Study on How Treatment Timing Affects Immunotherapy for Cancer
Sponsor: Liza Villaruz, MD
ClinicalTrials ID:NCT07224971
This clinical trial is exploring whether the time of day when immunotherapy is given affects its effectiveness in treating advanced or metastatic cancers. Patients will be randomly assigned to receive treatment either in the morning or afternoon.
Patient Parameters
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Program Overview
The study aims to find out if the timing of immunotherapy treatments, given either in the morning or afternoon, makes a difference in how well it works for patients with advanced or metastatic cancers. Participants will be randomly assigned to receive their treatment either before 11:00 AM or after 12:00 PM. The study will include patients with different types of cancer, such as Non-Small Cell Lung Cancer (NSCLC) and other solid tumors, who are receiving their first round of immunotherapy or are continuing treatment after initial therapy.
Description
This study is investigating whether the time of day affects the effectiveness of immunotherapy treatments for cancer. Immunotherapy drugs like pembrolizumab, nivolumab, and others are used to help the immune system fight cancer. The study will take place at a large cancer center in the US and will include three groups of patients: those with advanced Non-Small Cell Lung Cancer (NSCLC) starting immunotherapy, those with NSCLC continuing treatment after initial therapy, and patients with other advanced solid tumors starting immunotherapy. Researchers will look at how long patients live without the cancer getting worse, overall survival, safety, quality of life, and cost-effectiveness of the treatment. This is the first study in the US to look at how the timing of immunotherapy affects its success.
Eligibility Criteria
Inclusion Criteria
- Patients with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who are starting their first round of immunotherapy.
- NSCLC patients who have completed initial therapy and are continuing with maintenance immunotherapy.
- Patients with advanced or metastatic solid tumors starting their first round of immunotherapy.
- Patients must not have received immunotherapy before (for certain groups) or must be continuing after initial therapy.
- Willing to receive treatment at a specific time of day, either in the morning or afternoon.
- Eligible to receive immunotherapy alone or with other approved treatments.
- Able to understand and sign a consent form.
- Able to read and write in English.
Exclusion Criteria
- Unable to receive immunotherapy due to previous allergic reactions to the treatment or its ingredients.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UPMC Hillman Cancer Center | 15232 | Pittsburgh | Pennsylvania |
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