Study Comparing Chemotherapy Alone to Chemotherapy with Nivolumab or Nivolumab and BMS-986205 for Patients with Muscle-Invasive Bladder Cancer

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What is this study about?

This clinical trial is focused on studying treatments for Muscle-Invasive Bladder Cancer, a type of cancer that affects the bladder muscle. The study is comparing different treatment approaches to see which is more effective. One group of participants will receive standard chemotherapy, which involves using drugs to kill cancer cells. The chemotherapy drugs being used in this study include gemcitabine hydrochloride and cisplatin. Another group will receive chemotherapy combined with a drug called nivolumab, which is an immunotherapy that helps the immune system fight cancer. Some participants may also receive an additional drug known as BMS-986205, which is being tested for its potential to enhance the effects of nivolumab.

The purpose of the study is to determine if adding nivolumab, with or without BMS-986205, to chemotherapy before surgery can improve outcomes for patients with muscle-invasive bladder cancer. Participants will be randomly assigned to one of the treatment groups. After receiving the initial treatment, participants will undergo surgery to remove the bladder cancer. Following surgery, some participants will continue to receive nivolumab, with or without BMS-986205, to see if it helps prevent the cancer from returning.

The study will last for a period of time, during which participants will receive their assigned treatments and be monitored for any changes in their condition. The researchers will be looking at various outcomes, such as the rate of complete response to the treatment, which means no signs of cancer are found after treatment, and event-free survival, which refers to the length of time participants remain free from cancer-related events. The study will also track overall survival and any side effects or adverse events that may occur during the trial.

1 initial treatment phase

The initial treatment phase involves receiving neoadjuvant chemotherapy. This is a treatment given before surgery to shrink the tumor.

The medications used in this phase include gemcitabine hydrochloride and cisplatin. These are administered through an intravenous infusion, which means they are given directly into a vein.

The specific dosage and frequency of these medications will be determined by the healthcare provider based on individual patient needs.

2 additional treatment with nivolumab

In some cases, nivolumab may be added to the chemotherapy regimen. Nivolumab is a type of immunotherapy that helps the immune system fight cancer.

This medication is also administered intravenously. The healthcare provider will determine the appropriate dosage and schedule.

3 surgical intervention

After completing the neoadjuvant therapy, a surgical procedure called radical cystectomy (RC) is performed. This involves the removal of the bladder and surrounding tissues.

The decision to proceed with surgery is based on the patient’s response to the initial treatment phase and overall health status.

4 post-surgery therapy

Following surgery, additional therapy may be administered. This could include continued treatment with nivolumab to help prevent cancer recurrence.

The healthcare provider will determine the need for post-surgery therapy based on the patient’s condition and response to previous treatments.

5 monitoring and follow-up

Regular follow-up appointments are scheduled to monitor the patient’s recovery and check for any signs of cancer recurrence.

These appointments may include physical exams, imaging tests, and laboratory tests to assess the patient’s health and response to treatment.

Who Can Join the Study?

Participants must have bladder cancer that has spread into the muscle, known as Muscle-Invasive Bladder Cancer (MIBC). The cancer should be at a clinical stage between T2 and T4a, with no spread to lymph nodes larger than 10 mm, and no spread to other parts of the body. This should be confirmed by imaging tests.
Participants must be eligible for a surgery called radical cystectomy (RC), which is the removal of the bladder, as determined by their cancer doctor or bladder specialist. They must also agree to have this surgery after completing initial treatment.
Participants should have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. This is a scale used to assess how well a person can perform daily activities, with 0 meaning fully active and 1 meaning some restrictions but still able to do light work.
Participants must be adults, as the study includes age ranges typically for adults.
Both male and female participants are eligible to join the study.
The study does not include vulnerable populations, which means it is not designed for groups that might need special protection, like children or those unable to give consent.

Who Cannot Join the Study?

Patients with other types of cancer besides bladder cancer or muscle-invasive bladder cancer cannot participate.
Patients who have had previous treatment with nivolumab or similar medications are not eligible. Nivolumab is a type of medicine that helps the immune system fight cancer.
Patients with severe or uncontrolled medical conditions that could interfere with the study are excluded. This means if you have a serious health problem that is not well-managed, you cannot join.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have participated in another clinical trial within the last 30 days are not eligible.
Patients with known allergies to the study drugs or their ingredients cannot participate.
Patients with active infections that require treatment are excluded. This means if you have an infection that needs medication, you cannot join.
Patients with a history of certain autoimmune diseases are not eligible. Autoimmune diseases are conditions where the immune system attacks the body by mistake.
Patients with a history of organ transplant cannot participate.
Patients with a history of drug or alcohol abuse that could interfere with the study are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Oslo Universitetssykehus HF	Oslo	Norway
Centre Jean Perrin	Clermont Ferrand	France
Medical University Of Vienna	Vienna	Austria
University Hospital Jena KöR	Jena	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Klinikum Nuernberg	Nürnberg	Germany
Centre Antoine Lacassagne	Nice	France
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Netherlands Cancer Institute	Amsterdam	The Netherlands
Barmherzige Brueder Trier gGmbH	Trier	Germany
Universitaetsklinikum Aachen AöR	Aachen	Germany
HELIOS Klinikum Erfurt GmbH	Erfurt	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Az Maria Middelares Gent	Gent	Belgium
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
MD Anderson Cancer Center	Madrid	Spain
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti	Bucharest	Romania
Universitaetsklinikum Krems	Krems An Der Donau	Austria
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Landeskrankenanstalten-Betriebsgesellschaft Kabeg	Klagenfurt am Wörthersee	Austria
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
General University Hospital Of Larissa	Larissa	Greece
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Virgen del Rocío University Hospital	Sevilla	Spain
Universita’ Di Pisa	Pisa	Italy
Gasthuiszusters Antwerpen	Antwerp	Belgium
Sykehuset Oestfold HF Kalnes	Graalum	Norway
Hospital Universitario Lucus Augusti	Lugo	Spain
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Centre Hospitalier Universitaire De Nantes	Nantes	France
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr	Herne	Germany
Hopital Prive Clairval	Marseille	France
Pirkanmaan hyvinvointialue	Tampere	Finland
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Otto Von Guericke Universitaet Magdeburg	Magdeburg	Germany
Ctoqlhxie Uqzkkqymbrpgpi Smzxlcjez	Woluwe-Saint-Lambert	Belgium
Icnilhag Rlehzoqy Dj Cbmwyw Dx Mglupevnrrp	Montpellier	France
Oafrblswiogqfy Lqqt Grkq	Linz	Austria
Idfzdqdx Mojmqbtsfz Myslxpaawt	Paris	France
Afxx Mqdnai &iyrapm Oemrktbw By Rkogxrjbt	Carpi	Italy
Izhyjzmk Rjhzibixj Psr Lo Srkmay Dha Tjjhha Dayo Altywcb Ipgg Swjzyl	Meldola	Italy
Abttkssf Uriykgjwal Hdatpgeg	Lorenskog	Norway
Bzpitnvn Ukutjjcyep Hofvaaus Cmxthr	Besançon	France
Hculkzpf Uzelfcchpb Cgzbiyt Huwmuwwc	Helsinki	Finland
Gtphjv Uswivlgbfe Fowhhjoju	Frankfurt	Germany
Cyhmyn Haeebtgvims Rhnqdooa Dccgsykanwirar	Angers	France
Kulkkdvl Ezvnnnwpkpczqqcynesjqpec Hypmwqjiiijiikdws	Essen	Germany
Urfexbfebo Gnvykya Htqijwmd Amrbjey	Athens	Greece
Hxnvbevi Uylwodignotsgp Sfrqfrhoag &txtoev Htuglfq dh Hptpryapukb	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	11.01.2019
Belgium	Not recruiting	11.01.2019
Finland	Not recruiting	11.01.2019
France	Not recruiting	11.01.2019
Germany	Not recruiting	11.01.2019
Greece	Not recruiting	11.01.2019
Italy	Not recruiting	11.01.2019
Norway	Not recruiting	11.01.2019
Romania	Not recruiting	11.01.2019
Spain	Not recruiting	11.01.2019
The Netherlands	Not recruiting	11.01.2019

Trial locations

Investigated drugs:

Nivolumab is a medication used in this trial to help the body’s immune system fight cancer cells. It is an immunotherapy drug that works by blocking a protein called PD-1, which can prevent the immune system from attacking cancer cells. In this study, it is used both before and after surgery to treat muscle-invasive bladder cancer.

BMS-986205 is an investigational drug being studied for its potential to enhance the effects of immunotherapy. It is used in combination with nivolumab in this trial to see if it can improve treatment outcomes for patients with muscle-invasive bladder cancer.

Neoadjuvant Chemotherapy refers to the use of chemotherapy drugs before surgery to shrink tumors and make them easier to remove. In this trial, it is used alone or in combination with nivolumab or nivolumab and BMS-986205 to treat muscle-invasive bladder cancer.

Investigated diseases:

Bladder cancer

Bladder Cancer – Bladder cancer is a disease where abnormal cells grow uncontrollably in the bladder, which is the organ that stores urine. It often begins in the cells lining the inside of the bladder and can spread to nearby tissues. The most common type is transitional cell carcinoma, which starts in the urothelial cells. Symptoms may include blood in the urine, frequent urination, and pain during urination. As the disease progresses, it can invade deeper layers of the bladder wall and potentially spread to other parts of the body. Early detection is crucial for managing the disease effectively.

Muscle-Invasive Bladder Cancer – Muscle-invasive bladder cancer is a more advanced form of bladder cancer where the cancer cells have spread into the muscle layer of the bladder wall. This type of cancer is more aggressive and has a higher risk of spreading to other parts of the body. Symptoms can include blood in the urine, pelvic pain, and changes in bladder habits. The progression of the disease can lead to the involvement of nearby organs and lymph nodes. It requires more intensive treatment compared to non-muscle-invasive bladder cancer. Early intervention is important to control the spread of the disease.

Trial ID:

2024-512158-12-00

Protocol code:

CA017-078

NCT ID:

NCT03661320

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Chemotherapy Alone to Chemotherapy with Nivolumab or Nivolumab and BMS-986205 for Patients with Muscle-Invasive Bladder Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?