National clinical study

TOMBOLA: Treatment Of Metastatic Bladder cancer at the time Of biochemical reLApse following radical cystectomy

The TOMBOLA study aims to investigate the potential benefits of ctDNA-guided administration of adjuvant immunotherapy following radical cystectomy in patients diagnosed with locally advanced bladder cancer. Patients undergo monthly ctDNA testing during the first year after radical cystectomy, with less frequent testing in the second year. ctDNA-positive patients will receive immunotherapy regardless of their CT scan status. Additionally, ctDNA testing is performed during neoadjuvant chemotherapy and immunotherapy to monitor treatment response.

ClinicalTrials.gov: NCT04138628

The project received funding in 2022 and 2024.

Abstract

Localized, muscle invasive bladder cancer is treated with curative intent and cisplatin-eligible patients undergo radical cystectomy (RC) preceded by neoadjuvant chemotherapy (NAC). Within the first two years after surgery, about 45 % of patients will have experienced metastatic relapse. Prognosis for these patients is poor and only a subset of patients show benefit from treatment of metastatic disease. Early identification of metastatic relapse by detection of trace amounts of circulating tumor DNA (ctDNA) in the blood is feasible, offering the possibility to detect cancer relapse months to years earlier than standard radiographic imaging. In this national trial, we expect to detect ctDNA in serial blood samples after surgery in about 45% of the enrolled patients. Those patients experiencing a molecular relapse within 3 weeks to 2 years post RC will receive immunotherapy. We hypothesize that early treatment with immunotherapy administered at the time of molecular relapse will be more effective when applied at a stage of micrometastasis with improved response, recurrence free survival and overall survival compared to historical data. In addition, our strategy can be used to stratify treatment to high-risk patients only. If successful, our project will benefit both patients and the health care system as expensive oncological treatment can be administered only to patients that need treatment and who have a high likelihood of responding to the treatment.

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