Study of Sacituzumab Govitecan for Patients with Advanced or Metastatic Bladder Cancer

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for unresectable locally advanced or metastatic urothelial cancer, a type of cancer that affects the bladder and other parts of the urinary system. The treatment being tested is called sacituzumab govitecan, which is administered as a solution for infusion, meaning it is given directly into the bloodstream through a vein. The purpose of the study is to evaluate how well this treatment works in patients with this type of cancer.

Participants in the study will receive the treatment over a period of time, and their response to the treatment will be monitored. The study will look at how the cancer responds to the treatment, including whether it shrinks or stops growing. The study will also assess how long patients live without the cancer getting worse. Some participants may receive other medications as part of their treatment, such as cisplatin, gemcitabine, carboplatin, pembrolizumab (also known as Keytruda), avelumab (also known as Bavencio), domvanalimab (also known as AB154), and zimberelimab (also known as AB122).

The study is designed to gather information on the effectiveness and safety of sacituzumab govitecan in treating this type of cancer. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to collect data on the treatment’s impact on their cancer. The study aims to provide valuable insights that could lead to improved treatment options for patients with urothelial cancer.

Who Can Join the Study?

  • Must be a female or male who is 18 years or older (19 years or older for South Korea).
  • Must have locally advanced or metastatic urothelial cancer confirmed by a tissue sample.
  • Must have a life expectancy of at least 3 months.
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest during the day.
  • Must have adequate kidney and liver function.
  • Must have adequate blood cell counts without needing blood transfusions.
  • For certain groups, must have measurable disease by CT or MRI scans, which means the cancer can be measured in size.
  • For certain groups, must have not received certain treatments before, or must have had specific responses to previous treatments.
  • For certain groups, must have a creatinine clearance (a measure of kidney function) of at least 30 mL/min, calculated by a specific formula.
  • For certain groups, must provide a tumor tissue sample from a previous surgery or biopsy.

Who Cannot Join the Study?

  • Patients with other types of cancer that are not urothelial cancer cannot participate.
  • Patients who have had another cancer within the last 5 years, except for skin cancer that is not melanoma, cannot participate.
  • Patients who have had a heart attack or other serious heart problems in the last 6 months cannot participate.
  • Patients with uncontrolled high blood pressure cannot participate.
  • Patients with active infections that require treatment with antibiotics cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have received another experimental treatment within the last 4 weeks cannot participate.
  • Patients with severe liver disease cannot participate.
  • Patients with severe kidney disease cannot participate.
  • Patients with autoimmune diseases that require treatment with drugs that suppress the immune system cannot participate.
  • Patients who have had a stroke in the last 6 months cannot participate.
  • Patients with brain metastases that are not stable cannot participate.
  • Patients who have had a major surgery within the last 4 weeks cannot participate.
  • Patients with HIV, hepatitis B, or hepatitis C infections cannot participate.
  • Patients who have a history of allergic reactions to similar drugs cannot participate.

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
Oncopole Claudius Regaud Toulouse France
Centre Jean Perrin Clermont Ferrand France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
University Hospital Jena KöR Jena Germany
Hospital Clinico San Carlos Madrid Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Centre Antoine Lacassagne Nice France
Centre Hospitalier Universitaire Rouen Rouen France
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Azienda Socio Sanitaria Territoriale Di Cremona Cremona Italy
Hospital Foch Suresnes France
Centre Hospitalier Universitaire De Nimes Nimes France
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Azienda Ospedaliera S Maria Di Terni Terni Italy
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Del Mar Barcelona Spain
Centre Hospitalier Prive Saint-Gregoire Saint-Gregoire France
MD Anderson Cancer Center Madrid Spain
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada Manresa Spain
Henry Dunant Hospital Center Athens Greece
Centre Hospitalier Regional Universitaire Besançon France
University General Hospital Of Ioannina Ioannina Greece
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Di Pisa Pisa Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
Azienda USL Toscana Sud Est Arezzo Italy
Hopital Beaujon Clichy France
Hospital Universitario 12 De Octubre Madrid Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
CHU DeBordeaux Bordeaux France
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Czupbl Lsdi Bkalzy Lyon France
Irhkuh Ilsdcwns Fnrzatwkwcdys Ovxszrumcpa Rome Italy
Hmjgyobl Uzxymwrqyvled Mhbspcd Dl Vtutbalehm Santander Spain
Galkfnc Hesqpyht Oh Pupdix Amfly Appuiqu Patras Greece
Ikmmske Pzuftfw Cvyqygwfdmsezb Pxkafaqggzj Sssw Volos Greece
Czxjikn fet Hhuwnwzqank ubh Obsvscswu ae Bkkxuovokcckxtpcadrtd Frankfurt Germany
Iqguyabc Rhdqgbdhz Peo Lx Sgzoeo Daw Texygo Dprb Aykxsxb Itae Sdfrri Meldola Italy
Uwecbeyhvgelfbkcxwula Mscbhhvq Ags Munster Germany
Atrnmi Mbohlwk Cuhwrh Sgtm Thessaloniki Greece
Gckzdm Uvdzhzdggc Ftbjyilmv Frankfurt Germany
Iqvbbkpp Clacel Dgdlktxqgfatxwdbh L'hospitalet De Llobregat Spain
Ufchdxdian Hstexenvd Psmxb Szinxgqnrxw Czysujo Foch Paris France
Fvyugqymy Ptsq Lv Ijnvqvrywqkmu Bfmvqntqd Drl Hhwkasrf Urqjcwpiozxbw Lu Pux Madrid Spain
Hsydpexf Vbgq dztiuykf Barcelona Spain
Ispxrtsr Pfuhawafkuhseoa Cfqqur Cuxoyj Marseille France
Crtnvu Owlsq Lzajokj Lille France
Hsynlnrv Udxwmqtxxuzaru Sobmdhtvef &oanxhl Hpfanov dc Hyvyivhmdxh STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
13.06.2019
Germany Germany
Recruiting
13.06.2019
Greece Greece
Recruiting
13.06.2019
Italy Italy
Recruiting
13.06.2019
Spain Spain
Recruiting
13.06.2019

Trial locations

Sacituzumab Govitecan is a type of treatment used in this clinical trial for patients with a specific kind of cancer called urothelial cancer, which affects the urinary system. This medication is designed to target and attach to cancer cells, delivering a powerful drug directly to them. The goal is to help shrink the tumors or slow down their growth, making it easier to manage the disease. This treatment is particularly used when the cancer is advanced and cannot be removed by surgery. By focusing on the cancer cells, it aims to reduce the impact on healthy cells, potentially leading to fewer side effects compared to traditional chemotherapy. This trial is exploring how effective this medication is in improving the condition of patients with this type of cancer.

Locally Advanced/Metastatic Urothelial Cancer – This is a type of cancer that originates in the urothelial cells lining the bladder and can spread to nearby tissues or distant organs. In its locally advanced stage, the cancer has grown into nearby tissues or lymph nodes but has not spread to distant parts of the body. When it becomes metastatic, the cancer cells have spread to other parts of the body, such as the liver, lungs, or bones. The disease progresses as cancer cells continue to grow and invade other tissues, potentially leading to the formation of new tumors in different locations. The progression can vary greatly among individuals, with some experiencing rapid spread while others may have slower disease advancement. The symptoms and impact on the body depend on the extent and location of the cancer spread.

Trial ID:
2023-508302-24-00
Protocol code:
IMMU-132-06
NCT ID:
NCT03547973
Trial Phase:
Therapeutic exploratory (Phase II)

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