A Phase III, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 Versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012)
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, GI (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Tenner, Laura
Contact Information:
Jessica Delaney
jessdelaney@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06997497?term=NCT06997497&rank=1
Summary
Primary objectives: Part 1-To evaluate the safety and tolerability of treatment with MK-1084, cetuximab, and
mFOLFOX6. Part 2- To compare MK-1084, cetuximab, and mFOLFOX6 versus mFOLFOX6 with or without
bevacizumab with respect to PFS per RECIST 1.1 as assessed by blinded independent central review (BICR).
Secondary Objectives: Part 2- To compare MK-1084, cetuximab, and mFOLFOX6 versus mFOLFOX6 with or withoutbevacizumab with respect to ORR per RECIST 1.1 by BICR. - To compare MK-1084, cetuximab, and mFOLFOX6 versus mFOLFOX6 with or without bevacizumab with respect to OS. - To evaluate MK-1084, cetuximab, and mFOLFOX6 versus mFOLFOX6 with or without bevacizumab with respect to DOR per RECIST 1.1 by BICR.
- To evaluate the safety and tolerability of MK-1084 in combination with cetuximab and mFOLFOX6. -To evaluate MK-1084 with mFOLFOX6 plus cetuximab versus mFOLFOX6 with or without bevacizumab with respect to the mean change from baseline in global health status/QoL, physical functioning, role functioning, appetite loss, and bloating. -To evaluate MK-1084, cetuximab, and mFOLFOX6 versus mFOLFOX6 with or without bevacizumab with respect to time to deterioration in global health status/QoL, physical functioning, role functioning, appetite loss, and bloating.
Exploratory Objectives: Part 2-To evaluate MK-1084, cetuximab, and mFOLFOX6 versus mFOLFOX6 with or without
bevacizumab with respect to mean change from baseline in the EQ-5D-5L VAS score. - To evaluate MK-1084,
cetuximab, and mFOLFOX6 versus mFOLFOX6 with or without bevacizumab with respect to categorical change from baseline of participant-reported tolerability using FACIT Item GP5. - To characterize the PK of MK-1084. - To evaluate MK-1084, cetuximab, and mFOLFOX6 versus mFOLFOX6 with or without bevacizumab with respect to PFS2 as assessed by the investigator per RECIST 1.1. - To evaluate MK-1084 cetuximab, and mFOLFOX6 versus mFOLFOX6 with or without bevacizumab with respect to the time to first subsequent anticancer therapy (TFST) and the time to second subsequent anticancer therapy (TSST). -To identify molecular (genomic, metabolic, and/or proteomic) biomarkers that may be indicative of clinical response/resistance, safety, pharmacodynamic activity, and/or the mechanism of action of MK-1084, cetuximab, and mFOLFOX6, bevacizumab, and other treatments. - To evaluate the surgical conversion rate among participants treated with MK-1084 plus mFOLFOX6 plus cetuximab versus mFOLFOX6 with or without bevacizumab.