Can immune checkpoint drugs fight cancers beyond their approved uses?
NCT ID NCT07754292
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This phase 2 trial investigates whether immune checkpoint inhibitors—medicines that help the immune system attack cancer—can be effective when used off-label for different types of malignancies. Adults with cancer whose doctor is considering such treatment may join. Participants receive one of several ICI regimens, possibly combined with other therapies, and researchers track tumor response, side effects, and how long the disease stays controlled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- immune checkpoint inhibitors (ICIs) used off-label, alone or with other treatments
- What this could lead to
- If effective, this could expand treatment options for people with cancers that have not responded to standard therapies, potentially slowing disease progression.
- What could go wrong
- This is an early-phase trial, and off-label use may not work for all cancer types. Immune checkpoint inhibitors can cause serious immune-related side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 231 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2036
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 5\. 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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