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

August 11, 2026 updated by: Val Adams

Optimizing Ancillary Therapies (Acetaminophen, Cannabis, Antihistamines, and NSAIDS) With Immune Checkpoint Inhibitors for Solid Tumors (OAT ICI)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There are multiple reports of ancillary drugs impacting the efficacy of immune checkpoint inhibitor therapy. However, there are no prospective studies evaluating the potential benefit of optimizing multiple ancillary therapies in a prospective study. To address this gap in knowledge the approach is to compare two groups; the first group is a prospective interventional population consisting of 98 solid tumor patients who have radiologically measurable cancer which are scheduled to receive immunotherapy as part of the participant's cancer treatment. Enrolled patients will be asked to avoid daily acetaminophen and the use of cannabis/THC/CBD. The participants will also be prescribed aspirin 162 mg (2 x 81 mg baby aspirin) and loratadine 10 mg to be taken once daily for 126 days. Collectively, optimizing these 4 drugs is called the OAT protocol. Once the prospective patient enrollment is complete, a historical control will be created to match patients based on their cancer, the treatment regimen, line of therapy, performance status, and age. The control group will not have received the OAT protocol optimization. The primary endpoint of the trial will be response rate at 18 weeks. Other efficacy endpoints include progression free survival and overall survival at 12 months. Safety and toxicity endpoints include those associated with aspirin and loratadine as well as the rate of immune-related adverse events. The study will also capture drug discontinuation, including ICI therapy as a measure of toxicity. Lastly, the study will explore the efficacy of the OAT protocol in different populations based on disease, smoking status, genetics, and cytokines. The hypothesis is that optimizing these therapies will increase response rates by at least 15% compared to the controls.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Recruiting
        • University of Kentucky Markey Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: 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.
Drug: 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.
Behavioral: Acetaminophen Avoidance
Participants will be instructed to avoid acetaminophen-containing products during immune checkpoint inhibitor therapy as part of the OAT ICI protocol.
Behavioral: THC Avoidance
Participants will be instructed to avoid THC-containing products during immune checkpoint inhibitor therapy as part of the OAT ICI protocol.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
18- Week Response Rate
Time Frame: 18 Weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival by Disease Cohort
Time Frame: 12 Months
Progression-free survival among participants with lung cancer, head and neck cancer, bladder cancer, melanoma, and renal cell carcinoma compared with matched historical controls.
12 Months
Response Rate by Disease Cohort
Time Frame: 18 Weeks
Response rate (RECIST) at 18 weeks among participants with lung cancer, head and neck cancer, bladder cancer, melanoma, and renal cell carcinoma compared with matched historical controls
18 Weeks
Overall Survival
Time Frame: 12 Months
Overall survival at 12 months among participants receiving the OAT ICI protocol compared with matched historical controls.
12 Months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Immune Cell Populations
Time Frame: Baseline, 9 Weeks and 18 Weeks
T-cell subsets (including regulatory T cells [Tregs] and T-helper 17 [Th17] cells, monocytes, neutrophils at baseline, 9 and 18 weeks. Associations between baseline values and changes over time with response rate will be evaluated.
Baseline, 9 Weeks and 18 Weeks
Changes in Cytokine Profile
Time Frame: Baseline, 9 Weeks and 18 Weeks
Cytokine profiles, including inerleukin-10 (IL-10) and histamine concentrations, measured at baseline, 9 and 18 weeks. Associations between baseline values and changes over time with response rate will be evaluated.s.
Baseline, 9 Weeks and 18 Weeks
Response Rate by Tumor Histology
Time Frame: 18 Weeks
Response rate stratified by tumor histology including adenocarcinoma, squamous cell carcinoma, and other histologic subtypes.
18 Weeks
Response Rate by Smoking Status and Genetic Profile
Time Frame: 18 Weeks
Association of response rate with smoking status and genetic factors, including tumor mutational burden (TMB) and programmed death-ligand 1 (PD-L1) expression levels, using genetic data obtained from standard of care next-generation sequencing.
18 Weeks
Response Rate by Concurrent Ancillary Therapies
Time Frame: 18 Weeks
Association between response rate and use of other ancillary therapies that may affect immune checkpoint inhibitor effectiveness, including vaccines, proton pump inhibitors (PPIs), antibiotics and other concomitant treatments.
18 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Val Adams

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 114969

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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