Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer
Phase 3 – large-scale trial before approval
Conditions:
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Colorectal Neoplasms
Sponsor: Pfizer
trial.available_in:
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Overview
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.
Who can participate
Inclusion Criteria:
* Histological or cytological confirmed colorectal adenocarcinoma.
* Evidence of Stage IV metastatic disease.
* No prior systemic therapy for metastatic disease.
* Eastern Cooperative Oncology Group performance status (ECOG) 0-1
* At least one measurable lesion according to RECIST 1.1 per Investigator assessment.
* Adequate hepatic, liver, and renal function
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Locally confirmed BRAF V600E mutation
* Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer
* Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression
* Clinically significant risk of hemorrhage or fistula
* Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study
* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
* Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events
* Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose
* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years
* Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis
Interventions
PF-08634404
DRUG
Bevacizumab
BIOLOGICAL
Chemotherapy
DRUG
Locations
156
Australia (3)
Icon Cancer Centre Wesley
Auchenflower , Queensland
Icon Cancer Centre Hobart
Hobart , Tasmania
Peter MacCallum Cancer Centre
Melbourne , Victoria
Belgium (2)
Grand Hôpital de Charleroi
Charleroi , Hainaut
NOT_YET_RECRUITING
AZ Sint-Lucas
Ghent
NOT_YET_RECRUITING
Brazil (1)
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul , São Paulo
Canada (2)
McGill University Health Centre
Montreal , Quebec
Princess Margaret Cancer Centre
Toronto , Ontario
France (4)
CHU Brest, Hopital La Cavale Blanche
Brest
NOT_YET_RECRUITING
Henri Mondor Hospital
Créteil , Île-de-France Region
NOT_YET_RECRUITING
Hôpital Européen Georges Pompidou
Paris
NOT_YET_RECRUITING
Institut Gustave Roussy
Villejuif
NOT_YET_RECRUITING
Germany (3)
DRK Kliniken Berlin - Köpenick
Berlin
NOT_YET_RECRUITING
Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
Dresden
NOT_YET_RECRUITING
Asklepios Altona
Hamburg
NOT_YET_RECRUITING
Israel (3)
Hadassah Medical Center
Jerusalem , Jerusalem
NOT_YET_RECRUITING
Rabin Medical Center
Petah Tikva , HA Merkaz
NOT_YET_RECRUITING
Sourasky Medical Center
Tel Aviv , TELL ABĪB
NOT_YET_RECRUITING
Italy (1)
Pia Fondazione Di Culto E Di Religione Card. G. Panico
Tricase , Lecce
NOT_YET_RECRUITING
Japan (9)
Chiba cancer center
Chiba , Chiba
Kyushu University Hospital
Fukuoka
Saitama Medical University International Medical Center
Hidaka , Saitama
Saitama Prefectural Cancer Center
Kitaadachi-gun , Saitama
The Cancer Institute Hospital of JFCR
Koto-ku , Tokyo
Shizuoka Cancer Center
Nagaizumi-cho , Shizuoka
Aichi Cancer Center Hospital
Nagoya , Aichi-ken
National Hospital Organization Osaka Medical Center
Osaka
Kanagawa cancer center
Yokohama , Kanagawa
Poland (3)
Pratia Onkologia Katowice
Katowice , Silesian Voivodeship
NOT_YET_RECRUITING
SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
Opole
NOT_YET_RECRUITING
Pratia Poznań
Poznan
NOT_YET_RECRUITING
Puerto Rico (3)
Pan American Center for Oncology Trials - Mayaguez
Mayagüez
Pan American Center for Oncology Trials, LLC
Rio Piedras
Pan American Center for Oncology Trials, LLC
San Juan
Spain (7)
Hospital Universitari Vall d'Hebron
Barcelona , Barcelona [barcelona]
NOT_YET_RECRUITING
CETIR
Barcelona
NOT_YET_RECRUITING
Hospital Clinic de Barcelona
Barcelona
NOT_YET_RECRUITING
Hospital Universitario Reina Sofia
Córdoba
NOT_YET_RECRUITING
Hospital Jerez de la Frontera
Jerez de la Frontera , Cádiz
NOT_YET_RECRUITING
Clínica Radiológica HLA Mario Gallegos
Málaga , Andalusia
NOT_YET_RECRUITING
Hospital Regional Universitario de Malaga (Hospital Civil)
Málaga
NOT_YET_RECRUITING
Taiwan (6)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung City
NOT_YET_RECRUITING
National Cheng Kung University Hospital
Tainan
NOT_YET_RECRUITING
National Taiwan University Hospital
Taipei
NOT_YET_RECRUITING
Taipei Veterans General Hospital
Taipei
NOT_YET_RECRUITING
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District
NOT_YET_RECRUITING
United States (109)
Avera Cancer Institute- Aberdeen
Aberdeen , South Dakota
Texas Oncology - West Texas
Abilene , Texas
Oncology Associates of Oregon, P.C.
Albany , Oregon
Texas Oncology - West Texas
Amarillo , Texas
Virginia Cancer Specialists, PC
Arlington , Virginia
Illinois Cancer Specialists
Arlington Heights , Illinois
Texas Oncology - Gulf Coast
Beaumont , Texas
The Cancer & Hematology Centers
Big Rapids , Michigan
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg , Virginia
Illinois CancerCare - Bloomington
Bloomington , Illinois
Florida Cancer Specialists
Bonita Springs , Florida
Rocky Mountain Cancer Centers - Boulder
Boulder , Colorado
Florida Cancer Specialists
Bradenton , Florida
Hematology-Oncology Associates of Central New York, PC
Camillus , New York
Florida Cancer Specialists
Cape Coral , Florida
Ironwood Cancer & Research Centers
Chandler , Arizona
Illinois Cancer Specialists
Chicago , Illinois
Oncology Hematology Care - Eastgate
Cincinnati , Ohio
Kaiser Permanente Sunnyside Medical Center
Clackamas , Oregon
NOT_YET_RECRUITING
BRCR Global - Coral Springs
Coral Springs , Florida
Oncology Associates of Oregon, P.C.
Corvallis , Oregon
Texas Oncology - Northeast Texas
Denison , Texas
Texas Oncology - Northeast Texas
Denton , Texas
Intermountain Health Cancer Center Saint Joseph
Denver , Colorado
NOT_YET_RECRUITING
Intermountain Health Saint Joseph Hospital - Research Office
Denver , Colorado
NOT_YET_RECRUITING
Intermountain Health Saint Joseph Hospital
Denver , Colorado
NOT_YET_RECRUITING
Hematology-Oncology Associates of Central New York, PC
East Syracuse , New York
Texas Oncology - West Texas
El Paso , Texas
Texas Oncology - West Texas
El Paso , Texas
Texas Oncology - West Texas
El Paso , Texas
Oncology Associates of Oregon, P.C.
Eugene , Oregon
Virginia Cancer Specialists, PC
Fairfax , Virginia
Oncology Hematology Care Clinical Trials, LLC
Fairfield , Ohio
Highlands Oncology Group
Fayetteville , Arkansas
Texas Oncology - Northeast Texas
Flower Mound , Texas
Florida Cancer Specialists
Fort Myers , Florida
Florida Cancer Specialists
Fort Myers , Florida
Illinois CancerCare - Galesburg
Galesburg , Illinois
Ironwood Cancer & Research Centers
Gilbert , Arizona
Ironwood Cancer & Research Centers
Glendale , Arizona
Ironwood Cancer & Research Centers
Goodyear , Arizona
The Cancer & Hematology Centers
Grand Rapids , Michigan
The Cancer & Hematology Centers
Grand Rapids , Michigan
Kaiser Permanente Westside Medical Center
Hillsboro , Oregon
NOT_YET_RECRUITING
Hope and Healing Cancer Services
Hinsdale , Illinois
The Cancer & Hematology Centers
Holland , Michigan
Oncology Consultants P.A.
Houston , Texas
Oncology Consultants P.A.
Houston , Texas
Texas Oncology - Gulf Coast
Houston , Texas
Oncology Consultants P.A.
Houston , Texas
Texas Oncology - Gulf Coast
Houston , Texas
Texas Oncology - Gulf Coast
Houston , Texas
Radnet/Houston Medical Imaging
Houston , Texas
Texas Oncology - Gulf Coast
Humble , Texas
US Oncology Investigational Products Center (IPC)
Irving , Texas
US Oncology Investigational Products Center
Irving , Texas
Cancer Partners of Nebraska
Lincoln , Nebraska
Texas Oncology - Northeast Texas
Longview , Texas
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Low Moor , Virginia
Virginia Cancer Specialists, PC
Manassas , Virginia
Avera Cancer Institute- Marshall
Marshall , Minnesota
Virginia Cancer Institute
Mechanicsville , Virginia
NOT_YET_RECRUITING
Cancer Care Centers of Brevard, Inc.
Melbourne , Florida
Ironwood Cancer & Research Centers
Mesa , Arizona
Ironwood Cancer & Research Centers
Mesa , Arizona
Texas Oncology - West Texas
Midland , Texas
Virginia Cancer Institute
Midlothian , Virginia
NOT_YET_RECRUITING
Avera Cancer Institute- Mitchell
Mitchell , South Dakota
Florida Cancer Specialists
N. Venice , Florida
Florida Cancer Specialists
Naples , Florida
Henry-Joyce Cancer Clinic
Nashville , Tennessee
NOT_YET_RECRUITING
Hope and Healing Cancer Services
New Lenox , Illinois
Illinois Cancer Specialists
Niles , Illinois
The Cancer & Hematology Centers
Norton Shores , Michigan
Hematology Oncology Associates of Rockland
Nyack , New York
Texas Oncology - West Texas
Odessa , Texas
Mid Florida Hematology and Oncology Center
Orange City , Florida
Illinois CancerCare-Ottawa-Fox River Cancer Center
Ottawa , Illinois
Cancer Care Centers of Brevard, Inc.
Palm Bay , Florida
Texas Oncology - Gulf Coast
Pearland , Texas
Illinois CancerCare-Pekin
Pekin , Illinois
Illinois Cancer Care
Peoria , Illinois
Illinois CancerCare-Peru - Valley Regional Cancer Center
Peru , Illinois
Virginia Cancer Institute
Petersburg , Virginia
NOT_YET_RECRUITING
Ironwood Cancer & Research Centers
Phoenix , Arizona
Avera Cancer Institute- Pierre
Pierre , South Dakota
Florida Cancer Specialists
Port Charlotte , Florida
Kaiser Permanente Interstate Medical Office Central
Portland , Oregon
NOT_YET_RECRUITING
Renown Regional Medical Center
Reno , Nevada
Virginia Cancer Specialists, PC
Reston , Virginia
Virginia Cancer Institute
Richmond , Virginia
NOT_YET_RECRUITING
Virginia Cancer Institute
Richmond , Virginia
NOT_YET_RECRUITING
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke , Virginia
Cancer Care Centers of Brevard, Inc.
Rockledge , Florida
Highlands Oncology Group
Rogers , Arkansas
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Salem , Virginia
Florida Cancer Specialists
Sarasota , Florida
Ironwood Cancer & Research Centers
Scottsdale , Arizona
Avera Cancer Institute
Sioux Falls , South Dakota
Highlands Oncology Group
Springdale , Arkansas
Oncology Associates of Oregon, P.C.
Springfield , Oregon
Texas Oncology - Gulf Coast
Sugar Land , Texas
Texas Oncology - Gulf Coast
The Woodlands , Texas
Texas Oncology - Northeast Texas
Tyler , Texas
Illinois CancerCare-Washington
Washington , Illinois
Texas Oncology - West Texas
Wichita Falls , Texas
Virginia Cancer Specialists, PC
Woodbridge , Virginia
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
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