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RecruitingPHASE1, PHASE2INTERVENTIONAL

A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)

This research study is investigating a new medication called sacituzumab tirumotecan, either on its own or in combination with other established cancer treatments. The study focuses on people in the UK with advanced bowel (colorectal) cancer, pancreatic cancer, or bile duct cancer that has spread or cannot be removed by surgery. The main goals are to understand how safe the new treatment is, how well people tolerate it, and whether it can make the cancer smaller or even disappear. This is an early-stage study, meaning it's one of the first times this treatment is being studied in a larger group of people with these specific cancers.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
220
Start
20 Jun 2024
Estimated completion
16 Oct 2029

What is this study about?

This study is designed to explore new treatment options for certain types of advanced gastrointestinal (GI) cancers. These are cancers that affect parts of your digestive system, specifically bowel (colorectal) cancer, pancreatic cancer, and bile duct cancer. In this study, 'advanced' means the cancer has spread to other parts of the body, and 'unresectable' means it cannot be removed with surgery. This particular study is looking at a new drug called sacituzumab tirumotecan, sometimes by itself, and sometimes alongside other commonly used cancer medicines like Fluorouracil (5-FU) and Cisplatin.

The main reasons for doing this study are to find out if the new drug, sacituzumab tirumotecan, is safe to use and if people can cope with its potential side effects. Researchers also want to see how effective it might be at treating these cancers. They are particularly interested in whether the cancer shrinks or stops growing after treatment. This kind of research is crucial for developing better treatments for people living with these challenging cancers.

Studies like this are vital steps in medical research. They help doctors understand new medications better and how they might work. Even if a study doesn't lead to an immediate new treatment, the information gathered helps to advance our overall understanding of cancer and how to fight it.

Key takeaways

  • Investigating a new drug, sacituzumab tirumotecan, for advanced GI cancers.
  • Focuses on bowel, pancreatic, and bile duct cancers.
  • Aims to assess safety, tolerability, and effectiveness.
  • Could involve the new drug alone or with standard treatments.
  • Open to adults aged 18+ with specific cancer types.

Who may be eligible?

To join this study, you would need to have certain types of cancer: bowel cancer that has spread or can't be operated on, advanced pancreatic cancer, or advanced bile duct cancer. For most people, you would have already had some treatment for your cancer in the past and recovered from any side effects.

There are also some reasons why you might not be able to join. For example, if you've had severe eye problems in the past, or if you've recently had other cancer treatments, especially within the last four weeks. You also wouldn't be able to join if you have a history of serious lung conditions like pneumonitis/interstitial lung disease that needed steroid treatment, or if you currently have such conditions.

This study is open to both men and women, aged 18 and over. The research team will carefully review your medical history to make sure the study is right for you, and that it's safe for you to take part.

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.

  1. Do you have advanced bowel, pancreatic, or bile duct cancer?
  2. Has your cancer spread, or can it not be removed by surgery?
  3. Have you mostly recovered from any past cancer treatments?
  4. Do you currently have severe lung disease like pneumonitis?
  5. Have you had other cancer treatments within the last 4 weeks?
Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic for assessments. These assessments would help the doctors monitor your health, how you're reacting to the treatment, and how the cancer is responding. You would receive the study medication, sacituzumab tirumotecan, potentially alongside other established cancer treatments like 5-FU/Leucovorin or Cisplatin, depending on the specific group you're in. You may also receive 'rescue medication' and ‘supportive care’ to help manage any side effects. The total duration of your participation would involve the treatment period and follow-up appointments to track your progress and long-term health. The exact number of visits and the overall time commitment would be explained in full by the study team.

Potential risks and benefits

Taking part in any clinical study carries potential benefits and risks. You might benefit from receiving a new treatment that isn't widely available yet, which could help your cancer. However, this new treatment might also have side effects, some of which could be serious, and it's not guaranteed to work for everyone. The study team will monitor you very closely for any side effects and provide supportive care. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (55)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • UCLA ( Site 0317)
    Verified postcode
    Los Angeles, United States· Recruiting
  • University of Colorado Anschutz Medical Campus ( Site 0299)
    Verified postcode
    Aurora, United States· Recruiting
  • University of Colorado Anschutz Medical Campus ( Site 0325)
    Verified postcode
    Aurora, United States· Recruiting
  • University of Colorado Anschutz Medical Campus ( Site 0326)
    Verified postcode
    Aurora, United States· Recruiting
  • Sibley Memorial Hospital ( Site 0310)
    Verified postcode
    Washington D.C., United States· Recruiting
  • University of Florida College of Medicine ( Site 0281)
    Verified postcode
    Gainesville, United States· Recruiting
  • Mount Sinai Cancer Center ( Site 0287)
    Verified postcode
    Miami Beach, United States· Recruiting
  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)
    Verified postcode
    Marietta, United States· Completed
  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)
    Verified postcode
    Mineola, United States· Recruiting
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)
    Verified postcode
    New York, United States· Recruiting
  • University of Texas MD Anderson Cancer Center ( Site 0316)
    Verified postcode
    Houston, United States· Recruiting
  • Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)
    Verified postcode
    Roanoke, United States· Recruiting

Common questions

What kind of cancers are being studied?

This study is looking at advanced bowel (colorectal) cancer, pancreatic cancer, and bile duct cancer that has spread or cannot be removed by surgery.

What is sacituzumab tirumotecan?

Sacituzumab tirumotecan is an experimental drug that researchers are investigating as a new treatment for these cancers.

Will I receive other treatments alongside the new drug?

Depending on which group you are assigned to, you might receive sacituzumab tirumotecan alone or combined with other common cancer drugs like Fluorouracil or Cisplatin.

What are the main goals of this study?

The main goals are to check how safe the new drug is, how well people tolerate it, and if it can help shrink or get rid of the cancer.

Who can take part in this study?

Adults aged 18 and over with one of the specific advanced gastrointestinal cancers, who have usually had previous treatment, may be eligible. There are also specific health conditions that would prevent participation.

How to find out more

Toll Free Number

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Clinical Study of MK-2870 Alone or With Other Treatments t…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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