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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Active enrolling
United States, Argentina, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Peru, Poland, Singapore, Spain, Sweden, Taiwan, United Kingdom
EXPERIMENTAL: Tisotumab vedotin
Tisotumab vedotin monotherapy
DRUG: tisotumab vedotin
2.0 mg/kg every 3 weeks (Q3W)
ACTIVE_COMPARATOR: Chemotherapy
Investigator's choice of one chemotherapy treatment (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)
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
Inclusion Criteria
Exclusion Criteria
Overall survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Up to approximately 2 years
Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator
PFS per investigator is defined as the time from the date of randomization to the first documentation of disease progression per RECIST v.1.1 by the investigator, or to date of death due to any cause, whichever occurs earlier.
Up to approximately 1 year
Confirmed objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator
Confirmed objective response rate is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.
Up to approximately 6 months
Time-to-response (TTR) as assessed by the investigator
TTR is defined as the time from the date of randomization to the date of first confirmed objective response (CR or PR that is subsequently confirmed). Only participants with confirmed CR or PR will be included in the analysis.
Up to approximately 6 months
Duration of response (DOR) as assessed by the investigator
DOR is defined as the time from the date of first confirmed objective response (CR or PR that is subsequently confirmed) to the date of first documented PD per RECIST v1.1 or death from any cause, whichever occurs first. Only participants with confirmed CR or PR will be included in the analysis.
Up to approximately 1 year
Incidence of adverse events (AEs)
Analyses of AEs will be summarized descriptively
Up to approximately 2 years
Health-related quality of life as assessed by EQ-5D-5L index
EQ-5D-5L is a standardized instrument developed by the EuroQol Group as a measure of HRQOL that can be used in a wide range of health conditions and treatments. The EQ-5D-5L consists of a descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Up to approximately 2 years
Health-related quality of life as assessed by EQ-5D visual analog scale (VAS)
EQ-5D-5L is a standardized instrument developed by the EuroQol Group as a measure of HRQOL that can be used in a wide range of health conditions and treatments. The EQ-5D-5L consists of a descriptive system and the EQ VAS. The EQ VAS records the participant's self-rated health on a vertical VAS. This can be used as a quantitative measure of health outcome that reflects the participant's own judgment.
Up to approximately 2 years
Health-related quality of life as assessed by EORTC-QLQ-C30
The QLQ-C30 is a validated questionnaire developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess the quality of life of participants with cancer in multicultural clinical research settings.
Up to approximately 6 months
Health-related quality of life as assessed by EORTC-QLQ-CX24
The EORTC-QLQ-CX24 is a validated questionnaire developed by the EORTC to assess the quality of life in patients who are treated for cervical cancer both in clinical studies and in clinical practice.
Up to approximately 6 months
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Sponsor: Seagen Inc.
Collaborator: Genmab
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: