Phase 3 Colorectal Cancer Trial, Recruiting NCT06997497 Sponsor: Merck Sharp & Dohme LLC Condition: Colorectal Cancer
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Phase 3 Colorectal Cancer Trial, Recruiting

NCT06997497
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with colorectal cancer (a type of bowel cancer) that has been confirmed by a lab test and has either spread to other parts of the body or cannot be removed by surgery (Stage III unresectable or Stage IV)
  • For Part 2 of the trial only: People who have not yet received full systemic cancer treatment for their advanced colorectal cancer, though having received 1–2 cycles of a chemotherapy called FOLFOX, or 1 cycle of a chemotherapy called CAPOX, before or during screening is allowed
  • People whose cancer has a specific genetic change called a KRAS G12C mutation
  • People living with HIV, provided their HIV is well controlled with antiretroviral medication
  • People who are carriers of Hepatitis B, provided they are on antiviral treatment and the virus is undetectable in their blood
  • People with a history of Hepatitis C infection, provided the virus is currently undetectable in their blood

Who may not be able to join:

  • People who have active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) that requires immune-suppressing medication, or who have a clear history of such conditions including chronic diarrhoea
  • People who have serious, uncontrolled heart or blood vessel disease, or uncontrolled stroke-related conditions
  • People who have a known deficiency (partial or complete) of an enzyme called DPD, which affects how certain chemotherapy drugs are processed by the body
  • People living with HIV who have a history of a cancer called Kaposi's sarcoma or a condition called Multicentric Castleman's Disease
  • People who have received other systemic cancer treatments or experimental treatments within 4 weeks before joining the trial (with an exception for the specific optional chemotherapy mentioned above)
  • People who have one or more conditions that the treating doctor considers would make treatment with a drug called bevacizumab unsafe or unsuitable
  • People who have another cancer that is still growing or has required active treatment within the past 3 years
  • People who have cancer that has spread to the brain or the lining of the brain or spinal cord
  • People who currently have an active infection that requires treatment through the bloodstream or by mouth
  • People who have not fully recovered from major surgery, or who still have complications from a recent surgery
  • People who have a history of non-infectious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have this condition

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Medical Director, Merck Sharp & Dohme LLC

Phone: 1-888-577-8839

Australian sites

Wollongong Hospital ( Site 0453), Wollongong, New South Wales
+61242225000
Sunshine Coast University Hospital ( Site 0451), Birtinya, Queensland
+61752020000
Monash Health ( Site 0454), Clayton, Victoria
+61 03 8572-2941
Western Health-Sunshine & Footscray Hospitals ( Site 0450), St Albans, Victoria
+61383959167

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
16 July 2025
Est. completion
28 March 2029

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇨🇴 Colombia 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany Hong Kong 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇾 Malaysia 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇱 Poland 🇷🇴 Romania 🇸🇬 Singapore 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of Participants Experiencing Dose-Limiting Toxicity (DLT); Part 1: Number of Participants Who Experience an Adverse Event (AE); Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE; Progression Free Survival (PFS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov