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New treatment option for Vulvar Cancer
Official title AK104 for Recurrent or Metastatic Vulvar Cancer
ClinicalTrials.gov ID: NCT05932212
What this study is testing
What is AK104?
AK104 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for vulvar cancer.
Also referred to as Cadonilimab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, women only
You may be able to join if
- Age \>=18 and \<=80. ECOG of 0 or 2. Life expectancy ≥ 3 months. Histologically confirmed vulvar cancer (squamous cell carcinoma or adenosquamous...
- For Cohort A, people should have experienced failure on at least one previous systemic therapy, or intolerance to standard therapy.
- At least one measurable tumor lesion per RECIST v1.1. Adequate organ function as assessed in the laboratory tests. Female people of childbearing...
You likely can't join if
- people with other histopathological types of vulvar cancer, such as melanoma, sarcoma, etc.
- Systemic or curative (surgery or radiotherapy) anti-tumor therapy within 4 weeks prior to the first administration.
- Previous treatment with immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.).
- Active or potentially recurrent autoimmune disease.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Shijiangzhuang, Hebei, China
- Shenyang, Liaoning, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Shijiangzhuang, Hebei, China; Shenyang, Liaoning, China; Tianjin, Tianjin Municipality, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.