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Recruiting Phase 4

Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study

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About this study

This phase IV trial is evaluating whether morning versus afternoon administration of standard of care immunotherapy impacts its effectiveness in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Circadian rhythm refers to the internal biological clock in which various processes in the body, including immune cell activity, are controlled by the time of day. Exactly how this works is not fully understood, and the researchers want to see if circadian rhythm control of the immune system can influence response to immunotherapy based on whether it is given in the morning (before 11:00 am) or afternoon (12:00pm). The time of day that immunotherapy is given (morning versus afternoon) may impact the effectiveness in treating patients with advanced or metastatic solid tumors.

Condition
Advanced Biliary Tract Carcinoma, Advanced Head and Neck Squamous Cell Carcinoma, Advanced Hepatocellular Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Malignant Solid Neoplasm, Advanced Melanoma, Advanced Renal Cell Carcinoma, Metastatic Biliary Tract Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hepatocellular Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Metastatic Renal Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage III Lung Cancer AJCC v8, Stage III Renal Cell Cancer AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8
Tested
Biospecimen Collection, Immune Checkpoint Inhibitor
Sponsor
OHSU Knight Cancer Institute

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 13

  • Minimum age: 18 years
  • Study condition: Advanced Biliary Tract Carcinoma, Advanced Head and Neck Squamous Cell Carcinoma, Advanced Hepatocellular Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Malignant Solid Neoplasm, Advanced Melanoma, Advanced Renal Cell Carcinoma, Metastatic Biliary Tract Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hepatocellular Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Metastatic Renal Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage III Lung Cancer AJCC v8, Stage III Renal Cell Cancer AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8
  • 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

Exclusion 4

  • 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)
  • Uncontrolled autoimmune disease requiring immunosuppression
  • Active, uncontrolled central nervous system (CNS) metastases

Where

1 site, 1 recruiting

OHSU Knight Cancer Institute

Portland, Oregon, United States

Recruiting

Potential match only. Final eligibility is determined by the study team.