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Идёт набор NCT07446322

FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer

Фаза II С лечением Ras-mutated Metastatic Colorectal Cancer mCRC MSS Metastatic Colorectal Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Bevacizumab, FOLFIRI, Pelareorep.
Кому может быть актуально
Состояния в реестре: Ras-mutated Metastatic Colorectal Cancer, mCRC, MSS Metastatic Colorectal Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

An Open-Label, Randomized, Multicentre, Phase 2 Study of FOLFIRI + Bevacizumab + Pelareorep vs. FOLFIRI + Bevacizumab for the Second-Line Treatment of Metastatic, RAS-mutated, Microsatellite-Stable (MSS) Colorectal Cancer

Обзор

This is an open-label, randomized, multicenter Phase 2 study to assess the efficacy and safety of FOLFIRI + bevacizumab + pelareorep vs. FOLFIRI + bevacizumab in patients with RAS-mutated, MSS mCRC who have progressed after one prior line of oxaliplatin-based therapy.

Подробное описание

Approximately 60 patients will be randomized 1:1 to the following study arms:

* Arm A: FOLFIRI + bevacizumab + pelareorep * Arm B: FOLFIRI + bevacizumab The primary endpoint is ORR as assessed by the investigator per RECIST 1.1. OS, PFS, and assessment of the safety and tolerability of the study treatment combinations are secondary endpoints. The primary endpoint analysis will be performed after all patients have had at least one tumor assessment following initiation of study treatment or have progressed. The secondary endpoint analyses will take place at EOS.

Вмешательства

  • Препарат Bevacizumab
    Bevacizumab (5 mg/kg) IV infusion
  • Препарат FOLFIRI
    irinotecan (180mg/m2), leucovorin 400 mg/m2 ± 5-FU (400 mg/m2) IV infusion
  • Препарат Pelareorep
    pelareorep 4.5 x 10\^10 TCID50 IV infusion

Первичные конечные точки

  • Overall Response Rate (ORR) [Срок оценки: At week 8]
Вторичные конечные точки (4)
  • Overall Survival (OS) - [Срок оценки: From the date of randomization through long term follow up at two years]
  • Progression Free Survival (PFS) [Срок оценки: From randomization to objective progression or death from any cause, whichever occurs first, up to two years]
  • Disease Control Rate (DCR) [Срок оценки: From randomization to disease progression or death from any cause, whichever occurs first, up to two years]
  • Duration of Response (DOR) [Срок оценки: From randomization to disease progression or death from any cause, whichever occurs first, up to two years]

Критерии участия

Критерии включения

  • Histologically confirmed cancer of the colon or rectum with documented metastasis
  • Measurable disease per RECIST v. 1.1
  • Not candidates for curative surgery or curative radiation
  • Progressed on, or been intolerant to, a first-line, oxaliplatin-based chemotherapy regimen in the metastatic setting or relapsed within 6 months of completing adjuvant oxaliplatin
  • Considered medically eligible to receive standard of care (SOC) FOLFIRI with bevacizumab
  • Non-microsatellite instability high or non-deficient mismatch repair (non-MSI-H/non dMMR) tumor status per a standard local testing method
  • Tumor confirmed to harbor a known RAS mutation per a standard local testing method
  • ECOG performance status of 0 or 1
  • Patients must have adequate hematological, renal, and hepatic function
  • Female patients of childbearing potential must have a negative pregnancy test
  • Life expectancy of at least 6 months

Критерии исключения

  • Undergone systemic chemotherapy, radiotherapy, or surgery, <4 weeks before study treatment
  • Ongoing AEs of Grade ≥2 that are related to anti-cancer treatment
  • Prior treatment with irinotecan
  • Symptomatic brain metastases
  • Active autoimmune disease
  • Receiving immunosuppressive or myelosuppressive medications
  • Active, uncontrolled infections
  • Known HIV infection or active hepatitis B or C that requires anti-viral treatment
  • History of another primary cancer within the last 3 years except for non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ
  • History of allergy or known hypersensitivity to any of the study drugs, study drug classes,
  • Uncontrolled or severe cardiac disease
  • Received any vaccine within 28 days prior to first study treatment

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
Открытое
Основная цель
Лечение

Центры проведения

США · 13 центров
  • Central Alabama Research — Homewood
  • Clinical Research Advisors (Beverly Hills) — Beverly Hills
  • Clinical Research Advisors (Encino) — Encino
  • Clinical Research Advisors (Korea Town) — Koreatown
  • Clinical Research Advisors (Downtown LA) — Los Angeles
  • Clinical Research Advisors (West Hollywood) — Los Angeles
  • Clinical Research Advisors (West Covina) — West Covina
  • Emory Winship Cancer Institute — Atlanta
  • … и ещё 5 центров

Идентификаторы

NCT: NCT07446322 · REO 033

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗