Approval Probability
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OSE2101 · 1 trial · 2 indications
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...
OSE2101 is an investigational small molecule being studied for the treatment of platinum-sensitive recurrent ovarian cancer. It is currently in Phase 2 clinical development, and the ongoing trial is evaluating it alone or in combination with pembrolizumab versus best supportive care in patients with platinum-sensitive recurrent ovarian cancer.
OSE2101 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting a Phase 2 clinical trial of OSE2101 in platinum-sensitive recurrent ovarian cancer.
OSE2101 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is active but not recruiting participants, and it is studying OSE2101 in patients with platinum-sensitive recurrent ovarian cancer.
OSE2101 is being studied in one active Phase 2 clinical trial with the identifier NCT04713514. The trial is titled 'OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC' and enrolls 180 female patients aged 18 years and older in Belgium, France, and Germany.
No, OSE2101 is not the same as pembrolizumab. OSE2101 is an investigational small molecule being studied alone or in combination with pembrolizumab in a Phase 2 trial for platinum-sensitive recurrent ovarian cancer. Pembrolizumab is a separate drug used as a combination partner in the trial.