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Cadonilimab Plus Nab -Paclitaxel for Patients With Recurrent, or Metastatic Cervical Cancer Resistant to Immune Checkpoint Inhibitors

NCT05824494 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-05-06

No results posted yet for this study

Summary

This is a phase II trial of combination therapy of cadonilimab(Bispecific Anti-PD-1/CTLA-4 Antibody) plus nab-Paclitaxel in patients with recurrent or metastatic cervical cancer that had failed PD-1/PD-L1 blockade therapy. As a bispecific antibody against PD-1 and CTLA-4, cardonirimab can not only induce the production of a large number of T cells in the early stage of immune response by antagonizing CTLA-4, but also block PD-1 and PD-L1/L2 combination. Thereby restoring the killing function of T cells to tumor cells and reducing the exhaustion of T cells.The hypothesis is the combination of cadonilimab and nab-Paclitaxel will overcome PD-1/PD-L1 blockade-resistance to enhance the response of patients with persistant, recurrent or metastatic cervical cancer.

Conditions

  • Uterine Cervical Neoplasms
  • Cancer of Cervix
  • Cervical Cancer
  • Cervical Neoplasms
  • Uterine Cervical Cancer
  • Cancer of the Uterine Cervix

Interventions

DRUG

Cadonilimab

Cadonilimab 10mg/kg,every 3 weeks,IV infusion

DRUG

Nab paclitaxel

Nab paclitaxel ≤260mg/m2,every 3 weeks,IV infusion

Sponsors & Collaborators

  • Akeso

    collaborator INDUSTRY

  • Women's Hospital School Of Medicine Zhejiang University

    lead OTHER

Principal Investigators

  • hui Wang, PHD · Women's Hospital School Of Medicine Zhejiang University

  • bairong xia, PHD · Anhui Provincial Cancer Hospital

  • Ge Lou, PHD · The Second Affiliated Hospital of Harbin Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2026-06-30
Completion
2026-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05824494 on ClinicalTrials.gov