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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03833479 | TSR-042 as Maintenance Therapy for Patients With High-risk Locally Advanced Cervical Cancer After Chemo-radiation | PHASE2 | ACTIVE NOT_RECRUITING | 134 | — | — | Jun 28, 2019 | Dec 1, 2025 | May 21, 2025 | 29 | Spain, Turkey (Türkiye) |
Time from the date of randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first based on investigator assessment using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
| Arm | Type | Description |
|---|---|---|
| No further treatment | EXPERIMENTAL | No further treatment |
| TSR-042 | EXPERIMENTAL | TSR-042 treatment administered using a 30 -minute IV infusion (with a -5 minute and +15 minute window permitted). |
| Name | Type | Description |
|---|---|---|
| No Further Treatment | OTHER | No further treatment |
| TSR-042 | DRUG | Fixed 500 mg TSR-042 dose Q3W for the first 4 doses followed by a fixed 1000 mg TSR-042 dose Q6W for up to 24 months |
Inclusion Criteria: 1. Signed informed consent before any study-specific procedure 2. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 3. Participant must be a female ≥ 18 years of age 4. Life expectancy ≥3 months 5. Participant must have biopsy-confirmed...