Optimizing Ancillary Therapies With Immune Checkpoint Inhibitors for Solid Tumors (OAT ICI)
ConditionSolid Tumors
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorVal Adams
About 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Asprin
- Loratadine
- Acetaminophen Avoidance
- THC Avoidance
Treatment groups
98 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Val Adams
Lead sponsor
University of Kentucky
Sponsor institution
Source ClinicalTrials.gov