Off-Label Treatment With Immune Checkpoint Inhibitor Blockade

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT07754292
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Malignancy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • One or more off-label ICIs alone or with other on-label ICI(s) — DRUG
    Subjects will receive one of three ICI regimens, as prescribed by their treating medical oncologist.
  • Off-label ICI(s) with targeted therapy — DRUG
    Subjects 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 — DRUG
    Subjects will receive one of three ICI regimens, as prescribed by their treating medical oncologist.

Study Details

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.

Key Dates

First listed
Aug 10, 2026
Start date
Nov 1, 2026
Status verified
Aug 2026
Primary completion
Nov 1, 2032
Completion
Nov 1, 2036

Study Design

Enrollment
231 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: One or more off-label ICI(s) alone or with other on-label ICI(s).
    Study drug(s) will be administered at the discretion of the treating medical oncologist in accordance with the FDA-approved prescribing information for each agent and applicable institutional standards of care.
  • Experimental: Off-label ICI(s) with targeted therapy
    Study drug(s) will be administered at the discretion of the treating medical oncologist in accordance with the FDA-approved prescribing information for each agent and applicable institutional standards of care.
  • Experimental: Off-label ICI(s) with other agents that are not targeted with or without targeted agents.
    Not targeted includes, but is not limited to chemotherapy, hormonal therapy, immunotherapy other than ICIs. Study drug(s) will be administered at the discretion of the treating medical oncologist in accordance with the FDA-approved prescribing information for each agent and applicable institutional standards of care.

Primary Outcome Measure

Clinical response. [ Time Frame: at least 6 months ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert & the Medical College of WisconsinMilwaukeeWisconsin53226
Razelle Kurzrock, MD
[email protected]
414-955-2848
Razelle Kurzrock, MD (PRINCIPAL_INVESTIGATOR)

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Froedtert & the Medical College of Wisconsin· Milwaukee, WI

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