Optimizing Ancillary Therapies With Immune Checkpoint Inhibitors for Solid Tumors (OAT ICI)

NCT07661459 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 114969
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates whether optimization of ancillary therapies can improve the efficacy of immune checkpoint therapy in participants with solid tumors. The ancillary therapies being optimized include the avoidance of daily acetaminophen and cannabis/THC/CBD while prescribing aspirin and loratadine. The goal is to see if optimizing these four drugs can improve the efficacy of the treatment compared to a matched historical control.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 18- Week Response Rate

  To determine whether the OAT protocol improves therapeutic response to immune checkpoint inhibitor-containing regimens compared with matched historical controls, as measured by 18-week response rate.

  18 Weeks

Secondary Outcomes (3)

• Progression-Free Survival by Disease Cohort

  12 Months

• Response Rate by Disease Cohort

  18 Weeks

• Overall Survival

  12 Months

Other Outcomes (5)

• Changes in Immune Cell Populations

  Baseline, 9 Weeks and 18 Weeks

• Changes in Cytokine Profile

  Baseline, 9 Weeks and 18 Weeks

• Response Rate by Tumor Histology

  18 Weeks

Study Arms (2)

OAT ICI

EXPERIMENTAL

Participants with solid tumors receiving standard-of-care immune checkpoint inhibitor therapy will follow the OAT ICI protocol, which includes use of loratadine and aspirin (or continuation of an equivalent antihistamine/NSAID), avoidance of acetaminophen, and avoidance of THC-containing products.

Drug: Asprin; Drug: Loratadine; Behavioral: Acetaminophen Avoidance; Behavioral: THC Avoidance

Matched Historical Control

NO INTERVENTION

Retrospective matched controls identified from UK Healthcare EHR and Kentucky Cancer Registry data. Controls will be matched to enrolled participants by tumor type, disease stage, treatment regimen, line therapy, age group and ECOG performance status. Historical controls will not receive the OAT ICI protocol.

Interventions

Asprin DRUG

Participants will receive Aspirin or continue an equivalent NSAID as part of the OAT ICI protocol while receiving standard-of-care immune checkpoint inhibitor therapy.

OAT ICI

Loratadine DRUG

Participants will receive Loratadine or continue an equivalent antihistamine as part of the OAT ICI protocol while receiving standard-of-care immune checkpoint inhibitor therapy.

OAT ICI

Acetaminophen Avoidance BEHAVIORAL

Participants will be instructed to avoid acetaminophen-containing products during immune checkpoint inhibitor therapy as part of the OAT ICI protocol.

OAT ICI

THC Avoidance BEHAVIORAL

Participants will be instructed to avoid THC-containing products during immune checkpoint inhibitor therapy as part of the OAT ICI protocol.

OAT ICI

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Val Adams: lead

MeSH Terms

Interventions

acetylsalicylic acid lysinate; Loratadine

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Central Study Contacts

Val Adams

CONTACT

8592575202; val.adams@uky.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06