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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Immune Checkpoint Inhibitor — DRUG
  Receive immune checkpoint inhibitor therapy

Study Details

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.

Key Dates

Start date

Jul 31, 2026

Status verified

May 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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]) ]

Locations (1)

Find similar trials in Portland, OR

Related Studies

• Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Anchorage, Alaska
• Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama
• Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer
  PHASE3 · Recruiting · National Cancer Institute (NCI) · Anchorage, Alaska
• Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial
  PHASE3 · Recruiting · SWOG Cancer Research Network · Birmingham, Alabama