Recruiting nowPhase 3Randomised
| Registry number | NCT06997497 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 3 |
| Design | randomised, blinded |
| Taking part | 477 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Merck Sharp & Dohme LLC |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Calderasib
- Drug Oxaliplatin
- Drug Leucovorin/levofolinate calcium
- Drug 5-Fluorouracil
- Biological Cetuximab
- Drug Bevacizumab
- Drug Bevacizumab biosimilar
What it is measuring
Number of Participants Experiencing Dose-Limiting Toxicity (DLT)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
What this trial is trying to do
The researchers expect that blocking the KRAS G12C signal with calderasib, while also blocking the EGFR growth signal with cetuximab, could make chemotherapy (mFOLFOX6) work better against KRAS G12C-mutated colorectal cancer. The trial is testing this combination against mFOLFOX6 with or without bevacizumab, a drug that blocks blood-vessel growth.
The comparison asks whether adding calderasib and cetuximab helps people live longer without the cancer growing or spreading than standard chemotherapy with or without bevacizumab. It is also measuring dose-limiting toxicities—serious side effects that prevent treatment from being given at the planned dose—to assess safety and tolerability.
Worth knowing: The trial is restricted to unresectable locally advanced or metastatic colorectal cancer with a KRAS G12C mutation, and its main listed outcome is safety rather than survival or tumour control.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
Phase 3. Compares the treatment against current standard care in a large group. This is the design that changes practice.
How the researchers describe it
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.Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Locally advanced
- Rectal
- Colon
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
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
Exclusion Criteria
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 uncontro…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 223 sites. Listed in: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Finland, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Philippines, Poland, Romania, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT06997497, registered by Merck Sharp & Dohme LLC on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.