A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations
M.D. Anderson Cancer Center
Summary
To learn if the drug combination of adagrasib, cetuximab, and cemiplimab can help to control metastatic CRC with KRAS G12C mutations.
Description
Primary Objective • To determine the objective response rate of the adagrasib, cetuximab, and cemiplimab combination for treatment of advanced KRAS G12C MT CRC that has progressed on at least one line of prior systemic chemotherapy. Secondary Objectives * To estimate duration of response (DOR), progression free survival (PFS), and overall survival (OS) for the combination of adagrasib, cetuximab, and cemiplimab in participants with advanced KRAS G12C MT CRC that has progressed on at least one line of prior systemic chemotherapy. * To estimate the safety and tolerability of the combination o…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed diagnosis of advanced/metastatic microsatellite stable colorectal cancer with KRASG12C mutation with 1+ prior line(s) of therapy * Confirmed KRASG12C mutation status. If a molecular profiling report is not available, a representative paraffin-embedded tumor block or a minimum of 10 unstained slides will be requested for retrospective KRASG12C mutation testing. * Unresectable or metastatic disease. * Participants must have received at least one prior line of chemotherapy for metastatic disease with progression on treatment or intolerance to therap…
Interventions
- DrugCetuximab
Given by IV
- DrugCemiplimab
Given by IV
- DrugAdagrasib
Given by PO
Locations (2)
- Massachusetts General Hospital Cancer CenterBoston, Massachusetts
- MD Anderson Cancer CenterHouston, Texas