Launch of UMBRELLA study to personnalise post-treatment follow-up for cancer patients

A pragmatic study aiming to change a paradigm
The UMBRELLA trial assesses two post-treatment strategies based on the MRD status of patients with non-metastatic cancers (non-small cell lung, colorectal, pancreatic, and soft tissue sarcomas):
• For MRD-positive patients, the study tests the benefit of pre-emptive immunotherapy (tislelizumab) versus placebo, alongside standard medical follow-up (imaging and clinical examination every 3 to 6 months). The primary aim is to evaluate the treatment’s effect on disease-free survival.
• For MRD-negative patients, considered low-risk, UMBRELLA explores the possibility of a reduced follow-up (every 6 months, then annually), to limit unnecessary consultations and tests without compromising patient outcomes.

An ambitious and collaborative study
Spanning four years, UMBRELLA is a randomised, double-blind, multicentre trial aiming to enrol over 700 patients across 10 to 11 centres in France. The trial is sponsored by Gustave Roussy and coordinated by Professor Antoine Italiano, Head of the Institute’s Precision Medicine Programme. UMBRELLA also involves public–private collaborations with Integragen, responsible for molecular analyses, and BeiGene, supplier of tislelizumab. UMBRELLA’s pragmatic and inclusive approach allows the enrolment of any adult patient with one of the targeted indications, who has never received immunotherapy and has completed curative treatment within the last 3 to 4.5 months.

A new era in post-cancer monitoring
UMBRELLA is not merely assessing a new treatment; it challenges the very structure of cancer follow-up by introducing, for the first time, a biological stratification approach based on MRD. The study could pave the way for a more preventive, precision-driven, and less burdensome oncology.
(Umbrella trial : N° EU-CT : 2023-503316-33-00 et N° Clinicaltrials.gov : NCT06332274)