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AK104 for Recurrent or Metastatic Vulvar Cancer

StatusTerminated
PhasePhase 2
SponsorAkeso
Started2023-08-25
View on ClinicalTrials.gov ↗

Amendment history

2026-09-29
Trial terminated: Sponsor decision
Primary completion confirmed: May 2026 (last estimated December 2025)
2025-03-10
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-08-15→2025-12-15
Completion date2025-02-15→2025-12-15
Start dateestimated 2023-08-15→confirmed 2023-08-25
Study arms1→2
InterventionsAK104 (Drug)→AK104 (Drug), AK104+ Paclitaxel+Cisplatin or Carboplatin (Drug)
Eligibility criteria-2,592 characters
Inclusion Criteria: WomenAge aged>=18 ≥and 18<=80. ECOG of 0 or 12. Life expectancy ≥ 3 months. Histologically confirmed vulvar cancer (squamous cell carcinoma or adenocarcinomaadenosquamous carcinoma), not amenable to curative surgery or radical radiotherapy. SubjectsFor whoCohort A, subjects should have experienced failure on at least one previous systemic [...] antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.). Subjects received systemic treatment with either proprietary Chinese drugs with anti-tumor indications or herbal medicines with anti-tumor effects, or immunomodulatory drugs (thym [...] [...]
Study sites6 entries, revised
Clinical oncology school of Fujian Medical University, Fujian Cancer Hospital
Study title-20 characters
A Phase II Study of AK104 for Recurrent or Metastatic Vulvar Cancer
2023-06-27
Original filing
Akeso
96 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT05932212
Lead Sponsor Akeso
Conditions Vulvar Cancer
Enrollment 20 participants
Start Date 2023-08-25
Primary Completion 2026-05-31 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-28