NCT03108495Phase 2Terminated

Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma

Study sponsor: Iovance Biotherapeutics, Inc. · IOVA

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Primary completion2025-08-22Actual
Enrollment · participants210Actual
Source updated2026-09-25Last update listed in the registry record
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· 1 field changed

Primary outcomes · main study measures

Text edit · unverified significance
− Previous value

measure: Cohort 1 and 2: Objective Response Rate; description: To evaluate the efficacy of LN-145 in participants 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; timeFrame: Up to 60 months; measure: Cohort 3: Adverse Events; description: To characterize the safety profile of LN-145 in combination with pembrolizumab in participants with recurrent, metastatic, or persistent cervical carcinoma as assessed by incidence of adverse events.; timeFrame: Up to 60 months; measure: Cohort 4: Adverse Events; description: To explore the safety profile of LN-145 in previously enrolled participants with recurrent, metastatic, or persistent cervical carcinoma as assessed by incidence of adverse events.; timeFrame: Up to 60 months; measure: Cohort 4: Efficacy/Objective Response Rate; description: To explore the efficacy of LN-145 in previously enrolled participants with recurrent, metastatic, or persistent cervical carcinoma based on the objective response rate (ORR).; timeFrame: Up to 60 months; measure: Cohort 5: Adverse Events; description: To explore the safety profile of LN-145 in re-treated participants with recurrent, metastatic, or persistent cervical carcinoma as assessed by incidence of adverse events.; timeFrame: Up to 60 months; measure: Cohort 5: Efficacy/Objective Response Rate; description: To explore the efficacy of LN-145 in re-treated participants with recurrent, metastatic, or persistent cervical carcinoma based on the objective response rate (ORR).; timeFrame: Up to 60 months

+ Updated value

measure: Cohort 1 and 2: Objective Response Rate; description: To evaluate the efficacy of LN-145 in participants 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) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.; timeFrame: Up to 60 months; measure: Cohort 3: Number of Participants With Adverse Events; description: To characterize the safety profile of LN-145 in combination with pembrolizumab in participants with recurrent, metastatic, or persistent cervical carcinoma as assessed by number of participants with adverse events.; timeFrame: Up to 60 months; measure: Cohort 4: Number of Participants With Adverse Events; description: To explore the safety profile of LN-145 in previously enrolled participants with recurrent, metastatic, or persistent cervical carcinoma as assessed by number of participants with adverse events.; timeFrame: Up to 60 months; measure: Cohort 4: Efficacy/Objective Response Rate; description: To explore the efficacy of LN-145 in previously enrolled participants 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) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.; timeFrame: Up to 60 months; measure: Cohort 5: Number of Participants With Adverse Events; description: To explore the safety profile of LN-145 in re-treated participants with recurrent, metastatic, or persistent cervical carcinoma as assessed by number of participants with adverse events.; timeFrame: Up to 60 months; measure: Cohort 5: Efficacy/Objective Response Rate; description: To explore the efficacy of LN-145 in re-treated participants 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) for target lesions based on imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.; timeFrame: Up to 60 months

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· 1 field changed

Primary outcomes · main study measures

Text edit · unverified significance
− Previous value

measure: Cohort 1 and 2: Objective Response Rate; measure: Cohort 3: Adverse Events; measure: Cohort 4: Efficacy and Adverse Events; measure: Cohort 5: Efficacy and Adverse Events

+ Updated value

measure: Cohort 1 and 2: Objective Response Rate; measure: Cohort 3: Adverse Events; measure: Cohort 4: Adverse Events; measure: Cohort 4: Efficacy/Objective Response Rate; measure: Cohort 5: Adverse Events; measure: Cohort 5: Efficacy/Objective Response Rate

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