A Study of AK104（ an Anti-PD-1 and Anti-CTLA-4 Bispecific Antibody) in Recurrent or Metastatic Cervical Cancer

Conditions

• Recurrent or Metastatic Cervical Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• AK104 — BIOLOGICAL
  Subjects will receive AK104 intravenously.
• Bevacizumab — BIOLOGICAL
  Subjects will receive Bevacizumab intravenously.
• Paclitaxel — DRUG
  Subjects will receive Paclitaxel intravenously.
• Cisplatin or Carboplatin — DRUG
  Subjects will receive Cisplatin or Carboplatin intravenously.

Study Details

This is a multicenter, open-label, phase II clinical study conducted in China. All subjects will receive AK104 in combination with standard treatment regimens or AK104 alone. The primary end point is safety. The secondary end point is efficacy.

Key Dates

First listed

May 3, 2021

Start date

Apr 1, 2021

Status verified

Feb 2025

Primary completion

Feb 28, 2024

Completion

Feb 28, 2024

Study Design

Enrollment

50 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: AK104+Paclitaxel+Cisplatin/Carboplatin
  AK104 intravenously(IV) every 3 weeks (Q3W) Paclitaxel 175mg/m2 IV every 3 weeks (Q3W) Cisplatin 50mg/m2 or Carboplatin AUC5 IV every 3 weeks (Q3W)
• Experimental: AK104+Bevacizumab+Paclitaxel+Cisplatin/Carboplatin
  AK104 every 3 weeks (Q3W) Bevacizumab 15mg/kg IV every 3 weeks (Q3W) Paclitaxel 175mg/m2 IV every 3 weeks (Q3W) Cisplatin 50mg/m2 or Carboplatin AUC5 IV every 3 weeks (Q3W)
• Experimental: AK104
  AK104 IV every 2 weeks (Q2W)

Primary Outcome Measure

AE [ Time Frame: From the time of informed consent signed through 90 days after the last dose of AK104 ]