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

Conditions

• Colon Adenocarcinoma
• Rectal Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Calderasib — DRUG
  Oral tablet
• Oxaliplatin — DRUG
  Per label
• Leucovorin/levofolinate calcium — DRUG
  Per label
• 5-Fluorouracil — DRUG
  Per label
• Cetuximab — BIOLOGICAL
  Per label
• Bevacizumab — DRUG
  Per label
• Bevacizumab biosimilar — DRUG
  Per label

Study Details

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.

Key Dates

Start date

Jul 16, 2025

Status verified

Jun 2026

Primary completion

Mar 28, 2029

Completion

Oct 27, 2030

Study Design

Enrollment

477 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Calderasib + Cetuximab + mFOLFOX6
  Participants will receive calderasib orally, cetuximab per label every 2 weeks (Q2W), and mFOLFOX6 chemotherapy: oxaliplatin per label every 2 weeks (Q2W), leucovorin or levofolinate calcium per label Q2W, and 5-fluorouracil (5-FU) per label Q2W. Treatment will continue until criteria for discontinuation is met.
• Active Comparator: mFOLFOX6
  Participants will receive mFOLFOX6 chemotherapy: oxaliplatin per label Q2W, leucovorin or levofolinate calcium per label Q2W, and 5-fluorouracil (5-FU) per label Q2W. Participants may also receive bevacizumab or bevacizumab biosimilar Q2W at the investigator's discretion. Treatment will continue until criteria for discontinuation is met.

Primary Outcome Measure

Number of Participants Experiencing Dose-Limiting Toxicity (DLT) [ Time Frame: Up to approximately 28 days ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (26)

Find similar trials in Los Angeles, CA

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