MalignancyPhase 2NCT07754292
Off-Label Treatment With Immune Checkpoint Inhibitor Blockade
A Phase 2 study testing One or more off-label ICIs alone or with other on-label ICI(s), Off-label ICI(s) with targeted therapy and 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 in people with Malignancy, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancy
- What is being tested?
- One or more off-label ICIs alone or with other on-label ICI(s), Off-label ICI(s) with targeted therapy and 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Nov 2036
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
United States1 site
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Razelle Kurzrock, MD, 414-955-2848, rkurzrock@mcw.edu
Razelle Kurzrock, MD
About this study
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.
Read the detailed description
Subjects will be in one of the three following groups (n=69 for each group), depending on the therapy administered:
- Treatment Group A: One or more off-label immune checkpoint inhibitor (ICI) (s) alone or with other on-label ICI(s).
- Treatment Group B: Off-label ICI(s) with targeted therapy.
- Treatment Group C: Off-label ICI(s) with other agents that are not targeted (including, but not limited to, chemotherapy, hormonal therapy, and immunotherapy other than ICIs) with or without targeted agents.
At least one ICI agent must be off-label, and no agent can be investigational; agents other than ICI can be on-label or off-label, but all have to be FDA-approved.
- Conditions
- Malignancy
- Being tested
- One or more off-label ICIs alone or with other on-label ICI(s), 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
- Keywords
- immune checkpoint inhibitor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 therapyDrug
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 agentsDrug
Subjects will receive one of three ICI regimens, as prescribed by their treating medical oncologist.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at least 6 months
Secondary outcomes (3)
Serious adverse events
The number of Grade ≥3 serious adverse events at least possibly related to ICIs during treatment, per NCI CTCAE v6.0.
Measured: Up to 5 Years
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2032 (estimated)
- Study completion1 Nov 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignancyStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 231 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Razelle Kurzrock, MD, Medical College of Wisconsin
- Investigators
- Razelle Kurzrock, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754292
- Sponsor's protocol ID
- PRO00059781
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Off-Label Treatment With Immune Checkpoint Inhibitor Blockade
- ClinicalTrials.gov ID
- NCT07754292
- Acronym / sponsor ID
- PRO00059781
- Conditions
- Malignancy
- Keywords
- immune checkpoint inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 231 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2032 (estimated)
- Study completion
- 1 Nov 2036 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects will be in one of the three following groups (n=69 for each group), depending on the therapy administered:
- Treatment Group A: One or more off-label immune checkpoint inhibitor (ICI) (s) alone or with other on-label ICI(s).
- Treatment Group B: Off-label ICI(s) with targeted therapy.
- Treatment Group C: Off-label ICI(s) with other agents that are not targeted (including, but not limited to, chemotherapy, hormonal therapy, and immunotherapy other than ICIs) with or without targeted agents.
At least one ICI agent must be off-label, and no agent can be investigational; agents other than ICI can be on-label or off-label, but all have to be FDA-approved.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| One or more off-label ICI(s) alone or with other on-label ICI(s). | Experimental | Drug: One or more off-label ICIs 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. |
| Off-label ICI(s) with targeted therapy | Experimental | Drug: Off-label ICI(s) with targeted therapyStudy 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. |
| Off-label ICI(s) with other agents that are not targeted with or without targeted agents. | Experimental | 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 agentsNot 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | One or more off-label ICI(s) alone or with other on-label ICI(s). |
| Off-label ICI(s) with targeted therapySubjects will receive one of three ICI regimens, as prescribed by their treating medical oncologist. | Drug | 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 agentsSubjects 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 with or without targeted agents. |
Primary outcome
Clinical response.
Time frame: at least 6 months
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.
3 secondary outcomes
Serious adverse events
Time frame: Up to 5 Years
Progression-Free Survival
Time frame: Up to 5 years
Overall Survival
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
Razelle Kurzrock, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing One or more off-label ICIs alone or with other on-label ICI(s), Off-label ICI(s) with targeted therapy and 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 in people with Malignancy, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical College of Wisconsin Cancer Center Clinical Trials Office (866-680-0505 ext. 8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response. (time frame: at least 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.