AK104 for Recurrent or Metastatic Vulvar Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vulvar Cancer
• Intervention / Treatment: Drug: AK104; Drug: AK104+ Paclitaxel+Cisplatin or Carboplatin

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ting Liu, MD; Phone Number: +86(0760)89873999; Email: clinicaltrials@akesobio.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Recruiting
      • Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital
      • Principal Investigator: Yang Sun, MD
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yant-Sen Memorial Hospital
      • Principal Investigator: Tingting Yao, MD
  • Hebei
    • Shijiangzhuang, Hebei, China, 050000
      • Not yet recruiting
      • The Fourth Hospital of Hebei Medical University
      • Principal Investigator: Shuhuai Niu, MD
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Recruiting
      • Liaoning Cancer Hospital & Insitut
      • Principal Investigator: Danbo Wang, MD
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Recruiting
      • Tianjin medical university Cancer Institut & Hospital
      • Principal Investigator: Ke Wang, MD
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Not yet recruiting
      • Zhejiang Cancer Hospital
      • Principal Investigator: Xiaojuan Lv, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: AK104; AK104 monotherapy	Drug: AK104; AK104 15mg/kg intravenously(IV) every 3 weeks (Q3W), until progressive disease, unacceptable toxicity, completion of 2 years treatment or withdrawal of consent.; Other Names: Cadonilimab
Experimental: Cohort B: AK104+chemotherapy; AK104 combined with platinum-based chemotherapy (paclitaxel+ cisplatin or carboplatin)	Drug: AK104+ 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Overall survival (OS)	The time from the first administration to death due to any cause	Up to approximately 2 years
Adverse Events (AEs)	Characterization of incidence, severity and abnormal clinically significant manifestation or laboratory findings.	Up to approximately 2 years
serum concentrations of AK104	assessment of PK include serum concentrations of AK104 at different timepoints after study drug administration	Up to approximately 2 years
Antidrug antibodies (ADA) of AK104	Proportion of subjects who develop detectable anti-drug antibodies (ADAs)	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Akeso

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: vulvar cancer; PD-1/CTLA-4
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Genital Neoplasms, Female; Vulvar Diseases; Vulvar Neoplasms; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel
• Other Study ID Numbers: AK104-218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No