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PROSPECTIVE EVALUATION OF THE DDR GENES ALTERATION TO PREDICT RESPONSE TO PLATINUM-BASED CHEMOTHERAPY IN ADVANCED UROTHELIAL CANCER
EU CTIS ID: 2024-516450-21-00
What this study is testing
To assess if patients with metastatic or locally advanced urothelial cancer harboring DDR genes alterations have increased response to platinum-based chemotherapy compared to those who did not
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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
- 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 <2.5 mg/dl and creatinine clearance > 30 ml/min evaluated by the Cockcroft-Gault Formula. b Total bilirubin ≤1∙5 × the upper limit of normal (ULN); Synopsis_SELECTIO-UC_Version 1.0 of 29 May 2024 5 / 12 c Alanine aminotransferase and aspartate aminotransferase ≤2 × ULN (≤5 × ULN for patients with liver involvement of their cancer); d International normalized ratio (INR) and partial thromboplastin time (PTT) ≤1∙5 × ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no prior evidence of an underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care; e Platelet count ≥100 000/mm3, hemoglobin >9 g/dl, absolute neutrophil count >1,500/mm3; f Alkaline phosphatase limit ≤2∙5 × ULN (≤5 × ULN for patients with liver involvement of their cancer)
- 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
- 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 the time of study entry. Also, the patient must not be undergoing acute steroid therapy or tapering (chronic steroid therapy is acceptable provided that the dose is stable for 1 month before and after screening radiographic studies)
- 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
See the full eligibility criteria
Who can join
- Informed consent obtained before any study-specific procedures. Patients must be able to understand and be willing to sign a written informed consent
- 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 <2.5 mg/dl and creatinine clearance > 30 ml/min evaluated by the Cockcroft-Gault Formula. b Total bilirubin ≤1∙5 × the upper limit of normal (ULN); Synopsis_SELECTIO-UC_Version 1.0 of 29 May 2024 5 / 12 c Alanine aminotransferase and aspartate aminotransferase ≤2 × ULN (≤5 × ULN for patients with liver involvement of their cancer); d International normalized ratio (INR) and partial thromboplastin time (PTT) ≤1∙5 × ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no prior evidence of an underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care; e Platelet count ≥100 000/mm3, hemoglobin >9 g/dl, absolute neutrophil count >1,500/mm3; f Alkaline phosphatase limit ≤2∙5 × ULN (≤5 × ULN for patients with liver involvement of their cancer)
- 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 at least 180 days after the last dose of chemotherapy and 30 days after the last dose of avelumab. The investigator or a designated associate is requested to advise the subject how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically recommend method (or combination of methods) as per standard of care
What rules you out
- Previous treatment for metastatic or locally advanced disease
- 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 the time of study entry. Also, the patient must not be undergoing acute steroid therapy or tapering (chronic steroid therapy is acceptable provided that the dose is stable for 1 month before and after screening radiographic studies)
- 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
- 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 pT2 prostate cancer with PSA<0.01
- 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: a Congestive heart failure of New York Heart Association class 3 or worse. b 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. c Cardiac arrhythmias requiring anti-arrhythmic therapy (betablockers or digoxin are permitted). Synopsis_SELECTIO-UC_Version 1.0 of 29 May 2024 6 / 12 d Uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg despite optimal medical management). e 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
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.