Recruiting

Immunotherapy

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT07405086

Conditions

Advanced Biliary Tract Carcinoma

Advanced Head and Neck Squamous Cell Carcinoma

Advanced Hepatocellular Carcinoma

Advanced Lung Non-Small Cell Carcinoma

Advanced Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Immune Checkpoint Inhibitor

Study Details

Brief summary:

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.

Conditions

Advanced Biliary Tract Carcinoma

Advanced Head and Neck Squamous Cell Carcinoma

Advanced Hepatocellular Carcinoma

Advanced Lung Non-Small Cell Carcinoma

Advanced Malignant Solid Neoplasm

Study ID

NCT07405086

Start date

Jun 8, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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) (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 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
  • Active, uncontrolled central nervous system (CNS) metastases

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (AM cohort)

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.

experimental: Treatment (PM cohort)

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.

Interventions

Biospecimen Collection

Undergo blood sample collection

Immune Checkpoint Inhibitor

Receive immune checkpoint inhibitor therapy

Primary outcome measure

  • Progression free survival [ Time Frame: From date of randomization to date of first progression or death (any cause), whichever occurs first (up to 2 years from date of last dose of standard-of-care immune checkpoint inhibitor [ICI]) ]

Central Contacts and Locations

Locations

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Rajat Thawani

503-494-6574thawani@ohsu.edu

Principal Investigator:

Rajat Thawani

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2026-06-12.