A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
a study on Colon Cancer Colorectal Cancer Rectal Cancer Colorectal Tumor
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCLA
- Dates
- study startedstudy ends around
Description
Summary
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.
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)
Details
This study will have 2 parts.
Keywords
Colon Adenocarcinoma, Rectal Adenocarcinoma, Colonic Neoplasms, Rectal Neoplasms, Oxaliplatin, Leucovorin, Fluorouracil, Cetuximab, Bevacizumab, Calderasib, Leucovorin/levofolinate calcium, 5-Fluorouracil, Bevacizumab biosimilar, Calderasib + Cetuximab + mFOLFOX6, mFOLFOX6
Eligibility
You can join if…
Open to people ages 18 years and up
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
You CAN'T join if...
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
Locations
- UCLA Hematology/Oncology - Santa Monica ( Site 0088)
accepting new patients
Santa Monica California 90404 United States - Los Angeles Hematology Oncology Medical Group ( Site 0084)
accepting new patients
Los Angeles California 90017 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Merck Sharp & Dohme LLC
- Links
- Merck Clinical Trials Information
- ID
- NCT06997497
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 477 study participants
- Last Updated
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