[Translation] A randomized, open-label, phase III trial comparing tisotumab vedotin with investigator's choice of chemotherapy in patients with second- or third-line recurrent or metastatic cervical cancer
主要目的:在 2L-3L 宫颈癌参与者中证明 Tisotumab vedotin 相较于化疗的临床疗效改善
次要目的:1.在 2L-3L 宫颈癌参与者中评估 Tisotumab vedotin 相较于化疗的临床疗效改善
2.在 2L-3L 宫颈癌参与者中证明 Tisotumab vedotin 相较于化疗的抗肿瘤活性改善
3.在 2L-3L 宫颈癌参与者中表征 Tisotumab vedotin 和化疗的抗肿瘤应答
4.评估 Tisotumab vedotin 的安全性和耐受性
5.评估健康相关生活质量 (HRQOL)
6.评估 Tisotumab vedotin 的药代动力学 (PK) 和免疫原性
[Translation] Primary objective: To demonstrate improved clinical efficacy of Tisotumab vedotin compared to chemotherapy in participants with 2L-3L cervical cancer
Secondary objectives: 1. To evaluate the improved clinical efficacy of Tisotumab vedotin compared to chemotherapy in participants with 2L-3L cervical cancer
2. To demonstrate improved antitumor activity of Tisotumab vedotin compared to chemotherapy in participants with 2L-3L cervical cancer
3. To characterize the antitumor response of Tisotumab vedotin and chemotherapy in participants with 2L-3L cervical cancer
4. To evaluate the safety and tolerability of Tisotumab vedotin
5. To evaluate health-related quality of life (HRQOL)
6. To evaluate the pharmacokinetics (PK) and immunogenicity of Tisotumab vedotin