Off-Label Treatment With Immune Checkpoint Inhibitor Blockade

NCT07754292 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PRO00059781
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

immune checkpoint inhibitor

Outcome Measures

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.

  at least 6 months

Secondary Outcomes (3)

• Serious adverse events

  Up to 5 Years

• Progression-Free Survival

  Up to 5 years

• Overall Survival

  Up to 5 years

Study Arms (3)

One or more off-label ICI(s) alone or with other on-label ICI(s).

EXPERIMENTAL

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.

Drug: One or more off-label ICIs alone or with other on-label ICI(s)

Off-label ICI(s) with targeted therapy

EXPERIMENTAL

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.

Drug: Off-label ICI(s) with targeted therapy

Off-label ICI(s) with other agents that are not targeted with or without targeted agents.

EXPERIMENTAL

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.

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

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.

One or more off-label ICI(s) alone or with other on-label ICI(s).

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 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 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 with or without targeted agents.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. Females of child-bearing potential must have a negative pregnancy test and must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of informed consent, for the duration of study participation, and for 6 months following completion of therapy. Should a female patient become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception from the time of informed consent, for the duration of study participation, and 6 months after completion of administration.
• NOTE: A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy
• Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months)
• Ability to understand a written informed consent document and the willingness to sign it.
• Physician has verified coverage of the cost of the drug(s) via insurance, specialty pharmacy, patient assistance programs, or other means, as documented by physician/mid-level or nursing notes, pharmacist notes, or MCW/FH insurance approval.

You may not qualify if:

• 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.
• Other: pregnancy or lactation.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Razelle Kurzrock, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505; cccto@mcw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Faculty Director

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2032
• Study Completion (Estimated): November 1, 2036
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)