Actively Recruiting
Chemotherapy and Sequential Immunotherapy for Locally Advanced Urothelial Cancer
Led by Erasmus Medical Center · Updated on 2023-09-08
64
Participants Needed
4
Research Sites
208 weeks
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
M
Merck KGaA, Darmstadt, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
Patients with locally advanced or clinically node positive urothelial carcinoma treated with chemotherapy, will receive 3 cycles of avelumab, followed by radical surgery.
CONDITIONS
Official Title
Chemotherapy and Sequential Immunotherapy for Locally Advanced Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed urothelial carcinoma of the bladder, upper urinary tract, or urethra with up to 50% aberrant histology allowed
- Clinical stage cT4NxM0 or cTxN1-N3M0 confirmed by examination and imaging
- At least stable disease after 3 to 4 cycles of platinum-based chemotherapy according to RECIST v1.1
- Fit and willing to undergo radical surgery including removal of affected lymph nodes and primary tumor
- World Health Organization performance status of 0-2
- Provide written informed consent
- Negative pregnancy test for women with childbearing potential
- Adequate bone marrow function with specified blood counts
- Adequate renal function with creatinine clearance of 30 mL/min or higher
- Adequate liver function with bilirubin and liver enzymes below specified limits
You will not qualify if you...
- More than 50% non-urothelial carcinoma histology in diagnostic specimen
- Acute or chronic hepatitis B or C infection
- Creatinine clearance below 30 mL/min
- Prior immune-mediated therapy excluding Bacillus-Calmette Guérin intravesical instillations
- Persistent toxicity greater than Grade 2 from prior chemotherapy
- Diagnosis of other malignancy within 2 years except certain treated skin, breast, cervix, or prostate cancers
- Fewer than 2 cycles of induction platinum-based chemotherapy
- Disease progression during or after induction chemotherapy
- Presence of distant metastatic disease
- Previous pelvic radiation therapy
- Breastfeeding women
- Bilateral upper urinary tract urothelial carcinoma
- Active autoimmune disease that may worsen with immunotherapy (except certain controlled conditions)
- Major cardiovascular events or conditions within last 6 months
- Active infection requiring systemic treatment
- Severe hypersensitivity to monoclonal antibodies or history of anaphylaxis
- Known hypersensitivity to avelumab
- Current use of immunosuppressive medications beyond allowed exceptions
- Prior immunodeficiency, organ transplant needing immunosuppression, or HIV/AIDS
- Vaccination with live vaccines within 4 weeks before or during trial
- Severe acute or chronic medical or psychiatric conditions that increase risk or interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Radboud UMC
Nijmegen, Gelderland, Netherlands, 6525 GD
Actively Recruiting
2
Jeroen Bosch ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands, 5223 GZ
Actively Recruiting
3
Amphia ziekenhuis
Breda, North Brabant, Netherlands, 4818 CK
Actively Recruiting
4
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
Research Team
J
J L Boormans, MD PhD
CONTACT
V
V C Rutten, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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