Study on TAR-200 and Cetrelimab for Patients with Muscle-Invasive Bladder Cancer Ineligible for or Refusing Platinum-Based Chemotherapy

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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 Urothelial Carcinoma. The study is exploring the effects of two treatments: a combination of TAR-200 and Cetrelimab, and Cetrelimab alone. TAR-200 is a device that helps deliver medication directly into the bladder, while Cetrelimab is a type of medication known as a monoclonal antibody, which is designed to help the immune system fight cancer cells.

The purpose of the study is to understand how these treatments can affect the tumor in patients who are scheduled for a surgery called radical cystectomy, which involves removing the bladder. The study is open-label, meaning both the researchers and participants know which treatment is being given. Participants in the study are those who cannot or choose not to receive a type of chemotherapy known as platinum-based chemotherapy before surgery.

Participants will be randomly assigned to one of two groups: one group will receive the combination of TAR-200 and Cetrelimab, and the other group will receive Cetrelimab alone. The study will monitor the effects of these treatments over a period of time to see how well they work in reducing the cancer before surgery. The study will also look at the safety of the treatments and any side effects that may occur. The goal is to gather information that could help improve treatment options for this type of bladder cancer in the future.

1 initial assessment and randomization

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

Participants are then randomly assigned to one of two groups: one receiving TAR-200 in combination with cetrelimab, and the other receiving cetrelimab alone.

2 treatment administration

Participants in the first group receive TAR-200 via intravesical use, which involves administering the medication directly into the bladder.

Both groups receive cetrelimab through intravenous infusion. This involves administering the medication directly into a vein.

The treatment schedule and dosage are determined by the study protocol and are administered under medical supervision.

3 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment and any side effects. This includes physical examinations, blood tests, and imaging studies.

Participants are required to attend scheduled follow-up visits to ensure ongoing evaluation of their health status and treatment effects.

4 surgical procedure

Participants undergo a surgical procedure known as radical cystectomy, which involves the removal of the bladder. This is a planned part of the study for all participants.

The primary goal is to evaluate the complete response rate at the time of surgery.

5 post-surgery evaluation

After surgery, participants continue to be monitored for any adverse events and recovery progress.

Additional assessments are conducted to evaluate recurrence-free survival and any laboratory abnormalities.

Who Can Join the Study?

Must be at least 18 years old or the legal age of consent in the study location.
Any side effects from previous surgeries must have improved to a mild level before joining the study.
Participants must follow local rules for using birth control during the study. Women must not be pregnant, breastfeeding, or planning to become pregnant during the study and for 6 months after the last treatment. Men must use condoms during the study and for 6 months after the last treatment.
Women who can have children must have a negative pregnancy test before starting the study and agree to regular pregnancy tests during the study.
Must sign an informed consent form, or a legal representative must sign it on their behalf.
Must have a confirmed diagnosis of Muscle-Invasive Urothelial Carcinoma of the Bladder within 120 days before joining the study. This is a type of bladder cancer.
Participants with no remaining tumor or a tumor size of 3 cm or less after a procedure called TURBT (a surgery to remove bladder tumors) can join. If the tumor is larger than 3 cm, another surgery is needed to reduce its size.
Must be eligible and willing to undergo RC (removal of the bladder) as determined by a urologist.
Must have a good performance status, meaning they can carry out daily activities without help.
Thyroid function must be normal or stable with medication.
Must have adequate bone marrow, liver, and kidney function.
Must refuse or be ineligible for cisplatin-based chemotherapy (a type of cancer treatment) due to specific health reasons like poor kidney function, hearing loss, or nerve damage.
Previous chemotherapy for other conditions is allowed if it was more than 24 months ago and any side effects have improved to a mild level.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have had a recent major surgery or procedure.
Patients who are currently receiving another cancer treatment.
Patients with a history of severe allergic reactions to similar medications.
Patients with uncontrolled medical conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend required visits.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Haga Hospital	Hague	The Netherlands
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Canisius Wilhelmina Ziekenhuis	Nijmegen	The Netherlands
Ziekenhuisgroep Twente Stichting	Almelo	The Netherlands
AORN San Giuseppe Moscati Avellino	Avellino	Italy
Fundacio Puigvert	Barcelona	Spain
Clinique Tivoli Ducos	Bordeaux	France
Azienda Unita Sanitaria Locale Di Modena	Carpi	Italy
Capio La Croix Du Sud	Quint-Fonsegrives	France
Ospedale San Raffaele S.r.l.	Milan	Italy
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Sint-Lucas General Hospital	Brugge	Belgium
Universita’ Di Pisa	Pisa	Italy
Gasthuiszusters Antwerpen	Antwerp	Belgium
Ziekenhuis Oost Limburg	Genk	Belgium
CHU Helora	La Louviere	Belgium
Hopital Beaujon	Clichy	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Ipisjn Iunbxhre Fdqdmbwqrhhkq Oyejswektey	Rome	Italy
Hdwmnlog Udngkjuicevsh Mchqwoi Dn Vnjceapnhz	Santander	Spain
Muidsu Hdmuazbs Hntsa Uhvkbihzzrwfbbwlgfqz dao Rfuecrkivaxilnqk Bjjcdm	Herne	Germany
Anoaoki Otuunzgkveh Upcklpokjpjro Cdedbwdcdtga Dnkdk Sfdxqd E Dcoyk Sfxparl Dt Thousw	Turin	Italy

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.12.2021
France	Not recruiting	01.12.2021
Germany	Not recruiting	01.12.2021
Italy	Not recruiting	01.12.2021
Spain	Not recruiting	01.12.2021
The Netherlands	Not recruiting	01.12.2021

Trial locations

Investigated drugs:

TAR-200 is a medication being studied for its potential to treat muscle-invasive urothelial carcinoma of the bladder. It is designed to be used in combination with another medication to see if it can help reduce the size of tumors or slow their growth in patients who are not able to receive or choose not to receive standard chemotherapy.

Cetrelimab is another medication involved in this study. It is being tested both on its own and in combination with TAR-200. Cetrelimab is an immunotherapy drug, which means it works by helping the body’s immune system recognize and attack cancer cells. The study aims to see how effective Cetrelimab is in treating bladder cancer, either alone or when used with TAR-200.

Muscle-Invasive Urothelial Carcinoma of the Bladder – This is a type of bladder cancer that begins in the urothelial cells lining the bladder and invades into the muscle layer of the bladder wall. It is characterized by the growth of cancerous cells that can spread to nearby tissues and organs. As the disease progresses, it may cause symptoms such as blood in the urine, frequent urination, and pain during urination. The cancer can also lead to more severe symptoms if it spreads beyond the bladder. The progression of this disease often requires medical intervention to manage its impact on the bladder and surrounding areas.

Trial ID:

2023-507189-17-00

Protocol code:

17000139BLC2002

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on TAR-200 and Cetrelimab for Patients with Muscle-Invasive Bladder Cancer Ineligible for or Refusing Platinum-Based Chemotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?