Идёт набор NCT06997497

A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)

Фаза III С лечением Colon Adenocarcinoma Rectal Adenocarcinoma

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: Calderasib, Oxaliplatin, Leucovorin/levofolinate calcium, 5-Fluorouracil.
Кому может быть актуально: Состояния в реестре: Colon Adenocarcinoma, Rectal Adenocarcinoma. 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, Аргентина, Австралия, Бразилия, Канада +24
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

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 Versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012)

Обзор

Researchers are looking for other ways to treat locally advanced or metastatic colorectal cancer (mCRC) that is unresectable and has a gene mutation called KRAS G12C. Standard (or usual) treatments for this type of colorectal cancer may include mFOLFOX6 with or without bevacizumab. Researchers want to learn if adding calderasib (the study medicine) and cetuximab to mFOLFOX6 can treat locally advanced or mCRC with the KRAS G12C mutation. Calderasib and cetuximab are targeted therapies. The goals of this study are to learn: * About the safety of calderasib with cetuximab and mFOLFOX6 and if people tolerate the treatments * If people who receive calderasib with cetuximab and mFOLFOX6 live longer without mCRC growing or spreading compared to people who receive mFOLFOX6 with or without bevacizumab.

Подробное описание

This study will have 2 parts.

Вмешательства

Препарат Calderasib
Oral tablet
Препарат Oxaliplatin
Per label
Препарат Leucovorin/levofolinate calcium
Per label
Препарат 5-Fluorouracil
Per label
Биопрепарат Cetuximab
Per label
Препарат Bevacizumab
Per label
Препарат Bevacizumab biosimilar
Per label

Первичные конечные точки

Number of Participants Experiencing Dose-Limiting Toxicity (DLT) [Срок оценки: Up to approximately 28 days]
Part 1: Number of Participants Who Experience an Adverse Event (AE) [Срок оценки: Up to approximately 44 months]
Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE [Срок оценки: Up to approximately 44 months]
Progression Free Survival (PFS) [Срок оценки: Up to approximately 44 months]

Вторичные конечные точки (12)

Objective Response Rate (ORR) [Срок оценки: Up to approximately 3 years]
Overall Survival (OS) [Срок оценки: Up to approximately 5 years]
Duration of Response (DOR) [Срок оценки: Up to approximately 4 years]
Part 2: Number of Participants with an Adverse Event (AE) [Срок оценки: Up to approximately 5 years]
Part 2: Number of Participants who Discontinue Study Treatment Due to an AE [Срок оценки: Up to approximately 5 years]
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score [Срок оценки: Baseline and up to approximately 5 years]
Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score [Срок оценки: Baseline and up to approximately 5 years]
Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Combined Score [Срок оценки: Baseline and up to approximately 5 years]
Change from Baseline in the EORTC-QLQ-C30 Appetite Loss (Item 13) Score [Срок оценки: Baseline and up to approximately 5 years]
Change from Baseline in the EORTC-Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score [Срок оценки: Baseline and up to approximately 5 years]
Time to First Deterioration (TTD) in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score [Срок оценки: Baseline and up to approximately 5 years]
TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score [Срок оценки: Baseline and up to approximately 5 years]

Критерии участия

Критерии включения

The main inclusion criteria include but are not limited to the following:

Has a histologically confirmed diagnosis of locally advanced unresectable or metastatic (unresectable Stage III or Stage IV as defined by American Joint Committee on Cancer \[AJCC\] eighth edition) colorectal adenocarcinoma
Part 2 only: Has not received systemic anticancer therapy for locally advanced unresectable or metastatic colorectal cancer; an exception is permitted for 1-2 cycles of FOLFOX or 1 cycle of CAPOX as optional chemotherapy before or during the screening period
Demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Критерии исключения

The main exclusion criteria include but are not limited to the following:

Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has known partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization, with the exception of the optional chemotherapy
Has 1 or more conditions that, in the opinion of the investigator, make the participant ineligible for treatment with bevacizumab
Has known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease
Has active infection requiring systemic therapy
Has not adequately recovered from major surgery or have ongoing surgical complications
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

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

Китай · 34 центра

Anhui Provincial Cancer Hospital ( Site 0803) — Хэфэй
The Second Affiliated Hospital of Anhui Medical University ( Site 0813) — Хэфэй
Peking Union Medical College Hospital ( Site 0824) — Пекин
Peking University First Hospital(Daxing Area) ( Site 0838) — Пекин
Chongqing University Cancer Hospital ( Site 0808) — Чунцин
Chongqing University Three Gorges Hospital ( Site 0837) — Wanzhou
Fujian Cancer Hospital ( Site 0807) — Фучжоу
The First Affiliated Hospital of Xiamen University ( Site 0806) — Xiamen
… и ещё 26 центров

США · 32 центра

Los Angeles Hematology Oncology Medical Group ( Site 0084) — Los Angeles
UCLA Hematology/Oncology - Santa Monica ( Site 0088) — Santa Monica
University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 00 — Fort Collins
Rocky Mountain Cancer Centers (RMCC) ( Site 8000) — Lone Tree
Florida Cancer Specialists - South ( Site 7002) — Fort Myers
Orlando Health Cancer Institute ( Site 0065) — Orlando
Florida Cancer Specialists - North ( Site 7001) — St. Petersburg
Florida Cancer Specialists - East ( Site 7000) — West Palm Beach
… и ещё 24 центра

Япония · 16 центров