AK104 for Recurrent or Metastatic Vulvar Cancer

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Objective response rate (ORR) assessed by investigator. [Срок оценки: Up to approximately 1 years]

Вторичные конечные точки (8)

• Progression-free survival (PFS) Assessed by investigator [Срок оценки: Up to approximately 2 years]
• Duration of Response (DOR) Assessed by investigator [Срок оценки: Up to approximately 2 years]
• Disease control rate (DCR) Assessed by investigator [Срок оценки: Up to approximately 1 years]
• Time to Response (TTR) Assessed by investigator [Срок оценки: Up to approximately 1 years]
• Overall survival (OS) [Срок оценки: Up to approximately 2 years]
• Adverse Events (AEs) [Срок оценки: Up to approximately 2 years]
• serum concentrations of AK104 [Срок оценки: Up to approximately 2 years]
• Antidrug antibodies (ADA) of AK104 [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 6 центров

• Clinical oncology school of Fujian Medical University, Fujian Cancer Hospital — Фучжоу
• Sun Yant-Sen Memorial Hospital — Гуанчжоу
• The Fourth Hospital of Hebei Medical University — Shijiangzhuang
• Liaoning Cancer Hospital & Insitut — Шэньян
• Tianjin medical university Cancer Institut & Hospital — Тяньцзинь
• Zhejiang Cancer Hospital — Ханчжоу

Идентификаторы

NCT: NCT05932212 · AK104-218

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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