Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
- Trial number:
- NCT04697628
- Trial phase:
- 3
- Study type:
- Targeted therapy
- Overall status:
- Recruiting
Study start date
Scientific title
Summary
* 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:
* paclitaxel + cisplatin + bevacizumab + anti-PD-(L)1 agent, or * paclitaxel + carboplatin + bevacizumab + anti-PD-(L)1 agent, or * paclitaxel + topotecan/nogitecan + bevacizumab + anti-PD-(L)1 agent * 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.