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

Sponsor
Shandong New Time Pharmaceutical Co., LTD
Study ID
NCT06755515
Phase
PHASE2/PHASE3
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rulonilimab — DRUG
    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.
  • Placebo — DRUG
    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.
  • cisplatin/carboplatin + paclitaxel ± bevacizumab — DRUG
    cisplatin/carboplatin + paclitaxel ± bevacizumab

Study Details

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

Key Dates

First listed
Jan 1, 2025
Start date
Sep 26, 2024
Status verified
Dec 2024
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
510 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rulonilimab plus cisplatin/carboplatin + paclitaxel ± bevacizumab
  • Placebo Comparator: Placebo plus cisplatin/carboplatin + paclitaxel ± bevacizumab

Primary Outcome Measure

Objective tumor response rate (ORR) assessed by RECIST1.1 [ Time Frame: up to 2 years ]

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