RecruitingPhase 2NCT06292689

A Phase II, Single-arm, Multicenter, Prospective Study of Cardunolizumab in Recurrent or Metastatic Vulvar and Vaginal Cancer


Sponsor

Zhejiang Cancer Hospital

Enrollment

40 participants

Start Date

Mar 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy and safety of cardunolizumab in combination with/without chemotherapy ± bevacizumab for recurrent or metastatic vulvar and vaginal cancers that are not amenable to radical treatment.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an immunotherapy drug called cardunolizumab in women with recurrent or metastatic vulvar or vaginal cancer that cannot be cured with standard treatment. This is a phase II study to see how well the drug works and how safe it is. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed recurrent or metastatic squamous cell, adenocarcinoma, or adenosquamous carcinoma of the vulva or vagina - Your cancer is not curable and has at least one measurable tumor on imaging - You are in good general health (ECOG 0–1) with a life expectancy of at least 3 months - You have adequate organ function **You may NOT be eligible if...** - You have had prior immunotherapy that was not tolerated or caused severe immune reactions - You have active autoimmune disease - You are pregnant or breastfeeding - You have significant heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCardunolizumab

1. Not systematically treated: Cardunolizumab (10mg/kg) + Cisplatinum (50mg/m2)/ Carboplatinum (AUC 4-5) + Paclitaxel (175mg/m2) ± Bevacizumab (15mg/kg) for 6 cycles, every 3 weeks (Q3W), and then Cardunolizumab ± Bevacizumab Q3W maintenance treatment. 2. Previous systematic treatment: Cardunolizumab (10mg/kg) + Chemotherapy regimen selected by the investigator ± Bevacizumab (15mg/kg) for 6 cycles, every 3 weeks (Q3W), and then Cardunolizumab ± Bevacizumab Q3W maintenance treatment.


Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT06292689