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New treatment option for Urothelial Carcinoma
Official title Chemotherapy and Sequential Immunotherapy for Locally Advanced Urothelial Cancer
ClinicalTrials.gov ID: NCT05600127
What this study is testing
What is Avelumab?
Avelumab is an investigational medicine, being studied as a potential treatment for urothelial carcinoma.
Also referred to as Bavencio.
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
- Patients with locally advanced or clinically node positive urothelial carcinoma treated with chemotherapy, will receive 3 cycles of avelumab, followed by radical surgery.
- Phase 2: a mid-size study of how well it works
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
- Age ≥ 18 years.
- Have histologically confirmed urothelial carcinoma of the bladder, upper urinary tract or urethra; a maximum of 50% of aberrant histology is allowed.
- Have clinical stage cT4NxM0 or cTxN1-N3M0 as assessed by bimanual examination under anaesthesia, CT scan, MRI scan or PET-CT scan.
- Have at least stable disease after a minimum of 3 or a maximum of 4 cycles of induction chemotherapy with cisplatin / carboplatin + gemcitabine...
- Are fit and willing to undergo radical surgery with removal of lymph node template including all affected lymph nodes and the primary tumor.
You likely can't join if
- Predominant (\>50%) non-urothelial carcinoma histology in the diagnostic endoresection specimen of the bladder, urethra or upper urinary tract.
- Any test for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating acute or chronic infection.
- Have an estimated creatinin clearance as assessed by the CKD-EPI eGFR of \<30 ml/min.
- Prior exposure to immune-mediated therapy with exclusion of Bacillus-Calmette Guérin intravesical instillations, including but not limited to other...
- Persisting toxicity related to prior chemotherapy (Grade \>2 NCI CTCAE v5.0).
- A diagnosis of any other malignancy within 2 years prior to inclusion, except for adequately treated basal cell or squamous cell skin cancer or...
See the full eligibility criteria
- Age ≥ 18 years.
- Have histologically confirmed urothelial carcinoma of the bladder, upper urinary tract or urethra; a maximum of 50% of aberrant histology is allowed.
- Have clinical stage cT4NxM0 or cTxN1-N3M0 as assessed by bimanual examination under anaesthesia, CT scan, MRI scan or PET-CT scan.
- Have at least stable disease after a minimum of 3 or a maximum of 4 cycles of induction chemotherapy with cisplatin / carboplatin + gemcitabine according to RECIST v1.1.
- Are fit and willing to undergo radical surgery with removal of lymph node template including all affected lymph nodes and the primary tumor.
- World Health Organisation performance status of 0-2.
- Provide written informed consent.
- Negative pregnancy test in women with childbearing potential.
- Adequate bone marrow function, including:
- Absolute neutrophil count (ANC) ≥1,500/mm3 or 1.5 x 109/L;
- Platelets ≥100 x 109/L;
- Hemoglobin ≥5.6 mmol/L (may have been transfused).
- Adequate renal function, defined as estimated creatinine clearance ≥30 mL/min as calculated by the CKD-EPI eGFR.
- Adequate liver function, including:
- Total serum bilirubin \<1.5 x upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2.5 x ULN.
- Predominant (\>50%) non-urothelial carcinoma histology in the diagnostic endoresection specimen of the bladder, urethra or upper urinary tract.
- Any test for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating acute or chronic infection.
- Have an estimated creatinin clearance as assessed by the CKD-EPI eGFR of \<30 ml/min.
- Prior exposure to immune-mediated therapy with exclusion of Bacillus-Calmette Guérin intravesical instillations, including but not limited to other anti-CTLA-4, anti PD-1, anti PD-L1, or anti-PD-L2 antibodies.
- Persisting toxicity related to prior chemotherapy (Grade \>2 NCI CTCAE v5.0).
- A diagnosis of any other malignancy within 2 years prior to inclusion, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the breast or of the cervix, low grade prostate cancer...
- ≤2 cycles of induction platinum-based chemotherapy received.
- Progression of disease during or following induction platinum-based chemotherapy, as assessed by RECIST v1.1.
- Distant metastatic disease.
- Previous pelvic radiation therapy.
- Breastfeeding women.
- Bilateral upper urinary tract urothelial carcinoma.
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid disease not requiring immunosuppressive treatment...
- Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic...
- Active infection requiring systemic therapy.
- Known severe hypersensitivity reactions to monoclonal antibodies (Grade 3), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of asthma symptom control per the Global Initiative for Asthma 2015).
- Known prior or suspected hypersensitivity to avelumab.
- Current use of immunosuppressive medication, EXCEPT the following:
- Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection);
- Systemic corticosteroids at (equivalent) doses of maximum 10 mg prednisone;
- Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
- Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy, or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- Vaccination within 4 weeks of the first dose of study treatment and while on trial is prohibited except for administration of inactivate vaccines (for example, inactivated influenza vaccines) or mRNA vaccines (for...
- Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, and pneumonitis; psychiatric condition including recent (within the past year) or active suicidal ideation or behaviour; or...
The study team makes the final eligibility decision.
Where it's taking place
- Nijmegen, Gelderland, Netherlands
- 's-Hertogenbosch, North Brabant, Netherlands
- Breda, North Brabant, Netherlands
- Rotterdam, South Holland, Netherlands
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 Nijmegen, Gelderland, Netherlands; 's-Hertogenbosch, North Brabant, Netherlands; Breda, North Brabant, Netherlands; Rotterdam, South Holland, Netherlands. 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.