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.
Has other histologies not mentioned as part of the inclusion criteria above, i.e. HPV-independent adenocarcinoma or primary neuroendocrine.
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.
Subjects had clinically significant hydronephrosis that could not be relieved by nephrostomy or urethral stenting, as determined by the investigator.
Parallel
9MW2821
Drug1.25mg/kg of 9MW2821 by intravenous infusion on days 1, 8 and 15 of every 28-day cycle
Chemotherapy
Drug1.0 or 1.25 mg/m \^2 topotecan by intravenous infusion on days 1 to 5 or 1000 mg/m \^2 gemcitabine by intravenous infusion on days 1 and 8 or 500 mg/m \^2 pemetrexed by intravenous infusion on day 1 of every 21 days
Overall Survival
Time from the date of randomization until the date of death from any cause.
Objective Response Rate per investigator
The percentage of subjects who experience a best response of either CR or PR.
Disease Control Rate per investigator
The percentage of subjects who experience a best response of CR, PR or stable disease (SD).
Progression Free Survival per investigator
Time from the date of first randomization to the earliest date of documented disease progression per radiological evidence or death from any cause.
Duration of Response per investigator
Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause.
Mean change from baseline in the European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality-of-life questionnaire (QLQ-C30）
The EORTC QLQ-C30 is a 30-question instrument designed to assess overall QoL in cancer patients with 15 domains: 1 GHS/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptomatic scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items were scored from 1 ("not at all") to 4 ("very much"), with the exception of items contributing to the GHS/QoL, which were scored from 1 ("very poor") to 7 ("excellent"). Raw scores were linearly transformed so that all transformed scores ranged from 0 to 100. For the overall health status/quality of life scale and the 5 functioning scales, high scores indicated better overall health status/functioning, and negative change from baseline indicated less improvement. For the symptom scales, a high score indicates a high level of symptomatology, while a negative change from baseline indicates improvement in symptoms.
EORTC Quality of Life Questionnaire Cervical Cancer Module (QLQ-CX24) Total Scores
The EORTC QLQ-CX24 questionnaire is intended for patients with cervical cancer with different disease stages and treatment modalities. The EORTC-QLQ-CX24 questionnaire consists of 24 questions with answers ranging from 1 (not at all) to 4 (very much). Four functional scales and five symptom scales will be calculated using the EORTC QLQ-CX24 Scoring Manual. The 9 scores calculated from the EORTC-QLQ-CX24 questionnaire will be summarized in descriptive statistics by treatment arm. A high score indicates a high level of symptomatology, while a negative change from baseline indicates improvement in symptoms.
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