Study of Sasanlimab and Sacituzumab Govitecan for Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

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What is this study about?

This clinical trial is focused on studying a type of bladder cancer known as Non-Muscle Invasive Bladder Cancer (NMIBC). The study is investigating the effects of two treatments: Sasanlimab and Sacituzumab Govitecan. Sasanlimab is a type of medication called a monoclonal antibody, which is designed to help the immune system fight cancer. Sacituzumab Govitecan is another type of monoclonal antibody that targets cancer cells directly.

The purpose of this study is to evaluate how effective the combination of Sasanlimab and Sacituzumab Govitecan is in treating patients whose cancer has not responded to a previous treatment called BCG (Bacillus Calmette-Guérin). The study will observe patients over a period of time to see if the cancer responds to the treatment. Participants will receive the medications through injections and will be monitored regularly to assess their response to the treatment.

Throughout the study, doctors will check the patients’ health and the status of their cancer at different intervals. The main goal is to see if the cancer is completely gone after three months of treatment. The study will also look at how long any positive effects last and monitor for any side effects. This research aims to provide more information on the potential benefits of using these medications together for treating this type of bladder cancer.

1 initial visit

Upon joining the study, the first step involves an initial visit to the clinical trial site. During this visit, a healthcare professional will review the study procedures and answer any questions.

A series of tests and assessments will be conducted to confirm eligibility. These may include blood tests, urine tests, and a review of medical history.

2 treatment initiation

The treatment phase begins with the administration of the study medications. The first medication, sasanlimab, is given as a subcutaneous injection, which means it is injected under the skin.

The second medication, sacituzumab govitecan, is administered as an intravenous infusion, meaning it is delivered directly into a vein through a drip.

3 treatment schedule

The treatment involves regular administration of the medications. Sasanlimab is given once every three weeks, while sacituzumab govitecan is administered on days 1 and 8 of each 21-day cycle.

This schedule continues for the duration of the study, unless there are reasons to stop the treatment, such as side effects or disease progression.

4 regular assessments

Throughout the study, regular assessments are conducted to monitor health and response to treatment. These assessments include physical exams, blood tests, and imaging studies.

Cystoscopy, a procedure to look inside the bladder, and urine cytology, a test to check for abnormal cells in the urine, are performed to evaluate the response to treatment.

5 follow-up visits

Follow-up visits are scheduled at specific intervals to assess the effectiveness of the treatment and to monitor for any side effects.

These visits occur at 3, 6, 12, 18, and 24 months after starting the treatment. The primary goal is to determine the complete response rate of the disease.

6 end of study

The study is expected to conclude by March 31, 2025. At the end of the study, a final assessment will be conducted to evaluate the overall health and treatment outcomes.

Participants will receive information about the results of the study and any further steps that may be necessary for their care.

Who Can Join the Study?

Provide written informed consent, which means you understand the purpose of the study and agree to participate.
Be reliable and willing to be available for the entire duration of the study and follow the study procedures.
Have a confirmed diagnosis of BCG-unresponsive high-risk, non-muscle invasive urothelial carcinoma. This is a type of bladder cancer that has not responded to a treatment called BCG.
Have refused or are not eligible for a surgery called radical cystectomy, which involves removing the bladder.
Have a type of bladder cancer called urothelial carcinoma, which makes up at least 50% of the cancer cells.
Be at least 18 years old.
Have an ECOG performance status of 0-1, which means you are fully active or have some symptoms but do not need bed rest during the day.
Have adequate organ function, which includes:
- A certain level of white blood cells, platelets, and hemoglobin (a protein in red blood cells).
- Normal blood clotting ability.
- Normal liver function.
- Normal kidney function.
Have no other cancer diagnosis within the last 2 years, except for certain types of skin cancer and cervical cancer that have been treated.
Agree to avoid pregnancy or fathering children during the study and for 6 months after the last dose of study drugs. This includes:
- Men must take precautions to avoid fathering children and not donate sperm.
- Women of childbearing potential must have a negative pregnancy test and take precautions to avoid pregnancy. Women who cannot become pregnant are eligible.

Who Cannot Join the Study?

Patients with a history of severe allergic reactions to the study drugs cannot participate.
Patients who have received another investigational drug within the last 4 weeks are not eligible.
Patients with uncontrolled infections are excluded from the study.
Patients with other active cancers, except for non-muscle invasive bladder cancer, cannot join the study.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients with significant heart problems, such as heart failure or recent heart attack, are excluded.
Patients with severe liver or kidney disease cannot take part in the study.
Patients who have had major surgery within the last 4 weeks are not eligible.
Patients with a history of drug or alcohol abuse within the last 6 months are excluded.
Patients who are unable to comply with the study procedures are not allowed to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Fundacio Puigvert	Barcelona	Spain
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Hospital Universitario Central De Asturias	Oviedo	Spain
Hospital General Universitario De Elche	Elche	Spain
Hospital Arnau De Vilanova De Valencia	Valencia	Spain
Hospital Universitario Virgen Macarena	Sevilla	Spain
Hospital Universitario Reina Sofía	Cordoba	Spain
Hospital Universitario de Ourense	Ourense	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Salut Sant Joan De Reus	Reus	Spain
Csoafcds Hdofreaecddp Uqijziodgklnu Dd Vhgc	Vigo	Spain
Hbvouolp Sup Jswe Da Dynu Dwr Acxtutdy	Bormujos	Spain
Pics Tzwfv Hbytqgwd Uscbufyfqzhn	Sabadell	Spain
Itdcdsak Ctymrc Ddtwulimtxmhklwcy	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.03.2023

Trial locations

Investigated drugs:

Sasanlimab is a type of medication that helps the body’s immune system fight cancer. It works by blocking a specific protein that usually stops the immune system from attacking cancer cells. By blocking this protein, sasanlimab allows the immune system to better recognize and destroy cancer cells. In this trial, it is being used to treat bladder cancer that has not responded to other treatments.

Sacituzumab govitecan is a medication that combines an antibody with a chemotherapy drug. The antibody part of the medication helps it find and attach to cancer cells, while the chemotherapy part helps kill those cells. This combination allows the medication to deliver the chemotherapy directly to the cancer cells, which can help reduce the growth of the cancer. In this trial, sacituzumab govitecan is being used alongside sasanlimab to treat bladder cancer that has not responded to other treatments.

Investigated diseases:

Bladder cancer

Non-Muscle Invasive Bladder Cancer – This type of bladder cancer is characterized by cancerous cells that are confined to the inner layers of the bladder wall and have not spread into the muscle layer. It often begins with the formation of small tumors on the bladder lining. As the disease progresses, these tumors can grow in size and number, potentially leading to more severe symptoms. The progression of the disease can vary, with some cases remaining stable while others may become more aggressive. Monitoring is crucial to detect any changes in the disease’s behavior. Regular follow-ups are necessary to manage the condition effectively.

Trial ID:

2024-518486-10-00

Protocol code:

APRO07-2022

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Sasanlimab and Sacituzumab Govitecan for Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?