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Compares treatment options for Advanced Biliary Tract Carcinoma
Official title Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study
ClinicalTrials.gov ID: NCT07405086
What this study is testing
What is Immune Checkpoint Inhibitor?
Immune Checkpoint Inhibitor is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced biliary tract carcinoma.
Also referred to as ICI.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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),
You likely can't join if
- 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...
- Uncontrolled autoimmune disease requiring immunosuppression
- Active, uncontrolled central nervous system (CNS) metastases
See the full eligibility 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
- 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...
- Uncontrolled autoimmune disease requiring immunosuppression
- Active, uncontrolled central nervous system (CNS) metastases
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.