NCT03645928 Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors
| NCT ID | NCT03645928 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Iovance Biotherapeutics, Inc. |
| Condition | Metastatic Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 245 participants |
| Start Date | 2019-05-07 |
| Primary Completion | 2029-08-09 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL \[LN-144/LN-145 (lifileucel)\] in combination with immune checkpoint inhibitors or TIL \[LN-144/LN-145 (lifileucel) and LN-145-S1\] as a single agent therapy.
Eligibility Criteria
Inclusion Criteria * Must have a confirmed diagnosis of malignancy of their receptive histologies: unresectable or metastatic melanoma Stage IIIC to IV (Cohorts 1A,1B and 1C), advanced, recurrent or metastatic HNSCC (Cohort 2A), or Stage III or Stage IV non-small cell lung cancer (Cohorts 3A, 3B, and 3C). Stage IV NSCLC with no actionable mutations (EGFR, ALK, ROS1) with effective targeted therapy (Cohorts 3D and 3E). * Cohorts 1A, 1D, 2A, 3A, 3D and 3E: If previously treated, patients must have progressed on or after most recent therapy and must not have received ICIs as part of one of the counted lines of prior therapy. Patients must have radiologically documented disease progression while receiving or after the completion of the most recent prior treatment. Patients may have received up to 3 prior systemic anticancer therapies (except for Cohort 3A, where patients whose tumors harbor actionable mutations may have received up to 4 prior systemic therapies). Patients in Cohort 1D may
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