Volrustomig Priming Regimens Exploratory Phase II Platform Study

Официальное название

A Phase II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Volrustomig Priming Regimens in Combination With Other Anticancer Agents in Participants With Solid Tumors (eVOLVE-01)

Обзор

Purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of volrustomig in combination with other anticancer drugs in participants with specified solid tumors.

Подробное описание

This Phase II, platform, open-label, multicenter study will evaluate the efficacy, safety, and tolerability of volrustomig in combination with anticancer drugs in various solid tumor types.

This platform study currently includes 2 substudies:

Substudy 1: metastatic non-small cell lung cancer (mNSCLC) (non-squamous \[NSQ\]). Participants will be randomized in two treatment arms: Arm 1A and Arm 1B.

Substudy 2: mNSCLC (squamous \[SQ\] or NSQ). Participants will enroll to the Arm 2A only.

All arms will test a volrustomig dosing in combination with chemotherapy.

Вмешательства

• Препарат Volrustomig
  Participants will receive volrustomig via intravenous (IV) infusion.
• Препарат Carboplatin
  Participants will receive carboplatin via IV infusion.
• Препарат Pemetrexed
  Participants will receive pemetrexed via IV infusion.
• Препарат Ramucirumab
  Participants will receive ramucirumab via IV infusion.
• Препарат Paclitaxel
  Participants will receive paclitaxel via IV infusion.

Первичные конечные точки

• Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: From screening (Days -28 to Day -1) up to 2 year 10 months]
• Confirmed Objective Response rate (ORR) [Срок оценки: Up to 2 year 10 months]

Вторичные конечные точки (9)

• Disease Control Rate (DCR) [Срок оценки: Up to 2 year 10 months]
• Duration of Response (DOR) [Срок оценки: Up to 2 year 10 months]
• Progression Free Survival (PFS) [Срок оценки: Up to 2 year 10 months]
• Overall Survival (OS) [Срок оценки: Up to 2 year 10 months]
• Serum Concentration of Volrustomig [Срок оценки: Up to 2 year 10 months]
• Trough concentration (Ctrough) [Срок оценки: Up to 2 year 10 months]
• Maximum Observed Concentration (Cmax) [Срок оценки: Up to 2 year 10 months]
• Area Under the Curve (AUC) [Срок оценки: Up to 2 year 10 months]
• Number of Participants with Positive Antidrug Antibodies (ADAs) [Срок оценки: Up to 2 year 10 months]

Критерии участия

Критерии включения

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration.
• Life expectancy greater than or equal to (>=) 12 weeks.
• Adequate organ and bone marrow function.
• Body weight greater than (>) 35 kilograms (kg) at screening and at randomization.
• Histologically or cytologically documented NSQ NSCLC in substudy 1 and SQ or NSQ mNSCLC in substudy 2.
• Absence of sensitizing epidermal growth factor receptor (EGFR) mutations.
• Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies.
• At least one measurable lesion not previously irradiated that can be accurately measured at baseline as >= 10 millimeter (mm) in the longest diameter.

Критерии исключения

• Spinal cord compression.
• History of primary active immunodeficiency.
• Active or prior documented autoimmune or inflammatory disorders.
• Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant.
• Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of radiation therapy and study enrollment.
• Prior chemotherapy or any other systemic therapy for Stage IV NSCLC. Participants who have received prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for local disease are eligible, provided that progression has occurred greater (>) 12 months from end of last 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

Испания · 10 центров

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• Research Site — Madrid
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Италия · 9 центров

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США · 7 центров

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Грузия · 6 центров

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Португалия · 6 центров

• Research Site — Lisbon
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Китай · 5 центров

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Франция · 5 центров

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Греция · 5 центров

• Research Site — Athens
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• Research Site — Piraeus
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Швейцария · 5 центров

• Research Site — Basel
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Сербия · 4 центра

• Research Site — Belgrade
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South Korea · 4 центра

• Research Site — Seongnam
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Тайвань · 4 центра

• Research Site — Changhua
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Малайзия · 3 центра

• Research Site — Kuala Lumpur
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Румыния · 3 центра

• Research Site — Cluj-Napoca
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Канада · 1 центр

• Research Site — Montreal

Идентификаторы

NCT: NCT06448754 · D798KC00001 · 2023-509482-20-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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