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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
One or more off-label ICIs alone or with other on-label ICI(s)
DrugSubjects will receive one of three ICI regimens, as prescribed by their treating medical oncologist.
Off-label ICI(s) with targeted therapy
DrugSubjects will receive one of three ICI regimens, as prescribed by their treating medical oncologist.
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
DrugSubjects will receive one of three ICI regimens, as prescribed by their treating medical oncologist.
Treatment groups
231 Participants
are divided into 3 treatment groupsGroup A: One or more off-label ICI(s) alone or with other on-label ICI(s).Experimental treatment 1 intervention
Group B: Off-label ICI(s) with targeted therapyExperimental treatment 1 intervention
Group C: Off-label ICI(s) with other agents that are not targeted with or without targeted agents.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinical response.
The proportion of subjects who achieve complete response, partial response, or stable disease of at least 6 months, as evaluated by a physician investigator, who can use RECIST v1.1 and iRECIST. For non-solid malignancies, the standard evaluation criteria for that malignancy will be used.
Time frame
at least 6 monthsSecondary outcomes
1
Serious adverse events
The number of Grade ≥3 serious adverse events at least possibly related to ICIs during treatment, per NCI CTCAE v6.0.
Time frame
Up to 5 Years2
Progression-Free Survival
Time from the start of off-label ICI treatment to the earliest date of documented progression, symptomatic deterioration, start of new anti-cancer therapy, or death from any cause. Progression is assessed by the treating medical oncologist. Patients alive without reported progression (including no evaluation) are censored at last contact.
Time frame
Up to 5 years3
Overall Survival
Time from the start of off-label ICI treatment to the date of death from any cause. Patients last known to be alive are censored at the date of last contact.
Time frame
Up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov
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