Treatment Of Metastatic Bladder Cancer at the Time Of Biochemical reLApse Following Radical Cystectomy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bladder Cancer
- Bladder Cancer, Metastatic
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Single country Investigator Initiated, Open-label, Single-arm, Non-randomized, Phase II studyMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study aim at investigate the response rate and oncological outcome of systemic immunotherapy (PDL-1 inhibitor; atezolizumab) administered early at the time of biochemical relapse (circulating tumor DNA (ctDNA) positive) in patients who have undergone radical cystectomy because of muscle invasive...
The study aim at investigate the response rate and oncological outcome of systemic immunotherapy (PDL-1 inhibitor; atezolizumab) administered early at the time of biochemical relapse (circulating tumor DNA (ctDNA) positive) in patients who have undergone radical cystectomy because of muscle invasive bladder cancer. Biomarkers that predict response to systemic immunotherapy will be identified by comprehensive multi-omics analysis of primary tumors and metastatic lesions. Furthermore, we will determine if ctDNA levels during therapy can be used as a biomarker for early indication of therapy response. The hypotheses is that 1) early initiation of immunotherapy in high-risk (ctDNA positive) patients will result in better response rates and improved survival compared to later treatment following conventional imaging diagnosis of metastasis, and 2) biomarkers for predicting response can be identified and used for tailoring treatment regimens in the future to patients at high risk and at high likelihood of response.
Tracking Information
- NCT #
- NCT04138628
- Collaborators
- Aarhus University Hospital
- Herlev Hospital
- Rigshospitalet, Denmark
- Odense University Hospital
- Aalborg University Hospital
- Investigators
- Principal Investigator: Jørgen B Jensen, Professor Dept. Of Urology, Aarhus University Hospital, Denmark Study Chair: Lars Dyrskjøt, Professor Dept. Of Molecular Medicine (MOMA) Aarhus University Hospital, Denmark Principal Investigator: Mads Agerbæk, MD Dept. Of Oncology, Aarhus University Hospital, Denmark Study Chair: Karin Birkenkamp-Demtröder, Ass. professor Dept. Of Molecular Medicine (MOMA) Aarhus University Hospital, Denmark
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