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A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
Trial Status: active
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.
Inclusion 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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06997497.