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NCT Number: NCT05932212

AK104 for 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.

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Key information

Conditions

Vulvar Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Vulvar Diseases Vulvar Neoplasms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Clinical oncology school of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, Fujian, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AK104

Drug

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

AK104+ Paclitaxel+Cisplatin or Carboplatin

Drug

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.

Primary outcomes

  1. Objective response rate (ORR) assessed by investigator.

    Time frame: Up to approximately 1 years

    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1

Secondary outcomes

  1. Progression-free survival (PFS) Assessed by investigator

    Time frame: Up to approximately 2 years

    The time from the first administration to the first documented progressive disease (PD) or death due to any cause, whichever occurs first

  2. Duration of Response (DOR) Assessed by investigator

    Time frame: Up to approximately 2 years

    Measured from the date of partial or complete response to therapy until the disease progression per RECIST v1.1 criteria

  3. Disease control rate (DCR) Assessed by investigator

    Time frame: Up to approximately 1 years

    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

  4. Time to Response (TTR) Assessed by investigator

    Time frame: Up to approximately 1 years

    The time from the first administration to the date of documented CR or PR

  5. Overall survival (OS)

    Time frame: Up to approximately 2 years

    The time from the first administration to death due to any cause

  6. Adverse Events (AEs)

    Time frame: Up to approximately 2 years

    Characterization of incidence, severity and abnormal clinically significant manifestation or laboratory findings.

  7. serum concentrations of AK104

    Time frame: Up to approximately 2 years

    assessment of PK include serum concentrations of AK104 at different timepoints after study drug administration

  8. Antidrug antibodies (ADA) of AK104

    Time frame: Up to approximately 2 years

    Proportion of subjects who develop detectable anti-drug antibodies (ADAs)

Study contacts

Contact information is provided by the study sponsor or research team.

Ting Liu, MD

CONTACT

[email protected]

+86(0760)89873999

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 6, 2023
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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