Off-Label Treatment With Immune Checkpoint Inhibitor Blockade
Medical College of Wisconsin
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugOne or more off-label ICIs alone or with other on-label ICI(s)
Subjects will receive one of three ICI regimens, as prescribed by their treating medical oncologist.
- DrugOff-label ICI(s) with targeted therapy
Subjects will receive one of three ICI regimens, as prescribed by their treating medical oncologist.
- Drugoff-label ICI(s) with other agents that are not targeted (including, but not limited to, chemotherapy, hormonal therapy, immunotherapy other than ICIs) with or without targeted agents
Subjects will receive one of three ICI regimens, as prescribed by their treating medical oncologist.
Location
- Froedtert & the Medical College of WisconsinMilwaukee, Wisconsin