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RecruitingPhase 3

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, 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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for people with colon or rectal cancer that has spread nearby or to other parts of the body, cannot be removed by surgery, and has a KRAS G12C gene change. It tests adding calderasib and cetuximab, two targeted cancer drugs, to mFOLFOX6 chemotherapy. Researchers will check safety and whether this treatment keeps cancer from growing or spreading longer than mFOLFOX6 with or without bevacizumab.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage III or IV colon or rectal adenocarcinoma, a type of cancer confirmed by a tissue test, that cannot be removed by surgery.
  • Have cancer with the KRAS G12C gene change.
  • For Part 2 only: Have had no whole-body cancer treatment for this advanced cancer, except 1–2 rounds of FOLFOX or 1 round of CAPOX chemotherapy before or during screening.
  • If you have HIV, it must be well controlled with HIV medicines.
  • If you test positive for hepatitis B, you must have received treatment, and blood tests must not detect the virus.
  • If you have had hepatitis C, blood tests must not detect the virus.

Who can't join

  • Have active bowel inflammation needing medicines that weaken the immune system, or a clear past history of bowel inflammation, such as Crohn’s disease, ulcerative colitis, or long-term diarrhea.
  • Have serious, uncontrolled heart or blood vessel disease, including disease of blood vessels in the brain.
  • Have a partial or complete lack of DPD, an enzyme that helps break down certain chemotherapy drugs.
  • Have HIV with a history of Kaposi’s sarcoma or multicentric Castleman’s disease, or have an active infection needing whole-body treatment.
  • Received whole-body cancer treatment, including study drugs, within 4 weeks before being assigned a study group, except the allowed optional chemotherapy.
  • Have a condition that makes bevacizumab unsafe in the study doctor’s view, or have not healed enough from major surgery or still have surgery-related problems.
  • Have another cancer that is growing or needed treatment in the past 3 years, or have active cancer spread to the brain, spinal cord, or their coverings.
  • Have current lung inflammation or scarring, or previously had lung inflammation not caused by infection that needed steroid treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (48)

AZ

CA

CO

FL

GA

IA

ID

IL

KY

MD

MN

MO

MS

MT

  • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 2000) · Billings, MT 59102Study Coordinator · Study contact · 406-238-6685More trials in Billings

NC

NE

NJ

NM

NV

NY

OH

PA

TX

UT

VA

WA

WI

WV