Clinical trial NCT06332274: tislelizUMaB in canceR Patients With molEcuLar residuaL Disease
Official title: tislelizUMaB in canceR Patients With molEcuLar residuaL Disease
Conditions: Cancer
Lung Cancer
Colo-rectal Cancer
Pancreas Cancer
Soft Tissue Sarcoma
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(-)].
Interventions:
description: 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.<br/>Dose Regimen: Tislelizumab 400 mg every 6 weeks (Q6W) for a maximum of 9 cycles, on the first day of each cycle, in IV.
name: Tislelizumab
type: Drug
description: Blood sampling for analyses of MRD (Molecular Residual Disease)
name: Blood sampling
type: Other
description: 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.
name: Placebo
type: Drug
Study arms:
design_group_description: Systemic treatment with tislelizumab monotherapy at the recommended dose of 400 mg administered intravenously every 6 weeks for a maximum of 9 cycles and followed-up as per standard of care (clinical examination plus imaging every 3 months the first year and every 6 months the second year) in addition to ctDNA (circulating tumoral DNA) analysis at M6 and M12.
design_group_title: Arm A. MRD(+) - Tislelizumab treatment
design_group_type: Experimental
design_group_description: Control arm for MRD (+) subjects who will be administered with placebo instead of tislelizumab
design_group_title: Arm B. MRD(+) - placebo treatment
design_group_type: Placebo Comparator
design_group_description: De-escalated follow-up: clinical examination plus imaging every 6 months the first year and yearly the second year) with standard of care in addition to biobanking at M12 for subsequent ctDNA analyses.
design_group_title: Arm C. MRD(-) - De-escalated follow-up
design_group_type: Experimental
design_group_description: Control arm for MRD (-) subjects , followed up as per standard of care (clinical examination plus imaging every 3 months the first year and every 6 months the second year) in addition to biobanking at M12 for subsequent ctDNA analyses.
design_group_title: Arm D. MRD(-) - De-escalated follow-up
design_group_type: Other
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Collaborators: Veracyte, Inc.
BeOne Medicines Ltd.
Drug name mappings:
name: 替雷利珠单抗
lang: CN
name: Tislelizumab
lang: EN
name: チスレリズマブ（遺伝子組換え）（JAN）
lang: JP