clinical trial · NCT06755515
A Phase Ⅱ/Ⅲ Study of Rulonilimab Plus Chemotherapy± Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer
Shandong New Time Pharmaceutical Co., LTD·phase3·enrolling by invitation·n = 510
Cervical CancerRulonilimabPlacebocisplatin/carboplatin + paclitaxel ± bevacizumab
brief summary
This study was an randomized, double-Blind, placebo-controlled, multicenter Phase II/III study.
started
Sep 26, 2024
primary completion
Sep 1, 2028
completion
Sep 1, 2028
last updated
Jan 1, 2025
detailed description
The trial was divided into screening period, treatment period and follow-up period. Participants entered the screening period after signing informed consent and met the inclusion criteria. Subjects who did not meet the exclusion criteria were treated with Rulonilimab/placebo plus chemotherapy ± bevacizumab, intravenously, at target dose every 3 weeks until disease progression or intolerable toxicity or withdrawal for other reasons, for a maximum of 2 years.
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol