A Phase II Study of AK104 for Recurrent or Metastatic Vulvar Cancer

Trial Title: A Phase II Study of AK104 for Recurrent or Metastatic Vulvar Cancer

NCT ID: NCT05932212

Condition: Vulvar Cancer

Conditions: Official terms:
Vulvar Neoplasms

Conditions: Keywords:
PD-1/CTLA-4
vulvar cancer

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: AK104
Description: 15mg/kg, Q3W, IV infusion,
Arm group label: AK104

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, in subjects with recurrent or metastatic vulvar cancer not amenable to curative surgery or radiotherapy.

Criteria for eligibility:
Criteria:
Inclusion Criteria: Women aged ≥ 18. ECOG of 0 or 1. Life expectancy ≥ 3 months. Histologically confirmed vulvar cancer (squamous cell carcinoma or adenocarcinoma), not amenable to curative surgery or radical radiotherapy. Subjects who 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.). Subjects received systemic treatment with either proprietary Chinese drugs with anti-tumor indications or herbal medicines with anti-tumor effects, or immunomodulatory drugs (thymopeptide, interferon, interleukin) within 2 weeks prior to the first administration. Presence of nervous system (CNS) metastases or carcinomatous meningitis; Subjects with uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage. Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as judged by the Investigator. Patients with other active malignancies within 3 years prior to the first administration. Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or the follow-up period of an interventional study. Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to the first administration; or elective major surgical treatment required during the study. Active or potentially recurrent autoimmune disease. Subjects who require systemic treatment with glucocorticoid (> 10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to fist dose; Live or attenuated vaccination within 30 days prior to the first administration. Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. Known history of interstitial lung disease. Serious infections requiring hospitalization within 4 weeks prior to the first administration. Presence of active infection requiring systemic therapy. Subjects with active hepatitis B or active viral hepatitis C. Active or documented inflammatory bowel diseases or active diverticulitis. Presence of Intestinal obstruction. Any of the following cardiovascular events: -myocardial infarction, unstable angina pectoris, pulmonary embolism, aortic dissection, deep vein thrombosis or any arterial thromboembolisation events occured within 6 months prior to the first administration; -Heart function grade (New York Heart Association) ≥II; -Severe arrhythmias requiring long-term drug intervention; -Cerebrovascular event (CVA) occured within 6 months prior to the first administration; Left ventricular ejection fraction (LEVF) < 50%; -Previous history of myocarditis or cardiomyopathy; -Hypertension uncontrolled or history of hypertensive crisis. Subjects with known history of severe hypersensitivity reactions to other monoclonal antibodies. Pregnant or lactating women.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Fujian Cancer Hospital

Address:
City: Fuzhou
Zip: 350000
Country: China

Investigator:
Last name: Xiaojuan Lv, MD
Email: Principal Investigator

Facility:
Name: Sun Yant-Sen Memorial Hospital

Address:
City: Guangzhou
Zip: 510000
Country: China

Investigator:
Last name: Tingting Yao, MD
Email: Principal Investigator

Facility:
Name: The Fourth Hospital of Hebei Medical University

Address:
City: Shijiangzhuang
Zip: 050000
Country: China

Investigator:
Last name: Shuhuai Niu, MD
Email: Principal Investigator

Facility:
Name: Liaoning Cancer Hospital & Insitut

Address:
City: Shenyang
Zip: 110042
Country: China

Investigator:
Last name: Danbo Wang, MD
Email: Principal Investigator

Facility:
Name: Tianjin medical university Cancer Institut & Hospital

Address:
City: Tianjin
Zip: 300000
Country: China

Investigator:
Last name: Ke Wang, MD
Email: Principal Investigator

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Hangzhou
Zip: 310022
Country: China

Investigator:
Last name: Xiaojuan Lv, MD
Email: Principal Investigator

Start date: August 15, 2023

Completion date: February 15, 2025

Lead sponsor:
Agency: Akeso
Agency class: Industry

Source: Akeso

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05932212