Primary outcomes · main study measures
Text edit · unverified significancemeasure: 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
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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