Ancillary Therapies with Immune Checkpoint Inhibitors for Cancer
(OAT ICI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for people with solid tumors (early or advanced) who are about to start immune checkpoint inhibitor therapy. Participants must be willing to avoid daily acetaminophen and THC/cannabis products, take aspirin and loratadine, have good organ function, a life expectancy of at least 3 months, and be able to follow study procedures.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Acetaminophen Avoidance
- Aspirin
- Loratadine
- THC Avoidance
Trial Overview
The study tests if avoiding daily acetaminophen and cannabis/THC/CBD while taking aspirin and loratadine can make immune checkpoint inhibitors work better in people with solid tumors. Results will be compared to similar patients treated in the past.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Val Adams
Lead Sponsor
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