Phase 2, open-label, multicenter, randomized study comparing the safety and efficacy of personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) combined with immune checkpoint inhibitor (ICI) immunotherapy (PULSAR-ICI) + IMSA101 and PULSAR-ICI alone in patients with NSCLC or RCC
Patients shall be enrolled in 2 treatment arms as follows: 1. 20 patients in the control arm (PULSAR-ICI alone) 2. 20 patients in the experimental arm (PULSAR-ICI + IMSA101) Patients will be stratified by histology (NSCLC and RCC) in the randomized portion. PULSAR-ICI with or without IMSA101 treatment will be administered to the patients in Cycles 1, 2, and 3, and thereafter only standard of care ICI monotherapy will be administered to all patients. Each treatment cycle will be 28 days in duration for Cycles 1, 2 and 3, then per standard of care monotherapy thereafter based on the product labels of the prescribed ICI. The study will start with a safety run-in portion at 2 dose levels for the experimental arm, followed by a randomized portion for both treatment arms. The safety run-in shall employ a 3+3 safety run-in component. All patients will be followed throughout the study for drug tolerability and safety by collecting clinical and laboratory data, including adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria, SAEs, concomitant medications, and vital signs. All patients will be assessed for anti-tumor efficacy at screening, prior to the end of Cycle 3, and at 8-week intervals thereafter based on radiographic assessments (all outcome measures per RECIST Version 1.1 and iRECIST). All patients will continue to receive their assigned treatment throughout the study until the occurrence of disease progression (based on iRECIST), death, or other unacceptable treatment-related toxicity, or until the study is closed by the sponsor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Anti-tumor Effects
Progression-free rate at 18 months
Time frame: 18 months
Number of Participants With Treatment-related Adverse Events
Occurrence of treatment-related adverse events
Time frame: Enrolment through end of study period (1 year, 3 months). AE data captured continually.
Anti-tumor Effects
Progression-free at 8-week intervals from 6 months to 22 months
Time frame: 6 to 22 months
Anti-tumor Effects
Time to progression
Time frame: upon enrolment through end of study period (2 years)
Anti-tumor Effects
Overall response rate, duration of response, progression-free survival
Time frame: upon enrolment through end of study period (2 years)
Quality of Life (QoL)
Patient reported outcome on FACT-G questionnaire
Time frame: upon enrolment through end of study period (2 years)
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Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Baylor College of Medicine Medical Center
Houston, Texas, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States