Morning versus afternoon immunotherapy for advanced or metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase IV trial assigns adults with advanced or metastatic solid tumors to receive standard-of-care immune checkpoint inhibitors either before 10:30 AM or after 1:30 PM for the first four doses, with subsequent dosing per usual care. The primary endpoint is progression-free survival, with overall survival and rates of significant immune-related adverse events as key secondary endpoints and objective response, disease control, and duration of response as exploratory endpoints. Blood samples are collected during treatment to study immune and circadian biomarkers that might explain any timing effects. After completing immunotherapy, participants are followed every six months.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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) (non-actionable genomic alteration, 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
  * Gastroesophageal cancer, including esophageal cancer, gastroesophageal cancer, or gastric cancer
* 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 Criteria:

* 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
* Known Active, uncontrolled central nervous system (CNS) metastases

Where it's running

• OHSU Knight Cancer Institute
  Portland, Oregon, United States Recruiting

Study contacts

• Principal investigator: Rajat Thawani — OHSU Knight Cancer Institute

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.