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Looking for participantsPhase3

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

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06997497

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Calderasib (drug), Oxaliplatin (drug), Leucovorin/levofolinate calcium (drug), 5-Fluorouracil (drug)
How long the study runs
Study runs about 63 months (dates as stated)
About the drug or intervention
Calderasib — drug: Oral tablet · Oxaliplatin — drug: Per label · Leucovorin/levofolinate calcium — drug: Per label · 5-Fluorouracil — drug: Per label · Cetuximab — biological: Per label · Bevacizumab — drug: Per label · Bevacizumab biosimilar — drug: Per label
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
477
Started
2025-07-16
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for colon adenocarcinoma
  • • Phase3 - 477 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with colon adenocarcinoma

Where?

  • • Birmingham - Heartlands Hospital ( Site 1759)
  • • London - University College London Hospitals ( Site 1750)
  • • Oxford - Churchill Hospital ( Site 1756)
  • • Coventry - University Hospital Coventry & Warwickshire ( Site 1761)
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This study will have 2 parts.

Colon AdenocarcinomaRectal Adenocarcinoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

KRAS

Treatment history

Treatments you must have had:

  • ✓ well controlled HIV on antiretroviral therapy (ART)

What the study is looking for

  • ✓The main inclusion criteria include but are not limited to the following:
  • ✓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...
  • ✓Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Who cannot take part

  • ✗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...
  • ✗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
See the full criteria
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; 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 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 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

Where Is This Study? (6 UK sites)

Heartlands Hospital ( Site 1759)

Birmingham B9 5ss, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+4401214241396

University College London Hospitals ( Site 1750)

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator020 3456 7890

Churchill Hospital ( Site 1756)

Oxford ox3 7le, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+4403003047777

University Hospital Coventry & Warwickshire ( Site 1761)

Coventry CV2 2DX, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator024 7696 4000

Velindre Cancer Centre Hospital ( Site 1753)

Cardiff CF14 2TL, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+4402920615888

The Christie NHS Foundation Trust ( Site 1755)

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441614468370

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10