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RecruitingPhase 4

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

Knight Cancer Institute Study of Histology-Agnostic Immunotherapy With Focus on Timing: - Knight SHIFT - A Prospective, Multi-Histology Pragmatic Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients also undergo blood sample collection throughout the study."
  • "After completion of immunotherapy treatment, patients are followed up every 6 months for 2 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The Knight SHIFT Study tests whether standard immunotherapy works better when given in the morning (before 10:30 a.m.) or afternoon (12:30 p.m.). Immunotherapy helps the immune system fight cancer. This study is for adults with certain solid tumors that have spread.

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 10:30 am) or afternoon (12:30pm). The time of day that immunotherapy is given (morning versus afternoon) may impact the effectiveness in treating patients with advanced or metastatic solid tumors.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Sign a consent form before any study tests or treatments.
  • Have cancer confirmed by a tissue test that is advanced or has spread.
  • Have one of these cancers: non-small cell lung cancer, head and neck squamous cell cancer, kidney cancer, bile duct cancer, liver cancer, melanoma, or cancer of the stomach or food pipe.
  • For lung cancer, have no gene change that can guide targeted treatment and be able to receive the study's type of immunotherapy.
  • For head and neck cancer, have cancer that has returned or spread and be able to receive platinum-based chemotherapy.
  • Plan to receive an FDA-approved immune checkpoint inhibitor, a type of immunotherapy, for your cancer.
  • Have cancer that can be measured using the study's rules.

Who can't join

  • Have had an immune checkpoint inhibitor to treat cancer before.
  • Have used medicine that weakens the immune system within 28 days before the planned immunotherapy dose. Exceptions include steroid nose sprays, inhaled steroids, and body-wide steroids at replacement doses no higher than 10 mg of prednisone a day or an equal dose of another steroid.
  • Have an uncontrolled autoimmune disease, where the immune system attacks the body, that needs medicine to weaken the immune system.
  • Have known, active, uncontrolled cancer spread to the brain or spinal cord.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

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