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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)
NCT06997497 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL Cetuximab
- DRUG Oxaliplatin
- DRUG Calderasib
- DRUG Leucovorin/levofolinate calcium
- DRUG 5-Fluorouracil
Study Locations (20)
Kentucky
- University of Kentucky ( Site 0055) — Lexington
- Norton Cancer Institute, Audubon Hospital Campus ( Site 0054) — Louisville
Buenos Aires
- Hospital Italiano de Buenos Aires ( Site 0102) — Ciudad Autonoma de Buenos Aires
- Instituto Alexander Fleming ( Site 0101) — Mar del Plata
California
- Los Angeles Hematology Oncology Medical Group ( Site 0084) — Los Angeles
Florida
- Orlando Health Cancer Institute ( Site 0065) — Orlando
Iowa
- University of Iowa ( Site 0074) — Iowa City
Maryland
- Greater Baltimore Medical Center ( Site 0068) — Baltimore
Nebraska
- University Of Nebraska Medical Center ( Site 0078) — Omaha
Nevada
- Renown Regional Medical Center ( Site 0056) — Reno
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 477 participants |
| Start Date | 2025-07-16 |
| Est. Completion | 2030-10-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06997497
The ClinicalTrials.gov registry entry for NCT06997497 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 477 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Rectal Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions — of which Cetuximab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06997497 reports 20 study locations spanning 18 distinct geographic areas — top geographies include Kentucky, Buenos Aires, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06997497 about?
NCT06997497 is a clinical study titled "A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)". 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...
What is the current status of trial NCT06997497?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 477 participants. The study started on 2025-07-16. Estimated completion is 2030-10-27.
What conditions does trial NCT06997497 study?
This clinical trial studies the following conditions: Rectal Adenocarcinoma, Colon Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06997497?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Oxaliplatin (DRUG), Calderasib (DRUG), Leucovorin/levofolinate calcium (DRUG), 5-Fluorouracil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06997497?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06997497 being conducted?
This trial has 20 study locations across California, Florida, Iowa, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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