Calderasib and Chemotherapy for Colorectal Cancer

A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)

Recruiting Phase 3 Interventional Study
Colon Adenocarcinoma Rectal Adenocarcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
477 (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Who this trial is looking for

This trial is looking for people with certain types of colorectal cancer that cannot be surgically removed. Participants will receive a combination of the study drug calderasib with other cancer treatments to see if it helps them live longer without the cancer worsening.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have locally advanced or metastatic colorectal adenocarcinoma
  • I have a KRAS G12C gene mutation
  • I have not received certain cancer treatments recently
  • I am on well-controlled HIV treatment if I am HIV-positive
  • I have treated hepatitis B with undetectable viral load if I am HBsAg positive
  • I have undetectable hepatitis C viral load if I had hepatitis C

You may not be able to join if

  • I have active inflammatory bowel disease requiring medication
  • I have uncontrolled heart or brain disease
  • I have known DPD deficiency
  • I have a history of certain cancers related to HIV
  • I have received prior cancer treatments within 4 weeks of starting this trial
  • I have another cancer that is being treated or has progressed in the past 3 years
  • I have active brain metastases or certain types of meningitis
  • I have an active infection needing systemic treatment

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 adva…
Trial Locations
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Eligibility Criteria
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) colo…
Contacts

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