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New treatment option for Bladder (Urothelial, Transitional Cell) Cancer Metastatic or...
Official title DDR Genes Alteration and Response to Platinum-based Chemotherapy in Advanced Urothelial Cancer.
ClinicalTrials.gov ID: NCT06820255
What this study is testing
What is Platinum + Gemcitabine?
Platinum + Gemcitabine is an investigational medicine, being studied as a potential treatment for bladder (urothelial, transitional cell) cancer metastatic or unresectable.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to prospectively observe whether certain alterations in some genes related to the DNA repair mechanism are related to better response to platinum-based chemotherapy used to treat metastatic bladder or urothelial cancers.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Informed consent obtained before any study-specific procedures. Patients must be able to understand and be willing to sign a written informed consent.
- Male or female patient ≥18 years of age.
- Histological or cytological documentation of urothelial cancer.
- Available tumor tissue for analysis
- Measurable disease according to Response Evaluation Criteria in Solid Tumors criteria, version 1.1.
You likely can't join if
- Previous treatment for metastatic or locally advanced disease.
- Previous adjuvant therapy within 1 year from the diagnosis of metastatic disease.
- Prior treatment with immunotherapy.
- Previous or concurrent cancer that is distinct in primary site or histology from urothelial cancer within 3 years before enrollment EXCEPT for...
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication
- Pregnancy or breast-feeding. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and...
See the full eligibility criteria
- Informed consent obtained before any study-specific procedures. Patients must be able to understand and be willing to sign a written informed consent.
- Male or female patient ≥18 years of age.
- Histological or cytological documentation of urothelial cancer.
- Available tumor tissue for analysis
- Measurable disease according to Response Evaluation Criteria in Solid Tumors criteria, version 1.1.
- Eastern Cooperative Oncology Group performance status of ≤2. (Patients with ECOG PS of 2 were required to also meet the additional criteria: hemoglobin ≥10 g/dL, GFR ≥50mL/min, may not have NYHA class III heart failure).
- Life expectancy of at least 6 months.
- Eligible to standard chemotherapy with cisplatin or carboplatin + gemcitabine as per clinical practice.
- Women of childbearing potential and men must agree to use adequate contraception since signing of the informed consent form until 180 days after the last dose of chemotherapy and 30 days after the last dose of avelumab...
- Adequate bone-marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment: a Creatinine value \ 30 ml/min evaluated by the...
- Previous treatment for metastatic or locally advanced disease.
- Previous adjuvant therapy within 1 year from the diagnosis of metastatic disease.
- Prior treatment with immunotherapy.
- Previous or concurrent cancer that is distinct in primary site or histology from urothelial cancer within 3 years before enrollment EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and...
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication
- Pregnancy or breast-feeding. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment.
- Any cardiological condition among:
- Congestive heart failure of New York Heart Association class 3 or worse.
- Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study drug.
- Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted).
- Uncontrolled hypertension (systolic blood pressure \>150 mmHg or diastolic pressure \>90 mmHg despite optimal medical management).
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), pulmonary embolism within the 4 months before start of study medication.
- Ongoing infection higher than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 grade 2.
- Known history of human immunodeficiency (HIV) virus infection or known history of chronic hepatitis B or C.
- Any autoimmune disease that contraindicates the use of maintenance immunotherapy in case of stable or responsive disease to chemotherapy.
- Seizure disorder requiring medication.
- Symptomatic metastatic brain or meningeal tumors unless the patient is \>2 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at...
- History of organ allograft.
- Evidence or history of bleeding diathesis. Any hemorrhage or bleeding event of CTCAE grade 3 or higher within 4 weeks of start of study medication.
- Non-healing wound, ulcer, or bone fracture.
- Renal failure requiring hemodialysis or peritoneal dialysis.
- Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his or her compliance in the study.
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
- Participation to another clinical trial at the time of the enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.