AK104 for Recurrent or Metastatic Vulvar Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AK104, AK104+ Paclitaxel+Cisplatin or Carboplatin.
- Who it may be relevant to
- Registry conditions: Vulvar Cancer. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open-label, Phase II Study of AK104 in the Treatment of Recurrent or Metastatic Vulvar Cancer
Overview
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.
Interventions
- Drug AK104
AK104 15mg/kg intravenously(IV) every 3 weeks (Q3W), until progressive disease, unacceptable toxicity, completion of 2 years treatment or withdrawal of consent. - Drug AK104+ 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.
Primary outcome measures
- Objective response rate (ORR) assessed by investigator. [Time frame: Up to approximately 1 years]
Secondary outcome measures (8)
- Progression-free survival (PFS) Assessed by investigator [Time frame: Up to approximately 2 years]
- Duration of Response (DOR) Assessed by investigator [Time frame: Up to approximately 2 years]
- Disease control rate (DCR) Assessed by investigator [Time frame: Up to approximately 1 years]
- Time to Response (TTR) Assessed by investigator [Time frame: Up to approximately 1 years]
- Overall survival (OS) [Time frame: Up to approximately 2 years]
- Adverse Events (AEs) [Time frame: Up to approximately 2 years]
- serum concentrations of AK104 [Time frame: Up to approximately 2 years]
- Antidrug antibodies (ADA) of AK104 [Time frame: Up to approximately 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 6 centers
- Clinical oncology school of Fujian Medical University, Fujian Cancer Hospital — Fuzhou
- Sun Yant-Sen Memorial Hospital — Guangzhou
- The Fourth Hospital of Hebei Medical University — Shijiangzhuang
- Liaoning Cancer Hospital & Insitut — Shenyang
- Tianjin medical university Cancer Institut & Hospital — Tianjin
- Zhejiang Cancer Hospital — Hangzhou
Identifiers
NCT: NCT05932212 · AK104-218