Study of Pembrolizumab, Cisplatin, and Gemcitabine for Patients with Muscle-Invasive Bladder Cancer Eligible for Cisplatin Treatment

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What is this study about?

This clinical trial is focused on studying a type of bladder cancer known as muscle-invasive bladder cancer. The study is investigating the effects of a treatment called pembrolizumab, also known by its code name MK-3475, in combination with chemotherapy drugs cisplatin and gemcitabine. Pembrolizumab is a medication that helps the immune system fight cancer cells. The purpose of the study is to compare the effectiveness of pembrolizumab with chemotherapy against a placebo with chemotherapy in patients who are eligible to receive cisplatin.

Participants in the study will be randomly assigned to one of two groups. One group will receive pembrolizumab along with chemotherapy before and after surgery, while the other group will receive a placebo with the same chemotherapy regimen. The study will involve a series of treatments and follow-ups over a period of time to monitor the progress and outcomes of the treatment. The main goal is to see if the combination of pembrolizumab and chemotherapy can improve the time patients remain free from cancer events compared to the placebo group.

Throughout the study, participants will undergo various procedures, including surgery to remove the bladder and nearby lymph nodes, known as radical cystectomy and pelvic lymph node dissection. The study will also track other important outcomes, such as overall survival and the rate of complete response to the treatment. This research aims to provide valuable insights into the potential benefits of using pembrolizumab in treating muscle-invasive bladder cancer.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving either the experimental treatment or the standard treatment.

2 treatment group assignment

If you are assigned to the experimental group, you will receive pembrolizumab along with chemotherapy. If you are assigned to the standard group, you will receive a placebo along with chemotherapy. A placebo is a substance that looks like the treatment but does not have any active ingredients.

3 treatment administration

The treatment involves receiving medications through an intravenous infusion, which means the medication is given directly into a vein through a needle. This will be done at scheduled times as determined by the study protocol.

4 medications and dosage

If you are in the experimental group, you will receive pembrolizumab (also known as Keytruda) at a concentration of 25 mg/mL. You will also receive chemotherapy drugs, cisplatin and gemcitabine. The exact dosage and frequency will be explained to you by the study team.

5 surgery

After completing the initial treatment phase, you will undergo a surgical procedure called Radical Cystectomy (RC) and Pelvic Lymph Node Dissection (PLND). This surgery involves removing the bladder and nearby lymph nodes to treat bladder cancer.

6 follow-up and monitoring

Following surgery, you will continue to be monitored for any changes in your health. This includes regular check-ups and tests to assess your response to the treatment and to ensure your well-being.

7 study completion

The study is expected to continue until June 2025. During this time, you will be asked to attend follow-up visits and report any side effects or changes in your health to the study team.

Who Can Join the Study?

Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) with predominant (≥50%) urothelial histology. This means the cancer has been confirmed by examining tissue under a microscope and is mainly made up of urothelial cells.
Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI)) of the chest/abdomen/pelvis. This means the cancer has not spread to distant parts of the body, as shown by scans.
Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND). This means the patient is considered suitable for surgery to remove the bladder and nearby lymph nodes.
Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. This is a scale used to assess how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Have adequate organ function. This means the patient’s organs, such as the liver and kidneys, are working well enough to participate in the study.
Male and female participants are eligible to participate if they agree to the contraception use as per study protocol. This means participants must agree to use birth control methods as outlined in the study guidelines.

Who Cannot Join the Study?

Patients who do not have muscle-invasive bladder cancer that is eligible for a specific treatment called Cis cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial groups cannot participate.
Patients who are not male or female cannot participate.
Patients who are considered part of a vulnerable population cannot participate. This means individuals who might be at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Centre Jean Perrin	Clermont Ferrand	France
Comite Entreprise Paul Papin	Angers	France
University Of Pecs	Pecs	Hungary
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Algemeen Stedelijk Ziekenhuis Campus Aalst	Aalst	Belgium

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Hospital Del Mar	Barcelona	Spain
Az Maria Middelares Gent	Gent	Belgium
Centre Francois Baclesse	Caen	France
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Hopitaux Prives De Metz	Vantoux	France
Institut Sainte Catherine	Avignon	France
Europejskie Centrum Zdrowia Otwock Sp. z o.o.	Otwock	Poland
CHU UCL Namur	Yvoir	Belgium
Ukhukbnriu Oi Dvfmnyyo	Debrecen	Hungary
Ogxyjb Uqksffqxnc Hjvzhfnq	Odense	Denmark
Hpibla Hwpvpjxd	Herlev	Denmark
Uexhbxktspkelxrepjkzr Elspwpfw Asb	Erlangen	Germany
Ubvknborqnhcjgszihxgx Tpvciabdk Aja	Tuebingen	Germany
Umvpxgl Uegtodepgi Hmymghou	Uppsala	Sweden
Cyftgw Hhqnitwbwrr Uegfpohrygeip Df Muhmvfuhydc	Montpellier	France
Hggxphgb Crtxgxy Szi Cehgcj	Madrid	Spain
Jilyj Zvkxyxavnz	Hasselt	Belgium
Rphntp Jhxjbwztprmz Lexh	Jönköping	Sweden
Unzlrhnknv Ol Syaaep	Szeged	Hungary
Cafpij Lowq Bqgwbt	Lyon	France
Uubgzwcsyxcjpvideaszv Svbxwagtejfhpcofwu Asf	Kiel	Germany
Vrmen Ucrkrttsgoxn Bzxyuan	Jette	Belgium
Feimtlcub Psgk Lg Inwhmcbcxishr Bpkqfhrtf Dgu Hmnpykdz Ukywqsqltrwwf Lx Pzk	Madrid	Spain
Fwoxwxoyp Ihfesjima Vuvfrebict Dr Oybkvkngm	Valencia	Spain
Fdwxiroyww Ifyrwmljkd Ifufnrsw Nmtgoxmlgfm Bowix	Milan	Italy
Ajocyxm Ondmtolnkoulvucuhncxlkjst Puhqmjfssdd Gz Rmganstadvas Mkell Dw Cosabio	Catania	Italy
Cnxiisbw Vmfbrd Hmfk	Le Mans	France
Bnqtyhrnkspwhikyf Kyizgv Ee Rvtppkljkuvqlq	Budapest	Hungary
Uwszrmmslowsxwaritidw Mahtaboct Arz	Magdeburg	Germany
Vywnmznn Nlibrxhi fndg Gqcxlbmmmm Gvpw	Berlin	Germany
Hgkdffoz Usfjcihxusoex Qrvabdlfdzc Mrrfpi	Pozuelo De Alarcon	Spain
Hfpsctqz Uzumpxxkvapym Vlokwx Dx Vvybp	Sevilla	Spain
Gntjddcrnldlranyd Vcgfdqcir Pewg Aksqho Elwdrsnz Ostnoy Knbsmf	Gyor	Hungary
Hdcunko Plnpm Dqr Cmoef Desrtujnhqekw	Plerin	France
Lxr Mll Oaepmhjxl Sfg z odld	Warsaw	Poland
Cklwogi Ofmfvdrwq Itw Prddv Fizdrmvakx Lhkufrlwxpc W Bcwamdhzwi	Bydgoszcz	Poland
Rcqbud Vznixsffkiirq	Umea	Sweden
Adqceer Oqkszjimgwb S Mahks Dp Tyxau	Terni	Italy
Cmgvigd Rqxaotwh Omincuhijqtq Gkos	Berlin	Germany
Cvrq Uoviefqddb Hfrmjmcd	Cork	Ireland
Sxe Cnkrrtj Ftkkyyyct Hldukxrz	Rome	Italy
Hcangibx Sht Pdwmn Dd Aunvbhayv	Caceres	Spain
Jvxhewvntgbjbrheihgx Vxevbtnkt Hfhpdvi Gzod Kwqhdazapcqwoiimmhwhx	Szolnok	Hungary
Bzqsqnkors Cjmbolb Oeldmtwhb Spwwvfu Myxjhel Ijh Jkgb Povxy Iz W Bhqrwzdqrnqrir Stnfa	Bielsko-Biala	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	17.11.2023
Denmark	Not recruiting	17.11.2023
France	Not recruiting	17.11.2023
Germany	Not recruiting	17.11.2023
Hungary	Not recruiting	17.11.2023
Ireland	Not recruiting	17.11.2023
Italy	Not recruiting	17.11.2023
Poland	Not recruiting	17.11.2023
Spain	Not recruiting	17.11.2023
Sweden	Not recruiting	17.11.2023

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 used around the time of surgery to see if it can improve outcomes for patients with muscle-invasive bladder cancer. It is given in combination with chemotherapy before surgery to help shrink the tumor and make it easier to remove.

Neoadjuvant Chemotherapy refers to the use of chemotherapy drugs before surgery. The goal of this treatment is to reduce the size of the cancer, making it easier to remove during surgery. In this trial, neoadjuvant chemotherapy is used alongside pembrolizumab to see if this combination can improve the chances of successful treatment for bladder cancer.

Investigated Diseases:

Muscle-invasive bladder cancer – This type of bladder cancer occurs when cancer cells spread 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 invade deeper layers of the bladder and potentially spread to nearby tissues or lymph nodes. The progression may lead to symptoms such as blood in the urine, frequent urination, and pain during urination. If the cancer continues to advance, it can affect other parts of the body. The disease requires careful monitoring to understand its progression and impact on the bladder and surrounding areas.

Trial ID:

2022-501970-20-01

Protocol code:

MK-3475-866

NCT ID:

NCT03924856

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Pembrolizumab, Cisplatin, and Gemcitabine for Patients with Muscle-Invasive Bladder Cancer Eligible for Cisplatin Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?