Actively Recruiting
tislelizUMaB in canceR Patients With molEcuLar residuaL Disease
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2025-05-13
717
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
Sponsors
G
Gustave Roussy, Cancer Campus, Grand Paris
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 \[MRD(-)\].
CONDITIONS
Official Title
tislelizUMaB in canceR Patients With molEcuLar residuaL Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Completed surgical and peri-operative treatments according to international guidelines
- Finished standard curative-intent therapy (surgery, neoadjuvant and adjuvant therapy) between 3 and 4.5 months before MRD blood sampling
- No standard treatment within at least 3 weeks before blood sampling for circulating tumor DNA analysis
- No blood transfusion within 3 months before blood sampling for circulating tumor DNA analysis
- Histology showing TNM stage II-III non-small cell lung cancer, stage II-III colorectal cancer, stage I-III pancreatic cancer, or grade 3 limb or trunk wall soft-tissue sarcoma
- Sufficient archived primary tumor material available for circulating tumor DNA and research analyses
- Valid circulating tumor DNA test result (positive or negative) before randomization
- No prior immunotherapy with anti-PD-1 or anti-PD-L1
- No evidence of disease on imaging according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group performance status 0 or 1
- Adequate organ function based on specified laboratory values obtained within 7 days before randomization
- Compliance with French biomedical research social security law
- Ability to understand, sign, and comply with study procedures
- Females of childbearing potential must use highly effective birth control during the trial and for at least 120 days after last dose, have a negative pregnancy test within 7 days before first dose, and use a barrier contraceptive method
- Nonsterile males must use highly effective birth control during the trial and for at least 120 days after last dose, including a barrier contraceptive method
You will not qualify if you...
- Participation in another clinical trial with an investigational product within the last 3 to 4.5 months or while on study treatment
- Any condition deemed by the investigator to make participation undesirable or compromise protocol compliance
- Pregnant or breastfeeding women
- Subjects under guardianship, deprived of liberty, or unable to give consent
- Confirmed EGFR exon 19 deletions or exon 21 L858R substitutions
- Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives before enrollment
- Treatment with systemic immunosuppressive medication within 2 weeks before study treatment initiation, except certain low-dose or local steroid uses with investigator approval
- Prior Grade 3 or higher immune-related adverse events or unresolved immune-related adverse events above Grade 1
- Known intolerance to study drugs or their excipients
- Prior allogeneic stem cell or solid organ transplantation
- Live attenuated vaccine within 4 weeks before enrollment or planned during study or within 5 months after last dose (except COVID-19 vaccines)
- Active or history of autoimmune disease or immune deficiency except treated hypothyroidism and type 1 diabetes mellitus on insulin
- History or evidence of various lung diseases including idiopathic pulmonary fibrosis or active pneumonitis
- Major surgery within 56 days before inclusion or until wound fully healed
- History of HIV infection
- Active hepatitis B or C infection (with some exceptions for resolved infections)
- Active tuberculosis
- History of severe allergic or hypersensitivity reactions to similar antibodies
- Severe infection within 4 weeks before study treatment initiation
- Therapeutic antibiotics within 2 weeks before study treatment initiation
- Significant cardiovascular disease including recent myocardial infarction or severe heart failure
- Uncontrolled hypertension
- Recent history of stroke or transient ischemic attack within 6 months prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gustave Roussy
Villejuif, Val De Marne, France, 94800
Actively Recruiting
Research Team
A
Antoine ITALIANO, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here