A Study of AK104 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer

Summary

This is A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer

Timeline

Start

2021-08-27

Primary completion

2025-12-30

Completion

2025-12-30

Outcome

Met primary endpoint

release “一线治疗持续、复发或转移性宫颈癌的Ⅲ期临床研究达到由独立中心影像评估（BICR） 基于 RECIST v1.1 评估的无进展生存期（PFS）的主要研究终点” akesobio.com ↗

release “用于一线治疗持续、复发或转移性宫颈癌的III期临床研究（AK104-303）在期中分析中达到总生存期（OS）主要研究终点” akesobio.com ↗

Publications

• Wu X, Sun Y, Yang H, Wang J, Lou H, Li D, Wang K, Zhang H, Wu T, Li Y, Wang C, Li G, Wang Y, Li D, Tang Y, Pan M, Cai H, Wang W, Yang B, Qian H, Tian Q, Yao D, Cheng Y, Wei B, Li X, Wang T, Hao M, Wang X, Wang T, Ran J, Zhu H, Zhu L, Liu X, Li Y, Chen L, Li Q, Yan X, Wang F, Cai H, Zhang Y, Liang Z, Liu F, Huang Y, Xia B, Qu P, Zhu G, Chen Y, Song K, Sun M, Chen Z, Zhou Q, Hu L, Abulizi G, Guo H, Liao S, Ye Y, Yan P, Tang Q, Sun G, Liu T, Lu D, Hu M, Wang ZM, Li B, Xia M. Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China. Lancet. 2024 Oct 26;404(10463):1668-1676. doi: 10.1016/S0140-6736(24)02135-4. Epub 2024 Oct 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cadonilimab	Monoclonal antibody	—	Intravenous
Background	Bevacizumab	Monoclonal antibody	—	Intravenous
Background	Carboplatin	Small molecule	—	Intravenous
Background	Cisplatin	Other / unclassified	—	Intravenous
Background	Paclitaxel	Small molecule	—	Intravenous

Indications