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Recruiting Phase 3 NCT06997497

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

Phase 3 – large-scale trial before approval
Conditions: Colon Adenocarcinoma Rectal Adenocarcinoma

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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.
Description
This study will have 2 parts.
Who can participate
Inclusion Criteria: 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 * Tumor tissue 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 Exclusion Criteria: 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 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 * 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
Interventions
Calderasib
DRUG
Oxaliplatin
DRUG
Leucovorin/levofolinate calcium
DRUG
5-Fluorouracil
DRUG
Cetuximab
BIOLOGICAL
Bevacizumab
DRUG
Bevacizumab biosimilar
DRUG
Locations 152
Argentina (5)
Hospital Italiano de Buenos Aires ( Site 0102)
Ciudad Autonoma de Buenos Aires , Buenos Aires
Study Coordinator
Hospital Privado Universitario de Córdoba ( Site 0108)
Córdoba
Study Coordinator
Instituto Alexander Fleming ( Site 0101)
Mar del Plata , Buenos Aires
Study Coordinator
Fundacion Estudios Clinicos ( Site 0105)
Rosario , Santa Fe Province
Study Coordinator
Sanatorio Parque ( Site 0103)
Rosario , Santa Fe Province
Study Coordinator
Australia (3)
Sunshine Coast University Hospital ( Site 0451)
Birtinya , Queensland
Study Coordinator
Monash Health ( Site 0454)
Clayton , Victoria
Study Coordinator
Western Health-Sunshine & Footscray Hospitals ( Site 0450)
St Albans , Victoria
Study Coordinator
Brazil (10)
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0155)
Barretos , São Paulo
Study Coordinator
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0157)
Florianópolis , Santa Catarina
Study Coordinator
Hospital de Caridade de Ijuí ( Site 0150)
Ijuí , Rio Grande do Sul
Study Coordinator
Associação Hospitalar Beneficente São Vicente de Paulo ( Site 0153)
Passo Fundo , Rio Grande do Sul
Study Coordinator
Hospital Nossa Senhora da Conceição ( Site 0156)
Porto Alegre , Rio Grande do Sul
Study Coordinator
Hospital de Câncer de Recife ( Site 0158)
Recife , Pernambuco
Study Coordinator
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0159)
São José do Rio Preto , São Paulo
Study Coordinator
COE Ensino e Pesquisa ( Site 0151)
São José dos Campos , São Paulo
Study Coordinator
Instituto do Cancer Arnaldo Vieira de Carvalho ( Site 0160)
São Paulo
Study Coordinator
IBCC - Núcleo de Pesquisa e Ensino ( Site 0154)
São Paulo
Study Coordinator
Canada (5)
CIUSSS- saguenay-Lac-Saint-Jean ( Site 0007)
Chicoutimi , Quebec
Study Coordinator
Moncton Hospital - Horizon Health Network ( Site 0011)
Moncton , New Brunswick
Study Coordinator
Jewish General Hospital ( Site 0006)
Montreal , Quebec
Study Coordinator
Princess Margaret Cancer Centre ( Site 0001)
Toronto , Ontario
Study Coordinator
Cancercare Manitoba ( Site 0009)
Winnipeg , Manitoba
Study Coordinator
Chile (1)
CIDO SpA ( Site 0212)
Temuco , Araucania
Study Coordinator
China (28)
Peking Union Medical College Hospital ( Site 0824)
Beijing , Beijing Municipality
Study Coordinator
Peking University First Hospital(Daxing Area) ( Site 0838)
Beijing , Beijing Municipality
Study Coordinator
Hunan Cancer Hospital ( Site 0815)
Changsha , Hunan
Study Coordinator
The Third Xiangya Hospital of Central South University ( Site 0834)
Changsha , Hunan
Study Coordinator
Sichuan Cancer hospital. ( Site 0831)
Chengdu , Sichuan
Study Coordinator
Chongqing University Cancer Hospital ( Site 0808)
Chongqing , Chongqing Municipality
Study Coordinator
Fujian Cancer Hospital ( Site 0807)
Fuzhou , Fujian
Study Coordinator
Sun Yat-Sen University Cancer Center ( Site 0800)
Guangzhou , Guangdong
Study Coordinator
Southern Medical University Nanfang Hospital ( Site 0812)
Guangzhou , Guangdong
Study Coordinator
The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 0828)
Guangzhou , Guangdong
Study Coordinator
The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 0801)
Hangzhou , Zhejiang
Study Coordinator
Zhejiang Cancer Hospital ( Site 0821)
Hangzhou , Zhejiang
Study Coordinator
Anhui Provincial Cancer Hospital ( Site 0803)
Hefei , Anhui
Study Coordinator
The Second Affiliated Hospital of Anhui Medical University ( Site 0813)
Hefei , Anhui
Study Coordinator
Jinan Central Hospital ( Site 0817)
Jinan , Shandong
Study Coordinator
First Affiliated Hospital of Kunming Medical University ( Site 0845)
Kunming , Yunnan
Study Coordinator
The First Affiliated Hospital of Nanchang University ( Site 0826)
Nanchang , Jiangxi
Study Coordinator
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0825)
Nanjing , Jiangsu
Study Coordinator
Guangxi Medical University Affiliated Tumor Hospital ( Site 0804)
Nanning , Guangxi
Study Coordinator
Fudan University Shanghai Cancer Center ( Site 0816)
Shanghai , Shanghai Municipality
Study Coordinator
First Affiliated Hospital of Shanxi Medical University ( Site 0843)
Taiyuan , Shanxi
Study Coordinator
Chongqing University Three Gorges Hospital ( Site 0837)
Wanzhou , Chongqing Municipality
Study Coordinator
The First Affiliated Hospital of Wenzhou Medical University ( Site 0840)
Wenzhou , Zhejiang
Study Coordinator
Tongji Hospital Tongji Medical,Science & Technology ( Site 0839)
Wuhan , Hubei
Study Coordinator
Hubei Cancer Hospital ( Site 0814)
Wuhan , Hubei
Study Coordinator
The First Affiliated Hospital of Xiamen University ( Site 0806)
Xiamen , Fujian
Study Coordinator
Zhongshan Hospital Affiliated to Xiamen University ( Site 1902)
Xiamen , Fujian
Study Coordinator
Henan Cancer Hospital ( Site 0822)
Zhengzhou , Henan
Study Coordinator
Colombia (3)
Hospital Universitario San Ignacio ( Site 0254)
Bogota , Cundinamarca
Study Coordinator
IMAT S.A.S ( Site 0252)
Montería , Departamento de Córdoba
Study Coordinator
Oncologos Del Occidente ( Site 0255)
Pereira , Risaralda Department
Study Coordinator
Finland (2)
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1000)
Helsinki , Uusimaa
Study Coordinator
Tampere University Hospital ( Site 1001)
Tampere , Pirkanmaa
Study Coordinator
France (9)
Institut de Cancérologie de l'Ouest ( Site 1062)
Angers , Pays de la Loire Region
Study Coordinator
Sainte Catherine Institut du Cancer Avignon Provence ( Site 1065)
Avignon , Vaucluse
Study Coordinator
Centre François Baclesse ( Site 1061)
Caen , Calvados
Study Coordinator
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1064)
Limoges , Limousin
Study Coordinator
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1058)
Nice , Alpes-Maritimes
Study Coordinator
Institut Jean Godinot ( Site 1054)
Reims , Marne
Study Coordinator
CHU Charles Nicolle ( Site 1066)
Rouen , Seine-Maritime
Study Coordinator
CHU Rangueil ( Site 1063)
Toulouse , Haute-Garonne
Study Coordinator
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1053)
Vandœuvre-lès-Nancy , Lorraine
Study Coordinator
Germany (1)
Katholisches Marienkrankenhaus gGmbH ( Site 1103)
Hamburg
Study Coordinator
Hong Kong (2)
Prince of Wales Hospital. ( Site 0500)
Hong Kong
Study Coordinator
Queen Mary Hospital ( Site 0501)
Hong Kong
Study Coordinator
Hungary (1)
Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 1204)
Pécs , Baranya
Study Coordinator
Israel (4)
Rambam Health Care Campus ( Site 1253)
Haifa
Study Coordinator
Hadassah Medical Center ( Site 1252)
Jerusalem
Study Coordinator
Rabin Medical Center ( Site 1251)
Petah Tikva
Study Coordinator
Sheba Medical Center ( Site 1254)
Ramat Gan
Study Coordinator
Italy (6)
Ospedale San Raffaele. ( Site 1305)
Milan
Study Coordinator
AOU Cagliari ( Site 1306)
Monserrato , Cagliari
Study Coordinator
Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UOC Oncoematologia ( Site 1302)
Naples
Study Coordinator
Istituto Oncologico Veneto IRCCS ( Site 1307)
Padova
Study Coordinator
Azienda USL della Romagna ( Site 1303)
Ravenna
Study Coordinator
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 1304)
Verona
Study Coordinator
Japan (11)
Nippon Medical School Hospital ( Site 0859)
Bunkyo , Tokyo
Study Coordinator
Chiba Cancer Center ( Site 0858)
Chiba
Study Coordinator
National Cancer Center Hospital ( Site 0850)
Chūō , Tokyo
Study Coordinator
Kyushu University Hospital ( Site 0862)
Fukuoka
Study Coordinator
Saitama Medical University International Medical Center ( Site 0860)
Hidaka , Saitama
Study Coordinator
National Cancer Center Hospital East ( Site 0851)
Kashiwa , Chiba
Study Coordinator
Kagawa University Hospital ( Site 0861)
Kita-gun , Kagawa-ken
Study Coordinator
Cancer Institute Hospital of JFCR ( Site 0863)
Koto , Tokyo
Study Coordinator
Kindai University Hospital ( Site 0854)
Sakai , Osaka
Study Coordinator
Teine Keijinkai Hospital ( Site 0864)
Sapporo , Hokkaido
Study Coordinator
Tohoku University Hospital ( Site 0853)
Sendai , Miyagi
Study Coordinator
Netherlands (3)
Amsterdam UMC, locatie VUmc ( Site 1351)
Amsterdam , North Holland
Study Coordinator
Amphia Ziekenhuis, locatie Breda Molengracht ( Site 1352)
Breda , North Brabant
Study Coordinator
Radboudumc ( Site 1354)
Nijmegen , Gelderland
Study Coordinator
Poland (1)
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 1457)
Poznan , Greater Poland Voivodeship
Study Coordinator
Romania (5)
Fundeni Clinical Institute-Medical Oncology ( Site 1504)
Bucharest
Study Coordinator
Institutul Oncologic Cluj ( Site 1502)
Cluj-Napoca , Cluj
Study Coordinator
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 1501)
Cluj-Napoca , Cluj
Study Coordinator
Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1500)
Craiova , Dolj
Study Coordinator
Institutul Regional de Oncologie ( Site 1505)
Iași
Study Coordinator
Singapore (1)
National Cancer Centre Singapore ( Site 0650)
Singapore , Central Singapore
Study Coordinator
South Korea (8)
Kyungpook National University Chilgok Hospital ( Site 0701)
Buk-Gu , Taegu-Kwangyokshi
Study Coordinator
Samsung Medical Center ( Site 0708)
Gangnam , Seoul
Study Coordinator
National Cancer Center ( Site 0702)
Goyang-si , Kyonggi-do
Study Coordinator
Seoul National University Bundang Hospital ( Site 0705)
Seongnam-si , Kyonggi-do
Study Coordinator
Seoul National University Hospital ( Site 0706)
Seoul
Study Coordinator
Korea University Guro Hospital ( Site 0704)
Seoul
Study Coordinator
Asan Medical Center ( Site 0707)
Songpa-gu , Seoul
Study Coordinator
The Catholic University of Korea St. Vincent s Hospital ( Site 0703)
Suwon , Kyonggi-do
Study Coordinator
Spain (9)
Institut Català d'Oncologia (ICO) - Badalona ( Site 1552)
Badalona , Barcelona
Study Coordinator
Hospital Universitari Vall d'Hebron ( Site 1553)
Barcelona
Study Coordinator
Hospital Insular de Gran Canaria ( Site 1558)
Las Palmas de Gran Canaria , Las Palmas
Study Coordinator
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1554)
Madrid
Study Coordinator
Hospital Clinico San Carlos ( Site 1555)
Madrid
Study Coordinator
Hospital Universitario Central de Asturias ( Site 1550)
Oviedo , Principality of Asturias
Study Coordinator
Hospital Universitario Marqués de Valdecilla ( Site 1551)
Santander , Cantabria
Study Coordinator
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1556)
Seville
Study Coordinator
Instituto Valenciano de Oncologia - IVO ( Site 1557)
Valencia
Study Coordinator
Taiwan (4)
National Cheng Kung University Hospital ( Site 0754)
Tainan
Study Coordinator
National Taiwan University Hospital ( Site 0751)
Taipei
Study Coordinator
Taipei Veterans General Hospital ( Site 0752)
Taipei
Study Coordinator
Chang Gung Memorial Hospital - Linkou Branch ( Site 0753)
Taoyuan District
Study Coordinator
Ukraine (11)
MNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of CRC" ( Site 1706)
Cherkasy , Cherkasy Oblast
Study Coordinator
RMNE "Bukovyna Clinical Oncology Center" ( Site 1709)
Chernivtsi , Chernivetska Oblast
Study Coordinator
MNPE "Prykarpattia Clinical Oncology Center of Ivano-Frankivsk Regional Council" ( Site 1701)
Ivano-Frankivsk , Ivano-Frankivsk Oblast
Study Coordinator
CNE "Regional Clinical Oncology Center of the Kirovohrad Regional Council" ( Site 1702)
Kropyvnytskyi , Kirovohrad Oblast
Study Coordinator
Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1704)
Kyiv
Study Coordinator
SI "National Institute of Surgery and Transplantology named after O. O. Shalimov" ( Site 1713)
Kyiv
Study Coordinator
LLC "MEDICAL CENTER DOBROBUT-CLINIC" ( Site 1703)
Kyiv
Study Coordinator
ME "Volyn Regional Clinical Hospital" of the VRC ( Site 1712)
Lutsk , Volyn Oblast
Study Coordinator
MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 1708)
Lviv , Lviv Oblast
Study Coordinator
MNE "Central City Hospital" ( Site 1711)
Rivne , Rivne Oblast
Study Coordinator
Uzhgorod Central City Clinical Hospital ( Site 1700)
Uzhhorod , Zakarpattia Oblast
Study Coordinator
United Kingdom (3)
University College London Hospitals ( Site 1750)
London , London, City of
Study Coordinator
The Christie NHS Foundation Trust ( Site 1755)
Manchester
Study Coordinator
Churchill Hospital ( Site 1756)
Oxford , Oxfordshire
Study Coordinator
United States (16)
Greater Baltimore Medical Center ( Site 0068)
Baltimore , Maryland
Study Coordinator
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 2000)
Billings , Montana
Study Coordinator
Miami Valley Hospital South ( Site 0075)
Centerville , Ohio
Study Coordinator
University of Virginia ( Site 0080)
Charlottesville , Virginia
Study Coordinator
Florida Cancer Specialists - South ( Site 7002)
Fort Myers , Florida
Study Coordinator
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0060)
Hackensack , New Jersey
Study Coordinator
University of Iowa ( Site 0074)
Iowa City , Iowa
Study Coordinator
University of Kentucky ( Site 0055)
Lexington , Kentucky
Study Coordinator
Los Angeles Hematology Oncology Medical Group ( Site 0084)
Los Angeles , California
Study Coordinator
Norton Cancer Institute, Audubon Hospital Campus ( Site 0054)
Louisville , Kentucky
Study Coordinator
Community Cancer Trials of Utah ( Site 0086)
Ogden , Utah
Study Coordinator
University Of Nebraska Medical Center ( Site 0078)
Omaha , Nebraska
Study Coordinator
Orlando Health Cancer Institute ( Site 0065)
Orlando , Florida
Study Coordinator
Renown Regional Medical Center ( Site 0056)
Reno , Nevada
Study Coordinator
Florida Cancer Specialists - North ( Site 7001)
St. Petersburg , Florida
Study Coordinator
Florida Cancer Specialists - East ( Site 7000)
West Palm Beach , Florida
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
16.07.2025
Completion date
27.10.2030
Registry ID
NCT06997497
Source
clinicaltrials.gov
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