LN-144 infusion
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Lifileucel plus Pembrolizumab |
| Arm B | ACTIVE_COMPARATOR | Pembrolizumab alone with Optional Crossover Period |
| Cohort 1 | EXPERIMENTAL | Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed) |
| Cohort 2 | EXPERIMENTAL | Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) |
| Cohort 3 | EXPERIMENTAL | Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b). |
| Cohort 4 | EXPERIMENTAL | Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) |
| Participants with Melanoma Brain Metastases | EXPERIMENTAL | Participants have melanoma brain metastases who will undergo surgical excision to generate LN-144. |
| Name | Type | Description |
|---|---|---|
| Lifileucel plus Pembrolizumab | BIOLOGICAL | 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. |
| Pembrolizumab with Optional Crossover Period | BIOLOGICAL | 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. |
| Lifileucel | BIOLOGICAL | A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with lifileucel followed by IL-2. |
| Lifileucel (LN-144) | BIOLOGICAL | A portion of the patient's tumor is resected and serves as the starting material for manufacturing lifileucel. After preparative NMA-LD, patients are infused with their autologous TIL (lifileucel), followed by a short course of high-dose IL-2. |
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 est...