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

Sponsor
Akeso
Study ID
NCT04982237
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • AK104 — BIOLOGICAL
    IV infusion
  • paclitaxel — DRUG
    IV infusion
  • carboplatin — DRUG
    iv infusion
  • cisplatin — DRUG
    iv infusion
  • bevacizumab — DRUG
    iv infusion
  • Placebo — DRUG
    iv infusion

Study Details

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

Key Dates

First listed
Jul 29, 2021
Start date
Aug 27, 2021
Status verified
Nov 2025
Primary completion
Dec 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
445 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AK104+chemotherapy± bevacizumab
    AK104 in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
  • Placebo Comparator: Placebo+chemotherapy± bevacizumab
    Placebo in combination with cisplatin or carboplatin and paclitaxel± bevacizumab

Primary Outcome Measure

progression-free survival (PFS) assessed by blinded independent central review (BICR) per RECIST v1.1 [ Time Frame: Up to approximately 2 years ]

Related Studies