NCT05817214

Cadonilimab Plus Anlotinib for R/M/P Cervical Cancer

Cadonilimab Plus Anlotinib for Recurrent, Metastasis or Persistent Cervical Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Zhongnan Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test a new treatment combination including cadonilimab, anlotinib and granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent, metastasis and persistent cervical cancer. The main questions it aims to answer are: * The efficacy of this combination in R/M/P CC; * The tolerance of this combination in R/M/P CC; * Possible biomarker of treatment response for this combination. Participants will receive cadonilimab of 10mg/kg every three weeks at day 1, take anlotinib (12mg) orally in day 1 to day 14, then take a 7 days break and subcutaneously injection of GM-CSF (200ug) from day 1 to day 14, then also take a 7-days break. This treatment will continue until progression or intolerable toxicity or withdraw of participants and it will last for no longer than 2 years.

Detailed description

The prognosis was poor for recurrent, metastasis and persistent cervical cancer especially for those who had multiple lesions and history of previous radiation therapy. KEYNOTE-826 Study demonstrated survival benefit of adding pembrolizumab into the standard first-line treatment for cervical cancer. Here we designed a exploratory clinical study to test a new treatment combination including cadonilimab and anlotinib in recurrent, metastasis and persistent cervical cancer. All participants will receive cadonilimab of 10mg/kg every three weeks at day 1, take anlotinib (8mg) orally in day 1 to day 14, then take a 7-days break and subcutaneously injection of GM-CSF (200ug) from day 1 to day 14, then also take a 7-days break. This treatment will continue until progression or intolerable toxicity or withdraw of participants and it will last for no longer than 2 years.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Cadonilimab	All Participants will receive cadonilimab of 10mg/kg every three weeks at day 1
DRUG	Anlotinib	All Participants will take anlotinib (12mg) orally in day 1 to day 14, then take a 7 days break.
DRUG	Granulocyte-Macrophage Colony-Stimulating Factor	All Participants will have subcutaneously injection of granulocyte-macrophage colony-stimulating factor from day 1 to day 14, then take a 7 days break.

Timeline

• Start date: 2023-02-16
• Primary completion: 2025-11-30
• Completion: 2027-02-28
• First posted: 2023-04-18
• Last updated: 2024-04-19

Locations

1 site across 1 country: China