Under construction – not a live service
Sign in
Taking people in United KingdomPhase 3

Tests calderasib with chemotherapy and cetuximab in colorectal cancer

Tests calderasib with chemotherapy in adults with KRAS G12C colorectal cancer.

Key facts

Who runs it
Merck Sharp & Dohme LLC
Where
Birmingham, Cardiff, Coventry, London, Manchester, and Oxford, United KingdomSee the 6 sitesAlso in 28 other countries, 248 sites
Trial code
Registry title
A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
Status
Recruiting
Phase
Phase 3
People taking part
477 people, planned
Started
16 Jul 2025
Expected to end
27 Oct 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Calderasib
  • Oxaliplatin
  • Leucovorin/levofolinate calcium
  • 5-Fluorouracil
  • Cetuximab
  • Bevacizumab
  • Bevacizumab biosimilar
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with colorectal cancer that has a KRAS G12C mutation and cannot be removed by surgery or has spread. Part 2 is for people who have not had cancer drug treatment for it yet.

Age
18 years or older
Sex
All sexes can join
Disease stage
Colorectal adenocarcinoma that is locally advanced and cannot be removed by surgery, or has spread (unresectable Stage III or Stage IV)
Earlier treatment
Part 2 only: no earlier drug treatment for the advanced or spread cancer. Exception: 1-2 cycles of FOLFOX or 1 cycle of CAPOX before or during screening. No other cancer treatment, including trial drugs, within 4 weeks before randomization.
Biomarker or test result
KRAS G12C mutation must be present

Main reasons for not taking part

  • Active inflammatory bowel disease needing immune-suppressing medicine, or a clear past history of it
  • Uncontrolled, significant heart or brain blood vessel disease
  • Known partial or complete DPD deficiency
  • Active brain or spinal cord spread of the cancer (CNS metastases, carcinomatous meningitis or leptomeningeal disease)
  • Another cancer that is getting worse or needed treatment in the past 3 years

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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 take part

  • 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 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 not adequately recovered from major surgery or have ongoing surgical complications
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • 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 a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • The main exclusion criteria include but are not limited to the following:
  • Has known partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Has a test of your tumour shown a change (mutation) in the KRAS, NRAS or BRAF genes?

Where in United Kingdom

Also in 28 other countries, 248 sites

  • Heartlands Hospital (Site 1759)Birmingham, United KingdomContact: Study CoordinatorTaking people
  • Velindre Cancer Centre Hospital (Site 1753)Cardiff, United KingdomContact: Study CoordinatorTaking people
  • University Hospital Coventry & Warwickshire (Site 1761)Coventry, United KingdomContact: Study CoordinatorTaking people
  • University College London Hospitals (Site 1750)London, United KingdomContact: Study CoordinatorTaking people
  • The Christie NHS Foundation Trust (Site 1755)Manchester, United KingdomContact: Study CoordinatorTaking people
  • Churchill Hospital (Site 1756)Oxford, United KingdomContact: Study CoordinatorTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Calderasib + Cetuximab + mFOLFOX6Treatment being tested

    Participants 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.

    Treatment: Calderasib, Oxaliplatin, Leucovorin/levofolinate calcium, 5-Fluorouracil, and Cetuximab

  • mFOLFOX6Existing treatment, for comparison

    Participants 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.

    Treatment: Oxaliplatin, Leucovorin/levofolinate calcium, 5-Fluorouracil, Bevacizumab, and Bevacizumab biosimilar

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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)
Plain-language title
Tests calderasib with chemotherapy and cetuximab in colorectal cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06997497, who can take part
Record updated
12 November 2026
Under construction, not live – A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) (NCT06997497) – Frontlight Research