RecruitingPhase 3NCT06332274

tislelizUMaB in canceR Patients With molEcuLar residuaL Disease


Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrollment

717 participants

Start Date

Apr 16, 2025

Study Type

INTERVENTIONAL

Conditions

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 \[MRD(-)\].


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving immunotherapy (a drug called tislelizumab) to cancer patients who have finished their standard curative treatment but still show traces of cancer in their blood (called molecular residual disease, or MRD) can prevent the cancer from coming back. Even after successful surgery and chemotherapy, tiny amounts of cancer DNA can sometimes be detected in the bloodstream — a sign that the cancer may return. This study targets that window to intervene early. **You may be eligible if:** - You are 18 or older - You have completed standard curative treatment for stage II–III non-small cell lung cancer, stage II–III colorectal cancer, stage I–III pancreatic cancer, or grade 3 limb/trunk soft tissue sarcoma - Testing shows molecular residual disease (ctDNA positive) in your blood after completing treatment - You have no visible cancer on imaging - Your physical health (ECOG 0–1) and organ function meet requirements - You have not received prior immunotherapy **You may NOT be eligible if:** - You have visible cancer on imaging - You have previously received immunotherapy (anti-PD-1 or anti-PD-L1) - Your organ function is insufficient - Your blood tests for residual cancer were not done in the required timeframe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab

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.

OTHERBlood sampling

Blood sampling for analyses of MRD (Molecular Residual Disease)

DRUGPlacebo

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.


Locations(1)

Gustave Roussy

Villejuif, Val De Marne, France

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NCT06332274


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