Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)

This research study is looking for better ways to treat a serious type of bladder cancer called muscle-invasive urothelial carcinoma (MIUC). This is when cancer has spread into the deeper muscle layers of the bladder. Usually, people with this type of cancer have chemotherapy and then surgery to remove it. This study is testing a new treatment called intismeran autogene alongside pembrolizumab, a drug that helps your body’s immune system fight cancer. Intismeran autogene is specially designed to help your immune system recognise and kill your cancer cells. The main goal is to find out if this combination can keep the cancer from coming back after surgery for longer, and to see if the treatments are safe and well-tolerated.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

230

Start

28 Mar 2024

Estimated completion

20 Oct 2031

Bladder Cancer

What is this study about?

This study is about finding new and better ways to treat a specific type of bladder cancer called muscle-invasive urothelial carcinoma (MIUC). This means the cancer has grown into the muscle wall of the bladder. People with this condition usually receive chemotherapy (medicine to kill cancer cells) before having surgery to remove the cancerous part of the bladder. Sometimes, extra treatment is given after surgery to try and stop the cancer coming back.

The researchers are studying two main medicines. One is called pembrolizumab, which is a type of 'immunotherapy'. Immunotherapy works by boosting your body's own immune system to help it find and destroy cancer cells. The other medicine, intismeran autogene (also known as mRNA-4157), is newer. It's designed to be a personalised treatment that helps your immune system learn to recognise and attack your specific cancer cells based on unique markers they have.

The main aim of this study is to see if giving intismeran autogene together with pembrolizumab can help prevent the bladder cancer from returning after surgery for longer, compared to giving pembrolizumab with a 'placebo' (a dummy treatment). They also want to understand how safe these treatments are and how well people can tolerate them. The study also looks at another drug called enfortumab vedotin (EV), which is known as an 'antibody drug conjugate' (ADC). An ADC is like a guided missile, attaching to specific proteins on cancer cells and delivering medicine directly to them to destroy them.

Key takeaways

This study is testing a new personalised treatment, intismeran autogene, for bladder cancer.
It aims to see if this new treatment, along with pembrolizumab, can stop cancer returning after surgery.
The study focuses on a type of bladder cancer that has grown into the muscle wall.
Participants will receive either the study treatment or a placebo alongside pembrolizumab.
Researchers will monitor for treatment safety and how well people tolerate the drugs.

Who may be eligible?

To join this study, people generally need to have a confirmed diagnosis of bladder cancer, specifically the type that comes from cells lining the bladder (urothelial carcinoma). You would also need to provide blood and tissue samples so researchers can create the personalised intismeran autogene treatment and perform other important tests. Your general health would be assessed to make sure you're well enough to take part.

There are two main groups within the study. One group is for people who have already had surgery for their bladder cancer and have what doctors call 'high-risk' disease, meaning there's a higher chance of the cancer returning. The other group is for people who are about to have surgery and are considered suitable for removing the bladder and surrounding lymph nodes.

However, some things would prevent you from joining. For example, if you've recently had certain types of vaccines, or if you have another type of cancer that is currently active and requires treatment. People with certain lung conditions, active infections needing strong medicine, or specific liver infections (Hepatitis B or C) would also not be able to participate. If you've had a strong allergic reaction to any of the study drugs or similar medicines in the past, you would also be excluded.

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 I have bladder cancer that has grown into the muscle?
Am I generally well with no other active serious illnesses?
Have I recently received a live vaccine?
Do I have a history of severe allergies to similar drugs?
Am I open to providing blood and tissue samples for testing?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive either the study treatment (intismeran autogene plus pembrolizumab) or pembrolizumab plus a placebo. The study period involves several visits for treatments, health check-ups, and tests like blood samples. This is to monitor your health, how you are responding to the treatment, and to check for any side effects. The study will continue for a certain period after your surgery, with regular follow-up appointments to track your health and whether the cancer returns. The exact number of visits, tests, and the total length of your participation would be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial means you might be among the first to receive a new treatment that could potentially be more effective than current options, though this is not guaranteed. However, new treatments can also have unknown side effects or might not work for everyone. You could experience side effects from the study drugs, some of which may be serious. The study team will monitor you closely for any issues. You are free to withdraw from the study at any time and for any reason, without affecting your usual medical care.

Locations (74)

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

UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0104)
Verified postcode
Los Angeles, United States
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0102)
Verified postcode
Orlando, United States
University of Chicago Medical Center ( Site 0109)
Verified postcode
Chicago, United States
University of Iowa ( Site 0110)
Verified postcode
Iowa City, United States
Icahn School of Medicine at Mount Sinai ( Site 0101)
Verified postcode
New York, United States
Duke Cancer Institute ( Site 0107)
Verified postcode
Durham, United States
Cleveland Clinic Main ( Site 0100)
Verified postcode
Cleveland, United States
Fox Chase Cancer Center ( Site 0106)
Verified postcode
Philadelphia, United States
UT Southwestern Medical Center ( Site 0103)
Verified postcode
Dallas, United States
Houston Methodist Hospital-Department of Urology ( Site 0111)
Verified postcode
Houston, United States
Macquarie University-MQ Health Clinical Trials Unit ( Site 1803)
Unverified
Macquarie University, Australia
Westmead Hospital ( Site 1802)
Verified postcode
Westmead, Australia

Common questions

What is 'muscle-invasive urothelial carcinoma'?

This is a serious type of bladder cancer where the cancer has grown into the muscle layer of the bladder wall.

What is immunotherapy?

Immunotherapy is a treatment that helps your body's own immune system fight cancer cells more effectively.

What is a 'placebo'?

A placebo is a dummy treatment that looks like the real medicine but doesn't contain any active drug. It helps researchers compare the effects of the actual treatment.

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

No, in this type of study, neither you nor your doctors will usually know whether you are receiving the experimental treatment or the placebo. This helps ensure the results are fair.

What happens if the cancer comes back?

The study team will continuously monitor your health. If the cancer returns, you will discuss further treatment options with your doctor, which may be outside of this study.