Study Comparing Sacituzumab Govitecan with Other Treatments for Patients with Advanced Unresectable Urothelial Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer known as urothelial cancer, which affects the urinary system and can be either locally advanced or metastatic, meaning it has spread to other parts of the body. The study is comparing the effectiveness of a medication called sacituzumab govitecan with other treatments chosen by doctors. Sacituzumab govitecan is a type of medication known as an antibody-drug conjugate, which is designed to target and kill cancer cells.

The purpose of the study is to see how well sacituzumab govitecan works in helping patients live longer compared to other treatments. Participants in the study will receive either sacituzumab govitecan or a treatment selected by their doctor, which could include medications like docetaxel, vinflunine, or paclitaxel. These treatments are given as solutions for infusion, meaning they are administered directly into the bloodstream through a vein.

The study will follow participants over a period of time to monitor their health and the effects of the treatments. The goal is to gather information on how these treatments impact overall survival and other health outcomes in patients with advanced urothelial cancer. This information will help doctors understand which treatments may be most effective for this type of cancer.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the medication sacituzumab govitecan, and the other group will receive a treatment chosen by your doctor from a list of options.

2 treatment administration

If you are in the sacituzumab govitecan group, you will receive this medication through an intravenous infusion. This means the medication will be given directly into your vein. The specific dosage and frequency will be determined by your healthcare provider.

If you are in the group receiving a treatment of your doctor’s choice, the options include docetaxel, vinflunine, or paclitaxel. These medications are also administered through intravenous infusion. Your doctor will decide the best option for you, including the dosage and frequency.

3 monitoring and follow-up

Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and other necessary assessments to ensure your safety and to evaluate the effectiveness of the treatment.

You will be asked to report any side effects or changes in your health to the study team. This information is crucial for assessing the safety and tolerability of the treatments.

4 end of study participation

The study is expected to continue until July 31, 2025. Your participation may end earlier if you or your doctor decide it is in your best interest, or if the study team determines it is necessary for your safety.

At the end of your participation, you will have a final evaluation to assess your health and the outcomes of the treatment you received.

Who Can Join the Study?

Participants must be 18 years or older and able to understand and sign a consent form.
Both men and women can participate. Women who can have children and men must agree to use specific birth control methods during the study.
Participants must have a type of cancer called urothelial cancer that is either spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable).
Cancer can be in the upper or lower urinary tract. Mixed types of cancer are allowed if the main type is urothelial.
Participants must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest.
Participants must have had cancer that got worse or came back after receiving a platinum-containing treatment and a type of therapy called anti-PD-1/PD-L1.
Participants with treated brain metastases can join if their brain disease has been stable for at least 4 weeks, they have no new or growing brain tumors, and they are not taking high doses of steroids.
Participants must have adequate blood counts without needing blood transfusions or growth factors in the 2 weeks before starting the study drug.
Participants must have adequate liver function, meaning certain liver tests are within acceptable limits.
Participants must have a creatinine clearance of at least 30 mL/min, which is a measure of kidney function.

Who Cannot Join the Study?

Patients with other types of cancer that are not urothelial cancer cannot participate.
Patients who have had a different cancer treatment within the last 4 weeks are not eligible.
Patients with severe heart problems cannot join the study.
Patients with uncontrolled infections are not allowed to participate.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients with a history of severe allergic reactions to similar drugs are excluded.
Patients with significant liver or kidney disease cannot participate.
Patients who have received a live vaccine within 30 days before the study starts are not eligible.
Patients with a history of drug or alcohol abuse that could interfere with the study are excluded.
Patients who are unable to follow the study procedures for any reason cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
Centre Jean Perrin	Clermont Ferrand	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Comite Entreprise Paul Papin	Angers	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Az Maria Middelares Gent	Gent	Belgium
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada	Manresa	Spain
Henry Dunant Hospital Center	Athens	Greece
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
General University Hospital Of Larissa	Larissa	Greece
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Alexandra Hospital	Athens	Greece
Hospital Clinic De Barcelona	Barcelona	Spain
Karolinska University Hospital	Solna	Sweden
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Region Joenkoepings Laen	Jönköping	Sweden
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara	Chaidari	Greece
Centrum für Hämatologie und Onkologie Bethanien	Frankfurt	Germany
Ihzthhnp Rcahqglm Du Cdtdyc Dn Mggbndgkapp	Montpellier	France
Cdpkyf Lykx Bctpwd	Lyon	France
Iwxchoff Ranjxpvop Pix Lf Sbmxmg Dnn Tpukoa Dcjo Aktbzhm Ikka Sdxiww	Meldola	Italy
Uutsjsa Uhwjivxmhu Haelebjl	Uppsala	Sweden
Adabmc Mqfcoqd Ctebot Ssuy	Thessaloniki	Greece
Hdecjgsr Vabs dtplfmbi	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	28.06.2021
France	Not recruiting	28.06.2021
Germany	Not recruiting	28.06.2021
Greece	Not recruiting	28.06.2021
Ireland	Not recruiting	28.06.2021
Italy	Not recruiting	28.06.2021
Spain	Not recruiting	28.06.2021
Sweden	Not recruiting	28.06.2021

Trial locations

Investigated drugs:

Sacituzumab Govitecan is a type of medication used in cancer treatment. It is designed to target and attach to specific cancer cells, delivering a powerful drug directly to them. This helps to kill the cancer cells while trying to minimize damage to healthy cells. In this trial, it is being tested to see if it can help people with a type of bladder cancer that has spread or cannot be removed with surgery.

Locally Advanced or Metastatic Unresectable Urothelial Cancer – This is a type of cancer that originates in the urothelial cells lining the bladder and other parts of the urinary tract. When it is locally advanced, the cancer has spread beyond the bladder to nearby tissues or lymph nodes. In its metastatic form, the cancer has spread to distant parts of the body, such as the liver, lungs, or bones. The term “unresectable” indicates that the cancer cannot be removed completely through surgery. As the disease progresses, it can cause symptoms such as blood in the urine, pain during urination, and frequent urination. Over time, it may lead to more severe symptoms as it affects other organs.

Trial ID:

2024-513870-23-00

Protocol code:

IMMU-132-13

NCT ID:

NCT04527991

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Sacituzumab Govitecan with Other Treatments for Patients with Advanced Unresectable Urothelial Cancer

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