drugset / Trial / NCT06332274

tislelizUMaB in canceR Patients With molEcuLar residuaL Disease

NCT06332274

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Numerous studies have shown that even when imaging does not reveal the presence of cancer cells, traces of tumor DNA (i.e. originating from cancer cells) can be detected in the blood of certain patients: this is called molecular residual disease (MRD). When such traces are detected (we speak of MRD+ status), the risk of relapse is much higher than when there is no circulating tumor DNA (MRD - status). Given the success of immunotherapy in treating patients with metastatic disease in a variety of tumor types, there is enormous enthusiasm for expanding the use of immunotherapy to people with cancer at an early stage. UMBRELLA is a biology-driven trial designed to study the impact of systemic treatment with tislelizumab monotherapy after detection of MRD+ status after completion of surgery and perioperative treatments in patients with cancer of a solid tumor. Residual disease (MRD) will be determined by optimized detection and precise monitoring of circulating tumor DNA, enabling early detection of recurrence and disease monitoring, including in patients without MRD \[MRD(-)\].

Timeline

Start
2025-04-16
Primary completion
2029-04
Completion
2030-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Tislelizumab Monoclonal antibody 400 mg Intravenous