Clinical trial · Interventional
Off-Label Treatment With Immune Checkpoint Inhibitor Blockade
NCT07754292CI-TRIAL-00121137not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 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 | — | UNRESOLVED |
| Off-label ICI(s) with targeted therapy | Drug | — | UNRESOLVED |
| One or more off-label ICIs alone or with other on-label ICI(s) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- One or more off-label ICI(s) alone or with other on-label ICI(s).
- description
- 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.
- interventionNames
- Drug: One or more off-label ICIs alone or with other on-label ICI(s)
- type
- EXPERIMENTAL
- label
- Off-label ICI(s) with targeted therapy
- description
- 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.
- interventionNames
- Drug: Off-label ICI(s) with targeted therapy
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.