Cadonilimab Plus Nab-Paclitaxel for Recurrent or Metastatic Muscle Invasive Bladder Cancer

NCT06009848 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-08-24

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of Cadonilimab(AK104) combined with Nab -Paclitaxel as first line therapy for recurrent or metastatic muscle invasive bladder. Eligible participants will receive AK104 (up to 24 months) plus Nab-Paclitaxel (for 6 cycles) until radiologic disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurred first. The primary endpoint is objective response rate.

Conditions

Interventions

DRUG

Cadonilimab

Cadonilimab (10 mg/kg, administered on the first day of each cycle, Q3W, until there is no clinical benefit)+Nab-Paclitaxel(200 mg/m2, Q3W ,6 cycles), every 3 weeks (21 days) is a treatment cycle.

Sponsors & Collaborators

  • Tianjin Medical University Second Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT06009848 on ClinicalTrials.gov