Adoptive Cell Therapy With (LN-145) in Combination With Pembrolizumab in Treating Patients With Unresectable or Metastatic Transitional Cell Cancer Who Have Failed Cisplatin-Based Chemotherapy
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|ClinicalTrials.gov Identifier: NCT03935347|
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : October 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Bladder Urothelial Carcinoma Metastatic Renal Pelvis Urothelial Carcinoma Metastatic Ureter Urothelial Carcinoma Metastatic Urethral Urothelial Carcinoma Unresectable Renal Pelvis Urothelial Carcinoma Unresectable Ureter Urothelial Carcinoma||Drug: Cyclophosphamide Drug: Fludarabine Drug: Fludarabine Phosphate Biological: Pembrolizumab Biological: Autologous Tumor Infiltrating Lymphocytes LN-145 Biological: Aldesleukin||Phase 2|
I. To evaluate the efficacy of autologous tumor infiltrating lymphocytes LN-145 (LN-145) in combination with pembrolizumab in subjects with advanced transitional cell bladder cancer (TCC) using the objective response rate (ORR) and the duration of response (DoR), using the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST version [v] 1.1).
I. To evaluate the efficacy of LN-145 in combination with pembrolizumab in subjects with TCC based on the progression-free survival (PFS) and overall survival (OS).
II. To evaluate the safety of LN-145 in combination with pembrolizumab in subjects with TCC based on the adverse event (AE) profile per Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) With Pembrolizumab, in Subjects Who Have Failed Cisplatin-Based Chemotherapy With Locally Advanced (Unresectable) or Metastatic Transitional Cell Cancer (TCC) of the Urothelium|
|Actual Study Start Date :||June 20, 2019|
|Estimated Primary Completion Date :||May 1, 2022|
|Estimated Study Completion Date :||May 1, 2023|
Experimental: Treatment (cyclophosphamide, fludarabine, pembrolizumab)
Patients receive cyclophosphamide IV over 2 hours on days -8 and -7, fludarabine IV over 30 minutes on days -6 to -2, and pembrolizumab IV over 30 minutes on day -1. At least 24 hours later, patients receive autologous tumor infiltrating lymphocytes LN-145 IV on day 0, and receive aldesleukin IV over 30 minutes for up to 6 doses on days 1-4. Patients then continue receiving pembrolizumab IV over 30 minutes beginning on day 21. Cycles of pembrolizumab repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
Drug: Fludarabine Phosphate
Biological: Autologous Tumor Infiltrating Lymphocytes LN-145
- Objective response rate [ Time Frame: Up to 3 years ]The proportion of subjects who achieve either a confirmed partial response (PR) or complete response (CR) as best response as assessed per Response Evaluation Criteria in Solid Tumors 1.1. Will be evaluated per each disease assessment and calculated with the corresponding 95% two-sided confidence interval
- Incidence of adverse events (AEs) [ Time Frame: From the first dose of cyclophosphamide up to 30 days from the last dose of IL- ]Will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 by grade of severity and relationship to the study treatment.
- Duration of response [ Time Frame: Up to 3 years ]Will be assessed by Kaplan-Meier methods
- Disease Control Rate [ Time Frame: Up to 3 years ]Derived as the sum of the number of subjects who achieved confirmed PR/CR or sustained stable disease (at least 6 weeks) divided by the number of subjects in the all-treated population x 100%. Will be assessed by Kaplan-Meier methods
- Progression-free survival [ Time Frame: Up to 3 years ]Will be assessed by Kaplan-Meier methods
- Overall Survival [ Time Frame: Up to 3 years ]From time of lymphodepletion to death due to any cause
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935347
|Contact: ASK RPCI||1-800-767-9355||Askroswell@roswellpark.org|
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263-0001|
|Contact: ASK RPCI 877-275-7724 ASKRPCI@RoswellPark.org|
|Principal Investigator:||Gurkamal Chatta, MD||Roswell Park Cancer Institute|