IOVA

Iovance Biotherapeutics, Inc.

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8Trials in this database
10Recorded changes · last 12 months
Partial coverageOnly the trials and history collected so far

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.

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Latest recorded trial changes

· 1 field changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

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

+ After

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

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· 1 field changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

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

+ After

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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· 6 fields changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

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

+ After

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

Participant count type changed

− Before

Estimated

+ After

Actual

Enrollment · participant count changed

− Before

245 participants (planned)

+ After

225 participants (actual)

Completion date type changed

− Before

Estimated

+ After

Actual

Primary completion date changed

− Before

9 Aug 2029

+ After

20 Feb 2026

Recruitment status changed

− Before

Recruiting

+ After

Terminated

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