A Randomized, Open-label, Phase 3 Study to Evaluate 9MW2821 vs Treatment of Physician's Choice in Subjects With Recurrent or Metastatic Cervical Cancer Who Progressed on or After Platinum-based Chemotherapy
The purpose of this study is to compare the efficacy and safety of 9MW2821 and chemotherapy in participants with recurrent or metastatic cervical cancer who progressed on or after platinum-based chemotherapy.
• Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
• Female subjects aged 18 to 75 years (including 18 and 75 years).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Histologically confirmed recurrent or metastatic cervical cancer (squamous cell, HPV-associated adenocarcinoma, or adenosquamous), not amenable to resection or chemoradiation with curative intent.
• Subject must have received a platinum-based chemotherapy with or without bevacizumab and received no more than 2 prior systemic therapy in the metastatic/recurrent setting. Subject must have experienced radiographic progression during or after the last treatment regimen.
• An archival tumor tissue sample or a fresh tissue sample should be provided.
• Life expectancy of ≥ 12 weeks.
• Subjects must have measurable disease according to RECIST (version 1.1).
• Adequate to receive one of the chemotherapy regimens in the control group (gemcitabine, pemetrexed, topotecan);
⁃ Adequate organ functions.
⁃ Sexually active fertile subjects must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
⁃ Subjects are willing to follow study procedures.