NCT04697628

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 502 (actual)
• Sponsor: Seagen, a wholly owned subsidiary of Pfizer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	tisotumab vedotin	2.0 mg/kg every 3 weeks (Q3W)
DRUG	topotecan	1 or 1.25 mg/m2 intravenous (IV) on Days 1 to 5, every 21 days
DRUG	vinorelbine	30 mg/m2 IV on Days 1 and 8, every 21 days
DRUG	gemcitabine	1000 mg/m2 IV on Days 1 and 8, every 21 days
DRUG	irinotecan	100 or 125 mg/m2 IV weekly for 28 days, every 42 days
DRUG	pemetrexed	500 mg/m2 IV on Day 1, every 21 days

Timeline

• Start date: 2021-02-22
• Primary completion: 2023-07-24
• Completion: 2026-01-15
• First posted: 2021-01-06
• Last updated: 2026-02-24
• Results posted: 2024-08-09

Locations

211 sites across 25 countries: United States, Argentina, Austria, Belgium, Brazil, Canada, China, Czechia, Finland, France, Germany, Hungary, Italy, Japan, Mexico, Netherlands, Norway, Peru, Poland, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study