Vulvar Cancer
Conditions
Keywords
PD-1/CTLA-4, vulvar cancer
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.
Interventions
DRUGAK104
AK104 15mg/kg intravenously(IV) every 3 weeks (Q3W), until progressive disease, unacceptable toxicity, completion of 2 years treatment or withdrawal of consent.
DRUGAK104+ 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.
Sponsors
Akeso
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Adverse Events (AEs) | Up to approximately 2 years | Characterization of incidence, severity and abnormal clinically significant manifestation or laboratory findings. |
| serum concentrations of AK104 | Up to approximately 2 years | assessment of PK include serum concentrations of AK104 at different timepoints after study drug administration |
| Antidrug antibodies (ADA) of AK104 | Up to approximately 2 years | Proportion of subjects who develop detectable anti-drug antibodies (ADAs) |
| Overall survival (OS) | Up to approximately 2 years | The time from the first administration to death due to any cause |
Countries
China
Contacts
Primary ContactTing Liu, MD
Outcome results
None listed