AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER
Summary
The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have colorectal cancer that has spread to other parts of your body. * Be in good enough health to receive study treatment. * Should not be pregnant before starting treatment. Participants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects. The medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment. * The study is expected to last approximately 33 months for each participant. * Participants will have regular visits to the study site for treatment, health checks, and tests. * After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects. * Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.
Arms & interventions
- DrugPF-08634404
Solution for infusion
- BiologicalBevacizumab
Injection for intravenous use
- DrugChemotherapy
Injection for intravenous use
Outcome measures
Primary
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR)
Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by BICR per RECIST 1.1, or death due to any cause, whichever occurs first.
Time frame: Approximately 4 years
Overall survival (OS)
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Approximately 4 years
Secondary
PFS per RECIST 1.1 by investigator assessment
Time frame: Approximately 4 years
Objective Response Rate (ORR) by BICR
Time frame: Approximately 4 years
Objective Response Rate (ORR) by investigator
Time frame: Approximately 4 years
Duration of Response (DOR) by BICR
Time frame: Approximately 4 years
DOR by investigator
Time frame: Approximately 4 years
PFS2 (PFS after next-line therapy) by investigator
Time frame: Approximately 4 years
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Through 90 days after the last study intervention; Approximately 4 years
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Through 90 days after the last study intervention; Approximately 4 years
Pharmacokinetics (PK): Serum concentration of PF-08634404
Time frame: Approximately 21 months
Immunogenicity: Incidence of positive Anti-Drug Antibody (ADA)
Time frame: Approximately 21 months
Mean scores and Change from baseline in the global health status/quality of life (QoL) score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time frame: Approximately 4 years
Mean score change from baseline in participant reported function and symptoms scales per EORTC QLQ-CR29
Time frame: Approximately 4 years
Time to definitive deterioration (TTdD) in the global health status/QoL score on the EORTC QLQ-C30
Time frame: Approximately 4 years
Time to definitive deterioration (TTdD) in participant reported function and symptoms per EORTC QLQ-CR29
Time frame: Approximately 4 years
Eligibility criteria
Study locations (150)
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224
Ironwood Cancer & Research Centers
Gilbert, Arizona, 85297
Ironwood Cancer & Research Centers
Glendale, Arizona, 85306
Ironwood Cancer & Research Centers
Goodyear, Arizona, 85395
Ironwood Cancer & Research Centers
Mesa, Arizona, 85202
Ironwood Cancer & Research Centers
Mesa, Arizona, 85206
Ironwood Cancer & Research Centers
Phoenix, Arizona, 85028
Ironwood Cancer & Research Centers
Scottsdale, Arizona, 85260
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Highlands Oncology Group
Rogers, Arkansas, 72758
Highlands Oncology Group
Springdale, Arkansas, 72762
UCSF at Berkeley Outpatient Center
Berkeley, California, 94702
UCSF at China Basin
San Francisco, California, 94107
UCSF at Mount Zion
San Francisco, California, 94115
UCSF at Parnassus
San Francisco, California, 94143
UCSF Medical Center
San Francisco, California, 94158
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, 80012
Rocky Mountain Cancer Centers - Boulder
Boulder, Colorado, 80303
Rocky Mountain Cancer Centers, LLP
Centennial, Colorado, 80112
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, 80907
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, 80923
Intermountain Health Cancer Center Saint Joseph
Denver, Colorado, 80218
Intermountain Health Saint Joseph Hospital - Research Office
Denver, Colorado, 80218
Intermountain Health Saint Joseph Hospital
Denver, Colorado, 80218
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80220
Rocky Mountain Cancer Centers, LLP
Englewood, Colorado, 80113
Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado, 80228
Rocky Mountain Cancer Centers, LLP
Littleton, Colorado, 80120
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80124
Rocky Mountain Cancer Centers, LLP
Longmont, Colorado, 80504
Rocky Mountain Cancer Centers, LLP
Pueblo, Colorado, 81003
Rocky Mountain Cancer Centers, LLP
Thornton, Colorado, 80260
Florida Cancer Specialists
Bonita Springs, Florida, 34135
Florida Cancer Specialists
Bradenton, Florida, 34211
Comprehensive Hematology Oncology
Brandon, Florida, 33511
Florida Cancer Specialists
Cape Coral, Florida, 33909
BRCR Global - Coral Springs
Coral Springs, Florida, 33065
Florida Cancer Specialists
Fort Myers, Florida, 33905
Florida Cancer Specialists
Fort Myers, Florida, 33908
Comprehensive Hematology Oncology
Largo, Florida, 33770
Cancer Care Centers of Brevard, Inc.
Melbourne, Florida, 32935
Florida Cancer Specialists
N. Venice, Florida, 34275
Florida Cancer Specialists
Naples, Florida, 34102
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, 32909
Comprehensive Hematology Oncology
Palm Harbor, Florida, 34683
Florida Cancer Specialists
Port Charlotte, Florida, 33980
Cancer Care Centers of Brevard, Inc.
Rockledge, Florida, 32955
Florida Cancer Specialists
Sarasota, Florida, 34236
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33701
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33709
Comprehensive Hematology Oncology
Trinity, Florida, 34655
University Cancer & Blood Center, LLC
Athens, Georgia, 30607
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
Illinois CancerCare - Bloomington
Bloomington, Illinois, 61704
Illinois Cancer Specialists
Chicago, Illinois, 60631
Illinois CancerCare - Galesburg
Galesburg, Illinois, 61401
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
Hope and Healing Cancer Services
New Lenox, Illinois, 60451
Illinois Cancer Specialists
Niles, Illinois, 60714
Illinois CancerCare-Ottawa-Fox River Cancer Center
Ottawa, Illinois, 61350
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Illinois Cancer Care
Peoria, Illinois, 61615
Illinois CancerCare-Peru - Valley Regional Cancer Center
Peru, Illinois, 61354
Illinois CancerCare-Washington
Washington, Illinois, 61571
Franciscan Health
Indianapolis, Indiana, 46237
Franciscan Health Mooresville
Mooresville, Indiana, 46158
The Cancer & Hematology Centers
Big Rapids, Michigan, 49307
The Cancer & Hematology Centers
Grand Rapids, Michigan, 49503
The Cancer & Hematology Centers
Grand Rapids, Michigan, 49546
The Cancer & Hematology Centers
Holland, Michigan, 49424
The Cancer & Hematology Centers
Norton Shores, Michigan, 49444
Avera Cancer Institute- Marshall
Marshall, Minnesota, 56258
Cancer Partners of Nebraska
Lincoln, Nebraska, 68516
Renown Health Medical Oncology
Reno, Nevada, 89502
Renown Regional Medical Center
Reno, Nevada, 89502
NYOH Albany Cancer Center
Albany, New York, 12206
Hematology-Oncology Associates of Central New York, PC
Auburn, New York, 13021
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Babylon, New York, 11702
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Brooklyn, New York, 11210
Hematology-Oncology Associates of Central New York, PC
Camillus, New York, 13031
New York Oncology Hematology - Clifton Park Cancer Center
Clifton Park, New York, 12065
Hematology-Oncology Associates of Central New York, PC
East Syracuse, New York, 13057
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
New Hyde Park, New York, 11042
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
New York, New York, 10028
Hematology Oncology Associates of Rockland
Nyack, New York, 10960
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Patchogue, New York, 11772
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Port Jefferson Station, New York, 11776
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Riverhead, New York, 11901
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Shirley, New York, 11967
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
The Bronx, New York, 10469
Oncology Hematology Care - Eastgate
Cincinnati, Ohio, 45245
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Oncology Hematology Care Clinical Trials, LLC
Fairfield, Ohio, 45014
Oncology Associates of Oregon, P.C.
Albany, Oregon, 97321
Kaiser Permanente Sunnyside Medical Center
Clackamas, Oregon, 97015
Oncology Associates of Oregon, P.C.
Corvallis, Oregon, 97330
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401
Kaiser Permanente Westside Medical Center
Hillsboro, Oregon, 97124
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, 97227
Oncology Associates of Oregon, P.C.
Springfield, Oregon, 97477
Avera Cancer Institute- Aberdeen
Aberdeen, South Dakota, 57401
Avera Cancer Institute- Mitchell
Mitchell, South Dakota, 57301
Avera Cancer Institute- Pierre
Pierre, South Dakota, 57501
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
AMG Oncology & Hematology -Yankton
Yankton, South Dakota, 57078
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
Texas Oncology - West Texas
Abilene, Texas, 79606
Texas Oncology - West Texas
Amarillo, Texas, 79124
Texas Oncology - Gulf Coast
Beaumont, Texas, 77702
Texas Oncology - Northeast Texas
Denison, Texas, 75020
Texas Oncology - Northeast Texas
Denton, Texas, 76201
Texas Oncology - West Texas
El Paso, Texas, 79902
Texas Oncology - West Texas
El Paso, Texas, 79915
Texas Oncology - West Texas
El Paso, Texas, 79938
Texas Oncology - Northeast Texas
Flower Mound, Texas, 75028
Oncology Consultants P.A.
Houston, Texas, 77008
Oncology Consultants P.A.
Houston, Texas, 77024
Texas Oncology - Gulf Coast
Houston, Texas, 77024
Oncology Consultants P.A.
Houston, Texas, 77030
Texas Oncology - Gulf Coast
Houston, Texas, 77054
Texas Oncology - Gulf Coast
Houston, Texas, 77070
Radnet/Houston Medical Imaging
Houston, Texas, 77098
Texas Oncology - Gulf Coast
Humble, Texas, 77338
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063
US Oncology Investigational Products Center
Irving, Texas, 75063
Texas Oncology - Northeast Texas
Longview, Texas, 75601
Texas Oncology - West Texas
Midland, Texas, 79701
Texas Oncology - West Texas
Odessa, Texas, 79761
Texas Oncology - Gulf Coast
Pearland, Texas, 77584
Texas Oncology - Gulf Coast
Sugar Land, Texas, 77479
Texas Oncology - Gulf Coast
The Woodlands, Texas, 77380
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
Texas Oncology - West Texas
Wichita Falls, Texas, 76310
Virginia Cancer Specialists, PC
Arlington, Virginia, 22201
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Low Moor, Virginia, 24457
Virginia Cancer Specialists, PC
Manassas, Virginia, 20110
Virginia Cancer Institute
Mechanicsville, Virginia, 23116
Virginia Cancer Institute
Midlothian, Virginia, 23112
Virginia Cancer Institute
Petersburg, Virginia, 23805
Virginia Cancer Specialists, PC
Reston, Virginia, 20190
Virginia Cancer Institute
Richmond, Virginia, 23229
Virginia Cancer Institute
Richmond, Virginia, 23235
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia, 24014
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Salem, Virginia, 24153
Virginia Cancer Specialists, PC
Woodbridge, Virginia, 22191
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Wytheville, Virginia, 24382