RecruitingPhase 2NCT05932212

AK104 for Recurrent or Metastatic Vulvar Cancer

A Multicenter, Open-label, Phase II Study of AK104 in the Treatment of Recurrent or Metastatic Vulvar Cancer

Sponsor

Akeso

Enrollment

20 participants

Start Date

Aug 25, 2023

Study Type

INTERVENTIONAL

Conditions

Vulvar Cancer

Summary

This is a multicenter, open-label, phase II clinical study, aiming to the evaluate the efficacy and safety of AK104 (an anti- PD-1 and CTLA-4 bispecific antibody), alone or combined with chemotherapy, in subjects with recurrent or metastatic vulvar cancer not amenable to curative surgery or radiotherapy.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination immunotherapy drug called AK104 in women with vulvar cancer (cancer of the outer female genitals) that has come back or spread and cannot be cured with surgery or radiation. **You may be eligible if...** - You are a woman aged 18–80 - You have been diagnosed with vulvar squamous cell carcinoma or adenosquamous carcinoma - Your cancer cannot be cured with surgery or radiation - Your previous cancer treatment has stopped working or you could not tolerate it - You have at least one measurable tumor - You are in reasonable health and your organs are functioning adequately **You may NOT be eligible if...** - Your vulvar cancer is a different type, such as melanoma or sarcoma - You have had recent systemic cancer treatment without adequate recovery time - You are pregnant or breastfeeding - You have severe, uncontrolled other illnesses 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

DRUGAK104

AK104 15mg/kg intravenously(IV) every 3 weeks (Q3W), until progressive disease, unacceptable toxicity, completion of 2 years treatment or withdrawal of consent.

DRUGAK104+ Paclitaxel+Cisplatin or Carboplatin

AK104 (10 mg/kg) + paclitaxel (175 mg/m2)+ cisplatin (50 mg/m2) or carboplatin (AUC 4-5) , IV, Q3W, for up to 6 cycles, followed by maintenance therapy of AK104 10 mg/kg Q3W until disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years treatment.