PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer

Официальное название

A Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer.

Обзор

This Phase 2 study will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.

Подробное описание

This is a Phase 2 study of PRGN-2009 in patients with recurrent or metastatic cervical cancer who are pembrolizumab resistant. Patients meeting all eligibility criteria who consent to participate in the study will receive PRGN-2009 (5 x 10\^11 PU, subcutaneous injection) every 3 weeks for three administrations, thereafter every 6 weeks, plus pembrolizumab (400 mg IV) every 6 weeks.

Вмешательства

• Биопрепарат PRGN-2009 plus Pembrolizumab
  Subjects randomized will receive PRGN-2009 (5 x 10\^11 PU, subcutaneous (SC) injection) every 3 weeks for three administrations, thereafter subjects will continue to receive PRGN-2009 administrations every 6 weeks. Pembrolizumab will be administered concurrently as intravenous (IV) infusion (400 mg) every 6 weeks.

Первичные конечные точки

• Determine the Objective Response Rate (ORR) following treatment with PRGN-2009 in combination with pembrolizumab in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer. [Срок оценки: 1 year]

Вторичные конечные точки (5)

• Safety of PRGN-2009 in combination with pembrolizumab [Срок оценки: 1 year]
• Progression-Free Survival (PFS) and Overall Survival (OS) following treatment with PRGN-2009 in combination with pembrolizumab [Срок оценки: 1 year]
• Best Overall Responses (BOR) and Disease Control Rate (DCR) per RECIST v1.1 following treatment with PRGN-2009 in combination with pembrolizumab [Срок оценки: 1 year]
• Time to Response and Duration of Responses following treatment with PRGN-2009 in combination with pembrolizumab [Срок оценки: 1 year]
• Vector shedding following subcutaneous administration of PRGN-2009 [Срок оценки: Up to 4 months]

Критерии участия

Критерии включения

• Age 18 years and older.
• Recurrent or metastatic cervical cancer (histologically or cytologically confirmed)
• Must have been treated with pembrolizumab, either as monotherapy or in combination, for atleast 6 weeks.
• Subjects must have histologically or cytologically confirmed HPV positive disease
• Measurable disease that can be accurately measured by RECIST v1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 12 weeks from the time of enrollment.
• Must have adequate organ function
• Negative serum pregnancy test. Women of child-bearing potential (WOCBP) must agree to use adequate contraception prior to study entry and for at least 6 months following completion of study treatment.
• All patients must have the ability to understand and willingness to sign a written informed consent.

Критерии исключения

• Prior chemotherapy, targeted therapy within 14 days; monoclonal antibody within 4 weeks; unresolved AEs.
• Immunodeficiency, active autoimmune disease on immunosuppression, or immunosuppressive therapy within 7 days. HIV eligible with disease control.
• Active hepatitis B (HBsAg+) or hepatitis C (HCV RT-PCR+) within 30 days of enrollment.
• History of non-infectious pneumonitis or interstitial lung disease.
• History of endocrine autoimmune disease (exceptions: treated Graves' disease; hypothyroidism on replacement).
• Live vaccine within 30 days prior to first dose.
• Patients with presence of other active malignancy within 1 year prior to study entry
• Known Central Nervous System (CNS) disease
• Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
• Known history of active tuberculosis (TB, Bacillus tuberculosis).
• Pregnant and lactating women are excluded from this study.
• Patients with a history of solid organ transplant.
• Patients currently participating in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment.
• Patients, who in the opinion of the investigator, may not be able to comply with the monitoring requirements of the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• University of Arkansas for Medical Sciences — Little Rock
• National Institute of Health — Bethesda
• University of Washington — Seattle

Идентификаторы

NCT: NCT06157151 · PRGN-2009-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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