A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
Public ClinicalTrials.gov record NCT06997497. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06997497
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 477 participants
Conditions and interventions
Conditions
Interventions
- Calderasib Drug
- Oxaliplatin Drug
- Leucovorin/levofolinate calcium Drug
- 5-Fluorouracil Drug
- Cetuximab Biological
- Bevacizumab Drug
- Bevacizumab biosimilar Drug
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 15, 2025
- Primary completion
- Mar 27, 2029
- Completion
- Oct 26, 2030
- Last update posted
- Aug 27, 2026
2025 – 2030
United States locations
- U.S. sites
- 39
- U.S. states
- 25
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Los Angeles Hematology Oncology Medical Group ( Site 0084) | Los Angeles | California | 90017 | Recruiting |
| UCLA Hematology/Oncology - Santa Monica ( Site 0088) | Santa Monica | California | 90404 | Recruiting |
| University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0087) | Fort Collins | Colorado | 80528 | Recruiting |
| Rocky Mountain Cancer Centers (RMCC) ( Site 8000) | Lone Tree | Colorado | 80124 | Recruiting |
| Florida Cancer Specialists - South ( Site 7002) | Fort Myers | Florida | 33901 | Recruiting |
| Mayo Clinic in Florida ( Site 0092) | Jacksonville | Florida | 32224 | Recruiting |
| Orlando Health Cancer Institute ( Site 0065) | Orlando | Florida | 32806 | Recruiting |
| Florida Cancer Specialists - North ( Site 7001) | St. Petersburg | Florida | 33705 | Recruiting |
| Florida Cancer Specialists - East ( Site 7000) | West Palm Beach | Florida | 33401 | Recruiting |
| Piedmont Atlanta Hospital ( Site 2002) | Atlanta | Georgia | 30318 | Recruiting |
| Saint Alphonsus Regional Medical Center ( Site 0085) | Boise | Idaho | 83706 | Recruiting |
| Accellacare of Duly ( Site 2015) | Lisle | Illinois | 60532 | Recruiting |
| University of Iowa ( Site 0074) | Iowa City | Iowa | 52242 | Recruiting |
| University of Kentucky ( Site 0055) | Lexington | Kentucky | 40536 | Recruiting |
| Norton Cancer Institute, Audubon Hospital Campus ( Site 0054) | Louisville | Kentucky | 40217 | Recruiting |
| Greater Baltimore Medical Center ( Site 0068) | Baltimore | Maryland | 21204 | Recruiting |
| Mayo Clinic in Rochester, Minnesota ( Site 0091) | Rochester | Minnesota | 55905 | Recruiting |
| Hattiesburg Clinic ( Site 0064) | Hattiesburg | Mississippi | 39401 | Recruiting |
| Saint Luke's Cancer Institute ( Site 0082) | Kansas City | Missouri | 64111 | Recruiting |
| Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 2000) | Billings | Montana | 59102 | Recruiting |
| University Of Nebraska Medical Center ( Site 0078) | Omaha | Nebraska | 68198 | Recruiting |
| Comprehensive Cancer Centers of Nevada ( Site 2026) | Las Vegas | Nevada | 89169 | Recruiting |
| Renown Regional Medical Center ( Site 0056) | Reno | Nevada | 89502 | Recruiting |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0060) | Hackensack | New Jersey | 07601 | Recruiting |
| Atlantic Health System ( Site 0093) | Summit | New Jersey | 07901 | Recruiting |
| San Juan Oncology Associates, P.C ( Site 2011) | Farmington | New Mexico | 87401 | Recruiting |
| Memorial Sloan Kettering Cancer Center ( Site 0095) | New York | New York | 10065 | Recruiting |
| Ellis Hospital ( Site 0098) | Schenectady | New York | 12308 | Recruiting |
| WakeMed Raleigh Campus ( Site 0094) | Raleigh | North Carolina | 27610 | Recruiting |
| Miami Valley Hospital South ( Site 0075) | Centerville | Ohio | 45459 | Recruiting |
| Texas Oncology - DFW ( Site 8002) | Dallas | Texas | 75246 | Recruiting |
| UT Southwestern Medical Center ( Site 0059) | Dallas | Texas | 75390 | Recruiting |
| Texas Oncology - Northeast Texas ( Site 8001) | Denison | Texas | 75020 | Recruiting |
| Texas Oncology - San Antonio ( Site 8004) | San Antonio | Texas | 78240 | Recruiting |
| Community Cancer Trials of Utah ( Site 0086) | Ogden | Utah | 84405 | Recruiting |
| University of Virginia ( Site 0080) | Charlottesville | Virginia | 22908 | Recruiting |
| Virginia Cancer Specialists, PC ( Site 0069) | Fairfax | Virginia | 22031 | Recruiting |
| Fred Hutchinson Cancer Center ( Site 0076) | Seattle | Washington | 98109 | Recruiting |
| West Virginia University ( Site 2017) | Morgantown | West Virginia | 26506 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 193 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06997497, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2026 · Synced Sep 1, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06997497 live on ClinicalTrials.gov.