Clinical trial NCT06692166: A Study to Evaluate 9MW2821 Versus Treatment of Physician's Choice for Subjects With Recurrent or Metastatic Cervical Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cervical Cancer
Keywords: Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Cervical Neoplasms
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-18
Enrollment: 420
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Overall Survival
timeFrame: Up to 3 years
Secondary outcomes:
measure: Objective Response Rate per investigator
timeFrame: Up to 3 years
measure: Disease Control Rate per investigator
timeFrame: Up to 3 years
measure: Progression Free Survival per investigator
timeFrame: Up to 3 years
measure: Duration of Response per investigator
timeFrame: Up to 3 years
measure: Time to response per investigator
timeFrame: Up to 3 years
measure: Incidence of adverse events
timeFrame: Up to 3 years
measure: Incidence of Anti-Drug Antibody (ADA)
timeFrame: Up to 3 years
Other outcomes:
measure: Mean change from baseline in the European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality-of-life questionnaire (QLQ-C30）
timeFrame: Up to 3 years
measure: EORTC Quality of Life Questionnaire Cervical Cancer Module (QLQ-CX24) Total Scores
timeFrame: Up to 3 years
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References: