Compares 9MW2821 with chemotherapy in advanced cervical cancer
Tests 9MW2821 against chemotherapy in adults with returning or spreading cervical cancer.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate 9MW2821 Versus Treatment of Physician's Choice for Subjects With Recurrent or Metastatic Cervical Cancer
Key facts
- Where
- Beijing and Shanghai, ChinaSee the 2 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with cervical cancer that has come back or spread and got worse during or after platinum-based chemotherapy. It compares 9MW2821 with chemotherapy.
- Age
- 18 to 75 years
- Sex
- Women only
- Disease stage
- Recurrent or metastatic cervical cancer (squamous cell, HPV-associated adenocarcinoma, or adenosquamous) that cannot be removed by surgery or treated with chemoradiation meant to remove all of the disease. The cancer must be measurable on scans (RECIST version 1.1). ECOG performance status of 0 or 1.
- Earlier treatment
- Must have had platinum-based chemotherapy, with or without bevacizumab, and no more than 2 earlier systemic therapies for recurrent or metastatic disease. The cancer must have progressed on scans during or after the last treatment. Must be able to receive one of the chemotherapy options in the control group (gemcitabine, pemetrexed, topotecan).
- Biomarker or test result
- An archival or fresh tumor tissue sample must be provided.
Main reasons for not taking part
- HPV-independent adenocarcinoma or primary neuroendocrine tumor
- Earlier treatment with a nectin-4 targeted ADC or an ADC with an MMAE payload
- Cancer spread to the central nervous system
- Another cancer within the last 3 years (cancers that were removed completely are allowed)
- Preexisting peripheral neuropathy Grade ≥ 2 or treatment-related toxicity Grade ≥ 2
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06692166, who can take part
Where in China
- Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaTaking people
- Fudan University Shanghai Cancer CenterShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Trial code
- NCT06692166
- Record updated
- 22 November 2024
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, traditional Chinese medicine with anticancer indication within 14 days prior to the first dose of study drug, use of any investigational drug or device within 28 days prior to the first dose of study drug, received treatment of nectin-4 targeted ADC, received treatment of ADC with MMAE payload, received any strong CYP3A4 inhibitors within 14 days prior to the first dose of study drug; Preexisting treatment related toxicity Grade ≥ 2. Subjects experienced Grade ≥ 3 immune related adverse events during or after immunotherapy; Major surgery within 28 days prior to first dose of study drug; Any live vaccines within 28 days before first dose of study drug or during the study; Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug; Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness; Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection; History of another malignancy within 3 years before the first dose of study drug. Subjects with cured malignancies are allowed; History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug; Has ocular conditions that may increase the risk of corneal epithelium damage; Condition or situation which may put the subject at significant risk; Hemoglobin A1C (HbA1c) ≥ 8%; Has other histologies not mentioned as part of the inclusion criteria above, i.e. HPV-independent adenocarcinoma or primary neuroendocrine; Subjects had clinically significant hydronephrosis that could not be relieved by nephrostomy or urethral stenting, as determined by the investigator; Preexisting peripheral neuropathy Grade ≥ 2; Central nervous system metastases; Uncontrolled tumor-related bone pain or spinal cord compression; Pleural effusion, ascites or pericardial effusion with syptoms or needed drainage.