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NCT06997497 · ClinicalTrials.gov registry record · Phase 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 study of Rectal Adenocarcinoma and Colon Adenocarcinoma, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 477
- Enrollment target
- 20
- Study locations
NCT06997497 is a Phase 3 study of Rectal Adenocarcinoma and Colon Adenocarcinoma that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 477 participants, above the 96-participant average among 17 other Rectal Adenocarcinoma trials with a reported enrollment target (397% higher). The trial reports 20 study locations across 18 states.
The verdict
NCT06997497, a Phase 3 study of Rectal Adenocarcinoma and Colon Adenocarcinoma, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 477 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 477 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 96-participant average among 17 other Rectal Adenocarcinoma trials with a reported enrollment target (397% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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.
NCT06997497 reports 20 study locations spanning 18 distinct geographic areas - top geographies include Kentucky, Buenos Aires, California.
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.
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).
Who is sponsoring clinical trial NCT06997497?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.