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
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
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.
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), defined as either:
Note: In cases where bevacizumab and/or anti-PD-(L)1 agent is not a standard of care therapy or the participant was ineligible for such treatment according to local standards, prior treatment with bevacizumab and/or anti-PD-(L)1 agent is not required.
Has received 1 or 2 prior systemic therapy regimens for recurrent and/or metastatic cervical cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as a systemic therapy regimen. Single agent therapy with an anti-PD(L)1 agent for r/mCC cancer should be counted.
Measurable disease according to RECIST v1.1 as assessed by the investigator.
Has ECOG performance status of 0 or 1 prior to randomization.
Has life expectancy of at least 3 months.
Exclusion Criteria
There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
Louisville, Kentucky 40207, United States
Shreveport, Louisiana 71103, United States
Shreveport, Louisiana 71103, United States
Shreveport, Louisiana 71118, United States
Jackson, Mississippi 39216, United States
St Louis, Missouri 63108, United States
St Louis, Missouri 63110, United States
Cleveland, Ohio 44111, United States
Richmond, Virginia 23298, United States
Ljui, Rio Grande do Sul 98700-000, Brazil
Porto Alegre, Rio Grande do Sul 90610-000, Brazil
Porto Alegre, Rio Grande do Sul 90850-170, Brazil
Curitiba/PR, 81520-060, Brazil
Rio de Janeiro, 20220- 410, Brazil
São Paulo, 01509-010, Brazil
Wuhan, Hubei 430023, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Jinan, Shandong 250117, China
Ürümqi, Xinjiang Uygur Autonomous Region, China
Beijng, 100006, China
Prague, 12000, Czechia
Praha 8-Liben, 18081, Czechia
Besançon, 25030, France
Hamburg, North Rhine-Westphalia 20246, Germany
Kashiwa-shi, Chiba 277-8567, Japan
Ota-Shi, Gunma 373-8550, Japan
Shiwa-gun, Iwate 028-3695, Japan
Nakagami-gun, Okinawa 903-0215, Japan
Osaka, Osaka 541-8567, Japan
Nagaizumi-cho, Shizuoka 411-8777, Japan
Chuo-ku, Tokyo 104-0045, Japan
Minato-ku, Tokyo 105-8471, Japan
Shinjuku-ku, Tokyo 160-8582, Japan
Cheonan-si, Chungcheongnam-do 31151, South Korea
Cheonan-si, Chungcheongnam-do 31151, South Korea
Changwon-si, Gyeongsangnam-do 51353, South Korea
Taoyuan City Singapore, 333423, Taiwan
Cambridge, England CB2 0QQ, United Kingdom