Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

Official Title

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

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 four different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, 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.

Trial Description

Primary Outcome:

• Overall survival (OS)

• Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 as assessed by the investigator
• Confirmed objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator
• Time-to-response (TTR) as assessed by the investigator
• Duration of response (DOR) as assessed by the investigator
• Incidence of adverse events (AEs)
• Health-related quality of life as assessed by EQ-5D-5L index
• Health-related quality of life as assessed by EQ-5D visual analog scale (VAS)
• Health-related quality of life as assessed by EORTC-QLQ-C30
• Health-related quality of life as assessed by EORTC-QLQ-CX24

View this trial on ClinicalTrials.gov