JTX-2011-R01 is an open label, multicenter, rollover study that is designed to provide continued access to vopratelimab for eligible subjects with advanced solid tumor malignancies who have previously participated in a vopratelimab study (the parent study).
Vopratelimab is an agonist monoclonal antibody that specifically binds to the Inducible Co-Stimulator of T cells (ICOS) to generate an anti-tumor immune response. This is an open label, roll over study to evaluate the long-term safety of continued treatment with vopratelimab monotherapy or combination treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Washington University School of Medicine
St Louis, Missouri, United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia Health Systems
Charlottesville, Virginia, United States
Percentage of Subjects With Adverse Events (AEs)
Percentage of subjects with at least one AE
Time frame: Approximately 34 months
Percentage of Subjects With Serious Adverse Events (SAEs)
Percentage of subjects with at least one SAE
Time frame: Approximately 34 months
Percentage of Subjects With Clinically Significant Change From Baseline in Clinical Laboratory Tests
Percentage of subjects with at least one clinically significant change from baseline in clinical laboratory tests (i.e., change requiring adjustment of dose, clinical intervention or administration of concomitant medication)
Time frame: Approximately 34 months
Median Progression Free Survival (mPFS)
mPFS from start of therapy on the rollover study (not including duration of treatment on the applicable parent study)
Time frame: Approximately 34 months
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