Study on Chemo-Immunotherapy with Avelumab for Patients with Locally Advanced Urothelial Cancer

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What is this study about?

This clinical trial is focused on studying locally advanced urothelial cancer, a type of cancer that affects the bladder and urinary tract. The study will use a treatment called Bavencio, which is a medication given through an intravenous infusion. The active substance in Bavencio is called avelumab, which is a type of protein designed to help the immune system fight cancer cells. The purpose of the study is to see if using a combination of chemotherapy and this immune therapy can help more patients achieve a complete response to treatment before undergoing surgery.

Participants in the study will first receive chemotherapy, which is a standard cancer treatment using drugs to kill cancer cells. After completing chemotherapy, they will receive the immune therapy with Bavencio. The study will monitor how well the cancer responds to this treatment combination and whether it helps in preparing patients for surgery. The study will also look at the safety of Bavencio and any side effects that may occur during the treatment process.

The trial aims to understand if this approach can improve outcomes for patients with this type of cancer, particularly in terms of reducing the cancer to a point where it can be completely removed by surgery. The study will follow participants over a period of time to assess their progress and overall health, including their survival rates and any complications that may arise from the treatment or surgery.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This is a document that confirms your understanding of the study and your willingness to participate.

You will undergo a series of tests to confirm your eligibility, including assessments of your kidney, liver, and bone marrow function, as well as a pregnancy test if applicable.

2 initial chemotherapy

You will receive a minimum of 3 or a maximum of 4 cycles of induction chemotherapy. This treatment will include medications such as cisplatin or carboplatin combined with gemcitabine.

The goal of this phase is to stabilize your condition before moving on to the next stage of the trial.

3 immunotherapy with avelumab

After completing chemotherapy, you will begin treatment with avelumab, which is an immunotherapy medication.

Avelumab will be administered as an intravenous infusion, meaning it will be given directly into your vein. The frequency and duration of this treatment will be determined by the study protocol.

4 surgery preparation

If your condition remains stable, you will be prepared for radical surgery. This involves the removal of the primary tumor and affected lymph nodes.

The timing of the surgery will depend on your response to the avelumab treatment and your overall health status.

5 surgery

You will undergo radical surgery to remove the cancerous tissue. The aim is to achieve a pathological complete response, meaning no residual cancer is found in the tissue removed.

Your recovery and any potential complications will be monitored closely following the surgery.

6 follow-up and monitoring

After surgery, you will have regular follow-up appointments to monitor your recovery and check for any signs of cancer recurrence.

Your overall health, progression-free survival, and any side effects from the treatment will be assessed during these visits.

Who Can Join the Study?

Age must be 18 years or older.
Must have adequate kidney function, which means the kidneys are working well enough, with a creatinine clearance of at least 30 mL/min.
Must have adequate liver function, which includes:
- Total bilirubin (a substance made by the liver) less than 1.5 times the normal limit.
- AST and ALT (liver enzymes) less than 2.5 times the normal limit.
Must have a confirmed diagnosis of urothelial carcinoma (a type of cancer) in the bladder, upper urinary tract, or urethra, with no more than 50% of unusual cell types.
Must have a specific stage of cancer (cT4bNxM0 or cTxN1-N3M0) as determined by medical imaging or examination.
Must have at least stable disease after 3 to 4 cycles of chemotherapy with cisplatin or carboplatin plus gemcitabine, according to specific medical guidelines.
Must be fit and willing to undergo major surgery to remove the tumor and affected lymph nodes.
Must have a World Health Organisation performance status of 0 to 2, which indicates the ability to carry out daily activities.
Must provide written informed consent to participate in the study.
Women who can have children must have a negative pregnancy test.
Must have adequate bone marrow function, which includes:
- Absolute neutrophil count (a type of white blood cell) of at least 1,500/mm³.
- Platelet count of at least 100 x 10⁹/L.
- Hemoglobin level of at least 5.6 mmol/L, which may have been supported by a blood transfusion.

Who Cannot Join the Study?

Patients with other types of cancer besides locally advanced urothelial cancer cannot participate.
Patients who have had previous treatments that might interfere with the study cannot participate.
Patients with serious heart problems or other major health issues cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have allergies to the study drugs cannot participate.
Patients who are unable to follow the study procedures cannot participate.
Patients with active infections that require treatment cannot participate.
Patients who have received another investigational drug within a certain time frame cannot participate.
Patients with uncontrolled high blood pressure cannot participate.
Patients with mental health conditions that might affect their ability to participate cannot participate.

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
Jeroen Bosch Ziekenhuis Stichting	s-Hertogenbosch	The Netherlands
Canisius Wilhelmina Ziekenhuis	Nijmegen	The Netherlands
Amphia Hospital	Breda	The Netherlands
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Eeuzqaj Uyrwpkwuquwy Mhczoxh Chupygn Rzruqmukp (bssxcds Mwl	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.12.2022

Trial locations

Investigated drugs:

Avelumab

CHASIT-001 is an experimental medication being tested in this clinical trial. It is designed to work with the body’s immune system to help fight cancer cells. The goal of this medication is to improve the body’s natural defenses so that it can better target and destroy cancer cells in patients with advanced urothelial cancer. This medication is given after chemotherapy to see if it can help more patients achieve a complete response, meaning no signs of cancer are found during surgery.

Investigated diseases:

Transitional cell carcinoma

Urothelial Cancer – Urothelial cancer is a type of cancer that occurs in the urothelial cells lining the bladder and other parts of the urinary tract. It often begins in the bladder but can also affect the ureters and urethra. The disease progresses as cancer cells grow uncontrollably, potentially invading deeper layers of the bladder wall and spreading to nearby lymph nodes and other organs. In its locally advanced stage, the cancer may become irresectable, meaning it cannot be removed surgically due to its size or location. Clinically node-positive urothelial cancer indicates that cancer has spread to the lymph nodes. The progression of the disease can lead to symptoms such as blood in the urine, frequent urination, and pain during urination.

Trial ID:

2024-516940-24-00

Protocol code:

CHASIT

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Chemo-Immunotherapy with Avelumab for Patients with Locally Advanced Urothelial Cancer

What is this study about?

Who Can Join the Study?

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