Study of Pembrolizumab, Vibostolimab, and Favezelimab for Patients with High-Risk Non-Muscle Invasive Bladder Cancer Unresponsive to BCG Therapy

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What is this study about?

This clinical trial is focused on studying a type of bladder cancer known as Non-Muscle Invasive Bladder Cancer (NMIBC). This form of cancer affects the bladder but does not invade the muscle layer. The study is investigating the effectiveness and safety of a treatment called pembrolizumab, which is also known by its code name MK-3475. Pembrolizumab is a medication that helps the immune system fight cancer cells. In addition to pembrolizumab, the study is also testing combinations with other investigational agents, specifically MK-7684A and MK-4280A. These investigational agents include substances like vibostolimab and favezelimab, which are designed to enhance the body’s immune response against cancer.

The purpose of this study is to evaluate how well these treatments work in patients with high-risk NMIBC that has not responded to a common therapy called Bacillus Calmette-Guerin (BCG). The study aims to see if these treatments can help eliminate the cancer or prevent it from getting worse. Participants in the study will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor the participants over a period of time to assess the response to the treatment and any side effects that may occur.

Throughout the study, participants will undergo regular check-ups, including procedures like cystoscopy (a test that allows doctors to look inside the bladder), cytology (examining cells from the bladder), and imaging tests to track the progress of the disease. The study will also evaluate the complete response rate, which refers to the absence of detectable cancer, and the disease-free survival rate, which measures how long participants remain free from cancer. The trial is expected to continue until 2030, providing valuable insights into the potential benefits of these treatments for patients with high-risk NMIBC.

1 initial assessment

Upon joining the clinical trial, an initial assessment will be conducted. This includes a review of medical history and a physical examination to confirm eligibility based on specific criteria such as a diagnosis of high-risk non-muscle-invasive bladder cancer.

Additional tests may include a cystoscopy, which is a procedure to look inside the bladder, and imaging tests to evaluate the current state of the disease.

2 treatment initiation

The treatment phase begins with the administration of the medication pembrolizumab through an intravenous infusion. This means the medication is given directly into a vein.

The dosage and frequency of the medication will be determined by the study protocol and communicated by the healthcare team.

3 combination therapy

In addition to pembrolizumab, other investigational agents such as MK-7684A or MK-4280A may be administered. These are also given through intravenous infusion.

The combination therapy aims to evaluate the anti-tumor activity and is part of the study’s main objectives.

4 regular monitoring

Throughout the trial, regular monitoring will occur to assess the response to treatment. This includes repeated cystoscopies, imaging tests, and possibly biopsies to check for the presence of cancer cells.

The healthcare team will also monitor for any side effects or adverse events related to the treatment.

5 follow-up assessments

Follow-up assessments are scheduled at specific intervals, such as 3, 6, and 12 months, to evaluate the complete response rate and disease-free survival.

These assessments help determine the effectiveness of the treatment and any long-term effects.

6 end of trial

At the end of the trial, a final evaluation will be conducted to summarize the treatment outcomes and any ongoing health considerations.

Participants may receive guidance on further treatment options or follow-up care based on the results of the trial.

Who Can Join the Study?

Must have a confirmed diagnosis of high-risk non-muscle-invasive bladder cancer. This includes specific types like T1, high-grade Ta, or carcinoma in situ (CIS). If the tumor has different types of cells, the main type should be transitional cell.
The disease must be fully removed at the start of the study, but some remaining CIS is acceptable.
Must have BCG-unresponsive high-risk non-muscle-invasive bladder cancer after receiving enough BCG therapy. BCG is a treatment used for bladder cancer.
Cannot have surgery to remove the bladder (radical cystectomy) or must have chosen not to have this surgery.
Must have tissue available from a new biopsy of a tumor that has not been treated with radiation before.
Must have an ECOG performance status of 0, 1, or 2. This is a scale that measures how well you can perform daily activities.
Must have adequate organ function, meaning your organs are working well enough to participate in the study.
Female participants who can have children must have a negative pregnancy test and agree to use a reliable method of birth control.
Male participants must agree to use a reliable method of birth control.

Who Cannot Join the Study?

Patients who have a different type of bladder cancer that is not classified as Non-Muscle Invasive Bladder Cancer (NMIBC) cannot participate. NMIBC is a type of bladder cancer that has not spread into the muscle layer of the bladder.
Patients who have other serious medical conditions that could interfere with the study or make it unsafe for them to participate may be excluded.
Patients who are currently receiving other treatments for cancer that could interfere with the study may not be eligible.
Patients who have had a recent major surgery or a significant injury that has not fully healed may be excluded.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have a history of severe allergic reactions to similar medications used in the study may be excluded.
Patients who are unable to follow the study procedures or attend the required visits may not be eligible.
Patients who have participated in another clinical trial recently may be excluded to avoid interference with the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
General University Hospital Of Larissa	Larissa	Greece
Ospedale San Raffaele S.r.l.	Milan	Italy
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Turku University Hospital	Turku	Finland
Hospital Foch	Suresnes	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Azhxtym Odwepmgvgbz Ufjokccunwxtl Pywbp	Parma	Italy
Apsggytmsr Pigebvnw Hbvxwcdm Du Pxbtz	Paris	France
Ufdmdat Unxddurjpv Hqijcuuo	Uppsala	Sweden
Euhgobl Umvnamotywrj Mkqrbdq Crxvemf Rldwcskvl (kjajbjo Mzo	Rotterdam	The Netherlands
Hjgblqq Hombg Mxgryj &bjayno 1 rcl Gltpqcm Ehoqnr	Creteil	France

Trial status

Country	Status	Recruitment Start
Finland	Not recruiting	20.04.2016
France	Not recruiting	20.04.2016
Greece	Not recruiting	20.04.2016
Italy	Not recruiting	20.04.2016
Spain	Not recruiting	20.04.2016
Sweden	Not recruiting	20.04.2016
The Netherlands	Not recruiting	20.04.2016

Trial locations

Investigated drugs:

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, it is being used to see if it can help treat a type of bladder cancer that has not responded to other treatments.

MK-7684A is an investigational drug, which means it is still being studied and is not yet approved for general use. It is being tested to see if it can help treat bladder cancer by working with your immune system to fight the cancer cells.

MK-4280A is another investigational drug in this trial. Like MK-7684A, it is being studied to determine if it can help your immune system target and destroy cancer cells in the bladder. This medication is part of the research to find new ways to treat bladder cancer that has not responded to standard therapies.

Non-Muscle Invasive Bladder Cancer (NMIBC) – This type of bladder cancer is characterized by the presence of cancerous cells in the bladder lining that have not invaded the muscle layer. It often presents with symptoms such as blood in the urine or frequent urination. The disease progresses by potentially growing into larger tumors or spreading to other parts of the bladder lining. Over time, if not managed, it may develop into a more invasive form of bladder cancer. Monitoring typically involves regular cystoscopy to check for tumor recurrence or progression. The progression of NMIBC can vary, with some cases remaining stable while others may become more aggressive.

Trial ID:

2022-502526-41-00

Protocol code:

MK-3475-057

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Pembrolizumab, Vibostolimab, and Favezelimab for Patients with High-Risk Non-Muscle Invasive Bladder Cancer Unresponsive to BCG Therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?