OncoMatch/Clinical Trials/NCT06332274
tislelizUMaB in canceR Patients With molEcuLar residuaL Disease
Is NCT06332274 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Tislelizumab for cancer.
Treatment: Tislelizumab — 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 \[MRD(-)\].
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Colorectal Cancer
Pancreatic Cancer
Sarcoma
Biomarker criteria
Excluded: EGFR exon 19 deletion
Excluded: EGFR l858r
Disease stage
Required: Stage II, III
Grade: 3
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: curative-intent therapy — adjuvant/neoadjuvant/surgery
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
Cannot have received: immunotherapy
Subjects must not have had prior immunotherapy (anti-PD-1 or anti-PD-L1)
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, haemoglobin ≥90 g/L; INR or PT ≤ 1.5 x ULN; aPTT ≤ 1.5 x ULN
Kidney function
Creatinine clearance ≥60 mL/min for participants with creatinine levels above institutional normal (≥ULN)
Liver function
Serum total bilirubin ≤ 1.5 x ULN (total bilirubin must be < 3 x ULN for patients with Gilbert's syndrome); AST and ALT ≤ 3 x ULN
Subjects must have adequate organ function as indicated by the following laboratory values (obtained within 7 days prior to randomization): 1. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, haemoglobin ≥90 g/L. Note: Patients must not have required growth factor support ≤ 14 days before sample collection. 2. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x upper limit of normal (ULN). 3. Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. 4. Serum total bilirubin ≤ 1.5 x ULN (total bilirubin must be < 3 x ULN for patients with Gilbert's syndrome). 5. Aspartate and alanine aminotransferase (AST and ALT) ≤ 3 x ULN. 6. Creatinine clearance ≥60 mL/min for participants with creatinine levels above institutional normal (≥ULN).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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