Recruiting
Phase 2

Immune Checkpoint Therapy

Sponsor:

Val Adams

Code:

NCT07661459

Conditions

Solid Tumors

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Asprin

Loratadine

Acetaminophen Avoidance

THC Avoidance

Study Details

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

Study ID

NCT07661459

Start date

Jun 26, 2026

Status verified date

Aug, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

98 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OAT ICI

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.

no intervention: Matched Historical Control

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

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.

Loratadine

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.

Acetaminophen Avoidance

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

THC Avoidance

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

Primary outcome measure

  • 18- Week Response Rate [ Time Frame: 18 Weeks ]

Central Contacts and Locations

Central contacts

Val Adams

8592575202val.adams@uky.edu

Locations

University of Kentucky Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Val Adams

859-257-5202vadam0@uky.edu

More Information

Sponsor

Val Adams

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Val Adams on 2026-08-14.