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

ArmDescriptionAssigned 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

Ironwood Cancer and Research Centers Scottsdale
Chandler 5289282, Arizona 5551752 85224

Providence Saint Jude Medical Center
Fullerton 5351247, California 5332921 92835

City of Hope National Medical Center
Long Beach 5367929, California 5332921 90813

Cancer and Blood Research Center, LLC
Los Alamitos 5368304, California 5332921 90720

California Research Institute
Los Angeles 5368361, California 5332921 90027

Norwalk Hospital
Norwalk 4839822, Connecticut 4831725 06856

Cancer Specialists of North Florida - Southpoint
Jacksonville 4160021, Florida 4155751 32256

D and H Cancer Research Center
Margate 4163407, Florida 4155751 33063

Mid Florida Hematology and Oncology Centers PA
Orange City 4167055, Florida 4155751 32763

Boca Raton Clinical Research Medical Center Inc
Plantation 4168782, Florida 4155751 33322

Georgia Cancer Specialists
Atlanta 4180439, Georgia 4197000 30342

Insight Research Institute
Chicago 4887398, Illinois 4896861 60616

Hope and Healing Cancer Services
Hinsdale 4896012, Illinois 4896861 60521

Orchard Healthcare Research Inc
Skokie 4911600, Illinois 4896861 60076

Pikeville Medical Center
Pikeville 4304232, Kentucky 6254925 41501

Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202

Cancer and Hematology Centers of Western Michigan
Grand Rapids 4994358, Michigan 5001836 49503

Saint Louis Cancer Care West County
Bridgeton 4378391, Missouri 4398678 63044

Minniti Center for Medical Oncology and Hematology
Mickleton 4503013, New Jersey 5101760 08056

Duke Cancer Center
Durham 4464368, North Carolina 4482348 27710

FirstHealth Cancer Center
Pinehurst 4485272, North Carolina 4482348 28374

Thomas Jefferson University
Philadelphia 4560349, Pennsylvania 6254927 19107

Tennessee Oncology PLLC - Chattanooga
Nashville 4644585, Tennessee 4662168 37203

Tennessee Oncology, PLLC
Nashville 4644585, Tennessee 4662168 37203

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