NCT06332274: UMBRELLA

tislelizUMaB in canceR Patients With molEcuLar residuaL Disease

Recruiting now Phase 3 Last updated 7 May 2025

What this trial tests

Phase 3 trial testing Tislelizumab in Cancer in 717 participants. Currently enrolling.

Timeline

16 April 2025

Primary endpoint
1 April 2029

1 April 2030

Quick facts

Lead sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	717
Start date	16 April 2025
Primary completion	1 April 2029
Estimated completion	1 April 2030
Sites	1 location across France

Drugs / interventions tested

• Tislelizumab (TISLELIZUMAB) — full drug profile →
• Blood sampling — full drug profile →
• Placebo

Conditions studied

• Cancer — all drugs for Cancer →
• Lung Cancer — all drugs for Lung Cancer →
• Colo-rectal Cancer — all drugs for Colo-rectal Cancer →
• Pancreas Cancer — all drugs for Pancreas Cancer →

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris — full company profile →

Who can join

18 and older, any sex, with Cancer or Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.
  DFS for MRD (+) patients defined as the time from randomization to relapse or death, whichever occurs first. DFS rate will also be assessed at 12 months, 24 months, 48 months and 60 months.

Sponsor's own description

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 \[MRD(-)\].

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Japan society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing.
   Kobayashi S, Nakamura Y, Hashimoto T, Bando H, et al · · 2025 · cited 6× · PMID 39920551 · DOI 10.1007/s10147-024-02683-0
2. Focus on PD-1/PD-L1-Targeting Antibodies in Colorectal Cancer: Are There Options Beyond Dostarlimab, Nivolumab, and Pembrolizumab? A Comprehensive Review.
   Kciuk M, Wanke K, Kruczkowska W, Marciniak B, et al · · 2025 · cited 3× · PMID 40649207 · DOI 10.3390/molecules30132686