tislelizUMaB in canceR Patients With molEcuLar residuaL Disease

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT06332274
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tislelizumab — DRUG
    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.
  • Blood sampling — OTHER
    Blood sampling for analyses of MRD (Molecular Residual Disease)
  • Placebo — DRUG
    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.

Study Details

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 \[MRD(-)\].

Key Dates

First listed
Mar 27, 2024
Start date
Apr 16, 2025
Status verified
May 2025
Primary completion
Apr 30, 2029
Completion
Apr 30, 2030

Study Design

Enrollment
717 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A. MRD(+) - Tislelizumab treatment
    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.
  • Placebo Comparator: Arm B. MRD(+) - placebo treatment
    Control arm for MRD (+) subjects who will be administered with placebo instead of tislelizumab
  • Experimental: Arm C. MRD(-) - De-escalated follow-up
    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.
  • Other: Arm D. MRD(-) - De-escalated follow-up
    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.

Primary Outcome Measure

Efficacy of tislelizumab compared to placebo as measured by DFS (Disease-free survival) [ Time Frame: relapse/death assessed up to 60 months and at 12 months, 24 months, 48 months and 60 months. ]

Central Contacts

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