Clinical trial · Interventional
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
NCT05932212CI-TRIAL-00087091terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK104 | Drug | — | UNRESOLVED |
| AK104+ Paclitaxel+Cisplatin or Carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort A: AK104
- description
- AK104 monotherapy
- interventionNames
- Drug: AK104
- type
- EXPERIMENTAL
- label
- Cohort B: AK104+chemotherapy
- description
- AK104 combined with platinum-based chemotherapy (paclitaxel+ cisplatin or carboplatin)
- interventionNames
- Drug: AK104+ Paclitaxel+Cisplatin or Carboplatin
Primary outcomes (1)
- measure
- Objective response rate (ORR) assessed by investigator.
- timeFrame
- Up to approximately 1 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Age \>=18 and \<=80. ECOG of 0 or 2. Life expectancy ≥ 3 months. Histologically confirmed vulvar cancer (squamous cell carcinoma or adenosquamous carcinoma), not amenable to curative surgery or radical radiotherapy. For Cohort A, subjects 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 subjects of childbearing potential must have a negative serum pregnancy test prior to the the first administration and agree to use effective methods of contraception Exclusion Criteria: Subjects 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.
References
Publications (0)
Data not yet available
No reference posted for this study.