Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Rectal Adenocarcinoma and Colon Adenocarcinoma, sponsored by Merck Sharp & Dohme.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A DLT is defined as the occurrence of protocol-specified toxicities if assessed by the investigator to be possibly, probably, or definitely related to study intervention administration.
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 |
What NCT06997497 shows while recruiting
NCT06997497 is an interventional study that assigns participants to a tested intervention. The registered 477 participants enrollment target is mid-sized for trials with a published cap, above the 96-participant average among 17 other Rectal Adenocarcinoma trials with a reported enrollment target (397% higher).
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 names 20 study sites across 18 states, led by 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.
Learn More About Clinical Trials
Similar trials for Rectal Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06997497's enrollment target sits among peer trials
477 2nd of 17 the highest of 17 other Rectal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rectal Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Evaluating Novel Therapies in ctDNA Positive GI Cancers
RECRUITING · Phase 3
-
Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
RECRUITING · Phase 2
-
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
RECRUITING · Phase 2
-
Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
RECRUITING
-
Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy
RECRUITING · Phase 2
-
Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer
RECRUITING · Early Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03911700 · 477 participants · NA
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
- NCT05446272 · 478 participants · NA
The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
- NCT06172296 · 478 participants · Phase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
- NCT06754046 · 476 participants · NA
BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI
- NCT06358040 · started 2026-10 · NA
Opioid Dispenser for Microdiscectomy/Laminectomy