Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tislelizumab · 1 trial · 5 indications
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Arm B. MRD(+) - placebo treatment | PLACEBO_COMPARATOR | Control arm for MRD (+) subjects who will be administered with placebo instead of tislelizumab |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Tislelizumab | DRUG | 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 sampling | OTHER | Blood sampling for analyses of MRD (Molecular Residual Disease) |
| Placebo | DRUG | 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. |
Inclusion Criteria: 1. Age ≥ 18 years. 2. Completion of surgical and peri-operative treatments as per international guidelines. 3. 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 sendi...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
Tislelizumab is an investigational oncology drug being studied for use in cancer, specifically in patients with molecular residual disease. The ongoing Phase 3 trial includes conditions such as lung cancer, colorectal cancer, pancreas cancer, and soft tissue sarcoma. It is not yet approved and remains in clinical development.
Tislelizumab targets PDCD1, also known as programmed cell death protein 1, and acts as an inhibitor of this target. By inhibiting PDCD1, the drug is designed to modulate immune responses in the context of cancer treatment. This mechanism is being evaluated in a Phase 3 clinical trial.
Tislelizumab is being developed by Veracyte, Inc., a company traded on the stock exchange under the ticker VCYT. The company is conducting a Phase 3 clinical trial to evaluate the drug in cancer patients with molecular residual disease.
Tislelizumab is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is actively recruiting participants to assess its efficacy and safety in the studied cancer indications.
Tislelizumab is being studied in a single Phase 3 clinical trial registered as NCT06332274. This randomized, double-blind, placebo-controlled trial is recruiting 717 participants in France and is titled 'tislelizUMaB in canceR Patients With molEcuLar residuaL Disease'. The trial includes adults aged 18 years and older.
No alternative names for Tislelizumab have been identified in the available information. The drug is referred to solely as Tislelizumab in the context of its clinical development and trial documentation.