A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
NCT06997497Phase 3Recruiting
- Lead sponsor
- Merck Sharp & Dohme LLC (Industry)
- Enrollment
- 477 (estimated)
- Start date
- 16 Jul 2025
- Primary completion
- 28 Mar 2029 (estimated)
- Study completion
- 27 Oct 2030
- Last update posted
- 7 Oct 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Single
- Arms
- 2
Interventions
- Calderasib Drug
- Oxaliplatin Drug
- Leucovorin/levofolinate calcium Drug
- 5-Fluorouracil Drug
- Cetuximab Biological
- Bevacizumab Drug
- Bevacizumab biosimilar Drug
Conditions and primary outcome
- Colon Adenocarcinoma
- Rectal Adenocarcinoma
Primary outcome
Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Up to approximately 28 days); Part 1: Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 44 months); Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE (Up to approximately 44 months); Progression Free Survival (PFS) (Up to approximately 44 months)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT06997497.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT06997497 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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