Study on Mitomycin, Capecitabine, Ipilimumab, and Nivolumab for Muscle Invasive Bladder Cancer Treatment in Patients Seeking Bladder-Sparing Options

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What is this study about?

This clinical trial is focused on studying a treatment for muscle-invasive bladder cancer, a type of cancer that affects the bladder muscle. The study is exploring the use of a combination of medications and therapies to treat this condition. The medications involved in the study include mitomycin, capecitabine, ipilimumab (also known by its code name BMS734016), and nivolumab (also known by its code name BMS936558). These medications are used in different forms, such as solutions for infusion or tablets, and are combined with a treatment method called chemoradiotherapy, which uses both chemotherapy and radiation therapy to target cancer cells.

The purpose of the study is to evaluate the safety and effectiveness of these treatments when used together. Participants in the study will receive either a combination of these medications or nivolumab alone. The study aims to determine how well these treatments work in preserving the bladder while treating the cancer. Throughout the study, participants will undergo regular monitoring to assess their response to the treatment and any side effects they may experience.

The study will take place over a period of time, with participants receiving treatment and follow-up care to monitor their health and the progress of the cancer. The goal is to find a treatment approach that is both safe and effective in managing muscle-invasive bladder cancer, potentially offering a bladder-sparing option for patients. This study is an important step in exploring new ways to treat this type of cancer and improve outcomes for patients.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the details and potential risks of the study.

You will undergo a series of laboratory tests to ensure your organs are functioning adequately. These tests will be conducted within 28 days of your registration in the trial.

2 initial health assessment

A comprehensive health assessment will be conducted to confirm your eligibility. This includes checking your blood cell counts, liver function, and kidney function.

Female participants of childbearing potential will need to take a pregnancy test within 72 hours before registration. If the test is positive, further confirmation will be required.

3 treatment preparation

You must have undergone a transurethral biopsy of the bladder tumor within 35 days before starting treatment. This procedure involves taking a small tissue sample from the bladder for examination.

A maximal transurethral resection of the bladder tumor should also be completed within 35 days before treatment. This involves removing as much of the tumor as safely possible.

4 treatment phase 1b

During this phase, you will receive a combination of medications: nivolumab and ipilimumab through intravenous infusion, and mitomycin and capecitabine as part of chemoradiotherapy.

The focus will be on assessing the safety and any side effects of the treatment. This phase lasts for the first 6 weeks after starting the combination therapy.

5 treatment phase 2

In this phase, the treatment will continue with the aim of evaluating the disease-free survival rate. This means checking how long you remain free from cancer after treatment.

You will continue to receive the same medications as in phase 1b, with regular monitoring to assess the effectiveness and any side effects.

6 follow-up and monitoring

After completing the treatment phases, regular follow-up appointments will be scheduled to monitor your health and check for any signs of cancer recurrence.

These follow-ups will include physical examinations, imaging tests, and laboratory tests to ensure your continued well-being.

Who Can Join the Study?

Be willing and able to provide written informed consent for the trial.
Demonstrate adequate organ function. This means your body organs are working well enough. Specific blood tests will be done to check this within 28 days before joining the trial.
Female participants of childbearing potential should have a negative pregnancy test within 72 hours before joining the trial. If the urine test is positive or unclear, a blood test will be needed.
Female participants of childbearing potential should agree to use one highly effective method of birth control, be surgically sterile, or abstain from heterosexual activity during the study and for 5 months after the last dose of study medication. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menstrual periods for more than 1 year.
Male participants should agree to use condoms starting with the first dose of study therapy and continue for 7 months after the last dose of study therapy.
Agree to allow the use of their collected tumor specimen, blood, and urine for future scientific research, including DNA, RNA, and protein-based biomarker detection.
Be at least 18 years old on the day of signing the informed consent.
Wish to preserve their bladder function or be ineligible for bladder removal surgery (cystectomy).
Must have undergone a transurethral biopsy of the bladder tumor within 35 days before starting treatment. This means a small tissue sample was taken from the bladder tumor for examination. The patient should have a confirmed diagnosis of muscle-invasive bladder cancer.
Must have undergone maximal transurethral resection of the bladder tumor, which means removing as much of the tumor as safely possible, within 35 days before starting treatment.
Subjects with tumors of mixed cell types are allowed, but the majority of the tumor must be urothelial cell carcinoma (more than 50%). Subjects with mostly or only non-urothelial cell types are not allowed.
Have planned for chemoradiotherapy as the main treatment. This is a combination of chemotherapy and radiation therapy.
Have a performance status of 0 or 1 on the ECOG Performance Scale, which means you are fully active or have some symptoms but do not need to stay in bed for more than half of the day.
Have a bladder function that allows for follow-up examinations using a cystoscope, a tool used to look inside the bladder.

Who Cannot Join the Study?

Patients with any other type of cancer besides muscle invasive bladder cancer cannot participate.
Patients who have had a severe allergic reaction to nivolumab or ipilimumab in the past cannot participate. These are medications used in the study.
Patients with serious heart problems cannot participate.
Patients with uncontrolled high blood pressure cannot participate.
Patients with active infections that require treatment cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with autoimmune diseases, which are conditions where the immune system attacks the body, cannot participate.
Patients who have received another investigational drug within the last 4 weeks cannot participate.
Patients with a history of organ transplant cannot participate.
Patients with a history of drug or alcohol abuse that could interfere with the study cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Lsbvq Ugdojdftuwgi Mkvbxdg Cqupsvm (rdtse	Leiden	The Netherlands
Anjwccrfd Uze	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.10.2018

Trial locations

Investigated drugs:

Mitomycin-C is a type of chemotherapy drug used to treat cancer. In this trial, it is combined with other treatments to help destroy cancer cells in the bladder. It works by interfering with the DNA of the cancer cells, preventing them from growing and multiplying.

Capecitabine is another chemotherapy medication that is used to treat various types of cancer. In this study, it is used alongside other treatments to target cancer cells in the bladder. Capecitabine is taken orally and is converted into a substance that attacks cancer cells, helping to stop their growth.

Ipilimumab is an immunotherapy drug that helps the immune system fight cancer. It works by blocking a specific protein that usually keeps the immune system in check, allowing the immune system to attack cancer cells more effectively. In this trial, it is used to enhance the body’s natural defenses against bladder cancer.

Nivolumab is another immunotherapy medication that boosts the immune system’s ability to fight cancer. It works by blocking a protein that prevents the immune system from attacking cancer cells. In this study, it is used either alone or in combination with other treatments to help the immune system target and destroy bladder cancer cells.

Investigated diseases:

Bladder cancer

Muscle Invasive Bladder Cancer – This is a type of bladder cancer where the cancer cells have grown 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, it can spread to the surrounding tissues and organs. The cancer may also metastasize to distant parts of the body through the lymphatic system or bloodstream. Symptoms often include blood in the urine, frequent urination, and pain during urination. The progression of the disease can lead to more severe symptoms and complications as it advances.

Trial ID:

2023-509460-19-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Mitomycin, Capecitabine, Ipilimumab, and Nivolumab for Muscle Invasive Bladder Cancer Treatment in Patients Seeking Bladder-Sparing Options

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?