Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma
LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma. The cell transfer therapy used in this study involves patients receiving a NMA lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes.
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.
Cohort 1 and 2: Objective Response Rate
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 Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 60 months
Cohort 3: Adverse Events
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.
Time frame: Up to 60 months
Cohort 4: Efficacy and Adverse Events
To explore the efficacy and safety profile of LN-145 in previously enrolled patients with recurrent, metastatic, or persistent cervical carcinoma
Time frame: Up to 60 months
Cohort 5: Efficacy and Adverse Events
To explore the efficacy and safety profile of LN-145 in re-treated patients with recurrent, metastatic, or persistent cervical carcinoma
Time frame: Up to 60 months
Cohort 1 and 2: Duration of Response
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 Investigator per RECIST v1.1
Time frame: Up to 60 months
Cohort 1 and 2: Disease Control Rate
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 Investigator per RECIST v1.1
Time frame: Up to 60 months
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St. Joseph's Hospital and Medical Center Center For Women's Health
Phoenix, Arizona, United States
University of Southern California
Los Angeles, California, United States
University of California San Diego
San Diego, California, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
University of Florida Health Cancer Center
Orlando, Florida, United States
University of South Florida H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Augusta University
Augusta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
LSU Health Sciences Center
New Orleans, Louisiana, United States
...and 33 more locations
Cohort 1 and 2: Progression-Free Survival
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 Investigator per RECIST v1.1
Time frame: Up to 60 months
Cohort 1 and 2: Overall Survival
To evaluate overall survival (OS) in patients with recurrent, metastatic, or persistent cervical carcinoma
Time frame: Up to 60 months
Cohort 1 and 2: Adverse Events
To characterize the safety profile of LN-145 in patients with recurrent, metastatic, or persistent cervical carcinoma as assessed by incidence of adverse events
Time frame: Up to 60 months
Cohort 3: Objective Response Rate
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
Time frame: Up to 60 months
Cohort 3: Duration of Response
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.
Time frame: Up to 60 months
Cohort 3: Disease Control Rate
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.
Time frame: Up to 60 months
Cohort 3: Progression-Free Survival
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.
Time frame: Up to 60 months
Cohort 3: Overall Survival
To evaluate overall survival (OS) in patients with recurrent, metastatic, or persistent cervical carcinoma
Time frame: Up to 60 months