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 |