Active not recruitingPHASE2INTERVENTIONAL

Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008)

This research trial is investigating new treatment options for people with advanced (Stage IV) bowel cancer. Specifically, it's for those whose cancer has certain genetic features known as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). The study will compare different combinations of new drugs, including pembrolizumab, with standard treatments. The main goal is to find out if these new combinations are more effective at shrinking tumours and are safe for patients. We hope this study will lead to better treatments for this specific type of advanced bowel cancer.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

302

Start

25 Jun 2021

Estimated completion

13 Aug 2026

Colorectal Cancer

What is this study about?

This research study, called KEYSTEP-008, is focusing on people with advanced bowel cancer, also known as colorectal cancer, that has spread to other parts of the body (Stage IV). We're particularly interested in a type of bowel cancer that has specific genetic features, which doctors call MSI-H or dMMR. These features can sometimes mean that cancers respond differently to certain treatments.

The trial is looking at new combinations of drugs to see if they can work better than current treatments. One of the main drugs being studied is pembrolizumab, which is a type of immunotherapy. Immunotherapy works by helping your body's own immune system fight the cancer. We're testing pembrolizumab on its own, and in combination with other new drugs called quavonlimab, favezelimab, or vibostolimab. There's also another drug called MK-4830 being investigated. The aim is to understand how well these new treatments shrink tumours and how safe they are for patients.

By taking part, you would be helping doctors learn more about the best ways to treat this specific type of advanced bowel cancer. The information we gather from this study could help improve future care for many patients living with this condition.

Key takeaways

This study explores new treatments for advanced bowel cancer.
It's for people with specific genetic markers (MSI-H or dMMR).
Compares new drug combinations, including immunotherapies, with existing treatments.
Aims to find more effective and safer ways to treat this condition.
Accepting both previously treated and newly diagnosed patients.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to have bowel cancer that has been confirmed as Stage IV and has the specific MSI-H or dMMR genetic features. Doctors will also check that you are generally well enough to take part and have a life expectancy of at least three months.

There are two main groups of people we are looking for. Cohort A is for those who have already had treatment for their advanced bowel cancer, and it either didn't work well enough or they couldn't tolerate it. This previous treatment would typically have included a combination of standard chemotherapy drugs and sometimes other targeted therapies.

Cohort B is for people who have been newly diagnosed with advanced bowel cancer that is MSI-H or dMMR, and they haven't yet started any chemotherapy or immunotherapy for this advanced stage of their disease.

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.

Do you have Stage IV bowel cancer?
Has your cancer been tested for MSI-H or dMMR markers?
Are you able to attend regular clinic appointments?
Have you been told you have a life expectancy of at least 3 months?
For women, are you not pregnant, breastfeeding, or are using effective contraception if you could become pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive one of the experimental drug combinations or a standard treatment. We would regularly monitor your health and the size of your tumours through scans and other tests. You would have regular visits to the clinic for these assessments and to receive your study medication. The exact number of visits and the total duration would depend on which treatment group you are in and how you respond to the medication. We would explain all these details clearly before you decide to participate.

Potential risks and benefits

Participating in this study might offer you access to new treatments before they are widely available. However, there's no guarantee that the new treatments will work better than existing ones, and like all medicines, they can have side effects. Your doctor will discuss all known and potential risks and benefits with you in detail. Remember, joining any study is completely voluntary, and you can withdraw at any time without affecting your future medical care.

Locations (109)

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

Mid Florida Cancer Center ( Site 1519)
Verified postcode
Orange City, United States
University Cancer & Blood Center, LLC ( Site 1521)
Verified postcode
Athens, United States
University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P
Verified postcode
Chicago, United States
Icahn School of Medicine at Mount Sinai ( Site 1528)
Verified postcode
New York, United States
Hematology Oncology Associates of Rockland ( Site 1525)
Verified postcode
Nyack, United States
UPMC Hillman Cancer Center ( Site 1516)
Verified postcode
Pittsburgh, United States
The West Clinic, PLLC dba West Cancer Center ( Site 1576)
Verified postcode
Germantown, United States
Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 1509)
Verified postcode
Nashville, United States
UT Southwestern Medical Center ( Site 1551)
Verified postcode
Dallas, United States
Baylor Scott & White Medical Center - Temple-Division of Hematology/Oncology ( Site 1549)
Verified postcode
Temple, United States
Northwest Medical Specialties, PLLC ( Site 1546)
Verified postcode
Tacoma, United States
UZ Brussel ( Site 0105)
Verified postcode
Brussels, Belgium

Common questions

What does MSI-H or dMMR mean?

These are genetic markers in your cancer cells that can help doctors decide which treatments might work best. Your doctor can explain these in more detail.

What is immunotherapy?

Immunotherapy is a type of treatment that helps your body's own immune system recognise and fight cancer cells.

Will I know which treatment I'm receiving?

Sometimes in studies like this, you and your doctor might not know which specific treatment you're getting. This helps us ensure the results are accurate. All options are carefully chosen by the medical team.

What if I can't travel to the study clinic?

You would need to be able to comfortably attend the study sites for your appointments and treatments. Please discuss any travel concerns with the study team.

How long does the study last?

The duration can vary for each person. Your doctor will explain the expected treatment period and follow-up plan if you are eligible.