Study of Pembrolizumab and BCG for Patients with High-Risk Non-Muscle Invasive Bladder Cancer

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What is this study about?

This clinical trial is focused on studying a type of bladder cancer known as High-Risk Non-Muscle Invasive Bladder Cancer (HR 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 that combines two medications: Pembrolizumab and Bacillus Calmette-Guérin (BCG). Pembrolizumab, also known by its code name MK-3475, is a medication that helps the immune system fight cancer cells. BCG is a vaccine that is used to treat bladder cancer by stimulating the immune system to attack cancer cells in the bladder.

The purpose of the study is to compare the results of using Pembrolizumab with BCG against using BCG alone in patients with HR NMIBC. Participants in the study will be divided into different groups. Some will receive the combination of Pembrolizumab and BCG, while others will receive only BCG. The study will observe how well the cancer responds to these treatments and how long patients remain free of cancer events. The study will also monitor the overall health and quality of life of the participants during the treatment period.

Participants will receive the treatments over a period of time, with regular check-ups to monitor their health and the progress of the cancer. The study aims to provide valuable information on whether the combination of Pembrolizumab and BCG is more effective than BCG alone in treating HR NMIBC. This research could lead to improved treatment options for patients with this type of bladder cancer.

1 joining the trial

Upon joining the trial, participants will be assigned to one of two groups. One group will receive a combination of pembrolizumab and bacillus calmette-guérin (BCG), while the other group will receive BCG alone. This assignment is random and is done to compare the effectiveness of the treatments.

2 treatment administration

Participants receiving pembrolizumab will have it administered through an intravenous infusion. This means the medication is given directly into a vein. The dosage is 25 mg/mL and the frequency and duration will be determined by the study protocol.

Participants receiving BCG will have it administered intravesically. This means the medication is placed directly into the bladder through a catheter. The frequency and duration of this treatment will also be determined by the study protocol.

3 monitoring and follow-up

Throughout the trial, participants will undergo regular monitoring to assess the effectiveness of the treatment and to check for any side effects. This may include physical exams, blood tests, and imaging studies.

Participants will be required to provide tissue samples for biomarker analysis, which helps in understanding how the treatment is working.

4 end of treatment

After completing the treatment phase, participants will continue to be monitored for a specified period to evaluate long-term effects and outcomes. This may include follow-up visits and additional tests as needed.

Who Can Join the Study?

Must have a confirmed diagnosis of high-risk non-muscle invasive bladder cancer. This means the cancer is in the bladder but has not spread to the muscle layer.
Must have had a procedure called cystoscopy or transurethral resection of bladder tumor (TURBT) to remove any visible tumors. These are procedures to look inside the bladder and remove tumors.
Must provide a sample of tissue for biomarker analysis. This is a test to look for specific markers in the tissue that can help guide treatment.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. This is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, 1 means some symptoms but nearly fully active, and 2 means unable to work but can take care of themselves.
Must have adequate organ function. This means the organs in the body are working well enough to handle the treatment.
Male participants must either not engage in heterosexual intercourse or agree to use contraception during the treatment and for at least 7 days after the last dose of BCG, unless they are confirmed to be azoospermic (unable to produce sperm).
Female participants must not be pregnant or breastfeeding. If they can have children, they must agree to use a highly effective method of contraception or remain abstinent from heterosexual intercourse during the treatment and for at least 7 days after the last dose of BCG or 120 days after the last dose of pembrolizumab, whichever is longer.
For BCG Post-induction Cohort (Cohort A) only: Must have been treated with an adequate course of BCG induction therapy, which is a type of treatment for bladder cancer.
For BCG Post-induction Cohort (Cohort A) only: After receiving BCG induction therapy, must have persistent or recurrent high-risk non-muscle invasive bladder cancer.

Who Cannot Join the Study?

Patients with a history of severe allergic reactions to the study drugs cannot participate.
Patients who have received another investigational drug within the last 4 weeks are not eligible.
Patients with an active infection that requires treatment with antibiotics are excluded.
Patients with a known history of HIV (Human Immunodeficiency Virus) infection are not allowed to join the study.
Patients with hepatitis B or hepatitis C infections cannot participate. These are viral infections that affect the liver.
Patients with any other cancer that is progressing or requires treatment are excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients with a history of autoimmune disease, which is when the body’s immune system attacks its own tissues, are not eligible.
Patients who have had a major surgery within the last 4 weeks are excluded.
Patients with a history of heart problems, such as heart attack or heart failure, are not allowed to participate.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Medical Concierge Centrum Medyczne	Warsaw	Poland

Verified Sites

Site Name	City	Country
Medical University Of Vienna	Vienna	Austria
University Hospital Jena KöR	Jena	Germany
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Centre Hospitalier Universitaire De Lille	Lille	France
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Algemeen Stedelijk Ziekenhuis Campus Aalst	Aalst	Belgium
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
General University Hospital Of Larissa	Larissa	Greece
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Central Hospital Of Bolzano	Bolzano	Italy
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti	Chieti	Italy
University Of Pecs	Pecs	Hungary
Szpital Wojewodzki Im. Sw. Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie	Tarnow	Poland
University Of Debrecen	Debrecen	Hungary
Tampere University Hospital	Tampere	Finland
Universita’ Degli Studi Di Verona	Verona	Italy
Clinical Research Center Sp. z o.o. Medic-R sp.k.	Poznan	Poland
Azienda USL Toscana Sud Est	Arezzo	Italy
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Hospital Foch	Suresnes	France
Universitair Ziekenhuis Gent	Gent	Belgium
Barmherzige Brueder Trier gGmbH	Trier	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Az Maria Middelares Gent	Gent	Belgium
Fundacio Puigvert	Barcelona	Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
MD Anderson Cancer Center	Madrid	Spain
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.	Slupsk	Poland
MVZ Nordoberpfalz GmbH	Weiden I.D.Opf.	Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
University Of Szeged	Szeged	Hungary
Semmelweis University	Budapest	Hungary
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Uniklinikum Salzburg	Salzburg	Austria
Apzencythy Zevaygngug Mxqxgvamgg	Maastricht	The Netherlands
Cqfxjz Hygbdzzagow Uqxbadiejwmdr Di Dvbfz	Dijon	France
Ooxbocnt Bisxelqb Le Fexpq dr Pifxnca &arpcqp Fnhslgbmbyvtgajg	Palermo	Italy
Mzpxnqjgp Idjvmjfkgx Cwqjxqfe Swjdtkej Svm z oqog	Warsaw	Poland
Hmzqx Sdxjmeesl Hh	Stavanger	Norway
Aryxmzvm Uwyfyihavc Hbvnmlls	Lorenskog	Norway
Eessnxs Uruzumvydult Mfhmypn Cgrjvjk Rgzjkjrwq (leuybng Mzp	Rotterdam	The Netherlands
Uadkninpyuhfktohxyaxl Wlkktxzay Adu	Wuerzburg	Germany
Uhqmuvoznt On Aaztedj	Edegem	Belgium
Opgtcdzlrsxmkp Lnbh Gyur	Linz	Austria
Fsyxycqxe Psia Lt Isclqxsgpuueb Bgehgxaep Dxo Hxendghx Ugqncimlrgovn Ld Pfy	Madrid	Spain
Hftpkty Hwgsj Movehp &wzwrwj 1 rpg Gllrovf Ejzryx	Creteil	France
Weyncjjeqk Sohjovk Iqi Sggbbvo Psc W Pvtdhjqbp	Przemysl	Poland
Uxfgirxyua Gbkvnec Hhjnjhdx Aonfvab	Athens	Greece

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	13.11.2018
Belgium	Not recruiting	13.11.2018
Finland	Not recruiting	13.11.2018
France	Not recruiting	13.11.2018
Germany	Not recruiting	13.11.2018
Greece	Not recruiting	13.11.2018
Hungary	Not recruiting	13.11.2018
Italy	Not recruiting	13.11.2018
Norway	Not recruiting	13.11.2018
Poland	Not recruiting	13.11.2018
Portugal	Not recruiting	13.11.2018
Spain	Not recruiting	13.11.2018
The Netherlands	Not recruiting	13.11.2018

Trial locations

Investigated drugs:

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. In this trial, pembrolizumab is being tested to see if it can help treat high-risk non-muscle invasive bladder cancer, especially in cases where the cancer is persistent or has come back after initial treatment, or in patients who have not been treated with BCG before.

Bacillus Calmette-Guerin (BCG) is a type of therapy that uses a live, but weakened, form of bacteria to stimulate the immune system. It is commonly used to treat bladder cancer by being placed directly into the bladder. In this trial, BCG is being used alone and in combination with pembrolizumab to see if the combination is more effective in treating high-risk non-muscle invasive bladder cancer.

High Risk Non-muscle Invasive Bladder Cancer – This type of bladder cancer is characterized by the presence of cancerous cells in the bladder lining that have not yet invaded the muscle layer. It is considered high risk due to factors such as the presence of carcinoma in situ (CIS), high-grade tumors, or frequent recurrence. The disease often begins with symptoms like blood in the urine, frequent urination, or pain during urination. As it progresses, there is a risk of the cancer spreading deeper into the bladder wall or to other parts of the body. Monitoring and regular check-ups are crucial to manage the disease and prevent progression. The condition requires careful observation to detect any changes in the tumor’s behavior.

Trial ID:

2022-501817-29-00

Protocol code:

MK-3475-676

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Pembrolizumab and BCG for Patients with High-Risk Non-Muscle Invasive Bladder Cancer

What is this study about?

Who Can Join the Study?

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