Advanced Biliary Tract Carcinoma study: Biospecimen Collection vs Immune Checkpoint Inhibitor
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 (ICI)?
An investigational drug being studied as a potential treatment for advanced biliary tract carcinoma. It is designed to block checkpoint proteins on immune cells, helping the body’s immune system recognize and attack cancer cells.
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
- The study wants to see whether the time of day that immunotherapy is given, morning before 10:30 am or afternoon after 12:30 pm, affects how well it works for patients with advanced or metastatic solid tumors.
- Who it's for
- People who have advanced or metastatic solid tumors such as liver, lung, kidney, melanoma, head and neck cancers, or other solid cancers that have spread to nearby tissue, lymph nodes, or distant parts of the body.
- What's involved
- Participants will receive standard immunotherapy with monoclonal antibodies either in the morning or in the afternoon, and will have regular clinic visits and tests to monitor their health and the cancer’s response.
- 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
- 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)
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
- Known 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
- 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
- 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
- Known Active, uncontrolled central nervous system (CNS) metastases
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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?
This study is enrolling now at Portland, Oregon, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.