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

Condition(s) studied

Investigational drug(s) / intervention(s)

Calderasib: Oral tablet

Oxaliplatin: Per label

Leucovorin/levofolinate calcium: Per label

5-Fluorouracil: Per label

Cetuximab: Per label

Bevacizumab: Per label

Bevacizumab biosimilar: Per label

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.

Eligibility

Primary outcome measure(s)

• Number of Participants Experiencing Dose-Limiting Toxicity (DLT) — Up to approximately 28 days
  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.
• Part 1: Number of Participants Who Experience an Adverse Event (AE) — Up to approximately 44 months
  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
• Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE — Up to approximately 44 months
  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
• Progression Free Survival (PFS) — Up to approximately 44 months
  PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.

Trial sites (236)

+ 196 more sites — see the full list on the official registry below.