Study of Eciskafusp Alfa and BCG for Patients with High-Risk Bladder Cancer Not Responding to BCG Treatment

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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 that does not respond to a common treatment called Bacillus Calmette-Guérin (BCG). The study will explore a new treatment combination involving a medication called eciskafusp alfa and BCG. Eciskafusp alfa is being tested to see if it can help patients whose cancer has not been controlled by BCG alone.

The purpose of the study is to evaluate the safety and effectiveness of this new treatment combination. Participants will receive the treatment directly into the bladder, a method known as intravesical use. The study will be conducted in two phases. The first phase will focus on determining the safest dose of eciskafusp alfa when used with BCG. The second phase will assess how well the treatment works in preventing the cancer from returning or getting worse.

Throughout the study, participants will be monitored for any side effects and the overall response of their cancer to the treatment. The study aims to find out if this new combination can provide a better outcome for patients with this type of bladder cancer. Participants will undergo regular check-ups, including procedures like cystoscopy, which is a way to look inside the bladder, and imaging tests to track the progress of the treatment.

1 initial treatment phase

The study begins with the administration of two medications: eciskafusp alfa and bacillus Calmette-Guérin (BCG). These are given through a procedure called intravesical use, which means they are delivered directly into the bladder.

The purpose of this phase is to evaluate the safety and tolerability of the combination of these medications. The dosage may be adjusted to determine the most effective and safe amount.

2 dose escalation

During this phase, the dosage of eciskafusp alfa may be gradually increased. This is done to find the maximum dose that can be tolerated without causing severe side effects.

The goal is to identify the recommended dose for further treatment.

3 monitoring and evaluation

Regular monitoring is conducted to assess the response to the treatment. This includes checking for the absence of high-risk bladder cancer through procedures like cystoscopy and imaging tests.

The presence of any adverse effects is also closely monitored and recorded.

4 extension phase

If the initial phases show positive results, the study may continue with an extension phase. This involves using the recommended dose identified earlier to further evaluate its effectiveness.

The focus is on the anti-tumor activity and the duration of the response to the treatment.

5 long-term follow-up

Participants will be followed over a longer period to monitor the complete response rate at various intervals, such as 6, 12, 18, and 24 months.

The study will also track the progression-free survival, which means the time during which the cancer does not worsen or spread.

Who Can Join the Study?

The patient must have a confirmed diagnosis of high-risk non-muscle invasive bladder cancer. This type of cancer is found in the bladder but has not spread to the muscle layer.
The patient must have carcinoma in situ (CIS), which is a type of cancer that is flat and stays on the surface of the bladder. It can be with or without other types of early-stage bladder cancer (Ta/T1).
If the patient has tumors with different types of cancer cells, the main type must be transitional cell carcinoma, which is the most common type of bladder cancer.
The patient must have CIS present in the tumor sample from the most recent transurethral resection of bladder tumor (TURBT), a procedure to remove bladder tumors.
The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for Phase I, and 0, 1, or 2 for Phase II. This is a scale that measures how well the patient can perform daily activities.
The patient must not have any disease that can be surgically removed after TURBT procedures. If there is still CIS, it is acceptable. Patients with T1 tumors must have another resection and biopsy if the first one did not include a specific muscle layer called muscularis propria.
The patient must have BCG-unresponsive disease, meaning the cancer did not respond to or came back after treatment with Bacillus Calmette-Guérin (BCG), a common bladder cancer treatment. This must happen within 12 months of receiving enough BCG therapy.
The patient must be considered ineligible for radical cystectomy, a surgery to remove the bladder, or have chosen not to have this surgery. The reasons for this decision should be discussed and recorded.
The patient must be within the age range of adults and older adults.
Both male and female patients can participate.
The study may include vulnerable populations, which are groups that might need special protection or consideration.

Who Cannot Join the Study?

Patients who have a different type of bladder cancer that is not BCG-Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC).
Patients who are not within the specified age range for the study.
Patients who are not able to safely receive the study treatment due to other health conditions.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies or reactions to the study drugs or similar treatments.
Patients who have a history of other cancers that might interfere with the study results.
Patients who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr	Herne	Germany
Netherlands Cancer Institute	Amsterdam	The Netherlands
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Dllttzniwgtg Chfmaqr Odqqrbgrw Puaujcufmmpg I Hvezguelqkb	Wroclaw	Poland
Ceihnwsnwciwusorafw Sxd Jozze	Regensburg	Germany
Aflfwjh Scp z ojom	Poznan	Poland
Unctnvqoebpwvtmghtcsz Dqylttjqypd Arv	Duesseldorf	Germany
Axwrln Urjobdcbat Hcmbgzdx	Aarhus	Denmark
Uqgjyfnnppyewsrzlywxo Wziytdebm Ayb	Wuerzburg	Germany
Uysnrtndinhtdq Cjlkqow Kxhgnyrpj	Gdansk	Poland
Iqbqhyuc Pcrnbsdqpryppcc Crbrlr Cdatcu	Marseille	France

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.03.2025
France	Not recruiting	01.03.2025
Germany	Not recruiting	01.03.2025
Italy	Not recruiting	01.03.2025
Poland	Not recruiting	01.03.2025
Spain	Not recruiting	01.03.2025
The Netherlands	Not recruiting	01.03.2025

Trial locations

Investigated drugs:

RO7284755

Eciskafusp Alfa is an experimental medication being tested in this clinical trial. It is being studied to see if it can help treat high-risk non-muscle invasive bladder cancer that has not responded to other treatments. The trial aims to find out how safe and tolerable this medication is when used with another treatment, and to determine the best dose to use in future studies.

Bacillus Calmette-Guérin (BCG) is a type of immunotherapy used to treat bladder cancer. It is made from a weakened form of bacteria that helps stimulate the immune system to attack cancer cells in the bladder. In this trial, BCG is used in combination with eciskafusp alfa to see if the two treatments together can be more effective in treating bladder cancer.

BCG-Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) – This type of bladder cancer occurs when cancer cells form in the tissues of the bladder but have not spread into the muscle layer. It is considered high-risk due to its potential to recur or progress despite treatment. The term “BCG-unresponsive” indicates that the cancer does not respond to Bacillus Calmette-Guérin (BCG) therapy, a common treatment for bladder cancer. Patients with this condition may experience frequent urination, blood in the urine, and discomfort. The disease is monitored through cystoscopy and imaging to assess any changes in the bladder tissue. Regular follow-ups are essential to manage and observe the progression of the disease.

Trial ID:

2024-515410-41-00

Protocol code:

BP45381

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Eciskafusp Alfa and BCG for Patients with High-Risk Bladder Cancer Not Responding to BCG Treatment

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