NCT06332274

tislelizUMaB in canceR Patients With molEcuLar residuaL Disease

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 717 (estimated)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 \[MRD(-)\].

Conditions

• Cancer
• Lung Cancer
• Colo-rectal Cancer
• Pancreas Cancer
• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Tislelizumab	Formulation : 100 mg of antibody in 10 mL of isotonic solution (25 mM citrate buffer, 15 mM L-histidine/histidine hydrochloride, 190 mM trehalose-dihydrate, and 0.02% polysorbate 20 at pH 6.5) in a single-use vial. Dose Regimen: Tislelizumab 400 mg every 6 weeks (Q6W) for a maximum of 9 cycles, on the first day of each cycle, in IV.
OTHER	Blood sampling	Blood sampling for analyses of MRD (Molecular Residual Disease)
DRUG	Placebo	Pharmaceutical form : Solvent IV bags used for dilution of tislelizumab (for example: "CHLORURE DE SODIUM FRESENIUS 0,9 %, solution injectable") Dose Regimen: every 6 weeks (Q6W) for a maximum of 9 cycles, on the first day of each cycle, in IV.

Timeline

• Start date: 2025-04-16
• Primary completion: 2029-04-01
• Completion: 2030-04-01
• First posted: 2024-03-27
• Last updated: 2025-05-13

Locations

1 site across 1 country: France