AK104 for Recurrent or Metastatic Vulvar Cancer
- Conditions
- Vulvar Cancer
- Interventions
- Drug: AK104+ Paclitaxel+Cisplatin or Carboplatin
- Registration Number
- NCT05932212
- Lead Sponsor
- Akeso
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 20
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A: AK104 AK104 AK104 monotherapy Cohort B: AK104+chemotherapy AK104+ Paclitaxel+Cisplatin or Carboplatin AK104 combined with platinum-based chemotherapy (paclitaxel+ cisplatin or carboplatin)
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) assessed by investigator. Up to approximately 1 years The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1
- Secondary Outcome Measures
Name Time Method serum concentrations of AK104 Up to approximately 2 years assessment of PK include serum concentrations of AK104 at different timepoints after study drug administration
Overall survival (OS) Up to approximately 2 years The time from the first administration to death due to any cause
Adverse Events (AEs) Up to approximately 2 years Characterization of incidence, severity and abnormal clinically significant manifestation or laboratory findings.
Progression-free survival (PFS) Assessed by investigator Up to approximately 2 years The time from the first administration to the first documented progressive disease (PD) or death due to any cause, whichever occurs first
Duration of Response (DOR) Assessed by investigator Up to approximately 2 years Measured from the date of partial or complete response to therapy until the disease progression per RECIST v1.1 criteria
Disease control rate (DCR) Assessed by investigator Up to approximately 1 years The proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥6 weeks) based on RECIST
Time to Response (TTR) Assessed by investigator Up to approximately 1 years The time from the first administration to the date of documented CR or PR
Antidrug antibodies (ADA) of AK104 Up to approximately 2 years Proportion of subjects who develop detectable anti-drug antibodies (ADAs)
Trial Locations
- Locations (6)
Clinical oncology school of Fujian Medical University, Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Sun Yant-Sen Memorial Hospital
🇨🇳Guangzhou, Guangdong, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiangzhuang, Hebei, China
Liaoning Cancer Hospital & Insitut
🇨🇳Shenyang, Liaoning, China
Tianjin medical university Cancer Institut & Hospital
🇨🇳Tianjin, Tianjin, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China