Study of drug combination with gemcitabine, cisplatin, carboplatin and avelumab in patients with advanced urothelial cancer to evaluate response to platinum-based chemotherapy

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What is this study about?

This clinical trial focuses on patients with metastatic or locally advanced urothelial cancer. The study aims to determine if patients whose cancer has specific genetic changes in DDR genes respond better to treatment with platinum-based chemotherapy compared to those without these genetic changes.

The treatment in this study involves a combination of medications given through intravenous infusion. Patients will receive either cisplatin or carboplatin together with gemcitabine hydrochloride. Some patients may also receive avelumab, which belongs to a group of medications called monoclonal antibodies that help the immune system fight cancer cells.

During the study, doctors will regularly check how well the treatment is working by taking scans and monitoring any side effects. The treatment period may last up to 18 months for chemotherapy medications and up to 24 months for avelumab. The effectiveness of the treatment will be measured by looking at how the tumors respond and how long patients live without their cancer getting worse.

1 Initial eligibility assessment

Your eligibility for the study will be evaluated based on laboratory tests of your bone marrow, liver, and kidney function. These tests must be completed within 7 days before starting treatment.

A tissue sample from your tumor will be analyzed to determine if specific genetic changes are present.

Your overall health status will be evaluated using the ECOG performance status scale, which measures your ability to perform daily activities.

2 Treatment phase

You will receive chemotherapy treatment through intravenous infusion (medication delivered directly into your vein).

The treatment will include either cisplatin or carboplatin combined with gemcitabine.

Some patients may also receive avelumab as part of their treatment.

Your doctor will determine which specific combination is most appropriate for your situation.

3 Monitoring and evaluation

Your response to treatment will be regularly assessed using imaging scans to measure any changes in your cancer.

Side effects will be monitored and recorded throughout the treatment period.

Regular blood tests will be performed to check your health status.

4 Follow-up period

After completing treatment, you will need to use appropriate birth control methods for 180 days following the last chemotherapy dose.

If you received avelumab, birth control should be continued for 30 days after the last dose.

Your health status will continue to be monitored after treatment completion.

Who Can Join the Study?

Patient must be 18 years of age or older
Patient must be able to understand and sign a written informed consent form before any study procedures
Patient must have confirmed urothelial cancer (cancer of the urinary system) through tissue or cell examination
Patient must have cancer that can be measured using specific medical criteria (RECIST 1.1)
Patient must have tumor tissue available for testing
Patient must have adequate organ function, including:
- Good kidney function (creatinine less than 2.5 mg/dl)
- Acceptable liver function tests
- Adequate blood cell counts
Patient must have a good level of physical function (ECOG performance status of 2 or better)
Patient must have a life expectancy of at least 6 months
Patient must be suitable for standard chemotherapy with cisplatin or carboplatin plus gemcitabine
Patient must agree to use effective birth control methods during the study and for 180 days after the last chemotherapy dose

Who Cannot Join the Study?

Age below 18 years old
Previous treatment with platinum-based chemotherapy (drugs containing platinum used to treat cancer)
Presence of active brain metastases (cancer that has spread to the brain)
Severe kidney dysfunction (poor kidney function that could affect treatment)
Severe liver dysfunction (poor liver function that could affect treatment)
Uncontrolled heart conditions
Active infections requiring systemic treatment (infections needing medication that affects the whole body)
Known allergic reactions to platinum-containing medications
Pregnancy or breastfeeding
Unable to provide informed consent
Participation in another clinical trial within the past 30 days
Life expectancy less than 3 months
Any condition that, in the opinion of the investigator, would interfere with safe participation in the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Hospital Santa Maria Della Misericordia	Perugia	Italy
ARNAS Civico Di Cristina Benfratelli	Palermo	Italy
Ospedale Generale Provinciale Di Macerata	Macerata	Italy
Azienda Unita Sanitaria Locale Di Modena	Carpi	Italy
Azienda Sanitaria Locale Napoli 2 Nord	Frattamaggiore	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Asfdolp Ocsveriniqh Uhqvkrdvelnjg Phlrr	Parma	Italy
Iwidfwgv Rgixdfbae Pfb Li Sjixjm Dwy Tzdnan Dfqr Arzwlmk Iknq Spiysk	Meldola	Italy
Amfuzgo Uut Iokcx Dm Rswhch Ezdfyh	Reggio Emilia	Italy
Aqcwhcx Uwgjl Svsdnjkpe Llkkpk Dj Baoeabc	Bologna	Italy
Uvdvmngovu Mprgn Gkiftbx Ov Cscrwouqc	Catanzaro	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	02.12.2024

Trial locations

Investigated drugs:

Based on the provided trial data, I can identify that the trial involves:

Platinum-based chemotherapy is a type of cancer treatment that uses platinum-containing drugs to fight cancer cells. This type of chemotherapy works by damaging the DNA of cancer cells, preventing them from dividing and growing. It is commonly used to treat various types of cancer, including urothelial (bladder) cancer.

Note: The trial appears to focus on studying how genetic alterations (specifically in DDR genes) affect the response to this type of chemotherapy, rather than testing new medications. No other specific medications are mentioned in the provided trial data.

Investigated diseases:

Transitional cell carcinoma

Urothelial Cancer – A cancer that begins in the urothelial cells, which line the urinary system, including the bladder, urethra, ureters, and renal pelvis. The disease typically starts in the bladder’s inner lining and can spread to nearby tissues and organs. When described as locally advanced, it means the cancer has grown into deeper layers of the bladder wall or nearby structures. In metastatic cases, the cancer cells have spread beyond the original site to other parts of the body through the bloodstream or lymph system. The disease can progress from early stages where it affects only the urinary system lining to more advanced stages where it invades surrounding tissues.

Trial ID:

2024-516450-21-00

Protocol code:

SELECTIO-UC

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of drug combination with gemcitabine, cisplatin, carboplatin and avelumab in patients with advanced urothelial cancer to evaluate response to platinum-based chemotherapy

What is this study about?

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