Actively Recruiting
Efficacy and Safety of Cisplatin, Nab-paclitaxel, and Nivolumab With Radiotherapy After Maximal Tumor Resection in Non-metastatic Muscle Invasive Bladder Cancer
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-10-04
32
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the combination of cisplatin, nab-paclitaxel, and nivolumab with radiotherapy following maximal tumor removal in patients with non-metastatic muscle invasive bladder cancer. This phase II study focuses on patients who have undergone surgery and seeks to assess disease-free survival over a period of up to five years. Participants will receive chemotherapy drugs cisplatin and nab-paclitaxel weekly during a five-week course of radiotherapy, which is delivered Monday through Friday. Nivolumab infusions begin on the first day of radiotherapy and continue every four weeks for a total of 13 infusions over one year. After completing the combined chemo-radiotherapy, patients continue nivolumab treatment alone until the end of the planned cycles. Throughout the study, patients will undergo regular tumor assessments using CT scans and cystoscopies for up to five years after radiotherapy. Follow-up imaging and evaluations occur every 16 weeks for the first two years and every six months thereafter. Safety, quality of life, and treatment-related side effects will be monitored, with ongoing assessments up to 30 days after treatment completion and long-term follow-up extending to five years.
CONDITIONS
Brief Title
Cisplatin, Nab-paclitaxel, Nivolumab With Radiotherapy After Resection of Non-Metastatic Muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Histologic diagnosis of predominantly urothelial carcinoma of the bladder
- Stage T2-T3 N0M0 bladder cancer confirmed by imaging and examination
- FDG-PET within 6 weeks before treatment showing no lymph node or metastatic disease
- Complete transurethral resection of bladder tumor (TURBT) within 8 weeks before chemoradiotherapy or recent cystoscopy showing no residual disease
- Life expectancy greater than 6 months
- ECOG performance status of 1 or better
- Another primary cancer allowed if treated curatively at least 3 years prior without recurrence or clinically indolent
- Considered able to tolerate chemotherapy combined with pelvic radiotherapy by oncologists
- Able and willing to provide written informed consent
- Women of childbearing potential must use effective contraception during and for 5 months after treatment; men with partners must use contraception for 6 months after chemotherapy
- Adequate bone marrow, liver, and kidney function per laboratory tests within 7 days before treatment
You will not qualify if you...
- Prior systemic therapy for other urothelial tumors
- Prior pelvic radiotherapy
- Participation in another therapeutic clinical trial or investigational drug within 28 days before enrollment
- Other malignancies within 3 years except certain low-risk cancers or adequately treated cancers without recurrence
- Medical conditions preventing treatment such as prior severe immune-related adverse reactions
- Severe allergic or hypersensitivity reactions to antibody therapies
- History of autoimmune diseases except controlled hypothyroidism or Type I diabetes
- Active tuberculosis
- Use of systemic corticosteroids or immunosuppressants within 2 weeks before treatment
- Active autoimmune disease requiring systemic treatment in past 2 years
- Recent live vaccine within 4 weeks before study drug except COVID-19 vaccine
- History of certain lung diseases or active pneumonitis
- Active infections needing intravenous therapy
- Recent therapeutic antibiotics within 2 weeks before treatment
- Significant cardiovascular disease or unstable heart conditions
- Major surgery within 28 days before treatment
- Prior allogeneic stem cell or organ transplant
- Any condition that contraindicates study drug use or affects results
- Known HIV infection
- Active Hepatitis B or C infection
- Unwilling or unable to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 weeks for chemo-radiotherapy plus nivolumab followed by nivolumab alone for up to 13 cycles (approximately 52 weeks)
Participants receive concomitant chemo-radiotherapy with cisplatin, nab-paclitaxel, and nivolumab during radiotherapy followed by nivolumab alone.
Weekly visits for up to 5 weeks during chemo-radiotherapy; then visits every 4 weeks for nivolumab infusions for up to 13 cycles
Duration - Up to 5 years
Participants are followed with radiological assessments and clinical visits after treatment to monitor disease status and safety.
Visits every 4 weeks for the first 2 years with radiological assessments every 16 weeks, then visits every 6 months up to 5 years
Trial Site Locations
Total: 1 location
1
Roberto iacovelli
Roma, Italy, 00168
Actively Recruiting
Research Team
R
Roberto Iacovelli, MD, PhD
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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