Off-Label Treatment With Immune Checkpoint Inhibitor Blockade
ConditionMalignancy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical College of Wisconsin
About this trial
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.
Eligibility criteria
Qualifiers
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.
Absolute Neutrophil Count (ANC) ≥1,000/mcL
Disqualifiers
Uncontrolled illness, including symptomatic congestive heart failure (NYHA III/IV), unstable angina, or cardiac procedure within 2 weeks of start of ICI.
Concurrent therapy: use of other investigational (no FDA approval for any indication) anti-cancer agents within 14 days of registration.
Although other therapy is allowed together with the off-label ICI use as outlined in the protocol, before starting the study ICI off-label drug, the patient must be off other anti-cancer therapies for at least 2 weeks or 5 half-lives, whichever is shorter.
Major surgery (as defined by the treating medical oncologist) within two weeks of the start date of immunotherapy.
Trial design
Treatments tested in this trial
- One or more off-label ICIs alone or with other on-label ICI(s)
- Off-label ICI(s) with targeted therapy
- off-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
Treatment groups
231 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov