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tislelizUMaB in canceR Patients With molEcuLar residuaL Disease | Clinical Trials | Clareo Health

RECRUITINGPHASE3

tislelizUMaB in canceR Patients With molEcuLar residuaL Disease

NCT06332274•Gustave Roussy, Cancer Campus, Grand Paris

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years.
•2. Completion of surgical and peri-operative treatments as per international guidelines.
•3. Subject must have completed standard curative-intent therapy (i.e: Surgery, Neoadjuvant and adjuvant therapy) for minimum 3 months and maximum 4.5 months prior to sending samples for MRD analyses.
•4. Subject must not have standard treatment at least 3 weeks before blood sampling for ctDNA analyses.
•5. Patients must not have blood transfusion at least 3 months before blood sampling for ctDNA analyses.
•6. Histology: TNM stage II-III NSCLC, Stage II-III colorectal cancer, stage I-III pancreatic cancer, grade 3 limb or trunk wall soft-tissue sarcoma.
•7. Subjects must have sufficient amount of archived primary tumor material for ctDNA and translational research analyses that will be conducted as defined in the protocol.
•8. Subjects must have a valid (positive or negative) ctDNA test result prior to randomization.
•9. Subjects must not have had prior immunotherapy (anti-PD-1 or anti-PD-L1).
•10. No evidence of disease on imaging as per RECIST criteria 1.1.
+13 more criteria

Exclusion Criteria

•1. Participation in another clinical trial with an investigational product during the last 3 to 4.5 months and while on study treatment
•2. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol,
•3. Pregnant or breastfeeding women
•4. Subjects under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
•5. Patients with confirmed EGFR (Epidermal Growth Factor Receptor ) exon 19 deletions or exon 21 L858R substitutions are excluded from the study, due to the potential benefit from adjuvant osimertinib treatment, which represents a standard of care for these genetic profiles in non-small cell lung cancer (NSCLC).
•6. Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrolment
•7. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate and thalidomide) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
•* Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids as premedication for hypersensitivity reaction (e.g., CT scan premedication)) are eligible for the study after Principal investigator approval has been obtained
•* Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study
•* Patients who received intranasal, inhaled, topical or local steroid injections (e.g., intra articular injection)
+16 more criteria

Locations (1)

Gustave Roussy

Villejuif, Val De Marne, France

Key Dates

Start Date

April 16, 2025

Primary Completion Date

April 1, 2029

Completion Date

April 1, 2030

Last Updated

May 13, 2025

Enrollment

717

ESTIMATED participants

Conditions

CancerLung CancerColo-rectal CancerPancreas CancerSoft Tissue Sarcoma

Interventions

Tislelizumab

DRUG

Blood sampling

OTHER

Placebo

DRUG

Contacts

Antoine ITALIANO, MD

CONTACT

+33 (0)1 42 11 42 11 antoine.italiano@gustaveroussy.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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tislelizUMaB in canceR Patients With molEcuLar residuaL Disease

Inclusion Criteria

Exclusion Criteria

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