Indikation (Clinical Trials):
Squamous Cell Carcinoma of Head and Neck
Geschlecht:
Alle
Altersgruppe:
Alle
Phase:
Phase 2
Sponsor:
Iovance Biotherapeutics, Inc.
Collaborator:
-
Studienleiter
Iovance Biotherapeutics Medical Monitor Study Director Iovance Biotherapeutics
Kontakt
Iovance Biotherapeutics Study Team Kontakt: Phone: 1-844-845-4682 E-Mail: Clinical.Inquiries@iovance.com» Kontaktdaten anzeigen
Studienlocations (3 von 45)
Klinikum rechts der Isar der Technischen Universität München 81675 München (Bayern) GermanyRekrutierend» Google-MapsUniversitätsklinikum Carl Gustav Carus 01307 Dresden (Sachsen) GermanyZurückgezogen» Google-MapsUniversitätsklinikum Schleswig-Holstein - Campus Lübeck 23538 Lübeck (Schleswig-Holstein) GermanyRekrutierend» Google-Maps
University of California, San Diego 92093 La Jolla United StatesAbgebrochen» Google-MapsUniversity of Southern California 90007 Los Angeles United StatesAktiv, nicht rekrutierend» Google-MapsUniversity of California, Los Angeles 90095 Los Angeles United StatesAktiv, nicht rekrutierend» Google-MapsUniversity of Colorado 80045 Denver United StatesAktiv, nicht rekrutierend» Google-MapsYale University 06520 New Haven United StatesAktiv, nicht rekrutierend» Google-MapsGeorgetown University Medical Center 20007 Washington United StatesAktiv, nicht rekrutierend» Google-MapsMount Sinai Medical Center 33140 Miami Beach United StatesZurückgezogen» Google-MapsOrlando Health Cancer Institute 32610 Orlando United StatesRekrutierend» Google-MapsMoffitt Cancer Center 33612 Tampa United StatesAktiv, nicht rekrutierend» Google-MapsUniversity of Louisville 40292 Louisville United StatesRekrutierend» Google-MapsUniversity of Maryland 21201 Baltimore United StatesAktiv, nicht rekrutierend» Google-MapsMassachusetts General Hospital 02114 Boston United StatesRekrutierend» Google-MapsKarmanos Cancer Institute 48201 Detroit United StatesAktiv, nicht rekrutierend» Google-MapsHenry Ford Health System 48202 Detroit United StatesAktiv, nicht rekrutierend» Google-MapsMD Anderson at Cooper 08103 Camden United StatesRekrutierend» Google-MapsMorristown Medical Center 07960 Morristown United StatesRekrutierend» Google-MapsColumbia University 10027 New York United StatesZurückgezogen» Google-MapsMemorial Sloan Kettering Cancer Center 10065 New York United StatesAktiv, nicht rekrutierend» Google-MapsUniversity of Cincinnati 45219 Cincinnati United StatesAbgebrochen» Google-MapsOhio State University 43201 Columbus United StatesRekrutierend» Google-MapsAvera Cancer Institute 57105 Sioux Falls United StatesZurückgezogen» Google-MapsHuntsman Cancer Hospital 84112 Salt Lake City United StatesZurückgezogen» Google-MapsFred Hutchinson Cancer Research Center 98109 Seattle United StatesRekrutierend» Google-MapsMedical College of Wisconsin 53226 Milwaukee United StatesAbgebrochen» Google-MapsPrincess Margaret Cancer Centre M5G 2C1 Toronto CanadaAktiv, nicht rekrutierend» Google-MapsCentre Léon Berard 69008 Lyon FranceZurückgezogen» Google-MapsLaiko General Hospital of Athens 11527 Athens GreeceRekrutierend» Google-MapsAttikon University General Hospital 12461 Athens GreeceAktiv, nicht rekrutierend» Google-MapsHospital Universitario Marques de Valdecilla 39008 Santander SpainRekrutierend» Google-MapsUniversity Hospital Vall d'Hebron 08035 Barcelona SpainZurückgezogen» Google-MapsICO l'Hospitalet - Hospital Duran i Reynals 08908 Barcelona SpainRekrutierend» Google-MapsHospital General Universitario Gregorio Marañón 28007 Madrid SpainZurückgezogen» Google-MapsHospital Universitario Fundacion Jimenez Diaz 28040 Madrid SpainRekrutierend» Google-MapsHospital Universitario 12 de Octubre 28041 Madrid SpainRekrutierend» Google-MapsHospital Universitario HM Sanchinarro 28050 Madrid SpainRekrutierend» Google-MapsHospital Regional Universitario de Malaga - Hospital General 29016 Málaga SpainAbgebrochen» Google-MapsUniversitätsspital Basel 4031 Basel SwitzerlandZurückgezogen» Google-MapsUniversitaetsspital Bern 3010 Bern SwitzerlandAktiv, nicht rekrutierend» Google-MapsCentre Hospitalier Universitaire Vaudois 1011 Lausanne SwitzerlandAbgebrochen» Google-MapsGuy's Hospital SE19RT London United KingdomRekrutierend» Google-MapsThe Royal Marsden NHS Foundation Trust SW3 6JJ London United KingdomRekrutierend» Google-MapsBristol Haematology and Oncology Centre BS2 8ED Bristol United KingdomZurückgezogen» Google-Maps
1. Objective Response Rate (Time Frame - Up to 60 months): To evaluate the efficacy of autologous TIL in combination with CPIs in metastatic melanoma, HNSCC, and NSCLC patients and as a single therapy in metastatic melanoma and NSCLC patients as determined by objective response rate (ORR) using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Investigator
2. Safety Profile Measured by Grade ≥3 TEAEs (Time Frame - Up to 60 months): To characterize the safety profile of autologous TIL in combination with CPIs in metastatic melanoma, HNSCC, and NSCLC patients and as a single therapy in metastatic melanoma and NSCLC patients as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs)
Secondary outcome:
1. Complete Response Rate (Time Frame - Up to 60 months): To evaluate efficacy parameters such Complete Response (CR) rate per RECIST 1.1, as assessed by the Investigator
2. Duration of Response (Time Frame - Up to 60 months): To evaluate efficacy parameters such Duration of Response (DOR) per RECIST 1.1, as assessed by the Investigator
3. Disease Control Rate (Time Frame - Up to 60 months): To evaluate efficacy parameters such Disease Control Rate (DCR) per RECIST 1.1, as assessed by the Investigator
4. Progression-Free Survival (Time Frame - Up to 60 months): To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator
5. Overall Survival (Time Frame - Up to 60 months): To evaluate efficacy parameters such Overall Survival (OS)
Experimental: Cohort 1A LN-144 therapy in combination with pembrolizumab in patients with Stage IIIC to IV unresectable or metastatic melanoma with ≤ 3 prior lines of systemic therapy, excluding checkpoint inhibitors (CPI).
Experimental: Cohort 1B LN-145-S1 therapy as a single agent in patients with Stage IIIC or Stage IV unresectable or metastatic melanoma, who have previously received systemic therapy with a PD-1 blocking antibody. If the tumor is proto-oncogene B-Raf (BRAF) V600 mutation positive, patients must have received a BRAF inhibitor with or without a mitogen-activated extracellular signal-related kinase (MEK) inhibitor.
Experimental: Cohort 1C LN-144 Generation 3 (Gen 3) therapy as a single agent in patients with Stage IIIC or Stage IV unresectable or metastatic melanoma, who have previously received systemic therapy with a PD-1 blocking antibody. If the tumor is BRAF V600 mutation positive, patients must have received BRAF inhibitor with or without a MEK inhibitor.
Experimental: Cohort 2A LN-145 therapy in combination with pembrolizumab in patients with advanced, recurrent, or metastatic HNSCC, with ≤ 3 prior lines of systemic therapy, excluding CPIs.
Experimental: Cohort 3A LN-145 therapy in combination with pembrolizumab in patients with locally advanced or metastatic (Stage III or Stage IV) non-small-cell lung cancer (NSCLC) with ≤ 3 prior lines of systemic therapy, excluding CPIs, or ≤ 4 lines if 2 or more of the lines are TKI therapy for those with tumors that harbored actionable mutations (eg, EGFR, ALK, ROS).
Experimental: Cohort 3B LN-145 therapy as a single agent in patients with Stage III or Stage IV NSCLC, who have previously received 1-3 lines of prior systemic therapy. Patients with known oncogene drivers (eg, EGFR, ALK, ROS) who have mutations that are sensitive to targeted therapies are not required to have received prior systemic therapy with CPIs.
Experimental: Cohort 3C LN-145 therapy in combination with ipilimumab and nivolumab in patients with Stage III or Stage IV NSCLC who have previously received 1 line of CPI monotherapy. No other systemic therapy for metastatic disease is allowed. Prior chemoradiation and/or chemotherapy in the adjuvant and/or neo-adjuvant settings are allowed.
Lifileucel (LN-144, TIL, autologous tumor infiltrating lymphocytes, lifileucel): A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with Lifileucel followed by IL-2 administration. Lifileucel will be administered to patients once (on Day 0) during the study.
LN-145 (TIL, autologous tumor infiltrating lymphocytes): A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration. TIL will be administered to patients once (on Day 0) during the study.
Pembrolizumab (Keytruda): Humanized antibody.
Pembrolizumab will be administered following tumor resection and will continue every 3 weeks or every 6 weeks thereafter for up to 2 years.
LN-145-S1 (TIL, autologous tumor infiltrating lymphocytes): A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with their autologous TIL (LN-145-S1) followed by IL-2 administration. TIL will be administered to patients once (on Day 0) during the study.
Ipilimumab (Yervoy): Monoclonal antibody
Ipilimumab will be administered as a single dose prior to tumor resection.
Nivolumab (Opdivo): Monoclonal antibody
Nivolumab will be administered once prior to tumor resection. The second dose will be administered prior to TIL administration and dosing will continue every 4 weeks for up to 2 years.
Quelle: ClinicalTrials.gov
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"Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors"
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