CancerPhase 3UMBRELLANCT06332274
tislelizUMaB in canceR Patients With molEcuLar residuaL Disease
A Phase 3 study testing Tislelizumab and Blood sampling in people with Cancer and Lung Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Lung Cancer, Colo-rectal Cancer
- What is being tested?
- Tislelizumab and Blood sampling
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 717 participants
- Where
- 1 siteFrance
- Study dates
- 16 Apr 2025to Apr 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Completion of surgical and peri-operative treatments as per international guidelines.
- 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.
- Subject must not have standard treatment at least 3 weeks before blood sampling for ctDNA analyses.
- Patients must not have blood transfusion at least 3 months before blood sampling for ctDNA analyses.
- Histology: TNM stage II-III NSCLC, Stage II-III colorectal cancer, stage I-III pancreatic cancer, grade 3 limb or trunk wall soft-tissue sarcoma.
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- Subjects must have sufficient amount of archived primary tumor material for ctDNA and translational research analyses that will be conducted as defined in the protocol.
- Subjects must have a valid (positive or negative) ctDNA test result prior to randomization.
- Subjects must not have had prior immunotherapy (anti-PD-1 or anti-PD-L1).
- No evidence of disease on imaging as per RECIST criteria 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Subjects must have adequate organ function as indicated by the following laboratory values (obtained within 7 days prior to randomization):
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, haemoglobin ≥90 g/L. Note: Patients must not have required growth factor support ≤ 14 days before sample collection.
- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x upper limit of normal (ULN).
- Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN.
- Serum total bilirubin ≤ 1.5 x ULN (total bilirubin must be < 3 x ULN for patients with Gilbert's syndrome).
- Aspartate and alanine aminotransferase (AST and ALT) ≤ 3 x ULN.
- Creatinine clearance ≥60 mL/min for participants with creatinine levels above institutional normal (≥ULN). Creatinine clearance should be calculated per the Cockcroft-Gault formula (or local institutional standard method).
- Subjects with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code).
- Subjects should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
- Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the trial, and ≥ 120 days after the last dose of the trial drug and have a negative serum pregnancy test ≤ 7 days of the first dose of the trial drug. A barrier contraceptive method (e.g., condom) is also required. A woman is considered of childbearing potential following menarche and until becoming post-menopausal (≥ 12 months of non-therapy-induced amenorrhea) unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral oophorectomy and bilateral salpingectomy with surgery at least 1 month before the first dose of study drug or confirmed by follicle stimulating hormone (FSH) test >40 mIU/mL and estradiol <40 pg/mL (<140 pmol/L).
- Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of the trial drug. A barrier contraceptive method (e.g., condom) is also required.
Who cannot join
- Participation in another clinical trial with an investigational product during the last 3 to 4.5 months and while on study treatment
- Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol,
- Pregnant or breastfeeding women
- Subjects under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
- Patients with confirmed EGFR (Epidermal Growth Factor Receptor ) exon 19 deletions or exon 21 L858R substitutions are excluded from the study, due to the potential benefit from adjuvant osimertinib treatment, which represents a standard of care for these genetic profiles in non-small cell lung cancer (NSCLC).
- Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrolment
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- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate and thalidomide) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
- Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids as premedication for hypersensitivity reaction (e.g., CT scan premedication)) are eligible for the study after Principal investigator approval has been obtained
- Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study
- Patients who received intranasal, inhaled, topical or local steroid injections (e.g., intra articular injection)
- Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE > Grade 1.
- Known intolerance the study drugs or any of their excipients
- Patients with prior allogeneic stem cell or solid organ transplantation
- Administration of a live, attenuated vaccine within 4 weeks prior to enrolment or anticipation that such a live, attenuated vaccine will be required during the study or within 5 months after the last dose of the study drugs (except anti-COVID-19 vaccines)
- Active or history of autoimmune disease or immune deficiency, with the exception of history of treated autoimmune-related hypothyroidism and Type 1 diabetes mellitus on insulin regimen
- History of idiopathic pulmonary fibrosis (including pneumonitis or interstitial lung disease), drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis (history of radiation pneumonitis in the radiation field (fibrosis) is permitted).
- Patients who underwent major surgery within 56 days prior to inclusion or until the surgical wound is fully healed
- History of HIV infection
- Patients with active hepatitis infection (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
- Active tuberculosis.
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
- Significant cardiovascular disease, such as:
- History of myocardial infarction, acute coronary syndromes or coronary angioplasty/stenting/bypass grafting within the past 6 months,
- Congestive Heart Failure (CHF) NYHA class III or IV or history of CHF NYHA class III or IV, unless an echocardiogram or multi-gated acquisition scan performed within 3 months day 1 reveals a left ventricular ejection fraction ≥ 55%
- Uncontrolled hypertension defined by systolic pressure > 150 and/or diastolic pressure > 110 mmHg, with or without anti-hypertensive medication. Patients with initial blood pressure elevations are eligible if initiation or adjustment of anti-hypertensive medication lowers blood pressure to meet entry criteria
- History of stroke or transient ischemic attack within 6 months prior to randomization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Gustave Roussy
Villejuif, Val De Marne, 94800
Antoine ITALIANO, MD, +33 (0)1 42 11 42 11, Antoine.ITALIANO@gustaveroussy.fr
About this study
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
- Cancer, Lung Cancer, Colo-rectal Cancer, Pancreas Cancer, Soft Tissue Sarcoma
- Being tested
- Tislelizumab, Blood sampling, Placebo
- Medical subject headings
- Neoplasms, Lung Neoplasms, Colonic Neoplasms, Pancreatic Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Formulation : 100 mg of antibody in 10 mL of isotonic solution (25 mM citrate buffer, 15 mM L-histidine/histidine hydrochloride, 190 mM trehalose-dihydrate, and 0.02% polysorbate 20 at pH 6.5) in a single-use vial.
Dose Regimen: Tislelizumab 400 mg every 6 weeks (Q6W) for a maximum of 9 cycles, on the first day of each cycle, in IV.
Blood samplingOther
Blood sampling for analyses of MRD (Molecular Residual Disease)
PlaceboDrug
Pharmaceutical form : Solvent IV bags used for dilution of tislelizumab (for example: "CHLORURE DE SODIUM FRESENIUS 0,9 %, solution injectable") Dose Regimen: every 6 weeks (Q6W) for a maximum of 9 cycles, on the first day of each cycle, in IV.
| Study group | Role | What they receive |
|---|---|---|
| Arm A. MRD(+) - Tislelizumab treatment | Experimental | Systemic treatment with tislelizumab monotherapy at the recommended dose of 400 mg administered intravenously every 6 weeks for a maximum of 9 cycles and followed-up as per standard of care (clinical examination plus imaging every 3 months the first year and every 6 months the second year) in addition to ctDNA (circulating tumoral DNA) analysis at M6 and M12. Receives: Drug: Tislelizumab; Other: Blood sampling |
| Arm B. MRD(+) - placebo treatment | Placebo comparator | Control arm for MRD (+) subjects who will be administered with placebo instead of tislelizumab Receives: Other: Blood sampling; Drug: Placebo |
| Arm C. MRD(-) - De-escalated follow-up | Experimental | De-escalated follow-up: clinical examination plus imaging every 6 months the first year and yearly the second year) with standard of care in addition to biobanking at M12 for subsequent ctDNA analyses. Receives: Other: Blood sampling |
| Arm D. MRD(-) - De-escalated follow-up | Other | Control arm for MRD (-) subjects , followed up as per standard of care (clinical examination plus imaging every 3 months the first year and every 6 months the second year) in addition to biobanking at M12 for subsequent ctDNA analyses. Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of tislelizumab compared to placebo as measured by DFS (Disease-free survival)
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.
Measured: relapse/death assessed up to 60 months and at 12 months, 24 months, 48 months and 60 months.
Secondary outcomes (11)
Estimation of DFS in subjects without MRD
DFS for MRD (-) patients defined as the time from randomization to relapse or death, whichever occurs first.
Measured: relapse/death assessed up to 60 months
Estimation of overall survival (OS)
Measured: 12, 24, 48 and 60 months
Percentage of MRD (+) subject's completion of standard curative-intent therapy
Measured: 1 year after the end of enrollment
Time between detection of MRD and detection of relapse at imaging.
As documented per RECIST v1.1
Measured: 1 year after the end of enrollment
Percentage of subjects with MRD assessment failure.
Measured: 1 year after the end of enrollment
Estimation of the time to become MRD (-) for MRD(+) patients
Time from baseline to detection of MRD (-) status in subjects who were MRD (+) at baseline
Measured: 1 year after the end of enrollment
Evaluation of Health-Related Quality of Life (QLQ) by QLQ-C30
Scores from EORTC QLQ-C30 (Quality of Life Questionnaire)
Measured: Baseline and at months 6, 12, 18 and 24.
Evaluation of Health-Related Quality of Life (QLQ) by EQ-5D-5L
Scores from EuroQol EQ-5D-5L questionnaire
Measured: Baseline and at months 6, 12, 18 and 24.
Cost effectiveness analysis: incremental cost
Measured: 1 year after the end of enrollment
Cost effectiveness analysis: QALY
Quality-Adjusted Life Year
Measured: 1 year after the end of enrollment
Cost effectiveness analysis: ICER
Incremental Cost-Effectiveness Ratio (€/QALY).
Measured: 1 year after the end of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start16 Apr 2025
- Primary completionApr 2029 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 717 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- BeiGene, Veracyte, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332274
- Sponsor's protocol ID
- 2023-503316-33-00
- Other IDs
- 2023/3720, 2023
- Acronym
- UMBRELLA
- Status last verified
- May 2025
- First submitted
- 29 Feb 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tislelizUMaB in canceR Patients With molEcuLar residuaL Disease
- ClinicalTrials.gov ID
- NCT06332274
- Acronym / sponsor ID
- UMBRELLA / 2023-503316-33-00
- Conditions
- Cancer, Lung Cancer, Colo-rectal Cancer, Pancreas Cancer, Soft Tissue Sarcoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 717 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Collaborators
- BeiGene, Veracyte, Inc.
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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(-)].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A. MRD(+) - Tislelizumab treatment | Experimental | Drug: Tislelizumab, Other: Blood samplingSystemic treatment with tislelizumab monotherapy at the recommended dose of 400 mg administered intravenously every 6 weeks for a maximum of 9 cycles and followed-up as per standard of care (clinical examination plus imaging every 3 months the first year and every 6 months the second year) in addition to ctDNA (circulating tumoral DNA) analysis at M6 and M12. |
| Arm B. MRD(+) - placebo treatment | Placebo comparator | Other: Blood sampling, Drug: PlaceboControl arm for MRD (+) subjects who will be administered with placebo instead of tislelizumab |
| Arm C. MRD(-) - De-escalated follow-up | Experimental | Other: Blood samplingDe-escalated follow-up: clinical examination plus imaging every 6 months the first year and yearly the second year) with standard of care in addition to biobanking at M12 for subsequent ctDNA analyses. |
| Arm D. MRD(-) - De-escalated follow-up | Other | Other: Blood samplingControl arm for MRD (-) subjects , followed up as per standard of care (clinical examination plus imaging every 3 months the first year and every 6 months the second year) in addition to biobanking at M12 for subsequent ctDNA analyses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age ≥ 18 years.
- Completion of surgical and peri-operative treatments as per international guidelines.
- 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.
- Subject must not have standard treatment at least 3 weeks before blood sampling for ctDNA analyses.
- Patients must not have blood transfusion at least 3 months before blood sampling for ctDNA analyses.
Key exclusion criteria (28 listed)
- Participation in another clinical trial with an investigational product during the last 3 to 4.5 months and while on study treatment
- Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol,
- Pregnant or breastfeeding women
- Subjects under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
- Patients with confirmed EGFR (Epidermal Growth Factor Receptor ) exon 19 deletions or exon 21 L858R substitutions are excluded from the study, due to the potential benefit from adjuvant osimertinib treatment, which represents a standard of care for these genetic profiles in non-small cell lung cancer (NSCLC).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabFormulation : 100 mg of antibody in 10 mL of isotonic solution (25 mM citrate buffer, 15 mM L-histidine/histidine hydrochloride, 190 mM trehalose-dihydrate, and 0.02% polysorbate 20 at pH 6.5) in a single-use vial. Dose Regimen: Tislelizumab 400 mg every 6 weeks (Q6W) for a maximum of 9 cycles, on the first day of each cycle, in IV. | Drug | Arm A. MRD(+) - Tislelizumab treatment |
| Blood samplingBlood sampling for analyses of MRD (Molecular Residual Disease) | Other | Arm A. MRD(+) - Tislelizumab treatment, Arm B. MRD(+) - placebo treatment, Arm C. MRD(-) - De-escalated follow-up, Arm D. MRD(-) - De-escalated follow-up |
| PlaceboPharmaceutical form : Solvent IV bags used for dilution of tislelizumab (for example: "CHLORURE DE SODIUM FRESENIUS 0,9 %, solution injectable") Dose Regimen: every 6 weeks (Q6W) for a maximum of 9 cycles, on the first day of each cycle, in IV. | Drug | Arm B. MRD(+) - placebo treatment |
Primary outcome
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.
11 secondary outcomes
Estimation of DFS in subjects without MRD
Time frame: relapse/death assessed up to 60 months
Estimation of overall survival (OS)
Time frame: 12, 24, 48 and 60 months
Percentage of MRD (+) subject's completion of standard curative-intent therapy
Time frame: 1 year after the end of enrollment
Time between detection of MRD and detection of relapse at imaging.
Time frame: 1 year after the end of enrollment
Percentage of subjects with MRD assessment failure.
Time frame: 1 year after the end of enrollment
Estimation of the time to become MRD (-) for MRD(+) patients
Time frame: 1 year after the end of enrollment
Evaluation of Health-Related Quality of Life (QLQ) by QLQ-C30
Time frame: Baseline and at months 6, 12, 18 and 24.
Evaluation of Health-Related Quality of Life (QLQ) by EQ-5D-5L
Time frame: Baseline and at months 6, 12, 18 and 24.
Cost effectiveness analysis: incremental cost
Time frame: 1 year after the end of enrollment
Cost effectiveness analysis: QALY
Time frame: 1 year after the end of enrollment
Cost effectiveness analysis: ICER
Time frame: 1 year after the end of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tislelizumab and Blood sampling in people with Cancer and Lung Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine ITALIANO, MD (+33 (0)1 42 11 42 11, antoine.italiano@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.