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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Asprin

    Drug

    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

    Drug

    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

    Behavioral

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

  • THC Avoidance

    Behavioral

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

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: OAT ICIExperimental treatment 4 interventions
Group B: Matched Historical ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
18 Weeks

Secondary outcomes

1

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.

Time frame
12 Months
2

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

Time frame
18 Weeks
3

Overall Survival

Overall survival at 12 months among participants receiving the OAT ICI protocol compared with matched historical controls.

Time frame
12 Months

Other outcomes

1

Changes in Immune Cell Populations

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.

Time frame
Baseline, 9 Weeks and 18 Weeks
2

Changes in Cytokine Profile

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.

Time frame
Baseline, 9 Weeks and 18 Weeks
3

Response Rate by Tumor Histology

Response rate stratified by tumor histology including adenocarcinoma, squamous cell carcinoma, and other histologic subtypes.

Time frame
18 Weeks
4

Response Rate by Smoking Status and Genetic Profile

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.

Time frame
18 Weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Val Adams

Lead sponsor

University of Kentucky

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: