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

StatusRecruiting
PhasePhase 3
Started2025-07-16
View on ClinicalTrials.gov ↗

Amendment history

2026-10-02
Trial sites expanded: 239 → 243 locations
2026-09-10
Study Status, Contacts/Locations v46
Study sites234→236
2026-09-05
Study Status, Contacts/Locations v45
Study sites232→234
2026-08-27
Study Status, Contacts/Locations v44
Trial sites expanded: 228 → 232 locations
2026-08-20
Study Status, Contacts/Locations v43
Trial sites expanded: 133 → 228 locations
2026-08-13
Study Status, Contacts/Locations v42
Trial sites reduced: 223 → 133 locations
2026-08-06
Study Status, Contacts/Locations v41
Trial sites expanded: 220 → 223 locations
2026-07-30
Study Status, Contacts/Locations v40
Trial sites expanded: 217 → 220 locations
2026-07-23
Study Status, Contacts/Locations v39
Study sites215→217
2026-07-17
Study Status, Contacts/Locations v38
Trial sites expanded: 211 → 215 locations
2026-07-08
Study Status, Contacts/Locations v37
Trial sites expanded: 200 → 211 locations
2026-06-11
Study Status, Contacts/Locations v36
Trial sites expanded: 196 → 200 locations
2026-06-05
Study Status, Contacts/Locations v35
Trial sites expanded: 192 → 196 locations
2026-05-28
Study Status, Contacts/Locations v34
Trial sites expanded: 187 → 192 locations
2026-05-21
Study Status, Contacts/Locations v33
Trial sites expanded: 180 → 187 locations
2026-05-12
Study Status, Eligibility, Contacts/Locations v32
Trial sites expanded: 161 → 180 locations
Eligibility criteria+191 characters
[...] ocally advanced unresectable or metastatic colorectal cancer; an exception is permitted for 1-2 cycles of FOLFOX or 1 cycle of CAPOX as optional chemotherapy before or during the screening period Tumor tissue demonstratesDemonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G1 [...] cardiovascular disease or cerebrovascular disease Has known partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency HIV-infect [...] g investigational agents within 4 weeks before randomization, with the exception of the optional chemotherapy Has 1 or more conditions that, in the opinion of the inve [...]
2026-04-24
Study Status, Contacts/Locations v31
Trial sites expanded: 152 → 161 locations
2026-04-16
Study Status, Contacts/Locations v30
Trial sites expanded: 148 → 152 locations
2026-04-08
Study Status, Contacts/Locations v29
Trial sites expanded: 143 → 148 locations
2026-04-02
Study Status, Contacts/Locations v28
Trial sites expanded: 137 → 143 locations
2026-03-27
Study Status, Contacts/Locations v27
Trial sites expanded: 133 → 137 locations
2026-03-18
Study Status, Contacts/Locations v26
Study sites124→133
2026-03-13
Study Status, Contacts/Locations v25
Study sites115→124
2026-03-04
Study Status, Contacts/Locations v24
Study sites103→115
2026-02-26
Study Status, Contacts/Locations v23
Study sites100→103
2026-02-17
Study Status, Contacts/Locations v22
Study sites83→100
2026-02-10
Study Status, Contacts/Locations v21
Study sites78→83
2026-02-08
Study Identification, Study Status, Study Description, Arms and Interventions v20
Interventions5-Fluorouracil (Drug), Bevacizumab (Drug), Bevacizumab biosimilar (Drug), Cetuximab (Biological), Leucovorin/levofolinate calcium (Drug)…→5-Fluorouracil (Drug), Bevacizumab (Drug), Bevacizumab biosimilar (Drug), Calderasib (Drug), Cetuximab (Biological)…
Study title+13 characters
A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
2026-02-03
Study Status, Contacts/Locations v19
Study sites74→78
2026-01-29
Study Status, Contacts/Locations v18
Study sites71→74
2026-01-16
Study Status, Contacts/Locations v17
Study sites69→71
2026-01-08
Study Status, Contacts/Locations v16
Study sites68→69
2025-12-09
Study Status, Arms and Interventions, Outcome Measures v15
Primary completion date2029-08-27→2029-03-28
Interventions5-Fluorouracil (Drug), Bevacizumab (Drug), Cetuximab (Biological), Leucovorin/levofolinate calcium (Drug), MK-1084 (Drug), Oxaliplatin…→5-Fluorouracil (Drug), Bevacizumab (Drug), Bevacizumab biosimilar (Drug), Cetuximab (Biological), Leucovorin/levofolinate calcium (Drug)…
Secondary endpointsdetails revised at 12 of 15 entries
2025-12-04
Study Status, Contacts/Locations v14
Study sites65→68
2025-11-27
Study Status, Contacts/Locations v13
Study sites62→65
2025-11-20
Study Status, Contacts/Locations v12
Study sites59→62
2025-11-06
Study Status, Contacts/Locations v11
Study sites52→59
2025-10-23
Study Status, Contacts/Locations v10
Study sites43→52
2025-10-14
Study Status, Contacts/Locations v9
Study sites30→43
2025-10-07
Study Status, Arms and Interventions, Contacts/Locations v8
Study sites23→30
2025-09-24
Study Status, Contacts/Locations v7
Study sites19→23
2025-09-17
Study Status, Contacts/Locations v6
Study sites18→19
2025-09-08
Study Status, Contacts/Locations v5
Study sites8→18
2025-08-27
Study Status, Contacts/Locations v4
Study sites3→8
2025-08-04
Study Identification, Study Status v3
Re-verified, no change to tracked fields
2025-07-31
Study Status, Contacts/Locations v2
Completion date2031-06-29→2030-10-27
Study sites2→3
2025-07-24
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-07-17→confirmed 2025-07-16
Study sites0→2
2025-05-21
Original filing
Merck (MSD)
401 trials monitored
See 24 trials at risk
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.
Trial Details
NCT Number NCT06997497
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Colon Adenocarcinoma, Rectal Adenocarcinoma
Enrollment 477 participants
Start Date 2025-07-16
Primary Completion 2029-03-28 (estimated)
Study Completion 2030-10-27 (estimated)
Updated on ClinicalTrials.gov 2026-10-01