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Phase 3 clinical trial to evaluate the efficacy and safety of the lifileucel regimen in combination with pembrolizumab compared to pembrolizumab monotherapy in participants with untreated, unresectable or metastatic melanoma.
THE MAIN OBJECTIVE IS TO COMPARE THE EFFICACY OF LIFILEUCEL PLUS PEMBROLIZUMAB WITH THE EFFICACY OF PEMBROLIZUMAB ALONE AS MEASURED BY OBJECTIVE RESPONSE RATE (ORR) AND PROGRESSION-FREE SURVIVAL (PFS) AS ASSESSED BY THE BLINDED INDEPENDENT REVIEW COMMITTEE (BIRC) ACCORDING TO THE RESPONSE EVALUATION CRITERIA IN SOLID TUMORS (RECIST) V1.1.
Technical Summary
- PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP, MULTICENTER THERAPEUTIC STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINED TREATMENT REGIMEN OF LIFILEUCEL (LN-144, AUTOLOGOUS TUMOR INFILTRATING LYMPHOCYTES [TILS]) WITH PEMBROLIZUMAB COMPARED TO PEMBROLIZUMAB MONOTHERAPY IN PARTICIPANTS WITH UNTREATED, UNRESECTABLE OR METASTATIC MELANOMA ("CLINICAL TRIAL").
- Code EudraCT: 2022-503140-41-00
- Protocol number: IOV-MEL-301
- Promoter: Iovance Biotherapeutics
- Molecule/Drug: Lifileucel más Pembrolizumab
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