Comparing 9MW2821 to standard chemotherapy for advanced cervical cancer

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

This study is testing a new treatment called 9MW2821 to see if it works better than standard chemotherapy for women with advanced cervical cancer who haven't had success with previous treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. (Industry-sponsored)
• Drugs / interventions: bevacizumab, chemotherapy, immunotherapy
• Locations: 2 sites (Beijing and 1 other locations)
• Trial ID: NCT06692166 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of a new treatment, 9MW2821, against the physician's choice of chemotherapy in women with recurrent or metastatic cervical cancer who have previously progressed on platinum-based chemotherapy. Participants will be female, aged 18 to 75, with confirmed cervical cancer that is not suitable for curative treatment. The study aims to determine if 9MW2821 can provide better outcomes than existing chemotherapy options. Patients will be monitored for their response to treatment and any associated side effects.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 75 with recurrent or metastatic cervical cancer who have progressed after platinum-based chemotherapy.

Not a fit: Patients with cervical cancer that is amenable to curative resection or chemoradiation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with advanced cervical cancer who have limited treatment choices.

How similar studies have performed: Other studies have shown promise in targeting recurrent cervical cancer, but the specific approach of using 9MW2821 is novel.

Eligibility criteria

Inclusion Criteria:

1. Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
2. Female subjects aged 18 to 75 years (including 18 and 75 years).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histologically confirmed recurrent or metastatic cervical cancer (squamous cell, HPV-associated adenocarcinoma, or adenosquamous), not amenable to resection or chemoradiation with curative intent.
5. 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.
6. An archival tumor tissue sample or a fresh tissue sample should be provided.
7. Life expectancy of ≥ 12 weeks.
8. Subjects must have measurable disease according to RECIST (version 1.1).
9. Adequate to receive one of the chemotherapy regimens in the control group (gemcitabine, pemetrexed, topotecan);
10. Adequate organ functions.
11. Sexually active fertile subjects must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
12. Subjects are willing to follow study procedures.

Exclusion Criteria:

1. Has other histologies not mentioned as part of the inclusion criteria above, i.e. HPV-independent adenocarcinoma or primary neuroendocrine.
2. 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.
3. Preexisting treatment related toxicity Grade ≥ 2. Subjects experienced Grade ≥ 3 immune related adverse events during or after immunotherapy.
4. Subjects had clinically significant hydronephrosis that could not be relieved by nephrostomy or urethral stenting, as determined by the investigator.
5. Major surgery within 28 days prior to first dose of study drug.
6. Hemoglobin A1C (HbA1c) ≥ 8%.
7. Preexisting peripheral neuropathy Grade ≥ 2.
8. Any live vaccines within 28 days before first dose of study drug or during the study.
9. Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
10. Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.
11. Central nervous system metastases.
12. History of another malignancy within 3 years before the first dose of study drug. Subjects with cured malignancies are allowed.
13. History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.
14. Has ocular conditions that may increase the risk of corneal epithelium damage.
15. Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
16. Uncontrolled tumor-related bone pain or spinal cord compression.
17. Pleural effusion, ascites or pericardial effusion with syptoms or needed drainage.
18. Condition or situation which may put the subject at significant risk.

Where this trial is running

Beijing and 1 other locations

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Lingying Wu, Professor

Conditions Cervical Cancer; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases