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

February, 2021

Scientific 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 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.

* 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.

Study design

Primary purpose: TREATMENT, Allocation: RANDOMIZED, Intervention model: PARALLEL, Masking: NONE,

Conditions

Cervical Cancer

Other study ID numbers

C5721002; 2023-503813-31-01; SGNTV-003

Choose trial site (505)