Medical College of Wisconsin
This is a phase II therapeutic interventional clinical trial that will evaluate the efficacy, safety, and outcomes of off-label immune checkpoint blockade use across malignancies.
Subjects will be in one of the three following groups (n=69 for each group), depending on the therapy administered: * Treatment Group A: One or more off-label immune checkpoint inhibitor (ICI) (s) alone or with other on-label ICI(s). * Treatment Group B: Off-label ICI(s) with targeted therapy. * Treatment Group C: Off-label ICI(s) with other agents that are not targeted (including, but not limited to, chemotherapy, hormonal therapy, and immunotherapy other than ICIs) with or without targeted agents. At least one ICI agent must be off-label, and no agent can be investigational; agents other t…
Inclusion Criteria: * Age ≥18 years. * Zubrod Performance Status 0-2. * Patients must have a documented malignancy where an off-label ICI is being considered by a physician. * Patients must have adequate organ function as specified below: * Absolute Neutrophil Count (ANC) ≥1,000/mcL * Platelets ≥75,000/mcL * Total Bilirubin ≤2.0 × upper limit of normal (ULN), unless the patient has changes consistent with Gilbert's Syndrome. * Alanine Aminotransferase (ALT) ≤3.0 × ULN * Serum Creatinine ≤2.0 × ULN or CrCl ≥50 mL/min as calculated by the Cockcroft-Gault equation. * 5\. Females of ch…
Subjects will receive one of three ICI regimens, as prescribed by their treating medical oncologist.
Subjects will receive one of three ICI regimens, as prescribed by their treating medical oncologist.
Subjects will receive one of three ICI regimens, as prescribed by their treating medical oncologist.
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