Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer

Официальное название

A Randomized Phase 2 Study to Evaluate the Efficacy and Safety for Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer (Cornerstone-004)

Обзор

The purpose of this phase 2 study is to assess the efficacy and safety for adjuvant therapeutic cancer vaccine AST-201 (pUMVC3-hIGFBP-2) in patients with newly diagnosed homologous-recombination proficient(HRP) advanced ovarian cancer (Stage III) after debulking surgery. Patients will receive AST-201 with rhuGM-CSF(Colony Stimulating Factor) or placebo with rhuGM-CSF in combination with standard adjuvant chemotherapy(Paclitaxel/Carboplatin).

Подробное описание

The study will comprise a screening period of -28 Days prior to initiation of study treatment (Day 1); an enrollment period of 24 months; the treatment duration will be approximately of 5 months.

The study will evaluate whether the addition of AST-201/rhuGM-CSF to the standard adjuvant chemotherapy will extend the Progression Free Survival(PFS) rate. Survival follow-up will be performed every 3 months (±14 days) after the End of treatment (EOT) visit for 2 years after randomization and every 6 months (±28 days) thereafter until disease progression or death from any cause or withdrawal of consent whichever comes first. Survival follow-up visits will be conducted by telephone, in-person visit, or chart review. The end of study (EOS) is defined as 2 years after the date of last patient enrollment.

Вмешательства

• Биопрепарат AST-201
  i.d. (3-week interval, 3 cycles in total)
• Препарат Paclitaxel
  3-week interval, 6 cycles in total
• Препарат Carboplatin
  3-week interval, 6 cycles in total
• Препарат Placebo
  i.d. (3-week interval, 3 cycles in total)
• Препарат rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)
  i.d. (3-week interval, 3 cycles in total)

Первичные конечные точки

• Progression-Free Survival (PFS) [Срок оценки: overall study duration (approximately 48 months)]

Вторичные конечные точки (4)

• 2-year PFS rate [Срок оценки: 24months from the first dose of AST-301 administration]
• Overall Survival (OS) [Срок оценки: overall study duration (approximately 48 months)]
• AST-201 specific immunogenicity by Interferon gamma (IFN-gamma) enzyme-linked immunospot (ELISpot ) [Срок оценки: 17months]
• Number of participants with Adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0) [Срок оценки: 5 months]

Критерии участия

Критерии включения

• Newly diagnosed stage III (FIGO classification) epithelial ovarian cancer including primary peritoneal cancer, fallopian-tube cancer
• Has received upfront surgery and optimally debulked(a residual tumor less than 1 cm)
• Can start adjuvant therapy within 6 weeks of debulking surgery
• Has Homologous Recombination Proficiency (HRP) tumor defined by FDA-approved testing
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Demonstrates adequate organ function.

Критерии исключения

• Has a history of hypersensitivity or other contraindications to rhuGM-CSF
• Has a history of active malignancy ≤5 years prior to first administration of investigational drug except for adequately treated non-melanoma skin cancer or epithelial carcinoma without evidence of disease
• Is on immune suppression therapy or has a history of immune suppression therapy ≤4 weeks prior to the first administration of investigational drugs
• Has active or prior autoimmune disease or inflammatory disease
• Has active infectious disease including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
• Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Washington — Seattle

Идентификаторы

NCT: NCT05794659 · PN-201-22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗