AzTrials
AzTrials

Colon AdenocarcinomaPhase 3NCT06997497

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

A Phase 3 study testing Calderasib, Oxaliplatin and Leucovorin/levofolinate calcium in people with Colon Adenocarcinoma and Rectal Adenocarcinoma, run by Merck Sharp & Dohme LLC at 244 sites in 29 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Adenocarcinoma, Rectal Adenocarcinoma
What is being tested?
Calderasib, Oxaliplatin and Leucovorin/levofolinate calcium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
477 participants
Where
244 sitesin 29 countries
Study dates
16 Jul 2025to 27 Oct 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

244 sites in 29 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

244 sites in 29 countries

United States48 sites, 48 recruiting

  • Piedmont Atlanta Hospital ( Site 2002)

    Atlanta, Georgia, 30318

    Study Coordinator, 404-605-3068

    Recruiting

  • University of Maryland ( Site 2016)

    Baltimore, Maryland, 21201

    Study Coordinator, 410-328-8667

    Recruiting

  • Greater Baltimore Medical Center ( Site 0068)

    Baltimore, Maryland, 21204

    Study Coordinator, 443-849-3051

    Recruiting

  • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 2000)

    Billings, Montana, 59102

    Study Coordinator, 406-238-6685

    Recruiting

  • Saint Alphonsus Regional Medical Center ( Site 0085)

    Boise, Idaho, 83706

    Study Coordinator, 208-367-2121

    Recruiting

  • Miami Valley Hospital South ( Site 0075)

    Centerville, Ohio, 45459

    Study Coordinator, 937-438-2400

    Recruiting

  • University of Virginia ( Site 0080)

    Charlottesville, Virginia, 22908

    Study Coordinator, 434-243-8237

    Recruiting

  • University of Cincinnati Medical Center ( Site 2005)

    Cincinnati, Ohio, 45219

    Study Coordinator, 513-558-7650

    Recruiting

  • Texas Oncology - DFW ( Site 8002)

    Dallas, Texas, 75246

    Study Coordinator, 214-370-1000

    Recruiting

  • UT Southwestern Medical Center ( Site 0059)

    Dallas, Texas, 75390

    Study Coordinator, 214-645-9685

    Recruiting

  • Texas Oncology - Northeast Texas ( Site 8001)

    Denison, Texas, 75020

    Study Coordinator, 903-868-4700

    Recruiting

  • St. Luke's University Health Network ( Site 2014)

    Easton, Pennsylvania, 18045

    Study Coordinator, 484-658-1793

    Recruiting

  • Endeavor Health ( Site 2027)

    Evanston, Illinois, 60201

    Study Coordinator, 847-570-2112

    Recruiting

  • Virginia Cancer Specialists, PC ( Site 0069)

    Fairfax, Virginia, 22031

    Study Coordinator, 703-280-5390

    Recruiting

  • San Juan Oncology Associates, P.C ( Site 2011)

    Farmington, New Mexico, 87401

    Study Coordinator, 505-564-6850

    Recruiting

  • University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0087)

    Fort Collins, Colorado, 80528

    Study Coordinator, 970-493-6337

    Recruiting

  • Florida Cancer Specialists - South ( Site 7002)

    Fort Myers, Florida, 33901

    Study Coordinator, 239-274-9930

    Recruiting

  • Orange Coast Memorial Medical Center ( Site 2007)

    Fountain Valley, California, 92708

    Study Coordinator, 714-378-7000

    Recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0060)

    Hackensack, New Jersey, 07601

    Study Coordinator, 551-996-5855

    Recruiting

  • Hattiesburg Clinic ( Site 0064)

    Hattiesburg, Mississippi, 39401

    Study Coordinator, 601-288-2495

    Recruiting

  • University of Iowa ( Site 0074)

    Iowa City, Iowa, 52242

    Study Coordinator, 319-356-4200

    Recruiting

  • Mayo Clinic in Florida ( Site 0092)

    Jacksonville, Florida, 32224

    Study Coordinator, 904-953-5380

    Recruiting

  • Saint Luke's Cancer Institute ( Site 0082)

    Kansas City, Missouri, 64111

    Study Coordinator, 816-932-2677

    Recruiting

  • Comprehensive Cancer Centers of Nevada ( Site 2026)

    Las Vegas, Nevada, 89169

    Study Coordinator, 702-952-3400

    Recruiting

  • University of Kentucky ( Site 0055)

    Lexington, Kentucky, 40536

    Study Coordinator, 859-218-1758

    Recruiting

  • Accellacare of Duly ( Site 2015)

    Lisle, Illinois, 60532

    Study Coordinator, 630-545-7760

    Recruiting

  • Rocky Mountain Cancer Centers (RMCC) ( Site 8000)

    Lone Tree, Colorado, 80124

    Study Coordinator, 303-925-0700

    Recruiting

  • Los Angeles Hematology Oncology Medical Group ( Site 0084)

    Los Angeles, California, 90017

    Study Coordinator, 213-533-9655

    Recruiting

  • Norton Cancer Institute, Audubon Hospital Campus ( Site 0054)

    Louisville, Kentucky, 40217

    Study Coordinator, 502-636-7845

    Recruiting

  • Medical College of Wisconsin ( Site 2003)

    Milwaukee, Wisconsin, 53226

    Study Coordinator, 414-955-2607

    Recruiting

  • West Virginia University ( Site 2017)

    Morgantown, West Virginia, 26506

    Study Coordinator, 304-598-4000

    Recruiting

  • Memorial Sloan Kettering Cancer Center ( Site 0095)

    New York, New York, 10065

    Study Coordinator, 347-798-9213

    Recruiting

  • Community Cancer Trials of Utah ( Site 0086)

    Ogden, Utah, 84405

    Study Coordinator, 801-689-3909

    Recruiting

  • University Of Nebraska Medical Center ( Site 0078)

    Omaha, Nebraska, 68198

    Study Coordinator, 402-559-4000

    Recruiting

  • Orlando Health Cancer Institute ( Site 0065)

    Orlando, Florida, 32806

    Study Coordinator, 321-841-6780

    Recruiting

  • Mayo Clinic - Arizona ( Site 0090)

    Phoenix, Arizona, 85054

    Study Coordinator, 480-301-8000

    Recruiting

  • UPMC Hillman Cancer Center ( Site 2024)

    Pittsburgh, Pennsylvania, 15232

    Study Coordinator, 412-647-2811

    Recruiting

  • WakeMed Raleigh Campus ( Site 0094)

    Raleigh, North Carolina, 27610

    Study Coordinator, 919-350-2873

    Recruiting

  • Renown Regional Medical Center ( Site 0056)

    Reno, Nevada, 89502

    Study Coordinator, 775-982-4000

    Recruiting

  • Mayo Clinic in Rochester, Minnesota ( Site 0091)

    Rochester, Minnesota, 55905

    Study Coordinator, 507-284-2511

    Recruiting

  • University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 2021)

    Sacramento, California, 95817

    Study Coordinator, 916-734-5959

    Recruiting

  • Texas Oncology - San Antonio ( Site 8004)

    San Antonio, Texas, 78240

    Study Coordinator, 210-595-5300

    Recruiting

  • UCLA Hematology/Oncology - Santa Monica ( Site 0088)

    Santa Monica, California, 90404

    Study Coordinator, 310-794-6500

    Recruiting

  • Ellis Hospital ( Site 0098)

    Schenectady, New York, 12308

    Study Coordinator, 518-243-4762

    Recruiting

  • Fred Hutchinson Cancer Center ( Site 0076)

    Seattle, Washington, 98109

    Study Coordinator, 206-616-9025

    Recruiting

  • Florida Cancer Specialists - North ( Site 7001)

    St. Petersburg, Florida, 33705

    Study Coordinator, 727-216-1143

    Recruiting

  • Atlantic Health System ( Site 0093)

    Summit, New Jersey, 07901

    Study Coordinator, 908-522-2000

    Recruiting

  • Florida Cancer Specialists - East ( Site 7000)

    West Palm Beach, Florida, 33401

    Study Coordinator, 561-366-4100

    Recruiting

Other trials in United States

China36 sites, 36 recruiting

  • Peking Union Medical College Hospital ( Site 0824)

    Beijing, Beijing Municipality, 100730

    Study Coordinator, 8613910113193

    Recruiting

  • Peking University First Hospital(Daxing Area) ( Site 0838)

    Beijing, Beijing Municipality, 102627

    Study Coordinator, 010-56957544

    Recruiting

  • Jilin Cancer Hospital ( Site 0830)

    Changchun, Jilin, 130012

    Study Coordinator, 043180596065

    Recruiting

  • Hunan Cancer Hospital ( Site 0815)

    Changsha, Hunan, 410013

    Study Coordinator, 0731-89762130

    Recruiting

  • The Third Xiangya Hospital of Central South University ( Site 0834)

    Changsha, Hunan, 410013

    Study Coordinator, 0731-88638888

    Recruiting

  • West China Hospital, Sichuan University ( Site 0805)

    Chengdu, Sichuan, 610041

    Study Coordinator, 028-85422707

    Recruiting

  • Sichuan Cancer hospital. ( Site 0831)

    Chengdu, Sichuan, 610213

    Study Coordinator, 028-85420509

    Recruiting

  • Chongqing University Cancer Hospital ( Site 0808)

    Chongqing, Chongqing Municipality, 400030

    Study Coordinator, 13983841209

    Recruiting

  • Fujian Cancer Hospital ( Site 0807)

    Fuzhou, Fujian, 350014

    Study Coordinator, +86 13509339525

    Recruiting

  • Sun Yat-Sen University Cancer Center ( Site 0800)

    Guangzhou, Guangdong, 510060

    Study Coordinator, +86 02087343565

    Recruiting

  • Southern Medical University Nanfang Hospital ( Site 0812)

    Guangzhou, Guangdong, 510515

    Study Coordinator, +86 02062786845

    Recruiting

  • The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 0828)

    Guangzhou, Guangdong, 510655

    Study Coordinator, 020-38254000

    Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine ( Site 0801)

    Hangzhou, Zhejiang, 310017

    Study Coordinator, 0571-87783777

    Recruiting

  • Zhejiang Cancer Hospital ( Site 0821)

    Hangzhou, Zhejiang, 310022

    Study Coordinator, 0571-88122222

    Recruiting

  • Harbin Medical University Cancer Hospital ( Site 0847)

    Harbin, Heilongjiang, 150081

    Study Coordinator, 0451 86298278

    Recruiting

  • Anhui Provincial Cancer Hospital ( Site 0803)

    Hefei, Anhui, 230031

    Study Coordinator, 0551-65327666

    Recruiting

  • The Second Affiliated Hospital of Anhui Medical University ( Site 0813)

    Hefei, Anhui, 230601

    Study Coordinator, 0551-63869536

    Recruiting

  • Jinan Central Hospital ( Site 0817)

    Jinan, Shandong, 250013

    Study Coordinator, 0531-55739999

    Recruiting

  • Shandong Cancer Hospital ( Site 1901)

    Jinan, Shandong, 250117

    Study Coordinator, 053167626342

    Recruiting

  • First Affiliated Hospital of Kunming Medical University ( Site 0845)

    Kunming, Yunnan, 650032

    Study Coordinator, 087165324888

    Recruiting

  • The First Affiliated Hospital of Nanchang University ( Site 0826)

    Nanchang, Jiangxi, 330200

    Study Coordinator, 0791-88692748

    Recruiting

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0825)

    Nanjing, Jiangsu, 210000

    Study Coordinator, 025-83106666

    Recruiting

  • Guangxi Medical University Affiliated Tumor Hospital ( Site 0804)

    Nanning, Guangxi, 530200

    Study Coordinator, +86 07715323175

    Recruiting

  • Zhongshan Hospital of Fudan University ( Site 0832)

    Shanghai, Shanghai Municipality, 200032

    Study Coordinator, 02164041990

    Recruiting

  • Fudan University Shanghai Cancer Center ( Site 0816)

    Shanghai, Shanghai Municipality, 200120

    Study Coordinator, 021-64175590

    Recruiting

  • Shanghai Renji Hospital Affiliated to Jiao Tong University ( Site 1906)

    Shanghai, Shanghai Municipality, 200127

    Study Coordinator, +8615121110481

    Recruiting

  • The University of Hong Kong - Shenzhen Hospital ( Site 1903)

    Shenzhen, Guangdong, 518053

    Study Coordinator, +86075586913333

    Recruiting

  • First Affiliated Hospital of Shanxi Medical University ( Site 0843)

    Taiyuan, Shanxi, 030001

    Study Coordinator, 0351-4639931

    Recruiting

  • Chongqing University Three Gorges Hospital ( Site 0837)

    Wanzhou, Chongqing Municipality, 404199

    Study Coordinator, 023-58103019

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University ( Site 0840)

    Wenzhou, Zhejiang, 325000

    Study Coordinator, +86057755579591

    Recruiting

  • Tongji Hospital Tongji Medical,Science & Technology ( Site 0839)

    Wuhan, Hubei, 430030

    Study Coordinator, 027-83663940

    Recruiting

  • Hubei Cancer Hospital ( Site 0814)

    Wuhan, Hubei, 430079

    Study Coordinator, 027-87670500

    Recruiting

  • The First Affiliated Hospital of Xi an Jiaotong University ( Site 0802)

    Xi'an, Shaanxi, 710061

    Study Coordinator, 029-85324783

    Recruiting

  • The First Affiliated Hospital of Xiamen University ( Site 0806)

    Xiamen, Fujian, 361003

    Study Coordinator, +86 13575559341

    Recruiting

  • Zhongshan Hospital Affiliated to Xiamen University ( Site 1902)

    Xiamen, Fujian, 361004

    Study Coordinator, +8605922292201

    Recruiting

  • Henan Cancer Hospital ( Site 0822)

    Zhengzhou, Henan, 450008

    Study Coordinator, 037165587161

    Recruiting

Other trials in China

Japan16 sites, 16 recruiting

  • Nippon Medical School Hospital ( Site 0859)

    Bunkyo, Tokyo, 113-8603

    Study Coordinator, +81-3-3822-2131

    Recruiting

  • Chiba Cancer Center ( Site 0858)

    Chiba, 260-8717

    Study Coordinator, +81-43-264-5431

    Recruiting

  • National Cancer Center Hospital ( Site 0850)

    Chūō, Tokyo, 104-0045

    Study Coordinator, +81-3-3542-2511

    Recruiting

  • Kyushu University Hospital ( Site 0862)

    Fukuoka, 812-8582

    Study Coordinator, +81-92-642-5774

    Recruiting

  • Saitama Medical University International Medical Center ( Site 0860)

    Hidaka, Saitama, 350-1298

    Study Coordinator, +81-42-984-4111

    Recruiting

  • National Cancer Center Hospital East ( Site 0851)

    Kashiwa, Chiba, 277-8577

    Study Coordinator, +81-4-7133-1111

    Recruiting

  • Kagawa University Hospital ( Site 0861)

    Kita-gun, Kagawa-ken, 761-0793

    Study Coordinator, +81-87-891-2345

    Recruiting

  • Saitama Prefectural Cancer Center ( Site 0857)

    Kitaadachi-gun, Saitama, 362-0806

    Study Coordinator, +81-48-722-1111

    Recruiting

  • Cancer Institute Hospital of JFCR ( Site 0863)

    Koto, Tokyo, 135-8550

    Study Coordinator, +81-3-3520-0111

    Recruiting

  • Aichi Cancer Center ( Site 0855)

    Nagoya, Aichi-ken, 464-8681

    Study Coordinator, +81-52-762-6111

    Recruiting

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0852)

    Osaka, 541-8567

    Study Coordinator, +81-6-6945-1181

    Recruiting

  • Kindai University Hospital ( Site 0854)

    Sakai, Osaka, 590-0197

    Study Coordinator, +81-72-366-0221

    Recruiting

  • Teine Keijinkai Hospital ( Site 0864)

    Sapporo, Hokkaido, 006-8555

    Study Coordinator, +81-11-681-8111

    Recruiting

  • Tohoku University Hospital ( Site 0853)

    Sendai, Miyagi, 980-8574

    Study Coordinator, +81-22-717-7000

    Recruiting

  • Shizuoka Cancer Center ( Site 0856)

    Sunto-gun, Shizuoka, 411-8777

    Study Coordinator, +81-55-989-5222

    Recruiting

  • Kanagawa Cancer Center ( Site 0865)

    Yokohama, Kanagawa, 241-8515

    Study Coordinator, +81-45-520-2222

    Recruiting

Other trials in Japan

Ukraine12 sites, 12 recruiting

  • MNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of CRC" ( Site 1706)

    Cherkasy, Cherkasy Oblast, 18009

    Study Coordinator, +380472319418

    Recruiting

  • RMNE "Bukovyna Clinical Oncology Center" ( Site 1709)

    Chernivtsi, Chernivetska Oblast, 58013

    Study Coordinator, 0443344770

    Recruiting

  • MNPE "Prykarpattia Clinical Oncology Center of Ivano-Frankivsk Regional Council" ( Site 1701)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

    Study Coordinator, +380966059053

    Recruiting

  • CNE "Regional Clinical Oncology Center of the Kirovohrad Regional Council" ( Site 1702)

    Kropyvnytskyi, Kirovohrad Oblast, 25011

    Study Coordinator, +380508427973

    Recruiting

  • Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1704)

    Kyiv, 03057

    Study Coordinator, +380669472333

    Recruiting

  • SI "National Institute of Surgery and Transplantology named after O. O. Shalimov" ( Site 1713)

    Kyiv, 03126

    Study Coordinator, +380956017249

    Recruiting

  • LLC "MEDICAL CENTER DOBROBUT-CLINIC" ( Site 1703)

    Kyiv, 03151

    Study Coordinator, +380671502987

    Recruiting

  • ME "Volyn Regional Clinical Hospital" of the VRC ( Site 1712)

    Lutsk, Volyn Oblast, 43018

    Study Coordinator, 380503782998

    Recruiting

  • MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 1708)

    Lviv, Lviv Oblast, 79059

    Study Coordinator, +380977453295

    Recruiting

  • ME "Rivne Regional Antitumor Center" Rivne Regional Council ( Site 1714)

    Rivne, Rivne Oblast, 33010

    Study Coordinator, +380362633075

    Recruiting

  • MNE "Central City Hospital" ( Site 1711)

    Rivne, Rivne Oblast, 33017

    Study Coordinator, +380508266088

    Recruiting

  • Uzhgorod Central City Clinical Hospital ( Site 1700)

    Uzhhorod, Zakarpattia Oblast, 88000

    Study Coordinator, +380953274431

    Recruiting

Other trials in Ukraine

France11 sites, 11 recruiting

  • Institut de Cancérologie de l'Ouest ( Site 1062)

    Angers, Pays de la Loire Region, 49055

    Study Coordinator, +33241352700

    Recruiting

  • Sainte Catherine Institut du Cancer Avignon Provence ( Site 1065)

    Avignon, Vaucluse, 84918

    Study Coordinator, +33490276161

    Recruiting

  • Centre François Baclesse ( Site 1061)

    Caen, Calvados, 14000

    Study Coordinator, +33231455050

    Recruiting

  • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1064)

    Limoges, Limousin, 87042

    Study Coordinator, +33555056396

    Recruiting

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1058)

    Nice, Alpes-Maritimes, 06202

    Study Coordinator, +33492036021

    Recruiting

  • Hôpital Saint Antoine ( Site 1051)

    Paris, 75571

    Study Coordinator, +33149281839

    Recruiting

  • Hôpital Européen Georges Pompidou ( Site 1050)

    Paris, Île-de-France Region, 75015

    Study Coordinator, +33156092000

    Recruiting

  • Institut Jean Godinot ( Site 1054)

    Reims, Marne, 51100

    Study Coordinator, +33326504246

    Recruiting

  • CHU Charles Nicolle ( Site 1066)

    Rouen, Seine-Maritime, 76031

    Study Coordinator, +33232888148

    Recruiting

  • CHU Rangueil ( Site 1063)

    Toulouse, Haute-Garonne, 31059

    Study Coordinator, +33561322142

    Recruiting

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1053)

    Vandœuvre-lès-Nancy, Lorraine, 54511

    Study Coordinator, +33772081634

    Recruiting

Other trials in France

Brazil10 sites, 10 recruiting

  • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0155)

    Barretos, São Paulo, 14784-400

    Study Coordinator, +551733216600

    Recruiting

  • CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0157)

    Florianópolis, Santa Catarina, 88020-210

    Study Coordinator, +554833804828

    Recruiting

  • Hospital de Caridade de Ijuí ( Site 0150)

    Ijuí, Rio Grande do Sul, 98700-000

    Study Coordinator, +55 55 981580022

    Recruiting

  • Associação Hospitalar Beneficente São Vicente de Paulo ( Site 0153)

    Passo Fundo, Rio Grande do Sul, 99010-080

    Study Coordinator, +555433164000

    Recruiting

  • Hospital Nossa Senhora da Conceição ( Site 0156)

    Porto Alegre, Rio Grande do Sul, 91350-200

    Study Coordinator, +5551993590437

    Recruiting

  • Hospital de Câncer de Recife ( Site 0158)

    Recife, Pernambuco, 50040-000

    Study Coordinator, +558132178084

    Recruiting

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0159)

    São José do Rio Preto, São Paulo, 15090-000

    Study Coordinator, +55 17 3201-5054

    Recruiting

  • COE Ensino e Pesquisa ( Site 0151)

    São José dos Campos, São Paulo, 12242-660

    Study Coordinator, +5511960903468

    Recruiting

  • Instituto do Cancer Arnaldo Vieira de Carvalho ( Site 0160)

    São Paulo, 01209-000

    Study Coordinator, +55 11 3225-0155

    Recruiting

  • IBCC - Núcleo de Pesquisa e Ensino ( Site 0154)

    São Paulo, 04014-002

    Study Coordinator, +551134744222

    Recruiting

Other trials in Brazil

Chile10 sites, 10 recruiting

  • Clínica Puerto Montt ( Site 0206)

    Port Montt, Los Lagos Region, 5500243

    Study Coordinator, +56652484800

    Recruiting

  • Fundacion Arturo Lopez Perez ( Site 0201)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, 56224205098

    Recruiting

  • Centro de Oncología de Precisión ( Site 0207)

    Santiago, Region M. de Santiago, 7560908

    Study Coordinator, +56991612199

    Recruiting

  • Clínica UC San Carlos de Apoquindo ( Site 0211)

    Santiago, Region M. de Santiago, 7620002

    Study Coordinator, +56991290140

    Recruiting

  • CECIM ( Site 0210)

    Santiago, Region M. de Santiago, 8331143

    Study Coordinator, +56226965804

    Recruiting

  • Bradfordhill ( Site 0200)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, 56229490970

    Recruiting

  • CIDO SpA ( Site 0212)

    Temuco, Araucania, 4810148

    Study Coordinator, +56452657374

    Recruiting

  • Oncocentro Valdivia ( Site 0204)

    Valdivia, Los Ríos Region, 5112129

    Study Coordinator, 56958537020

    Recruiting

  • ONCOCENTRO APYS ( Site 0203)

    Viña del Mar, Valparaiso, 2520598

    Study Coordinator, +56323320850

    Recruiting

  • Clínica RedSalud Vitacura ( Site 0202)

    Vitacura, Region M. de Santiago, 7650018

    Study Coordinator, +56223954046

    Recruiting

Other trials in Chile

Spain9 sites, 9 recruiting

  • Institut Català d'Oncologia (ICO) - Badalona ( Site 1552)

    Badalona, Barcelona, 08916

    Study Coordinator, 34 934 97 89 25

    Recruiting

  • Hospital Universitari Vall d'Hebron ( Site 1553)

    Barcelona, 08035

    Study Coordinator, +34 93 489 43 50

    Recruiting

  • Hospital Insular de Gran Canaria ( Site 1558)

    Las Palmas de Gran Canaria, Las Palmas, 35016

    Study Coordinator, 34 928441738

    Recruiting

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1554)

    Madrid, 28007

    Study Coordinator, +34914269325

    Recruiting

  • Hospital Clinico San Carlos ( Site 1555)

    Madrid, 28040

    Study Coordinator, 34913303000x484833

    Recruiting

  • Hospital Universitario Central de Asturias ( Site 1550)

    Oviedo, Principality of Asturias, 33011

    Study Coordinator, 34 985108000x36582

    Recruiting

  • Hospital Universitario Marqués de Valdecilla ( Site 1551)

    Santander, Cantabria, 39008

    Study Coordinator, +34 942202525

    Recruiting

  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1556)

    Seville, 41013

    Study Coordinator, +34 955 013 068

    Recruiting

  • Instituto Valenciano de Oncologia - IVO ( Site 1557)

    Valencia, 46009

    Study Coordinator, 34961114000

    Recruiting

Other trials in Spain

South Korea8 sites, 8 recruiting

  • Kyungpook National University Chilgok Hospital ( Site 0701)

    Buk-Gu, Taegu-Kwangyokshi, 41404

    Study Coordinator, +82532003011

    Recruiting

  • Samsung Medical Center ( Site 0708)

    Gangnam, Seoul, 06351

    Study Coordinator, +82234100297

    Recruiting

  • National Cancer Center ( Site 0702)

    Goyang-si, Kyonggi-do, 10408

    Study Coordinator, +82319201737

    Recruiting

  • Seoul National University Bundang Hospital ( Site 0705)

    Seongnam-si, Kyonggi-do, 13620

    Study Coordinator, +8215883369

    Recruiting

  • Seoul National University Hospital ( Site 0706)

    Seoul, 03080

    Study Coordinator, +82-2-1588-5700

    Recruiting

  • Korea University Guro Hospital ( Site 0704)

    Seoul, 08308

    Study Coordinator, 82226263060

    Recruiting

  • Asan Medical Center ( Site 0707)

    Songpa-gu, Seoul, 05505

    Study Coordinator, 82-2-3010-3204

    Recruiting

  • The Catholic University of Korea St. Vincent s Hospital ( Site 0703)

    Suwon, Kyonggi-do, 16247

    Study Coordinator, 82-31-881-8893

    Recruiting

Other trials in South Korea

Italy7 sites, 7 recruiting

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 1300)

    Milan, Lombardy, 20162

    Study Coordinator, 00390264442291

    Recruiting

  • Ospedale San Raffaele. ( Site 1305)

    Milan, 20132

    Study Coordinator, +39.0226435138

    Recruiting

  • AOU Cagliari ( Site 1306)

    Monserrato, Cagliari, 09042

    Study Coordinator, +39 07051096037

    Recruiting

  • Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UOC Oncoematologia ( Site 1302)

    Naples, 80131

    Study Coordinator, 00390815666760

    Recruiting

  • Istituto Oncologico Veneto IRCCS ( Site 1307)

    Padova, 35128

    Study Coordinator, 390498215910

    Recruiting

  • Azienda USL della Romagna ( Site 1303)

    Ravenna, 48100

    Study Coordinator, 00390544285247

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 1304)

    Verona, 37134

    Study Coordinator, 00393200117982

    Recruiting

Other trials in Italy

Argentina6 sites, 6 recruiting

  • Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0110)

    Berazategui, Buenos Aires, B1884BBF

    Study Coordinator, +541142262013

    Recruiting

  • Hospital Italiano de Buenos Aires ( Site 0102)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB

    Study Coordinator, +5491155960279

    Recruiting

  • Hospital Privado Universitario de Córdoba ( Site 0108)

    Córdoba, X5016KEH

    Study Coordinator, +543514688846

    Recruiting

  • Instituto Alexander Fleming ( Site 0101)

    Mar del Plata, Buenos Aires, C1426ANZ

    Study Coordinator, +5491166936669

    Recruiting

  • Fundacion Estudios Clinicos ( Site 0105)

    Rosario, Santa Fe Province, S2000CEJ

    Study Coordinator, +5493413168137

    Recruiting

  • Sanatorio Parque ( Site 0103)

    Rosario, Santa Fe Province, S2000CUB

    Study Coordinator, +5493464586234

    Recruiting

Other trials in Argentina

Canada6 sites, 6 recruiting

  • CIUSSS- saguenay-Lac-Saint-Jean ( Site 0007)

    Chicoutimi, Quebec, G7H 5H6

    Study Coordinator, 41854112342707

    Recruiting

  • London Health Sciences Centre ( Site 0012)

    London, Ontario, N6A 5W9

    Study Coordinator, 5196858500

    Recruiting

  • Moncton Hospital - Horizon Health Network ( Site 0011)

    Moncton, New Brunswick, E1C 6Z8

    Study Coordinator, 5068575756

    Recruiting

  • Jewish General Hospital ( Site 0006)

    Montreal, Quebec, H3T 1E2

    Study Coordinator, 514-340-8222

    Recruiting

  • Princess Margaret Cancer Centre ( Site 0001)

    Toronto, Ontario, M5G 2M9

    Study Coordinator, 416-946-4559

    Recruiting

  • Cancercare Manitoba ( Site 0009)

    Winnipeg, Manitoba, R3E 0V9

    Study Coordinator, 204-787-4156

    Recruiting

Other trials in Canada

Mexico6 sites, 6 recruiting

  • Centro de Investigación Oncológica Galerías SC ( Site 0408)

    Aguascalientes, 20124

    Study Coordinator, +525527280926

    Recruiting

  • Centro de Inmuno Oncología de Occidente SA de CV ( Site 0403)

    Guadalajara, Jalisco, 44630

    Study Coordinator, +523313587270

    Recruiting

  • Higiea Oncologia ( Site 0404)

    Mexico City, Mexico City, 11810

    Study Coordinator, +525554137773

    Recruiting

  • Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 0401)

    Monterrey, Nuevo León, 64460

    Study Coordinator, 8183338111 ext 1100

    Recruiting

  • Centro de Investigacion Clinica de Oaxaca ( Site 0402)

    Oaxaca City, 68020

    Study Coordinator, +529516035559

    Recruiting

  • Oncare Oncology (Servicios de Oncologia Médica Integral S.A. de C.V. - unidad San Pedro) ( Site 0407)

    San Pedro Garza García, Nuevo León, 66220

    Study Coordinator, 8110674829

    Recruiting

Other trials in Mexico

Turkey (Türkiye)6 sites, 6 recruiting

  • Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1652)

    Adana, 01250

    Study Coordinator, +905334473857

    Recruiting

  • Gazi Universitesi ( Site 1651)

    Ankara, 06560

    Study Coordinator, +900552 405 94 79

    Recruiting

  • Dicle Üniversitesi ( Site 1654)

    Diyarbakır, 21200

    Study Coordinator, +9005531193420

    Recruiting

  • Istanbul Universitesi Cerrahpasa ( Site 1656)

    Istanbul, 34098

    Study Coordinator, 90 537 998 3832

    Recruiting

  • Ege Universitesi Hastanesi ( Site 1653)

    Izmir, 35080

    Study Coordinator, +900538 269 01 34

    Recruiting

  • Hacettepe Universite Hastaneleri ( Site 1650)

    Sıhhiye, Ankara, 06230

    Study Coordinator, +90506 099 24 19

    Recruiting

Other trials in Turkey (Türkiye)

United Kingdom6 sites, 6 recruiting

  • Heartlands Hospital ( Site 1759)

    Birmingham, England, B9 5ss

    Study Coordinator, +4401214241396

    Recruiting

  • Velindre Cancer Centre Hospital ( Site 1753)

    Cardiff, CF14 2TL

    Study Coordinator, +4402920615888

    Recruiting

  • University Hospital Coventry & Warwickshire ( Site 1761)

    Coventry, Warwickshire, CV2 2DX

    Study Coordinator, 024 7696 4000

    Recruiting

  • University College London Hospitals ( Site 1750)

    London, London, City of, NW1 2PG

    Study Coordinator, 020 3456 7890

    Recruiting

  • The Christie NHS Foundation Trust ( Site 1755)

    Manchester, M20 4BX

    Study Coordinator, +441614468370

    Recruiting

  • Churchill Hospital ( Site 1756)

    Oxford, Oxfordshire, ox3 7le

    Study Coordinator, +4403003047777

    Recruiting

Other trials in United Kingdom

Israel5 sites, 5 recruiting

  • Rambam Health Care Campus ( Site 1253)

    Haifa, 3109601

    Study Coordinator, +97247776234

    Recruiting

  • Hadassah Medical Center ( Site 1252)

    Jerusalem, 9112001

    Study Coordinator, 02-6777111

    Recruiting

  • Rabin Medical Center ( Site 1251)

    Petah Tikva, 4941492

    Study Coordinator, 03-9377589

    Recruiting

  • Sheba Medical Center ( Site 1254)

    Ramat Gan, 5265601

    Study Coordinator, +97235303030

    Recruiting

  • Sourasky Medical Center ( Site 1255)

    Tel Aviv, 6423906

    Study Coordinator, +97236974444

    Recruiting

Other trials in Israel

Poland5 sites, 5 recruiting

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1452)

    Gliwice, Silesian Voivodeship, 44-101

    Study Coordinator, +48322788237

    Recruiting

  • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 1456)

    Koszalin, West Pomeranian Voivodeship, 75-581

    Study Coordinator, +48943488930

    Recruiting

  • Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 1457)

    Poznan, Greater Poland Voivodeship, 61-866

    Study Coordinator, +48943488930

    Recruiting

  • Mrukmed ( Site 1450)

    Rzeszów, Podkarpackie Voivodeship, 35-021

    Study Coordinator, +48178530728

    Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site 1451)

    Warsaw, Masovian Voivodeship, 02-034

    Study Coordinator, +48225709241

    Recruiting

Other trials in Poland

Romania5 sites, 5 recruiting

  • Fundeni Clinical Institute-Medical Oncology ( Site 1504)

    Bucharest, 022328

    Study Coordinator, +4021 275 0500

    Recruiting

  • Institutul Oncologic Cluj ( Site 1502)

    Cluj-Napoca, Cluj, 400015

    Study Coordinator, +40 264 598 362

    Recruiting

  • SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 1501)

    Cluj-Napoca, Cluj, 407280

    Study Coordinator, 021 9368

    Recruiting

  • Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1500)

    Craiova, Dolj, 200746

    Study Coordinator, +40 731 604 432

    Recruiting

  • Institutul Regional de Oncologie ( Site 1505)

    Iași, 700483

    Study Coordinator, +40374278811

    Recruiting

Other trials in Romania

Australia4 sites, 4 recruiting

  • Sunshine Coast University Hospital ( Site 0451)

    Birtinya, Queensland, 4575

    Study Coordinator, +61752020000

    Recruiting

  • Monash Health ( Site 0454)

    Clayton, Victoria, 3168

    Study Coordinator, +61 03 8572-2941

    Recruiting

  • Western Health-Sunshine & Footscray Hospitals ( Site 0450)

    St Albans, Victoria, 3021

    Study Coordinator, +61383959167

    Recruiting

  • Wollongong Hospital ( Site 0453)

    Wollongong, New South Wales, 2500

    Study Coordinator, +61242225000

    Recruiting

Other trials in Australia

Germany4 sites, 4 recruiting

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1101)

    Berlin, 10117

    Study Coordinator, 00493045050

    Recruiting

  • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 1104)

    Essen, North Rhine-Westphalia, 45136

    Study Coordinator, +49 20117424001

    Recruiting

  • Katholisches Marienkrankenhaus gGmbH ( Site 1103)

    Hamburg, 22087

    Study Coordinator, 00494025460

    Recruiting

  • Asklepios Klinik Altona ( Site 1100)

    Hamburg, 22763

    Study Coordinator, 0049401818810

    Recruiting

Other trials in Germany

Netherlands4 sites, 4 recruiting

  • Amsterdam UMC, locatie VUmc ( Site 1351)

    Amsterdam, North Holland, 1081 HV

    Study Coordinator, +31204444321

    Recruiting

  • Amphia Ziekenhuis, locatie Breda Molengracht ( Site 1352)

    Breda, North Brabant, 4818 CK

    Study Coordinator, +31 76 5951006

    Recruiting

  • Radboudumc ( Site 1354)

    Nijmegen, Gelderland, 6525 GA

    Study Coordinator, +31 24 3610353

    Recruiting

  • Erasmus Medisch Centrum ( Site 1353)

    Rotterdam, South Holland, 3015 GD

    Study Coordinator, +31107034447

    Recruiting

Other trials in Netherlands

Taiwan4 sites, 4 recruiting

  • National Cheng Kung University Hospital ( Site 0754)

    Tainan, 704

    Study Coordinator, +88662353535

    Recruiting

  • National Taiwan University Hospital ( Site 0751)

    Taipei, 100

    Study Coordinator, +886-2-23123456

    Recruiting

  • Taipei Veterans General Hospital ( Site 0752)

    Taipei, 112

    Study Coordinator, +886228712121

    Recruiting

  • Chang Gung Memorial Hospital - Linkou Branch ( Site 0753)

    Taoyuan, 333

    Study Coordinator, +88633281200

    Recruiting

Other trials in Taiwan

Colombia3 sites, 3 recruiting

  • Hospital Universitario San Ignacio ( Site 0254)

    Bogota, Cundinamarca, 110231

    Study Coordinator, +573152931879

    Recruiting

  • IMAT S.A.S ( Site 0252)

    Montería, Departamento de Córdoba, 230002

    Study Coordinator, +576047862333

    Recruiting

  • Oncologos Del Occidente ( Site 0255)

    Pereira, Risaralda Department, 660001

    Study Coordinator, +57 3187715522

    Recruiting

Other trials in Colombia

Malaysia3 sites, 3 recruiting

  • Hospital Pulau Pinang ( Site 0550)

    George Town, Pulau Pinang, 10990

    Study Coordinator, +6042225333

    Recruiting

  • Sarawak General Hospital ( Site 0551)

    Kuching, Sarawak, 93586

    Study Coordinator, +6082276666

    Recruiting

  • National Cancer Institute ( Site 0552)

    Putrajaya, Putrajaya, 62250

    Study Coordinator, +60388925555

    Recruiting

Other trials in Malaysia

Philippines3 sites, 3 recruiting

  • Cebu Doctors University Hospital ( Site 0602)

    Cebu, 6000

    Study Coordinator, +63 32 253 7511

    Recruiting

  • Davao Doctors Hospital ( Site 0603)

    Davao City, Davao Del Sur, 8000

    Study Coordinator, 639171129752

    Recruiting

  • Mary Mediatrix Medical Center ( Site 0600)

    Lipa, Batangas, 4217

    Study Coordinator, 639173145800

    Recruiting

Other trials in Philippines

Finland2 sites, 2 recruiting

  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1000)

    Helsinki, Uusimaa, 00290

    Study Coordinator, +358504272703

    Recruiting

  • Tampere University Hospital ( Site 1001)

    Tampere, Pirkanmaa, 33520

    Study Coordinator, +358503375000

    Recruiting

Other trials in Finland

Hong Kong2 sites, 2 recruiting

  • Prince of Wales Hospital. ( Site 0500)

    Hong Kong

    Study Coordinator, + 852 3505 2211

    Recruiting

  • Queen Mary Hospital ( Site 0501)

    Hong Kong

    Study Coordinator, +852 2255 3838

    Recruiting

Other trials in Hong Kong

Hungary2 sites, 2 recruiting

  • Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 1200)

    Budapest, 1088

    Study Coordinator, +3614591500

    Recruiting

  • Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 1204)

    Pécs, Baranya, 7624

    Study Coordinator, +3672536480

    Recruiting

Other trials in Hungary

Singapore1 site, 1 recruiting

  • National Cancer Centre Singapore ( Site 0650)

    Singapore, Central Singapore, 168583

    Study Coordinator, +6564368000

    Recruiting

Other trials in Singapore

About this study

Official title: 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)

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.

Read more

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.
Read the detailed description

This study will have 2 parts.

Being tested
Calderasib, Oxaliplatin, Leucovorin/levofolinate calcium, 5-Fluorouracil, Cetuximab
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CalderasibDrug

    Also called MK-1084

    Oral tablet

  • OxaliplatinDrug

    Per label

  • Leucovorin/levofolinate calciumDrug

    Per label

  • 5-FluorouracilDrug

    Per label

  • CetuximabBiological

    Also called Erbitux

    Per label

  • BevacizumabDrug

    Also called Avastin

    Per label

  • Bevacizumab biosimilarDrug

    Also called MVASI

    Per label

Study groups in NCT06997497
Study groupRoleWhat they receive
Calderasib + Cetuximab + mFOLFOX6ExperimentalParticipants will receive calderasib orally, cetuximab per label every 2 weeks (Q2W), and mFOLFOX6 chemotherapy: oxaliplatin per label every 2 weeks (Q2W), leucovorin or levofolinate calcium per label Q2W, and 5-fluorouracil (5-FU) per label Q2W. Treatment will continue until criteria for discontinuation is met.
Receives: Drug: Calderasib; Drug: Oxaliplatin; Drug: Leucovorin/levofolinate calcium; Drug: 5-Fluorouracil; Biological: Cetuximab
mFOLFOX6Active comparatorParticipants will receive mFOLFOX6 chemotherapy: oxaliplatin per label Q2W, leucovorin or levofolinate calcium per label Q2W, and 5-fluorouracil (5-FU) per label Q2W. Participants may also receive bevacizumab or bevacizumab biosimilar Q2W at the investigator's discretion. Treatment will continue until criteria for discontinuation is met.
Receives: Drug: Oxaliplatin; Drug: Leucovorin/levofolinate calcium; Drug: 5-Fluorouracil; Drug: Bevacizumab; Drug: Bevacizumab biosimilar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing Dose-Limiting Toxicity (DLT)

    A DLT is defined as the occurrence of protocol-specified toxicities if assessed by the investigator to be possibly, probably, or definitely related to study intervention administration.

    Measured: Up to approximately 28 days

  2. Part 1: Number of Participants Who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 44 months

  3. Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 44 months

  4. Progression Free Survival (PFS)

    PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 44 months

Secondary outcomes (15)

  1. Objective Response Rate (ORR)

    ORR is defined as a confirmed complete response (CR: the disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). The percentage of participants who experience CR or PR as assessed by BICR will be presented.

    Measured: Up to approximately 3 years

  2. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 5 years

  3. Duration of Response (DOR)

    For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.

    Measured: Up to approximately 4 years

  4. Part 2: Number of Participants with an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 5 years

  5. Part 2: Number of Participants who Discontinue Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 5 years

  6. 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

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score will be presented. A higher score indicates a better outcome.

    Measured: Baseline and up to approximately 5 years

  7. Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate better physical functioning. The change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) combined score will be presented.

    Measured: Baseline and up to approximately 5 years

  8. Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Combined Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. The role functioning score is based on participant responses to questions scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate better role functioning. The change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) combined score will be presented.

    Measured: Baseline and up to approximately 5 years

  9. Change from Baseline in the EORTC-QLQ-C30 Appetite Loss (Item 13) Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life questionnaire, including a single-item scale score for appetite loss (QLQ-C30 Item 13). For this item, individual responses to the question "Have you lacked appetite?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-C30 appetite loss (Item 13) scale score will be presented.

    Measured: Baseline and up to approximately 5 years

  10. Change from Baseline in the EORTC-Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score

    The EORTC QLQ-CR29 is a health-related quality-of life questionnaire specific for colorectal cancer, including a single-item scale score for bloating (QLQ-CR29 Item 37). For this item, individual responses to the question "Did you have a bloated feeling in your abdomen?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-CR29 bloating (Item 37) scale score will be presented.

    Measured: Baseline and up to approximately 5 years

  11. Time to First Deterioration (TTD) in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in global health status (GHS) (EORTC QLQ-C30 Item 29) \& quality of life (QoL) combined score (EORTC QLQ-C30 Item 30). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome.

    Measured: Baseline and up to approximately 5 years

  12. TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome.

    Measured: Baseline and up to approximately 5 years

  13. TTD in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. The role functioning score is based on participant responses to questions scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better role functioning. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in role functioning score, will be presented. A longer TTD indicates a better outcome.

    Measured: Baseline and up to approximately 5 years

  14. TTD in EORTC QLQ-C30 Appetite Loss (Item 13) Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in appetite loss score (EORTC QLQ-C30 Item 13). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome.

    Measured: Baseline and up to approximately 5 years

  15. TTD in EORTC QLQ-CR29 Bloating (Item 37) Score

    The EORTC QLQ-CR29 is a health-related quality-of life questionnaire specific for colorectal cancer, including a single-item scale score for bloating (QLQ-CR29 Item 37). TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in bloating score (QLQ-CR29 Item 37). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in appetite loss score, will be presented. A longer TTD indicates a better outcome.

    Measured: Baseline and up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2025
  2. Study start16 Jul 2025
  3. Primary completion28 Mar 2029 (estimated)
  4. Study completion27 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
477 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06997497
Sponsor's protocol ID
1084-012
Other IDs
MK-1084-012, KANDLELIT-012, 2024-517232-22-00, U1111-1311-8311, jRCT2031250265
Status last verified
Oct 2026
First submitted
21 May 2025
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Calderasib, Oxaliplatin and Leucovorin/levofolinate calcium in people with Colon Adenocarcinoma and Rectal Adenocarcinoma, run by Merck Sharp & Dohme LLC at 244 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 244 sites in United States, China, Japan, Ukraine, France and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (time frame: Up to approximately 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06997497.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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