A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer

Официальное название

A Phase II, Open-label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants With Colorectal Cancer (CANTOR)

Обзор

The main purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with Colorectal Cancer (CRC).

Подробное описание

This is a Phase II, platform, open-label, multi-drug, multicenter, global study.

This is a modular study, that includes a master protocol and substudies.

Partcipants will be randomised to one of the following intervention groups:

* Volrustomig + FOLFIRI + bevacizumab group (Arm A) * FOLFIRI + bevacizumab group (Arm B)

The substudy will evaluate the effects of volrustomig in combination with FOLFIRI (irinotecan, 5-FU, and leucovorin) and bevacizumab versus FOLFIRI and bevacizumab only in participants with Mismatch-repair-proficient (pMMR)/Microsatellite stable (MSS) metastatic CRC (mCRC) in the absence of liver metastases and who have not received previous systemic treatment for advanced or metastatic disease.

Вмешательства

• Препарат Volrustomig
  Volrustomig will be administered as intravenous (IV) infusion.
• Препарат FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)
  FOLFIRI will be administered as IV infusion.
• Препарат Bevacizumab
  Bevacizumab will be administered as IV infusion.

Первичные конечные точки

• Progression Free Survival (PFS) [Срок оценки: Approximately 3 years]
• Number of Participants with Adverse Events (AEs) [Срок оценки: Approximately 3 years]

Вторичные конечные точки (8)

• Overall Survival (OS) [Срок оценки: Approximately 3 years]
• Objective Response Rate (ORR) [Срок оценки: Approximately 3 years]
• Disease Control Rate (DCR) [Срок оценки: Approximately 3 years]
• Duration of Response (DOR) [Срок оценки: Approximately 3 years]
• Time to second progression or death (PFS2) [Срок оценки: Approximately 3 years]
• Maximum Observed Concentration (Cmax) [Срок оценки: Approximately 3 years]
• Observed lowest concentration before the next dose is administered (Ctrough) [Срок оценки: Approximately 3 years]
• Number of patients with positive Antidrug Antibodies (ADAs) [Срок оценки: Approximately 3 years]

Критерии участия

Overall Inclusion Criteria:

• Histopathologically confirmed colorectal adenocarcinoma.
• Provision of FFPE tumor sample collected as per SoC.
• Presence of measurable disease by RECIST 1.1 criteria.
• ECOG performance status of 0 or 1.
• Life expectancy ≥ 12 weeks at the time of screening.

Substudy Inclusion Criteria:

• No radiological evidence of liver metastasis.
• No prior systemic therapy for mCRC, except for neoadjuvant/adjuvant chemotherapy where, > 6 months have elapsed between completion of therapy and documented date of diagnosis of recurrent or metastatic disease.
• Known pMMR/MSS status (only pMMR/MSS mCRC allowed).
• Adequate organ and bone marrow function
• Body weight > 35 kg at screening and at randomization.
• Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Overall Exclusion Criteria:

• Central nervous system metastases or spinal cord compression
• Known history of severe allergy to any monoclonal antibody or study intervention.
• Any unresolved toxicity CTCAE Grade ≥ 2 from a previous anticancer therapy.
• History of another primary malignancy.

Substudy Exclusion Criteria:

• Potentially resectable disease with multidisciplinary plan for radical surgery.
• Active or prior documented autoimmune or inflammatory disorders or cardiac conditions.
• Participants with a prior history of hypertensive crisis or hypertensive encephalopathy or bleeding risks.
• Deep venous thrombosis, pulmonary embolism, arterial thrombosis, transient ischemic attack or cerebrovascular accident.
• History of abdominal or tracheoesophageal fistula, GI perforation and/or fistulae, or intraabdominal abscess within 6 months prior to randomization.
• Prior exposure to immune mediated therapy.

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 · 14 центров

• Research Site — Scottsdale
• Research Site — Los Angeles
• Research Site — Washington D.C.
• Research Site — Chicago
• Research Site — Baltimore
• Research Site — Boston
• Research Site — Rochester
• Research Site — Trenton
• … и ещё 6 центров

Италия · 9 центров

• Research Site — Bologna
• Research Site — Castelfranco Veneto
• Research Site — Florence
• Research Site — Milan
• Research Site — Milan
• Research Site — Naples
• Research Site — Pavia
• Research Site — Pisa
• … и ещё 1 центр

Испания · 9 центров

• Research Site — Barcelona
• Research Site — Barcelona
• Research Site — Madrid
• Research Site — Madrid
• Research Site — Madrid
• Research Site — Málaga
• Research Site — Pamplona
• Research Site — Santander
• … и ещё 1 центр

Китай · 8 центров

• Research Site — Пекин
• Research Site — Чэнду
• Research Site — Харбин
• Research Site — Шанхай
• Research Site — Шанхай
• Research Site — Шанхай
• Research Site — Ухань
• Research Site — Чжэнчжоу

Франция · 7 центров

• Research Site — Bordeaux
• Research Site — Marseille
• Research Site — Montpellier
• Research Site — Montpellier
• Research Site — Poitiers
• Research Site — Saint-Priez En Jarez
• Research Site — Villejuif

Германия · 5 центров

• Research Site — Berlin
• Research Site — Dresden
• Research Site — Essen
• Research Site — Hamburg
• Research Site — Marburg

South Korea · 5 центров

• Research Site — Seoul
• Research Site — Seoul
• Research Site — Seoul
• Research Site — Seoul
• Research Site — Yongin-si

Великобритания · 5 центров

• Research Site — Cambridge
• Research Site — London
• Research Site — London
• Research Site — Manchester
• Research Site — Metropolitan Borough of Wirral

Канада · 4 центра

• Research Site — Victoria
• Research Site — Barrie
• Research Site — Toronto
• Research Site — Montreal

Тайвань · 4 центра

• Research Site — Kaohsiung City
• Research Site — Taipei
• Research Site — Taoyuan
• Research Site — Yung Kang City

Австралия · 3 центра

• Research Site — East Melbourne
• Research Site — Wollongong
• Research Site — Woodville South

Нидерланды · 3 центра

• Research Site — Amsterdam
• Research Site — Maastricht
• Research Site — Zwolle

Идентификаторы

NCT: NCT06792695 · D798VC00001 · 2024-518469-84

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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