protocolSection identificationModule nctId: NCT06332274, orgStudyIdInfo id: 2023-503316-33-00, secondaryIdInfos id: 2023/3720, type: OTHER, domain: CSET number, briefTitle: tislelizUMaB in canceR Patients With molEcuLar residuaL Disease, acronym: UMBRELLA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-05, completionDateStruct date: 2029-04, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Gustave Roussy, Cancer Campus, Grand Paris, class: OTHER, collaborators name: BeiGene, collaborators name: C2i Genomics, descriptionModule briefSummary: 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 \[MRD(-)\]., conditionsModule conditions: Cancer, conditions: Lung Cancer, conditions: Colo-rectal Cancer, conditions: Pancreas Cancer, conditions: Soft Tissue Sarcoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a double-blinded, randomized, placebo-controlled, multi-center, national, Phase 3 biology-driven trial designed to investigate the impact of systemic treatment with tislelizumab or placebo following detection of MRD minimum 3 months and maximum 4.5 months after completion of curative-intent therapy., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 717, type: ESTIMATED, armsInterventionsModule interventions name: Tislelizumab, interventions name: Blood sampling, interventions name: Placebo, outcomesModule primaryOutcomes measure: Efficacy of tislelizumab compared to placebo as measured by DFS (Disease-free survival), secondaryOutcomes measure: Estimation of DFS in subjects without MRD, secondaryOutcomes measure: Estimation of overall survival (OS), secondaryOutcomes measure: Percentage of MRD (+) subject's completion of standard curative-intent therapy, secondaryOutcomes measure: Time between detection of MRD and detection of relapse at imaging., secondaryOutcomes measure: Percentage of subjects with MRD assessment failure., secondaryOutcomes measure: Estimation of the time to become MRD (-) for MRD(+) patients, secondaryOutcomes measure: Evaluation of Health-Related Quality of Life (QLQ) by QLQ-C30, secondaryOutcomes measure: Evaluation of Health-Related Quality of Life (QLQ) by EQ-5D-5L, secondaryOutcomes measure: Cost effectiveness analysis: incremental cost, secondaryOutcomes measure: Cost effectiveness analysis: QALY, secondaryOutcomes measure: Cost effectiveness analysis: ICER, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gustave Roussy, city: Villejuif, state: Val De Marne, zip: 94800, country: France, geoPoint lat: 48.7939, lon: 2.35992, hasResults: False