Lactulose to Improve Gut Health in Cancer Patients Receiving Immunotherapy (NCT07354100)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Inclusion Criteria Phase I
2. Patients must have a histologically confirmed malignancy that is to receive exclusively ICIs (no chemotherapy or RT in combination) per standard of care during the time in which lactulose will be administered. This includes, but is not limited to, melanoma, cutaneous squamous cell carcinoma, non-small cell lung cancer, mesothelioma, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial cancer, MSI/MMRd cancer, cancers with high tumor mutational burden (\>=10 muts/mB), esophageal cancer, hepatocellular carcinoma, and renal cell carcinoma. Anti-PD-1 or anti-PD-L-1 therapy combinations with anti-LAG-3 or anti-CTLA-4 combinations are permitted.
3. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of lactulose in combination with ICIs in patients \<18 years of age, children are excluded from this study.
4. ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
5. Patients must be able to ingest liquids.
6. Inclusion Criteria Phase II
7. Patients must have a histologically confirmed cutaneous or mucosal melanoma. Uveal melanoma is excluded.
8. Measurable disease per RECIST 1.1.32
9. Documented primary or acquired resistance to anti-PD-1 and anti-CTLA4 therapy per SITC guidelines.21 Primary resistance is defined as disease progression after a minimum of 6 weeks of therapy, provided the patient has received at least two full cycles of treatment, and there has been no prior evidence of clinical benefit (partial response, complete response, or stable disease lasting at least 6 months). Acquired resistance is defined as disease progression after an initial clinical benefit while still on therapy or within 12 weeks of discontinuing therapy, provided the patient received at least two cycles and 6 weeks of therapy.
10. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
11. Planned to receive standard ICI therapy (no RT/ICI or chemotherapy/ICI combinations).
12. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of lactulose in combination with ICIs in patients \<18 years of age, children are excluded from this study.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• University of Chicago Medicine Comprehensive Cancer Center — Chicago, Illinois

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.