Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma
Trial details
- Registry ID
- NCT02360579
- Phase
- Phase 2
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Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.
NCT03108495 · Iovance Biotherapeutics, Inc.
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: Up to 60 months
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. Time frame: 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. Time frame: 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. Time frame: 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. Time frame: 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. Time frame: 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. Time frame: Up to 60 months
NCT03108495 · Iovance Biotherapeutics, Inc.
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
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
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
NCT03645928 · Iovance Biotherapeutics, Inc.
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Measure: Objective Response Rate
Measure: Safety Profile Measured by Grade ≥3 TEAEs
Measure: To evaluate the feasibility of producing lifileucel using tumor samples obtained before (Cohort 3D) or during (Cohort 3E) frontline platinum doublet chemotherapy and pembrolizumab in patients with Stage IV NSCLC
Measure: Objective Response Rate Measure: Safety Profile Measured by Grade ≥3 TEAEs Measure: Percentage of patients for whom lifileucel is successfully manufactured and meets release specification
Estimated
Actual
245 participants (planned)
225 participants (actual)
Estimated
Actual
9 Aug 2029
20 Feb 2026
Recruiting
Terminated
NCT07288203 · Iovance Biotherapeutics, Inc.
Recruiting
Active not recruiting
NCT02360579 · Iovance Biotherapeutics, Inc.
178 participants (actual)
220 participants (actual)