Study of Disitamab Vedotin and Pembrolizumab for Patients with Untreated Advanced Urothelial Cancer Expressing HER2

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What is this study about?

This clinical trial is focused on studying a type of cancer called urothelial carcinoma, which affects the lining of the bladder and other parts of the urinary system. The study aims to compare the effectiveness of a new treatment combination against standard chemotherapy. The new treatment involves two medications: Disitamab Vedotin and Pembrolizumab. Disitamab Vedotin is a type of medication that targets cancer cells, while Pembrolizumab is an immunotherapy drug that helps the immune system fight cancer. The chemotherapy options being compared include Cisplatin, Carboplatin, and Gemcitabine, which are commonly used to treat various cancers.

The purpose of this study is to determine if the combination of Disitamab Vedotin and Pembrolizumab is more effective than the standard chemotherapy treatments for patients with advanced urothelial carcinoma that shows a specific protein called HER2. HER2 is a protein that can affect the growth of cancer cells. The study will involve patients who have not received prior treatment for their advanced cancer. Participants will be randomly assigned to receive either the new treatment combination or one of the standard chemotherapy options. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments.

Throughout the study, participants will receive their assigned treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor the participants’ health and response to the treatment over a period of time to gather information on the effectiveness and safety of the treatments. The goal is to find out which treatment option provides better outcomes for patients with this type of cancer. This research could potentially lead to improved treatment options for people with advanced urothelial carcinoma.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, laboratory values, and medical history.

Consent is documented, and the ability to comply with trial procedures is assessed.

2 initial assessment

A comprehensive medical evaluation is conducted, including a review of medical history and current health status.

Baseline laboratory tests and imaging studies are performed to assess the condition and eligibility.

3 randomization

Participants are randomly assigned to one of two groups: one receiving disitamab vedotin with pembrolizumab, and the other receiving chemotherapy.

4 treatment administration

For the disitamab vedotin and pembrolizumab group, disitamab vedotin is administered via intravenous infusion, and pembrolizumab is given as a concentrate for solution for infusion.

For the chemotherapy group, medications such as cisplatin, carboplatin, and gemcitabine are administered through intravenous infusion.

The frequency and dosage of each medication are determined by the study protocol and the participant’s health status.

5 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment and any side effects.

Follow-up visits include physical examinations, laboratory tests, and imaging studies to evaluate the progress of the condition.

6 completion of treatment

Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response and any long-term effects.

Participants may be asked to continue follow-up visits to monitor their health status.

Who Can Join the Study?

  • Must be 18 years or older, or considered an adult by local rules.
  • Must have certain laboratory test results within specific ranges, such as:
    • Hemoglobin (Hb) of at least 9 grams per deciliter without needing a blood transfusion.
    • Absolute Neutrophil Count (ANC) of at least 1.5 x 109 per liter.
    • Platelet count of at least 100 x 109 per liter.
    • ALT and AST (liver enzymes) within 2.5 times the normal limit if no liver spread, or 5 times if there is liver spread.
    • Serum total bilirubin within 1.5 times the normal limit, or direct bilirubin within normal limits if total bilirubin is higher.
    • Creatinine clearance (CrCl) of at least 30 milliliters per minute, calculated using a specific formula.
    • INR or PT and aPTT (blood clotting tests) within 1.5 times the normal limit. If on blood thinners, these should be within the therapeutic range.
  • If able to have children, must:
    • Have a negative pregnancy test before starting the study.
    • Agree not to become pregnant during the study and for a certain period after the last dose of study drugs.
    • Agree not to breastfeed or donate eggs during the study and for a certain period after the last dose of study drugs.
    • If sexually active, use at least two methods of birth control, one being highly effective, during the study and for a certain period after the last dose of study drugs.
  • If able to father children, must:
    • Agree not to donate sperm during the study and for a certain period after the last dose of study drugs.
    • If sexually active with someone who can become pregnant, use at least two methods of birth control, one being highly effective, during the study and for a certain period after the last dose of study drugs.
    • If sexually active with someone who is pregnant or breastfeeding, consistently use a condom during the study and for a certain period after the last dose of study drugs.
  • Must provide written consent to participate in the study.
  • Must be willing and able to follow the study procedures and schedule.
  • Must have a specific type of cancer called locally advanced or metastatic urothelial carcinoma, confirmed by a lab test, and it must be the main type of cancer cell.
  • Must have cancer that can be measured by the study doctor using specific guidelines. If radiation therapy was received before, the cancer must be measurable outside the treated area or have clearly grown since the treatment.
  • Must not have received previous treatment for advanced or spread urothelial cancer, except if it was given before surgery or after surgery and the cancer returned more than 12 months after the last treatment.
  • Must be eligible to receive certain chemotherapy drugs, as determined by the study doctor. If not eligible for one drug, another will be given.
  • Must be willing and able to provide a sample of the cancer tissue for testing before starting the study treatment. If a previous sample is not available, a new biopsy must be done.
  • The cancer must show a certain level of a protein called HER2 as determined by a lab test.
  • Must have a performance status score of 0, 1, or 2, which measures the ability to perform daily activities. If the score is 2, additional health criteria must be met.
  • Must have adequate heart function, including:
    • Left Ventricular Ejection Fraction (LVEF) of at least 50%.
    • Corrected QT interval (QTcF) less than 470 milliseconds, which is a measure of heart rhythm.

Who Cannot Join the Study?

  • Patients who have had another type of cancer in the past, unless it was a type that is not expected to come back.
  • Patients who have serious heart problems, such as heart failure or a recent heart attack.
  • Patients who have an active infection that needs treatment with antibiotics.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a known allergy to the study drugs or similar drugs.
  • Patients who have received certain treatments for cancer in the past, like chemotherapy or radiation, that might interfere with the study.
  • Patients who have a condition that affects their immune system, like HIV or autoimmune diseases.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse that could interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Haga Hospital Hague The Netherlands
Centre Antoine Lacassagne Nice France
Orszagos Onkologiai Intezet Budapest Hungary
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Azienda Socio Sanitaria Territoriale Di Cremona Cremona Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Azienda Ospedaliera S Maria Di Terni Terni Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Amphia Hospital Breda The Netherlands
Helse Stavanger HF Stavanger Norway
Az Maria Middelares Gent Gent Belgium
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
AZ Sint-Lucas & Volkskliniek Gent Belgium
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
MD Anderson Cancer Center Madrid Spain
Bioclinic S.A. Thessaloniki Greece
Azienda Sanitaria Locale Napoli 2 Nord Frattamaggiore Italy
Polyclinique De Limoges Limoges France
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A Cholargos Greece
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Semmelweis University Budapest Hungary
Stichting Radboud University Medical Center Nijmegen The Netherlands
Champalimaud Clinical Centre Lisbon Portugal
Hospital Universitario De Cruces Barakaldo Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Di Pisa Pisa Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital General Universitario De Valencia Valencia Spain
Gasthuiszusters Antwerpen Antwerp Belgium
Region Joenkoepings Laen Jönköping Sweden
University Hospital Olomouc Olomouc Czechia
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Netherlands Cancer Institute Amsterdam The Netherlands
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Beaumont Hospital Dublin Ireland
Centre Francois Baclesse Caen France
Cnqkpqzho Uxmauhtkdsryyf Szvqbmppz Woluwe-Saint-Lambert Belgium
Isdqykmk Rfuolxxf Dl Csoazm Dt Mwtkkanldjg Montpellier France
Oajshnjdozfaav Llpu Gmng Linz Austria
Rvkjwasuu Zoqablxsaq Sujcfvxzx Arnhem The Netherlands
Heumklca Ufxxlwybcozpu De Lf Pizgecii Madrid Spain
Humxrcyv Uheqsohgtnyoy Mfounvm Df Vxibwlwhgo Santander Spain
Cias Umvgfgwmvn Hrqyenxj Cork Ireland
Iwurtouf Cmyxxw Dsizallqygfzynmwg L'hospitalet De Llobregat Spain
Hbtrvpoy Uxmklekwnugdq Dk Bwxqxcc Badajoz Spain
Bdccmrdmknb Vqfxdnopc Olqxiqpscchj Kecskemet Hungary
Cackgz dz Rrhvkivqjjvnu &ukblcp Ccornkjx Skoiys Amyy STRASBOURG, Alsace France
Ifcukxma Repbhipwf Pzx Ly Svvwde Dqn Talhnf Djpi Aodykca Ikqr Sjgjzb Meldola Italy
Adugoban Uciluvrvau Hqinwtmc Lorenskog Norway
Uzjpuzm Urcclsobui Hwxxaole Uppsala Sweden
Bppghucx Urquvazhrm Hqaajyqb Cynfcg Besançon France
Akamxa Mzajiue Cvrywx Stjr Thessaloniki Greece
Hjxaiwen Dd Lz Ssqvm Cgvx I Srgc Pnu Barcelona Spain
Fbdktkeao Perh Ls Iicwmiksxzgob Bczqphvsd Dpp Hohoiivs Udkteamjqaepm Ln Pqr Madrid Spain
Hewqczge Ubctylndwvdbi Hmsiwhrn Twrrv y Pdyvhj Ilcgpayz Cheljl dxknztlqjftsudepw (asqv Badalona Spain
Hyyihwtp Vqqe dohkdmhc Barcelona Spain
Irzfjwfs Peomnpvamlekcbw Cgofks Cseenc Marseille France

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.07.2024
Belgium Belgium
Not recruiting
01.07.2024
Czechia Czechia
Not recruiting
01.07.2024
France France
Not recruiting
01.07.2024
Greece Greece
Not recruiting
01.07.2024
Hungary Hungary
Not recruiting
01.07.2024
Ireland Ireland
Not recruiting
01.07.2024
Italy Italy
Not recruiting
01.07.2024
Norway Norway
Not recruiting
01.07.2024
Portugal Portugal
Not recruiting
01.07.2024
Spain Spain
Not recruiting
01.07.2024
Sweden Sweden
Not recruiting
01.07.2024
The Netherlands The Netherlands
Not recruiting
01.07.2024

Trial locations

Disitamab Vedotin is a medication used in this trial to treat advanced urothelial carcinoma, a type of bladder cancer. It is designed to target and attach to cancer cells that express a protein called HER2, helping to deliver a cancer-fighting agent directly to the tumor cells.

Pembrolizumab is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. It is used in combination with disitamab vedotin in this trial to enhance the treatment’s effectiveness against advanced urothelial carcinoma.

Chemotherapy refers to the use of drugs to kill or slow the growth of cancer cells. In this trial, chemotherapy is used as a comparison treatment to evaluate the effectiveness of the combination of disitamab vedotin and pembrolizumab.

Urothelial Carcinoma – Urothelial carcinoma is a type of cancer that begins in the urothelial cells lining the bladder and other parts of the urinary tract. It is the most common form of bladder cancer and can also occur in the ureters and renal pelvis. The disease often starts in the innermost layer of the bladder and can grow into deeper layers over time. As it progresses, it may spread to nearby tissues and organs, and in advanced stages, it can metastasize to distant parts of the body. Symptoms may include blood in the urine, frequent urination, and pain during urination. The progression of the disease can vary, with some cases remaining superficial while others become invasive.

Trial ID:
2022-501105-12-00
Protocol code:
SGNDV-001/KN-D74
NCT ID:
NCT05911295
Trial Phase:
Therapeutic confirmatory (Phase III)

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