Clinical trial NCT05932212: AK104 for Recurrent or Metastatic Vulvar Cancer
Official title: A Multicenter, Open-label, Phase II Study of AK104 in the Treatment of Recurrent or Metastatic Vulvar Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Vulvar Cancer
Keywords: PD-1/CTLA-4
vulvar cancer
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2023-07-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective response rate (ORR) assessed by investigator.
timeFrame: Up to approximately 1 years
Secondary outcomes:
measure: Progression-free survival (PFS) Assessed by investigator
timeFrame: Up to approximately 2 years
measure: Duration of Response (DOR) Assessed by investigator
timeFrame: Up to approximately 2 years
measure: Disease control rate (DCR) Assessed by investigator
timeFrame: Up to approximately 1 years
measure: Time to Response (TTR) Assessed by investigator
timeFrame: Up to approximately 1 years
measure: Overall survival (OS)
timeFrame: Up to approximately 2 years
measure: Adverse Events (AEs)
timeFrame: Up to approximately 2 years
measure: serum concentrations of AK104
timeFrame: Up to approximately 2 years
measure: Antidrug antibodies (ADA) of AK104
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Clinical oncology school of Fujian Medical University, Fujian Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yant-Sen Memorial Hospital
state: Guangdong
city: Shijiangzhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Insitut
state: Liaoning
city: Tianjin
country: China
facility: Tianjin medical university Cancer Institut & Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: