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

11 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

98

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Stany Zjednoczone
    • Kentucky
      • Lexington, Kentucky, Stany Zjednoczone, 40506
        • Rekrutacyjny
        • University of Kentucky Markey Cancer Center
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: 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.
Lek: 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.
Behawioralne: Acetaminophen Avoidance
Participants will be instructed to avoid acetaminophen-containing products during immune checkpoint inhibitor therapy as part of the OAT ICI protocol.
Behawioralne: THC Avoidance
Participants will be instructed to avoid THC-containing products during immune checkpoint inhibitor therapy as part of the OAT ICI protocol.
Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
18- Week Response Rate
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Progression-Free Survival by Disease Cohort
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 12 Months
Overall survival at 12 months among participants receiving the OAT ICI protocol compared with matched historical controls.
12 Months

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Changes in Immune Cell Populations
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Val Adams

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

26 czerwca 2026

Zakończenie podstawowe (Szacowany)

31 lipca 2027

Ukończenie studiów (Szacowany)

31 lipca 2027

Daty rejestracji na studia

Pierwszy przesłany

16 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

22 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

14 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 114969

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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