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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04697628 | Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer | PHASE3 | COMPLETED | 502 | — | — | Feb 22, 2021 | Jan 15, 2026 | Feb 24, 2026 | 211 | United States, Argentina +23 |
| NCT03438396 | A Trial of Tisotumab Vedotin in Cervical Cancer | PHASE2 | COMPLETED | 102 | — | — | Jun 12, 2018 | Aug 2, 2022 | Jul 25, 2023 | 53 | United States, Belgium +6 |
Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.
The confirmed OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based upon RECIST v1.1, assessed by the IRC. The CR is disappearance of all target and non-target lesions and no new lesions. A confirmed CR is 2 CRs (CR-CR sequence) that were separated by at least 4 weeks with no evidence of progression in-between. The PR is ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion. A confirmed PR is PR-PR sequence or PR-CR sequence that were separated by at least 4 weeks. The intermediate missing (Not Evaluable \[NE\]) scan evaluations between response scan and confirmation scan were allowed, eg, PR-NE-PR and PR-NE-NE-PR was considered PR confirmed (a repeat scan not earlier than 4 weeks after initial scan documenting response). 95% CI was calculated using the Clopper-Pearson method.
| Arm | Type | Description |
|---|---|---|
| Tisotumab vedotin | EXPERIMENTAL | Tisotumab vedotin monotherapy |
| Chemotherapy | ACTIVE_COMPARATOR | Investigator's choice of one chemotherapy treatment (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed) |
| Single arm | EXPERIMENTAL | tisotumab vedotin (IV), 2.0 mg/kg, every 3 weeks (1Q3W) |
| Name | Type | Description |
|---|---|---|
| tisotumab vedotin | DRUG | 2.0 mg/kg every 3 weeks (Q3W) |
| topotecan | DRUG | 1 or 1.25 mg/m2 intravenous (IV) on Days 1 to 5, every 21 days |
| vinorelbine | DRUG | 30 mg/m2 IV on Days 1 and 8, every 21 days |
| gemcitabine | DRUG | 1000 mg/m2 IV on Days 1 and 8, every 21 days |
| irinotecan | DRUG | 100 or 125 mg/m2 IV weekly for 28 days, every 42 days |
| pemetrexed | DRUG | 500 mg/m2 IV on Day 1, every 21 days |
Inclusion Criteria * Has recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and: * Has experienced disease progression during or after treatment with a standard of care systemic chemotherapy doublet, or platinum-based therapy (if eligible), defin...