At a glance
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A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer
In Brief
A Phase 3 clinical trial evaluating tisotumab vedotin, topotecan, and 4 other interventions for Cervical Cancer. Completed, enrolled 502 participants across 211 sites in 25 countries.
Detailed Summary
This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.
Study Details
Timeline
Interventions
2.0 mg/kg every 3 weeks (Q3W)
1 or 1.25 mg/m2 intravenous (IV) on Days 1 to 5, every 21 days
30 mg/m2 IV on Days 1 and 8, every 21 days
1000 mg/m2 IV on Days 1 and 8, every 21 days
100 or 125 mg/m2 IV weekly for 28 days, every 42 days
500 mg/m2 IV on Day 1, every 21 days