Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study

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
• Advanced Melanoma
• Advanced Renal Cell Carcinoma
• Metastatic Biliary Tract Carcinoma
• Metastatic Head and Neck Squamous Cell Carcinoma
• Metastatic Hepatocellular Carcinoma
• Metastatic Lung Non-Small Cell Carcinoma
• Metastatic Malignant Solid Neoplasm
• Metastatic Melanoma
• Metastatic Renal Cell Carcinoma
• Recurrent Head and Neck Squamous Cell Carcinoma
• Stage III Hepatocellular Carcinoma AJCC v8
• Stage III Lung Cancer AJCC v8
• Stage III Renal Cell Cancer AJCC v8
• Stage IV Hepatocellular Carcinoma AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Immune Checkpoint Inhibitor

Receive immune checkpoint inhibitor therapy

Sponsors & Collaborators

• Oregon Health and Science University

  collaborator OTHER

• OHSU Knight Cancer Institute

  lead OTHER

Principal Investigators

• Rajat Thawani · OHSU Knight Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2028-12-31

Completion

2028-12-31

FDA Drug

Yes

Countries

• United States

Study Locations