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Calderasib with Targeted Therapy and Chemotherapy for Colorectal Cancer

This study is looking for new ways to treat advanced colorectal cancer (cancer of the colon or rectum) that has spread or cannot be removed by surgery, and has a specific gene change called KRAS G12C. Researchers are testing if adding calderasib and cetuximab (both targeted therapies) to standard chemotherapy (oxaliplatin, leucovorin, and 5-fluorouracil) is safe and helps people live longer without their cancer growing or spreading. You may be able to join if you are 18 or older, have this type of colorectal cancer with the KRAS G12C mutation, and meet other specific criteria. The study will look at side effects and how well people tolerate the treatments.

Study design
This interventional study plans to enroll 477 participants. It has two parts, but the specific design (like randomization or blinding) is not detailed.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects for up to approximately 44 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06997497

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~477 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:CalderasibOxaliplatinLeucovorin/levofolinate calcium5-FluorouracilCetuximabBevacizumab

At a glance

Recruiting sites
228 of 228 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Experiencing Dose-Limiting Toxicity (DLT)
Measured over Up to approximately 28 days
+3 more outcomes measured

Conditions

Colon Adenocarcinoma
Rectal Adenocarcinoma

Explore related trials

Colon AdenocarcinomaRectal AdenocarcinomaGTPase KRas

Where it's being run

228 sites across 148 states
Region M. de Santiago6
Israel5
Italy5
Spain5
Turkey (Türkiye)5
Florida4
Texas4
Guangdong4

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Number of Participants Experiencing Dose-Limiting Toxicity (DLT)Up to approximately 28 days

    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.

  • Part 1: Number of Participants Who Experience an Adverse Event (AE)Up to approximately 44 months

    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.

  • Part 1: Number of Participants Who Discontinue Study Treatment Due to an AEUp to approximately 44 months

    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.

  • Progression Free Survival (PFS)Up to approximately 44 months

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