A Phase Ⅱ/Ⅲ Randomized, Double-Blind, Placebo-Controlled Trial of Rulonilimab Plus Chemotherapy± Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer

NCT06755515 Phase 2/Phase 3 ENROLLING_BY_INVITATION

This study was an randomized, double-Blind, placebo-controlled, multicenter Phase II/III study.

Details

Lead sponsor	Shandong New Time Pharmaceutical Co., LTD
Phase	Phase 2/Phase 3
Status	ENROLLING_BY_INVITATION
Enrolment	510
Start date	2024-09-26
Completion	2028-09

Conditions

• Cervical Cancer

Interventions

• Rulonilimab
• Placebo
• cisplatin/carboplatin + paclitaxel ± bevacizumab

Primary outcomes

• Objective tumor response rate (ORR) assessed by RECIST1.1 — up to 2 years
  Defined as the proportion of subjects who achieves a best overall response of CR or PR based on RECIST1.1
• Progression Free Survival (PFS) assessed by RECIST1.1 — up to 2 years
  Defined as the time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.
• Overall Survival (OS) — up to 2 years
  Defined as the time from the date of randomization to the date of death due to any Defined as the time from the date of randomization to the date of death due to any reason

Countries

China