Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04713514 | OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC | PHASE2 | ACTIVE NOT_RECRUITING | 180 | — | — | Aug 5, 2021 | Dec 1, 2025 | Dec 2, 2024 | 40 | Belgium, France +1 |
Progression-free survival (PFS) is the time from randomization to progression measured radiologically using RECIST v1.1 guidelines as reported by the investigator or death, whatever the cause, whichever comes first. Patients alive and free of progression at the cut-off date will be censored at the last tumor assessment date
| Arm | Type | Description |
|---|---|---|
| Arm A : Best Supportive Care | NO_INTERVENTION | Observational arm (Standard of care) |
| Arm B : OSE2101 | EXPERIMENTAL | OSE2101 monotherapy - subcutaneous injection on day 1, every 3 weeks for 7 doses then every 6 weeks up to week 48 and then every 12 weeks until intolerance, disease progression, or up to 2 years. OSE2101 vaccine is an emulsion of peptides suspension in in Montanide® ISA 51 adjuvant and containing 0.5 mg/mL of each 10 synthetically manufactured peptides (5.0 mg/mL total peptide) in 1.5 mL of emulsion. |
| Arm C : OSE2101 + Pembrolizumab | EXPERIMENTAL | OSE2101 (subcutaneous injection on day 1, every 3 weeks for 7 doses then every 6 weeks up to week 48 and then every 12 weeks until intolerance, disease progression, or up to 2 years) + pembrolizumab (400 mg IV infusion on day 1 every 6 weeks until intolerance, disease progression, or up to 2 years. |
| Name | Type | Description |
|---|---|---|
| OSE2101 | DRUG | subcutaneous injection on day 1, every 3 weeks for 7 doses then every 6 weeks up to week 48 and then every 12 weeks until intolerance, disease progression, or up to 2 years. |
| Pembrolizumab 25 MG/ML [Keytruda] | DRUG | 400 mg IV infusion on day 1 every 6 weeks until intolerance, disease progression, or up to 2 years. |
Inclusion Criteria: 1. Signed and dated informed consent document for the study, willing and able to comply with protocol requirements, including: 1. HLA-A2 phenotype determination by genetic test (blood) 2. participation in translational research in HLA-A2 positive 3. authorization for l...