Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants with Advanced and/or Unresectable Biliary Tract Carcinoma

This important study is investigating a new treatment approach for advanced biliary tract cancer, which is a cancer affecting the bile ducts. Researchers want to find out if adding a drug called pembrolizumab, also known as Keytruda, to the usual chemotherapy (gemcitabine and cisplatin) helps patients live longer. The study is comparing this new combination treatment against the standard chemotherapy plus a dummy drug (placebo). This is a 'Phase 3' study, meaning it's a large trial designed to confirm if the new treatment is safe and effective before it can be widely used. The main goal is to see if patients receiving the new combination treatment live longer overall.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

196

Start

24 Nov 2023

Biliary Tract Carcinoma

What is this study about?

This study focuses on a type of cancer called biliary tract carcinoma. This cancer affects the bile ducts, which are tubes that carry digestive fluid (bile) from the liver. When this cancer is advanced or can't be removed by surgery, doctors are always looking for better ways to treat it and help patients.

The current study is testing a new treatment combination. One of the drugs being tested is pembrolizumab, which you might know as Keytruda. This type of drug works by helping your own immune system fight the cancer. It's being given alongside two standard chemotherapy drugs, gemcitabine and cisplatin. The study is comparing this new combination to the standard chemotherapy given with a placebo, which is an inactive substance that looks just like the real drug. By comparing these two groups, doctors can clearly see if adding pembrolizumab makes a difference.

The main goal of this study is to see if patients who receive the new combination treatment live longer than those who receive the standard chemotherapy. They will also be looking at other important things, like how long patients live without their cancer growing or spreading, how many people see their cancer shrink or disappear, and how long those improvements last. Safety is also very important, so researchers will carefully track any side effects patients experience.

Key takeaways

This study tests a new drug (Keytruda) plus chemotherapy for advanced bile duct cancer.
It aims to see if this combination helps people live longer.
Patients are randomly assigned to either the new combination or standard chemotherapy.
It's a 'double-blind' study, meaning you won't know which treatment you're getting.
Regular medical checks will monitor your health and the treatment's effects.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. There isn't an upper age limit mentioned, so older adults could also be part of the study.

This study is for both men and women. The specific type of cancer being studied is advanced or inoperable biliary tract carcinoma. This means the cancer has spread or cannot be removed through surgery.

There will be other detailed medical criteria that your doctor will check to see if this study is right for you. These criteria are in place to make sure the study includes people who can benefit most and to keep everyone safe.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced or inoperable biliary tract carcinoma?
Are you able to attend regular clinic visits and tests?
Are you generally able to cope with chemotherapy treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to one of two groups, like flipping a coin. One group will receive the new drug pembrolizumab along with standard chemotherapy (gemcitabine and cisplatin). The other group will receive a placebo (a dummy drug) along with the same standard chemotherapy. Neither you nor your study doctor will know which treatment you are receiving – this is called a 'double-blind' study.

Treatment will involve regular visits to the clinic for infusions of the medications. You will have regular tests, scans, and blood checks to monitor your health, how the treatment is working, and any side effects. These assessments will help the doctors understand the treatment's impact. The exact number of visits and tests will be detailed by the study team. You will have follow-up appointments even after your treatment phase is complete to continue monitoring your health. The total duration of your participation will depend on how you respond to treatment and the study plan, but it could last for an extended period.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving close medical attention and access to a new treatment that might be more effective than standard care for your advanced biliary tract cancer. However, there are also potential risks, including experiencing side effects from the study medications. Pembrolizumab and chemotherapy drugs can have various side effects, which your doctor will explain in detail. It's important to remember that the new treatment might not work, or it might not work better than standard treatment. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Ireland
—
Unverified
Germany
—
Unverified
Spain
—
Unverified
Netherlands
—
Unverified
Italy
—
Unverified
France
—
Unverified
Belgium

Common questions

What is biliary tract carcinoma?

It's a type of cancer that develops in the bile ducts, which are small tubes that carry a digestive fluid called bile from the liver.

What is pembrolizumab (Keytruda)?

It's a modern treatment called immunotherapy that helps your body's own immune system find and fight cancer cells.

What does 'Phase 3' mean for a clinical trial?

It means this is a large study comparing a new treatment to the standard treatment to see if it's safe and works better, before it can be widely available.

Will I know if I'm getting the new drug or the standard treatment?

No, in this study, neither you nor your doctor will know which treatment you are receiving. This helps make the study results fair.

What is the main goal of this study?

The main goal is to see if patients who receive the new combination treatment live longer overall compared to those receiving standard chemotherapy alone.