Hautkrebszentrum Universitätsklinikum Erlangen Ulmenweg 18 91054 Erlangen (Bayern) DeutschlandAbgebrochen» Google-MapsUniversitätsklinikum Carl Gustav Carus 01307 Dresden (Sachsen) GermanyRekrutierend» Google-MapsSt. Joseph's Hospital and Medical Center Center For Women's Health 85013 Phoenix United StatesRekrutierend» Google-Maps
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1. Cohort 1 and 2: Objective Response Rate (Time Frame - Up to 6 months): To evaluate the efficacy of LN-145 in patients with recurrent, metastatic, or persistent cervical carcinoma based on the objective response rate (ORR) as assessed by the Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
2. Cohort 3: Adverse Events (Time Frame - Up to 60 months): To characterize the safety profile of LN-145 in combination with pembrolizumab in patients with recurrent, metastatic, or persistent cervical carcinoma as assessed by incidence of adverse events.
3. Cohort 4: Efficacy and Adverse Events (Time Frame - Up to 60 months): To explore the efficacy and safety profile of LN-145 in previously enrolled patients with recurrent, metastatic, or persistent cervical carcinoma
4. Cohort 5: Efficacy and Adverse Events (Time Frame - Up to 60 months): To explore the efficacy and safety profile of LN-145 in re-treated patients with recurrent, metastatic, or persistent cervical carcinoma
Secondary outcome:
1. Cohort 1 and 2: Duration of Response (Time Frame - Up to 60 months): To evaluate the efficacy parameters of LN-145 in patients with recurrent, metastatic, or persistent cervical carcinoma by assessing duration of response (DOR) as assessed by the IRC per RECIST v1.1
2. Cohort 1 and 2: Disease Control Rate (Time Frame - Up to 60 months): To evaluate the efficacy parameters of LN-145 in patients with recurrent, metastatic, or persistent cervical carcinoma by assessing disease control rate (DCR) as assessed by the IRC per RECIST v1.1
3. Cohort 1 and 2: Progression-Free Survival (Time Frame - Up to 60 months): To evaluate the efficacy parameters of LN-145 in patients with recurrent, metastatic, or persistent cervical carcinoma by assessing progression-free survival (PFS) as assessed by the IRC per RECIST v1.1
4. Cohort 1 and 2: Objective Response Rate (Time Frame - Up to 60 months): To evaluate the efficacy of LN-145 in patients with recurrent, metastatic, or persistent cervical carcinoma based on the objective response rate (ORR) as assessed by the Investigator per RECIST v1.1
5. Cohort 1 and 2: Duration of Response (Time Frame - Up to 60 months): To evaluate the efficacy of LN-145 in patients with recurrent, metastatic, or persistent cervical carcinoma by assessing duration of response (DOR) as assessed by the Investigator per RECIST v1.1
6. Cohort 1 and 2: Disease Control Rate (Time Frame - Up to 60 months): To evaluate the efficacy of LN-145 in patients with recurrent, metastatic, or persistent cervical carcinoma by assessing disease control rate (DCR) as assessed by the Investigator per RECIST v1.1
7. Cohort 1 and 2: Progression-Free Survival (Time Frame - Up to 60 months): To evaluate the efficacy of LN-145 in patients with recurrent, metastatic, or persistent cervical carcinoma by assessing progression-free survival (PFS) as assessed by the Investigator per RECIST v1.1
8. Cohort 1 and 2: Overall Survival (Time Frame - Up to 60 months): To evaluate overall survival (OS) in patients with recurrent, metastatic, or persistent cervical carcinoma
9. Cohort 1 and 2: Adverse Events (Time Frame - Up to 60 months): To characterize the safety profile of LN-145 in patients with recurrent, metastatic, or persistent cervical carcinoma as assessed by incidence of adverse events
10. Cohort 3: Objective Response Rate (Time Frame - Up to 60 months): To evaluate the efficacy of LN-145 in combination with pembrolizumab in patients with recurrent, metastatic, or persistent cervical carcinoma based on the objective response rate (ORR) as assessed by the Investigator per RECIST v1.1
11. Cohort 3: Duration of Response (Time Frame - Up to 60 months): To evaluate the efficacy of LN-145 in combination with pembrolizumab in patients with recurrent, metastatic, or persistent cervical carcinoma by assessing duration of response (DOR) as assessed by the Investigator per RECIST v1.1.
12. Cohort 3: Disease Control Rate (Time Frame - Up to 60 months): To evaluate the efficacy of LN-145 in combination with pembrolizumab in patients with recurrent, metastatic, or persistent cervical carcinoma by assessing disease control rate (DCR) as assessed by the Investigator per RECIST v1.1.
13. Cohort 3: Progression-Free Survival (Time Frame - Up to 60 months): To evaluate the efficacy of LN-145 in combination with pembrolizumab in patients with recurrent, metastatic, or persistent cervical carcinoma by assessing progression-free survival (PFS) as assessed by the Investigator per RECIST v1.1.
14. Cohort 3: Overall Survival (Time Frame - Up to 60 months): To evaluate overall survival (OS) in patients with recurrent, metastatic, or persistent cervical carcinoma
Experimental: Cohort 1 LN-145 monotherapy Post-NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
Experimental: Cohort 2 LN-145 monotherapy Patients previously treated with an antiprogrammed cell death protein-1 (PD-1) or anti-programmed death-ligand 1 (PD-L1) checkpoint inhibitor: Post-NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
Experimental: Cohort 3 - Combination Arm (TIL + Pembrolizumab) - US Only Patients will be administered with pembrolizumab, followed by NMA lymphodepletion, then infused with their autologous TIL (LN-145) followed by pembrolizumab every 3 or 6 weeks post IL-2 administration up to 24 months.
Experimental: Cohort 4 - Non-enrolling Cohort Cohort includes patient population not meeting inclusion criteria in cohort 1 and 2. Post-NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
Experimental: Cohort 5 Retreatment Cohort Patients who have been previously treated with LN-145 may be given a second treatment with TIL.
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.
LN-145 + pembrolizumab (TIL, autologous tumor infiltrating lymphocytes; pembrolizumab (anti-PD-1 immunotherapy)): A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. The first dose of anti-PD-1 immunotherapy will be administered following tumor resection.
Quelle: ClinicalTrials.gov
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"Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma"
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