Solid TumorsPhase 2OAT ICINCT07661459
Optimizing Ancillary Therapies With Immune Checkpoint Inhibitors for Solid Tumors (OAT ICI)
A Phase 2 study testing Asprin, Loratadine and Acetaminophen Avoidance in people with Solid Tumors, run by Val Adams at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Asprin, Loratadine and Acetaminophen Avoidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2026to 31 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40506
Val Adams, 859-257-5202, vadam0@uky.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Solid Tumors
- Being tested
- Asprin, Loratadine, Acetaminophen Avoidance, THC Avoidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsprinDrug
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.
LoratadineDrug
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 AvoidanceBehavioural
Participants will be instructed to avoid acetaminophen-containing products during immune checkpoint inhibitor therapy as part of the OAT ICI protocol.
THC AvoidanceBehavioural
Participants will be instructed to avoid THC-containing products during immune checkpoint inhibitor therapy as part of the OAT ICI protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 Weeks
Secondary outcomes (3)
Progression-Free Survival by Disease Cohort
Progression-free survival among participants with lung cancer, head and neck cancer, bladder cancer, melanoma, and renal cell carcinoma compared with matched historical controls.
Measured: 12 Months
Response Rate by Disease Cohort
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
Measured: 18 Weeks
Overall Survival
Overall survival at 12 months among participants receiving the OAT ICI protocol compared with matched historical controls.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start26 Jun 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Val Adams
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Val Adams, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661459
- Sponsor's protocol ID
- 114969
- Acronym
- OAT ICI
- Status last verified
- Aug 2026
- First submitted
- 16 Jun 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Ancillary Therapies (Acetaminophen, Cannabis, Antihistamines, and NSAIDS) With Immune Checkpoint Inhibitors for Solid Tumors (OAT ICI)
- ClinicalTrials.gov ID
- NCT07661459
- Acronym / sponsor ID
- OAT ICI / 114969
- Conditions
- Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Val AdamsUniversity, hospital or other
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OAT ICI | Experimental | Drug: Asprin, Drug: Loratadine, Behavioral: Acetaminophen Avoidance, Behavioral: THC AvoidanceParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AsprinParticipants 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 | OAT ICI |
| LoratadineParticipants will receive Loratadine or continue an equivalent antihistamine as part of the OAT ICI protocol while receiving standard-of-care immune checkpoint inhibitor therapy. | Drug | OAT ICI |
| Acetaminophen AvoidanceParticipants will be instructed to avoid acetaminophen-containing products during immune checkpoint inhibitor therapy as part of the OAT ICI protocol. | Behavioural | OAT ICI |
| THC AvoidanceParticipants will be instructed to avoid THC-containing products during immune checkpoint inhibitor therapy as part of the OAT ICI protocol. | Behavioural | OAT ICI |
Primary outcome
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.
3 secondary outcomes
Progression-Free Survival by Disease Cohort
Time frame: 12 Months
Response Rate by Disease Cohort
Time frame: 18 Weeks
Overall Survival
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Asprin, Loratadine and Acetaminophen Avoidance in people with Solid Tumors, run by Val Adams at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Val Adams (8592575202, val.adams@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18- Week Response Rate (time frame: 18 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.