A Phase Ⅱ/Ⅲ Study of Rulonilimab Plus Chemotherapy± Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer

PHASE2/PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

510

Participants

Timeline

Start Date

September 26, 2024

Primary Completion Date

September 30, 2028

Study Completion Date

September 30, 2028

Conditions
Cervical Cancer
Interventions
DRUG

Rulonilimab

"Drug: Rulonilimab Description: iv, 200mg every 3 weeks, for up to 2 years until disease progression, intolerable toxic reactions, or termination of treatment for other reasons.~Drug: Bevacizumab Description: iv, 15mg/kg every 3 weeks, for up to 2 years until disease progression, intolerable toxic reactions, or termination of treatment for other reasons.~Drug: Cisplatin Description: iv, 50mg/m\^2 every 3 weeks, for up to 6 cycles. Drug: Carboplatin Description: iv, AUC 4\~6 every 3 weeks, for up to 6 cycles. Drug: Paclitaxel Description: iv, 175mg/m\^2 every 3 weeks, for up to 6 cycles."

DRUG

Placebo

"Drug: placebo Description: iv, every 3 weeks, for up to 2 years until disease progression, intolerable toxic reactions, or termination of treatment for other reasons.~Drug: Bevacizumab Description: iv, 15mg/kg every 3 weeks, for up to 2 years until disease progression, intolerable toxic reactions, or termination of treatment for other reasons.~Drug: Cisplatin Description: iv, 50mg/m\^2 every 3 weeks, for up to 6 cycles. Drug: Carboplatin Description: iv, AUC 4\~6 every 3 weeks, for up to 6 cycles. Drug: Paclitaxel Description: iv, 175mg/m\^2 every 3 weeks, for up to 6 cycles."

DRUG

cisplatin/carboplatin + paclitaxel ± bevacizumab

cisplatin/carboplatin + paclitaxel ± bevacizumab

Trial Locations (1)

Unknown

Shandong New Time Pharmaceutical Co., LTD, Linyi

All Listed Sponsors
lead

Shandong New Time Pharmaceutical Co., LTD

INDUSTRY