AK104 for Recurrent or Metastatic Vulvar Cancer
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups
Trial contacts and locations
Loading...
Central trial contact
Ting Liu, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal