Optimizing Additional Therapies With Immune Checkpoint Inhibitors for Solid Tumors
Official title: Optimizing Ancillary Therapies (Acetaminophen, Cannabis, Antihistamines, and NSAIDS) With Immune Checkpoint Inhibitors for Solid Tumors (OAT ICI)
Run by University of Kentucky · NCT07661459 · Data updated 2026-11-12
This study tests whether avoiding daily acetaminophen and cannabis products while taking aspirin and loratadine can boost the effectiveness of immune checkpoint therapy for people with solid tumors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 98 (estimated) |
| Sponsor | University of Kentucky Academic / other |
| Drugs / interventions | immunotherapy, radiation, prednisone |
| Locations | 1 site (Lexington, Kentucky) |
| Status | Recruiting |
| Started | June 26, 2026 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | August 14, 2026 |
| Trial ID | NCT07661459 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with measurable solid tumors planned to receive a PD-1 or PD-L1 inhibitor as part of standard care, willing to avoid acetaminophen and THC-containing products, and willing to take aspirin and loratadine for ~126 days.
✕Probably not a fit
Patients who do not respond to immunotherapy due to factors unrelated to the ancillary drugs, or who cannot safely discontinue acetaminophen or cannabis, may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2 interventional trial explores whether optimizing four ancillary drugs around immune checkpoint therapy can improve responses in solid tumor patients. Participants will abstain from daily acetaminophen and cannabis products, and will take aspirin and loratadine daily for about four months. The study compares outcomes to a matched historical control to see if this OAT protocol affects response rate at 18 weeks, with secondary endpoints including progression-free and overall survival, plus safety related to the ancillary medications and immune-related adverse events. Enrollment targets 98 patients receiving a PD-1/PD-L1 inhibitor as part of standard care, with follow-up through 12 months for survival outcomes. Data will be collected on treatment discontinuation and ICI therapy adherence.
Why it matters
Potential benefit: If successful, the protocol could improve responses to immunotherapy and extend survival for some patients with solid tumors.
How similar studies have gone: Prospective data on optimizing ancillary therapies with immunotherapy are limited; this approach is relatively novel and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Solid tumor patients with measurable disease. Including patients with early stage and advanced stage cancer. * Patients who are to get neoadjuvant or induction therapy prior to planned surgery or radiation are included if definitive therapy is planned to occur at least 18 weeks after ICI initiation. * Treatment plan includes an immune checkpoint inhibitor (PD1 or PD-L1 inhibitor) as standard of care. Standard of care will be determined by referring to the NCCN guidelines. For rare situations where a disease is not found in the NCCN guideline, the treatment must be considered standard of care at the MCC. * ECOG Performance Status 0-3. * Life expectancy of at least 3 months. * Adequate hematologic, renal and hepatic function based on institutional standards. * Must be willing to stop/not start daily acetaminophen during the study period * Must be willing to stop/not start THC-containing agent (e.g., medical or recreational marijuana, CBD) during the study period * Patients willing to take a second-generation antihistamine (loratadine) and an NSAID (aspirin). Patients already taking a daily antihistamine and/or NSAID can participate and will continue the class of drug already being taken * Ability to understand and the willingness to follow study procedures, including urine testing for THC. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Contraindication to immunotherapy, aspirin, or loratadine (including patients on blood thinners or antiplatelet agents that pose a high risk of bleeding based on the treating oncologist's opinion) * History of allergic reactions attributed to loratadine or aspirin (true allergy, not intolerance) * Known immunocompromised patients; defined as disease or drug related. This includes solid organ transplant patients, patients with active human immunodeficiency virus (detectable disease within the last 60 days), and those with autoimmune diseases on immune modulating drugs (disease modifying agents or steroids at a prednisone equivalent dose \> 10 mg daily). * Early-stage disease patients who are scheduled for definitive therapy in less than 126 days from treatment initiation * Patients must not have had prior ICIs for advanced disease except as neoadjuvant + adjuvant therapy. Patients with recurrence after definitive therapy may have had prior ICIs for earlier stage disease if it was \> 6 months since the last dose. * Patients on an interventional cancer study * History or evidence of any other clinically significant condition that, in the opinion of the investigator or treating physician, would pose a risk to subject safety or interfere with study procedures, evaluation or completion
Where it's running
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University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States Recruiting
Study contacts
- Study coordinator: Val Adams
- Email: val.adams@uky.edu
- Phone: 8592575202
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.