Clareo Health | Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
OHSU Knight Cancer Institute
With
Oregon Health and Science University
PRIMARY OBJECTIVE:
I. To compare progression-free survival among participants receiving immunotherapy based on time of day (ToD) administration (early versus \[vs.\] late).
SECONDARY OBJECTIVES:
I. To compare overall survival among participants receiving immunotherapy based on ToD administration (am vs. pm).
II. To compare rates of significant immune-related adverse events (irAEs) based on ToD administration (am vs. pm).
EXPLORATORY OBJECTIVES:
I. To compare objective responses among participants receiving immunotherapy based on ToD administration (am vs. pm).
II. To compare disease control among participants receiving immunotherapy based on ToD administration (am vs. pm).
III. To compare the duration of response among participants receiving immunotherapy based on ToD administration (am vs. pm).
OUTLINE: Patients are randomized to 1 of 2 cohorts.
AM COHORT: Patients receive standard of care immunotherapy before 10:30 for 4 doses in the absence of disease progression or unacceptable toxicity. Subsequent doses may be given per standard of care timing. Patients also undergo blood sample collection throughout the study.
PM COHORT: Patients receive standard of care immunotherapy after 13:30 for 4 doses in the absence of disease progression or unacceptable toxicity. Subsequent doses may be given per standard of care timing. Patients also undergo blood sample collection throughout the study.
After completion of immunotherapy treatment, patients are followed up every 6 months for 2 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Must provide written informed consent before any study-specific procedures or interventions are performed
Aged ≥ 18 years
Histologically confirmed advanced/metastatic solid tumor as follows:
* Non small cell lung cancer (NSCLC) (driver-negative, immune checkpoint inhibitor \[ICI\]-eligible)
* Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) (platinum-eligible),
* Renal cell carcinoma (RCC)
* Biliary-tract cancer (BTC)
* Hepatocellular carcinoma (HCC)
* Melanoma
Planned to receive a Food and Drug Administration (FDA)-approved immune check point inhibitor (e.g., anti-PD-1, anti-PD-L1, anti-CTLA4) regimen for the treatment of their malignancy
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
You may not be if
Prior ICI-based regimen for treatment of cancer
Current or prior use of immunosuppressive medication within 28 days before planned standard-of-care immunotherapy infusion, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses not exceeding 10 mg/day of prednisone (or equivalent corticosteroid)
