Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Atezolizumab

Immunomodulating Agents

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Flat dose 1200 mg Atezolizumab every three weeks for up to 13 months

The study drug will be given according to current recommendations as systemic treatment every third week for 12 months or until progression. Treatment will be initiated within 28 days of detection of ctDNA.

Jørgen B Jensen, MD, DMSc

Lars Dyrskjøt, Professor

Astrid Livbjerg, MD

Andreas Carus, MD

Jørgen B Jensen, MD

Mads Agerbæk, MD

Ulla N Joensen, MD

Helle Pappot, MD

Gitte W Lam, MD

Line H Dohn, MD

Thor K Jensen, MD

Niels V Jensen, MD

Jørgen B Jensen, Professor

Karin Birkenkamp-Demtröder, Ass. professor

Immunotherapy (checkpoint inhibitors) is approved as first and second line treatment to patients with metastatic bladder cancer. However, response rates are low and no biomarkers have yet shown strong predictive value for patient selection. Moreover, the term 'metastatic' is based on metastases visible on conventional CT scans and, thus, require a certain size of tumour load. Clinical trials are currently being conducted that investigate the use of adjuvant immunotherapy for this group of patients (treatment to all), which will result in massive over-treatment and huge costs to the healthcare system.

This project has the primary objective to identify new indications for initiating immunotherapy in patients with metastatic bladder cancer. Sensitive molecular techniques for detection of tumor DNA in the blood will be used to identify patients with early signs of metastatic disease. In addition, comprehensive biomarker analysis will be performed to identify predictors of treatment response.

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.

Single country Investigator Initiated, Open-label, Single-arm, Non-randomized, Phase II study

Treatment Of Metastatic Bladder Cancer at the Time Of Biochemical reLApse Following Radical Cystectomy

CR in the current study is defined as ctDNA negative status combined with regular imaging (CT) after treatment. Thus, any metastasis visible on CT at the time of treatment initiation should undergo complete response. In Study Subjects without visible metastasis on CT at the time of treatment, initiation should result in unchanged status on CT.

Data will be compared to available historical data on response to PD-1 / PD-L1 targeted agents.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Treatment Of Metastatic Bladder Cancer at the Time Of Biochemical reLApse Following Radical Cystectomy	NCT04138628	Bladder Cancer Bladder Cancer,...	Atezolizumab	18 Years -	Aarhus University Hospital
Treatment Of Metastatic Bladder Cancer at the Time Of Biochemical reLApse Following Radical Cystectomy	NCT04138628	Bladder Cancer Bladder Cancer,...	Atezolizumab	18 Years -	Aarhus University Hospital

Spots Global Cancer Trial Database for bladder cancer, metastatic