Immunotherapy Timing for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Rajat Thawani
Principal Investigator
OHSU Knight Cancer Institute
Are You a Good Fit for This Trial?
Adults with certain advanced or metastatic solid tumors, including lung, head and neck, kidney, liver cancers, melanoma and biliary-tract cancer. Participants must be planning to receive FDA-approved immunotherapy and have measurable disease. They need to consent to study procedures.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard of care immunotherapy either in the morning or afternoon for 4 doses, with subsequent doses per standard of care timing
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Immune Checkpoint Inhibitor
Trial Overview
The trial is testing if the time of day immunotherapy is given affects its effectiveness against advanced/metastatic solid tumors. Patients will receive standard care monoclonal antibody treatments either in the morning (before 11 am) or afternoon (after 12 pm).
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
OHSU Knight Cancer Institute
Lead Sponsor
Oregon Health and Science University
Collaborator
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