Vanderbilt Clinical Trials

Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation

Purpose

The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.

Condition

Metastatic Colorectal Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay. - Central laboratory detection of KRAS p.G12C mutation. - Measurable metastatic disease per RECIST v1.1 criteria. - Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1. - Adequate organ function.

Exclusion Criteria

Active, untreated brain metastases. - Leptomeningeal disease - Previous treatment with a KRAS p.G12C inhibitor - History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Arm A: Sotorasib + Panitumumab + FOLFIRI	Sotorasib will be taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI will be received every 2 weeks (Q2W) via intravenous (IV) infusion.	Drug: FOLFIRI Regimen Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W. Drug: Sotorasib Immediate-release solid dosage form administered orally. Other names: AMG 510 Lumakras Lumykras Drug: Panitumumab Administered via IV infusion Q2W. Other names: Vectibix
Active Comparator Arm B: FOLFIRI with or Without Bevacizumab-awwb	Participants will receive FOLFIRI Q2W with or without bevacizumab-awwb.	Drug: FOLFIRI Regimen Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W. Drug: Bevacizumab-awwb Administered via IV infusion Q2W. Other names: MVASI

Recruiting Locations

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232

More Details

Status: Recruiting
Sponsor: Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.