Study of Pembrolizumab with Chemoradiotherapy for Patients with Muscle-Invasive Bladder Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called muscle-invasive bladder cancer. The study is investigating the effectiveness and safety of a treatment called pembrolizumab, also known by its code name MK-3475, when used in combination with chemoradiotherapy. Chemoradiotherapy is a treatment that combines chemotherapy, which uses drugs to kill cancer cells, and radiation therapy, which uses high-energy rays to target and destroy cancer cells. The study will compare this combination treatment to chemoradiotherapy alone.

Participants in the study will receive either pembrolizumab with chemoradiotherapy or a placebo with chemoradiotherapy. A placebo is a substance with no active drug, used to compare the effects of the actual treatment. The chemotherapy drugs used in this study include fluorouracil, gemcitabine hydrochloride, cisplatin, and mitomycin. These drugs are administered through an intravenous infusion, which means they are given directly into a vein. The purpose of the study is to see if the combination of pembrolizumab and chemoradiotherapy can improve outcomes for patients with muscle-invasive bladder cancer.

The study will take place over a period of time, during which participants will undergo regular assessments to monitor their health and the effectiveness of the treatment. These assessments may include procedures like cystoscopy, which is a test that allows doctors to look inside the bladder, and various imaging tests. The study aims to determine if the combination treatment can help patients live longer without the cancer returning or spreading, and to evaluate the overall survival and quality of life of the participants.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure the diagnosis of muscle-invasive bladder cancer is accurate and that the cancer has not spread beyond the bladder.

2 randomization

Participants will be randomly assigned to one of two groups. One group will receive pembrolizumab in combination with chemoradiotherapy, while the other group will receive a placebo with chemoradiotherapy. This process is double-blind, meaning neither the participants nor the researchers will know which group each participant is in.

3 treatment administration

Participants in the pembrolizumab group will receive pembrolizumab through an intravenous infusion. The dosage is 25 mg/mL, and the frequency and duration will be determined by the study protocol.

Chemoradiotherapy will include medications such as fluorouracil, gemcitabine hydrochloride, cisplatin, and mitomycin, all administered via intravenous infusion. The specific dosage and schedule will be provided by the healthcare team.

4 regular monitoring

Throughout the trial, regular monitoring will occur to assess the effectiveness and safety of the treatment. This includes cystoscopy, biopsy if necessary, urine tests, and imaging studies. These assessments help determine the response to treatment and monitor for any side effects.

5 follow-up visits

Participants will have scheduled follow-up visits to track progress and manage any side effects. These visits are crucial for ensuring the safety and well-being of participants and for collecting data on the treatment’s impact on bladder cancer.

6 end of treatment

At the end of the treatment period, a final assessment will be conducted to evaluate the overall response to the therapy. This includes a comprehensive review of all test results and any changes in health status.

7 long-term follow-up

Participants may be asked to continue with long-term follow-up visits to monitor for any late effects of the treatment and to gather additional data on long-term outcomes such as overall survival and quality of life.

Who Can Join the Study?

The patient must have a confirmed diagnosis of muscle-invasive bladder cancer with mostly urothelial histology. This means the cancer has spread into the muscle layer of the bladder and is mainly made up of urothelial cells.
The patient must have bladder cancer that has not spread to other parts of the body. This is referred to as nonmetastatic bladder cancer (N0M0).
The patient must be planning to receive and be eligible for chemoradiotherapy (CRT), which is a combination of chemotherapy and radiation therapy, and one of the specific chemotherapy regimens that make the radiation work better.
The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. This is a scale used to assess how the disease affects the daily living abilities of the patient, with 0 being fully active and 2 being capable of all self-care but unable to carry out any work activities.
The patient must have adequate organ function, meaning their organs are working well enough to handle the treatment.
Male patients must agree to certain conditions during the treatment period and for at least 90 days after the last dose of CRT treatment. They must refrain from donating sperm and either abstain from heterosexual intercourse or use contraception unless they are confirmed to be azoospermic (unable to produce sperm).
Female patients must not be pregnant or breastfeeding. They must either not be of childbearing potential or, if they are, they must use a highly effective contraceptive method or abstain from heterosexual intercourse during the treatment period and for at least 180 days after the last dose of treatment. They must also agree not to donate eggs during this period.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Muscle Invasive Bladder Cancer.
Patients who have had a previous treatment for bladder cancer that involved surgery to remove the bladder.
Patients who have received chemotherapy or radiation therapy for bladder cancer in the past.
Patients with a history of another type of cancer, unless it was treated successfully and has not returned for at least 5 years.
Patients with serious heart problems, such as a recent heart attack or heart failure.
Patients with uncontrolled high blood pressure.
Patients with active infections that require treatment with antibiotics.
Patients who are pregnant or breastfeeding.
Patients who have an allergy to the study drugs or similar medications.
Patients who are participating in another clinical trial at the same time.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.	Cracow	Poland
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland
Unidade Local De Saude De Lisboa Ocidental E.P.E.	Carnaxide	Portugal
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Oncomed S.R.L.	Timisoara	Romania
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
University Hospital Olomouc	Olomouc	Czechia
Amphia Hospital	Breda	The Netherlands
Pauls Stradins Clinical University Hospital	Riga	Latvia
University Of Debrecen	Debrecen	Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar	Hungary
Virgen del Rocío University Hospital	Sevilla	Spain
Assistance Publique Hopitaux De Paris	Paris	France
Tartu University Hospital	Tartu	Estonia
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz	Miskolc	Hungary
Spitalul De Oncologie Monza S.R.L.	Bucharest	Romania
Netherlands Cancer Institute	Amsterdam	The Netherlands
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Hospital Beatriz Angelo	Loures	Portugal
Radiotherapy Center Cluj S.R.L.	Floresti	Romania
Institut Sainte Catherine	Avignon	France
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.	Siedlce	Poland
Ospedale Generale Provinciale Di Macerata	Macerata	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
North Estonia Medical Centre Foundation	Tallin	Estonia
Cjohzj Hmlvmyjtjqz Uzamqeixjltxx Anfpht Prsysopi	Amiens	France
Ejscvwl Uryrwyzkmmng Meqvulo Ccchicr Retkpajjc (hkoegxf Mwv	Rotterdam	The Netherlands
Bcrhhztdsqw Vnrzlkumw Ofwlyouolawh	Kecskemet	Hungary
Fquutzux nhsbknfxk Migjy a Hapdkwl	Prague	Czechia
Gbcthbcqxdufhflmt Vllggphed Pyjx Aiglgp Edvmlsee Oboxrj Kyibnq	Gyor	Hungary
Iayswfjm Cezkbn Dqvmzhtvinvpmbqcz	L'hospitalet De Llobregat	Spain
Ipqmrphp Cisma	Paris	France

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	19.05.2020
Estonia	Not recruiting	19.05.2020
France	Not recruiting	19.05.2020
Hungary	Not recruiting	19.05.2020
Italy	Not recruiting	19.05.2020
Latvia	Not recruiting	19.05.2020
Poland	Not recruiting	19.05.2020
Portugal	Not recruiting	19.05.2020
Romania	Not recruiting	19.05.2020
Spain	Not recruiting	19.05.2020
The Netherlands	Not recruiting	19.05.2020

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 improve the treatment of muscle-invasive bladder cancer when used together with chemoradiotherapy. The goal is to see if this combination can help keep the bladder intact and free from cancer longer than using chemoradiotherapy alone.

Muscle Invasive Bladder Cancer – Muscle Invasive Bladder Cancer is a type of bladder cancer that occurs when cancer cells grow into the muscle layer of the bladder wall. It typically begins in the urothelial cells that line the inside of the bladder. As the disease progresses, the cancer can spread to the surrounding tissues and organs, including the lymph nodes, lungs, liver, and bones. The progression of the disease can lead to symptoms such as blood in the urine, frequent urination, and pain during urination. Over time, the cancer may invade deeper layers of the bladder and potentially metastasize to other parts of the body. The disease requires careful monitoring to assess the extent of invasion and potential spread.

Trial ID:

2023-503500-87-00

Protocol code:

MK-3475-992

NCT ID:

NCT04241185

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Pembrolizumab with Chemoradiotherapy for Patients with Muscle-Invasive Bladder Cancer

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