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tislelizUMaB in canceR Patients With molEcuLar residuaL Disease

Study acronym: UMBRELLA
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 6 more changesShow less
    • Primary completion date: May 2028 to Apr 2029
    • Start date changed from estimate of May 2024 to Apr 16, 2025
    • Study completion date: Apr 2029 to Apr 2030
    • Eligibility criteria expanded, about 9 words
    • Site details revised
    • Collaborators revised (2)
  2. Minor Re-verified, no change to tracked fieldsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
4,790 trials monitored
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3,394 trials monitored
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1,739 trials monitored
See 106 trials at risk
and 1 more disease
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 \[MRD(-)\].
Trial Details
NCT Number NCT06332274
Lead Sponsor Gustave Roussy, Cancer Campus, Grand Paris
Collaborators: BeiGene, Veracyte, Inc.
Conditions
(from sponsor)
Cancer, Lung Cancer, Colo-rectal Cancer, Pancreas Cancer, Soft Tissue Sarcoma
Related terms Colonic Neoplasms, Lung Neoplasms, Neoplasms, Pancreatic Neoplasms, Sarcoma
Enrollment 717 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov