Phase 2 OAT ICI tests COX inhibition + H1 antihistamine modulation alongside ICIs

This Phase 2, single-site interventional study at University of Kentucky/Markey Cancer Center evaluates whether “optimizing” common ancillary meds can improve outcomes for patients with radiographically measurable early, advanced, or metastatic solid tumors receiving standard-of-care immune checkpoint inhibitors (e.g., PD-1/PD-L1 and/or CTLA-4 antibodies from companies such as Merck, Bristol Myers Squibb, Roche/Genentech, AstraZeneca, and Regeneron, depending on tumor type). The OAT ICI protocol adds loratadine (an H1 histamine receptor antagonist; Bayer’s Claritin heritage, now widely generic) and aspirin/acetylsalicylic acid (a COX-1/COX-2–biased NSAID; originally Bayer) or allows continuation of an equivalent antihistamine/NSAID, while asking participants to avoid daily acetaminophen (central prostaglandin synthesis inhibition; widely generic) and avoid THC-containing products such as dronabinol (cannabinoid receptor agonist; now generic, historically Marinol). The comparator is a retrospective matched historical control drawn from UK Healthcare EHR and the Kentucky Cancer Registry, matched by tumor type, stage, regimen, line of therapy, age group, and ECOG. The key angle is commercially practical: if simple, low-cost supportive-medication choices shift ICI response rates (the primary endpoint is response rate at 18 weeks), it could change routine “everything-else-the-patient-takes” guidance across many ICI regimens; today’s care is tumor-specific ICI-based therapy (often ICI alone or ICI + chemotherapy/targeted therapy) plus symptom-control meds chosen pragmatically rather than for immune-optimization.