Study on Morning Versus Afternoon Immunotherapy for Treating Advanced or Metastatic Solid Tumors

Sponsor: OHSU Knight Cancer Institute

Sponsor score: 60

ClinicalTrials ID:NCT07405086

Provider View

This clinical trial is exploring whether the time of day when immunotherapy is given affects its effectiveness in treating advanced or metastatic solid tumors. Researchers are comparing morning and afternoon treatments to see if the body's internal clock influences the response to immunotherapy.

Patient Parameters

Program Overview

This study is investigating if the timing of immunotherapy—morning versus afternoon—affects its success in treating advanced or metastatic solid tumors. Immunotherapy uses monoclonal antibodies to help the immune system attack cancer cells. The body's internal clock, or circadian rhythm, may influence how well the immune system responds to treatment. Researchers want to find out if giving immunotherapy in the morning (before 11:00 am) or in the afternoon (after 12:00 pm) makes a difference in its effectiveness.

Description

The main goal of this study is to compare how long patients live without their cancer getting worse when they receive immunotherapy in the morning versus the afternoon. Researchers will also look at overall survival rates and any significant side effects related to the immune system based on the time of day the treatment is given.

Participants will be randomly assigned to one of two groups:

  • Morning Group: Patients will receive their immunotherapy treatment before 10:30 am for four doses, unless the cancer progresses or side effects become unacceptable. After these doses, treatment will continue as per standard timing. Blood samples will be collected throughout the study.

  • Afternoon Group: Patients will receive their immunotherapy treatment after 1:30 pm for four doses, unless the cancer progresses or side effects become unacceptable. After these doses, treatment will continue as per standard timing. Blood samples will be collected throughout the study.

After completing the immunotherapy treatment, patients will have follow-up visits every six months for two years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced or metastatic solid tumor, such as:
    • Non-small cell lung cancer (NSCLC) eligible for immune checkpoint inhibitors.
    • Recurrent or metastatic head and neck cancer eligible for platinum-based treatment.
    • Renal cell carcinoma (RCC).
    • Biliary-tract cancer (BTC).
    • Hepatocellular carcinoma (HCC).
    • Melanoma.
  • Planned to receive an FDA-approved immune checkpoint inhibitor for their cancer.
  • Have measurable disease according to specific medical criteria.

Exclusion Criteria

  • Have previously received an immune checkpoint inhibitor for cancer treatment.
  • Currently using or have recently used immunosuppressive medication, except for certain low-dose steroids.
  • Have an uncontrolled autoimmune disease that requires immunosuppression.
  • Have active, uncontrolled cancer that has spread to the central nervous system.

Locations

FACILITYZIPCITYSTATE
OHSU Knight Cancer Institute97239PortlandOregon

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