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Off-Label Treatment With Immune Checkpoint Inhibitor Blockade

NCT07754292 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2026-08-10

No results posted yet for this study

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.

Conditions

  • Malignancy

Interventions

DRUG

One 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.

DRUG

Off-label ICI(s) with targeted therapy

Subjects will receive one of three ICI regimens, as prescribed by their treating medical oncologist.

DRUG

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

Subjects will receive one of three ICI regimens, as prescribed by their treating medical oncologist.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Razelle Kurzrock, MD · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-01
Primary Completion
2032-11-01
Completion
2036-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07754292 on ClinicalTrials.gov