AK104 for Recurrent or Metastatic Vulvar Cancer

NCT05932212 · tracked via the Priya Life Science China tracker

Sponsor

Akeso

Phase

Phase 2

Started

2023-08-25

Last updated

2025-03-12

Condition(s) studied

Vulvar Cancer

Investigational drug(s) / intervention(s)

AK104 →AK104+ Paclitaxel+Cisplatin or CarboplatinAll Cadonilimab trials (55) →All Paclitaxel trials (419) →All Cisplatin trials (287) →All Carboplatin trials (346) →

AK104: AK104 15mg/kg intravenously(IV) every 3 weeks (Q3W), until progressive disease, unacceptable toxicity, completion of 2 years treatment or withdrawal of consent.

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.

Study 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

Sex

FEMALE

Min age

18 Years

Max age

80 Years

Healthy volunteers

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 outcome measure(s)

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

Trial sites (6)

Facility	City	Region	Status
Clinical oncology school of Fujian Medical University, Fujian Cancer Hospital	Fuzhou	Fujian	Recruiting
Sun Yant-Sen Memorial Hospital	Guangzhou	Guangdong	Recruiting
The Fourth Hospital of Hebei Medical University	Shijiangzhuang	Hebei	Not Yet Recruiting
Liaoning Cancer Hospital & Insitut	Shenyang	Liaoning	Recruiting
Tianjin medical university Cancer Institut & Hospital	Tianjin	Tianjin Municipality	Recruiting
Zhejiang Cancer Hospital	Hangzhou	Zhejiang	Not Yet Recruiting

More Akeso trials in China

AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer Active, not recruiting

A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC) Recruiting

A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast Cancer Starting soon

A Study of AK138D1 in Advanced Malignant Tumors Recruiting

AK112 in Non-squamous Non-small Cell Lung Cancer (NSCLC)Patients With Actionable Genomic Alterations (AGA) Who Have Failed to Previous Tyrosine Kinase Inhibitor (TKI) Treatment Starting soon

Other trials for the same condition

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Retrospective Study of Brachytherapy Recruiting

Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05932212 on ClinicalTrials.gov ↗ ← All trials in China