NCT05932212
Recruiting
Phase 2
A Multicenter, Open-label, Phase II Study of AK104 in the Treatment of Recurrent or Metastatic Vulvar Cancer
ConditionsVulvar Cancer
Overview
- Phase
- Phase 2
- Intervention
- AK104
- Conditions
- Vulvar Cancer
- Sponsor
- Akeso
- Enrollment
- 20
- Locations
- 6
- Primary Endpoint
- Objective response rate (ORR) assessed by investigator.
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \>=18 and \<=
- •ECOG of 0 or
- •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.
- •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.
Arms & Interventions
Cohort A: AK104
AK104 monotherapy
Intervention: AK104
Cohort B: AK104+chemotherapy
AK104 combined with platinum-based chemotherapy (paclitaxel+ cisplatin or carboplatin)
Intervention: AK104+ Paclitaxel+Cisplatin or Carboplatin
Outcomes
Primary Outcomes
Objective response rate (ORR) assessed by investigator.
Time Frame: 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 Outcomes
- serum concentrations of AK104(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
- Adverse Events (AEs)(Up to approximately 2 years)
- Progression-free survival (PFS) Assessed by investigator(Up to approximately 2 years)
- Duration of Response (DOR) Assessed by investigator(Up to approximately 2 years)
- Disease control rate (DCR) Assessed by investigator(Up to approximately 1 years)
- Time to Response (TTR) Assessed by investigator(Up to approximately 1 years)
- Antidrug antibodies (ADA) of AK104(Up to approximately 2 years)
Study Sites (6)
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