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

Vulvar Cancer Clinical Trial

Official title:

A Multicenter, Open-label, Phase II Study of AK104 in the Treatment of Recurrent or Metastatic Vulvar Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05932212
• Other study ID #: AK104-218
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 15, 2023
• Est. completion date: February 15, 2025

Study information

• Verified date: June 2023
• Source: Akeso
• Contact: Ting Liu, MD
• Phone: +86(0760)89873999
• Email: clinicaltrials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 15, 2025
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vulvar Cancer
• Vulvar Neoplasms

Intervention

Drug:
• AK104
15mg/kg, Q3W, IV infusion,

Locations

Country	Name	City	State
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Sun Yant-Sen Memorial Hospital	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Liaoning Cancer Hospital & Insitut	Shenyang	Liaoning
China	The Fourth Hospital of Hebei Medical University	Shijiangzhuang	Hebei
China	Tianjin medical university Cancer Institut & Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR) assessed by investigator.	The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1	Up to approximately 1 years
Secondary	Progression-free survival (PFS) Assessed by investigator	The time from the first administration to the first documented progressive disease (PD) or death due to any cause, whichever occurs first	Up to approximately 2 years
Secondary	Duration of Response (DOR) Assessed by investigator	Measured from the date of partial or complete response to therapy until the disease progression per RECIST v1.1 criteria	Up to approximately 2 years
Secondary	Disease control rate (DCR) Assessed by investigator	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	Up to approximately 1 years
Secondary	Time to Response (TTR) Assessed by investigator	The time from the first administration to the date of documented CR or PR	Up to approximately 1 years
Secondary	Overall survival (OS)	The time from the first administration to death due to any cause	Up to approximately 2 years
Secondary	Adverse Events (AEs)	Characterization of incidence, severity and abnormal clinically significant manifestation or laboratory findings.	Up to approximately 2 years
Secondary	serum concentrations of AK104	assessment of PK include serum concentrations of AK104 at different timepoints after study drug administration	Up to approximately 2 years
Secondary	Antidrug antibodies (ADA) of AK104	Proportion of subjects who develop detectable anti-drug antibodies (ADAs)	Up to approximately 2 years