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
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
3 other identifiers
interventional
800
17 countries
228
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2025
Longer than P75 for phase_3
228 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2025
CompletedFirst Posted
Study publicly available on registry
October 30, 2025
CompletedStudy Start
First participant enrolled
December 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2031
June 4, 2026
June 1, 2026
4.3 years
October 28, 2025
June 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Approximately 4 years
Secondary Outcomes (14)
PFS per RECIST 1.1 by investigator assessment
Approximately 4 years
Objective Response Rate (ORR) by BICR
Approximately 4 years
Objective Response Rate (ORR) by investigator
Approximately 4 years
Duration of Response (DOR) by BICR
Approximately 4 years
DOR by investigator
Approximately 4 years
- +9 more secondary outcomes
Study Arms (2)
PF-08634404 + Chemotherapy
EXPERIMENTALParticipants will receive PF-08634404 intravenously (IV) in combination with Chemotherapy.
Bevacizumab + Chemotherapy
ACTIVE COMPARATORParticipants will receive bevacizumab IV in combination with Chemotherapy.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (228)
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224, United States
Ironwood Cancer & Research Centers
Gilbert, Arizona, 85297, United States
Ironwood Cancer & Research Centers
Glendale, Arizona, 85306, United States
Ironwood Cancer & Research Centers
Goodyear, Arizona, 85395, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, 85202, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, 85206, United States
Ironwood Cancer & Research Centers
Phoenix, Arizona, 85028, United States
Ironwood Cancer & Research Centers
Scottsdale, Arizona, 85260, United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Highlands Oncology Group
Rogers, Arkansas, 72758, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
UCSF at Berkeley Outpatient Center
Berkeley, California, 94702, United States
UCSF at China Basin
San Francisco, California, 94107, United States
UCSF at Mount Zion
San Francisco, California, 94115, United States
UCSF at Parnassus
San Francisco, California, 94143, United States
UCSF Medical Center
San Francisco, California, 94158, United States
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, 80012, United States
Rocky Mountain Cancer Centers - Boulder
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers, LLP
Centennial, Colorado, 80112, United States
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, 80923, United States
Intermountain Health Cancer Center Saint Joseph
Denver, Colorado, 80218, United States
Intermountain Health Saint Joseph Hospital - Research Office
Denver, Colorado, 80218, United States
Intermountain Health Saint Joseph Hospital
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80220, United States
Rocky Mountain Cancer Centers, LLP
Englewood, Colorado, 80113, United States
Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers, LLP
Littleton, Colorado, 80120, United States
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Centers, LLP
Longmont, Colorado, 80504, United States
Rocky Mountain Cancer Centers, LLP
Pueblo, Colorado, 81003, United States
Rocky Mountain Cancer Centers, LLP
Thornton, Colorado, 80260, United States
Florida Cancer Specialists
Bonita Springs, Florida, 34135, United States
Florida Cancer Specialists
Bradenton, Florida, 34211, United States
Comprehensive Hematology Oncology
Brandon, Florida, 33511, United States
Florida Cancer Specialists
Cape Coral, Florida, 33909, United States
BRCR Global - Coral Springs
Coral Springs, Florida, 33065, United States
Florida Cancer Specialists
Fort Myers, Florida, 33905, United States
Florida Cancer Specialists
Fort Myers, Florida, 33908, United States
Comprehensive Hematology Oncology
Largo, Florida, 33770, United States
Cancer Care Centers of Brevard, Inc.
Melbourne, Florida, 32935, United States
Florida Cancer Specialists
N. Venice, Florida, 34275, United States
Florida Cancer Specialists
Naples, Florida, 34102, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763, United States
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, 32909, United States
Comprehensive Hematology Oncology
Palm Harbor, Florida, 34683, United States
Florida Cancer Specialists
Port Charlotte, Florida, 33980, United States
Cancer Care Centers of Brevard, Inc.
Rockledge, Florida, 32955, United States
Florida Cancer Specialists
Sarasota, Florida, 34236, United States
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33701, United States
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33709, United States
Comprehensive Hematology Oncology
Trinity, Florida, 34655, United States
University Cancer & Blood Center, LLC
Athens, Georgia, 30607, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois, 61704, United States
Illinois Cancer Specialists
Chicago, Illinois, 60631, United States
Illinois CancerCare - Galesburg
Galesburg, Illinois, 61401, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521, United States
Hope and Healing Cancer Services
New Lenox, Illinois, 60451, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
Illinois CancerCare-Ottawa-Fox River Cancer Center
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
Illinois CancerCare-Peru - Valley Regional Cancer Center
Peru, Illinois, 61354, United States
Illinois CancerCare-Washington
Washington, Illinois, 61571, United States
Franciscan Health
Indianapolis, Indiana, 46237, United States
Franciscan Health Mooresville
Mooresville, Indiana, 46158, United States
The Cancer & Hematology Centers
Big Rapids, Michigan, 49307, United States
The Cancer & Hematology Centers
Grand Rapids, Michigan, 49503, United States
The Cancer & Hematology Centers
Grand Rapids, Michigan, 49546, United States
The Cancer & Hematology Centers
Holland, Michigan, 49424, United States
The Cancer & Hematology Centers
Norton Shores, Michigan, 49444, United States
Avera Cancer Institute- Marshall
Marshall, Minnesota, 56258, United States
Cancer Partners of Nebraska
Lincoln, Nebraska, 68516, United States
Renown Health Medical Oncology
Reno, Nevada, 89502, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
NYOH Albany Cancer Center
Albany, New York, 12206, United States
Hematology-Oncology Associates of Central New York, PC
Auburn, New York, 13021, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Babylon, New York, 11702, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Brooklyn, New York, 11210, United States
Hematology-Oncology Associates of Central New York, PC
Camillus, New York, 13031, United States
New York Oncology Hematology - Clifton Park Cancer Center
Clifton Park, New York, 12065, United States
Hematology-Oncology Associates of Central New York, PC
East Syracuse, New York, 13057, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
New Hyde Park, New York, 11042, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
New York, New York, 10028, United States
Hematology Oncology Associates of Rockland
Nyack, New York, 10960, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Patchogue, New York, 11772, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Port Jefferson Station, New York, 11776, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Riverhead, New York, 11901, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Shirley, New York, 11967, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
The Bronx, New York, 10469, United States
Oncology Hematology Care - Eastgate
Cincinnati, Ohio, 45245, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Oncology Hematology Care Clinical Trials, LLC
Fairfield, Ohio, 45014, United States
Oncology Associates of Oregon, P.C.
Albany, Oregon, 97321, United States
Kaiser Permanente Sunnyside Medical Center
Clackamas, Oregon, 97015, United States
Oncology Associates of Oregon, P.C.
Corvallis, Oregon, 97330, United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401, United States
Kaiser Permanente Westside Medical Center
Hillsboro, Oregon, 97124, United States
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, 97227, United States
Oncology Associates of Oregon, P.C.
Springfield, Oregon, 97477, United States
Avera Cancer Institute- Aberdeen
Aberdeen, South Dakota, 57401, United States
Avera Cancer Institute- Mitchell
Mitchell, South Dakota, 57301, United States
Avera Cancer Institute- Pierre
Pierre, South Dakota, 57501, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
AMG Oncology & Hematology -Yankton
Yankton, South Dakota, 57078, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232, United States
Texas Oncology - West Texas
Abilene, Texas, 79606, United States
Texas Oncology - West Texas
Amarillo, Texas, 79124, United States
Texas Oncology - Gulf Coast
Beaumont, Texas, 77702, United States
Texas Oncology - Northeast Texas
Denison, Texas, 75020, United States
Texas Oncology - Northeast Texas
Denton, Texas, 76201, United States
Texas Oncology - West Texas
El Paso, Texas, 79902, United States
Texas Oncology - West Texas
El Paso, Texas, 79915, United States
Texas Oncology - West Texas
El Paso, Texas, 79938, United States
Texas Oncology - Northeast Texas
Flower Mound, Texas, 75028, United States
Oncology Consultants P.A.
Houston, Texas, 77008, United States
Oncology Consultants P.A.
Houston, Texas, 77024, United States
Texas Oncology - Gulf Coast
Houston, Texas, 77024, United States
Oncology Consultants P.A.
Houston, Texas, 77030, United States
Texas Oncology - Gulf Coast
Houston, Texas, 77054, United States
Texas Oncology - Gulf Coast
Houston, Texas, 77070, United States
Radnet/Houston Medical Imaging
Houston, Texas, 77098, United States
Texas Oncology - Gulf Coast
Humble, Texas, 77338, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063, United States
US Oncology Investigational Products Center
Irving, Texas, 75063, United States
Texas Oncology - Northeast Texas
Longview, Texas, 75601, United States
Texas Oncology - West Texas
Midland, Texas, 79701, United States
Texas Oncology - West Texas
Odessa, Texas, 79761, United States
Texas Oncology - Gulf Coast
Pearland, Texas, 77584, United States
Texas Oncology - Gulf Coast
Sugar Land, Texas, 77479, United States
Texas Oncology - Gulf Coast
The Woodlands, Texas, 77380, United States
Texas Oncology - Northeast Texas
Tyler, Texas, 75702, United States
Texas Oncology - West Texas
Wichita Falls, Texas, 76310, United States
Virginia Cancer Specialists, PC
Arlington, Virginia, 22201, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Low Moor, Virginia, 24457, United States
Virginia Cancer Specialists, PC
Manassas, Virginia, 20110, United States
Virginia Cancer Institute
Mechanicsville, Virginia, 23116, United States
Virginia Cancer Institute
Midlothian, Virginia, 23112, United States
Virginia Cancer Institute
Petersburg, Virginia, 23805, United States
Virginia Cancer Specialists, PC
Reston, Virginia, 20190, United States
Virginia Cancer Institute
Richmond, Virginia, 23229, United States
Virginia Cancer Institute
Richmond, Virginia, 23235, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Salem, Virginia, 24153, United States
Virginia Cancer Specialists, PC
Woodbridge, Virginia, 22191, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Wytheville, Virginia, 24382, United States
Hospital Universitario Austral
Pilar, Buenos Aires, 1629, Argentina
Centro Para la Atención Integral del Paciente Oncologico (CAIPO)
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Instituto de Investigaciones Clínicas Córdoba S.A.
Córdoba, X5000AAW, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer
La Rioja, F5300COE, Argentina
Icon Cancer Centre Wesley
Auchenflower, Queensland, 4066, Australia
Icon Cancer Centre Hobart
Hobart, Tasmania, 7000, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Grand Hôpital de Charleroi
Charleroi, Hainaut, 6060, Belgium
UZ Leuven
Leuven, Vlaams Brabant, 3000, Belgium
AZ Delta vzw
Roeselare, WEST Vlaanderen, 8800, Belgium
AZ Sint-Lucas
Ghent, 9000, Belgium
Hospital de Câncer de Recife
Recife, Pernambuco, 50040-000, Brazil
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul, São Paulo, 09541-270, Brazil
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Peking University First Hospital
Beijing, Beijing Municipality, 102627, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510555, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530200, China
Vejle Sygehus
Vejle, Region Syddanmark, 7100, Denmark
Institut Gustave Roussy
Villejuif, Val-de-marne, 94800, France
CHU Brest, Hopital La Cavale Blanche
Brest, 29200, France
Centre Georges-François Leclerc health establishment, centre or care home
Dijon, 21079 Cedex, France
CHU de Lille, Hopital Claude Huriez
Lille, 59037, France
Hôpital Saint-Louis
Paris, 75010, France
Hôpital Européen Georges Pompidou
Paris, 75015, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021, France
Henri Mondor Hospital
Créteil, Île-de-France Region, 94000, France
Universitäres Krebszentrum Leipzig (UCCL), UKL AöR
Leipzig, Saxony, 04103, Germany
DRK Kliniken Berlin - Köpenick
Berlin, 12559, Germany
Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
Dresden, 01307, Germany
Asklepios Altona
Hamburg, 22763, Germany
Rabin Medical Center
Petah Tikva, HA Merkaz, 4941492, Israel
Sheba Medical Center
Ramat Gan, HA Merkaz, 5265601, Israel
Rambam Health Care Campus
Haifa, HA Tsafon, 3109601, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001, Israel
Sourasky Medical Center
Tel Aviv, TELL ABĪB, 6423906, Israel
Pia Fondazione Di Culto E Di Religione Card. G. Panico
Tricase, Lecce, 73039, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, ROME, 00168, Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681, Japan
Chiba cancer center
Chiba, Chiba, 260-8717, Japan
Kanagawa cancer center
Yokohama, Kanagawa, 241-8515, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298, Japan
Saitama Prefectural Cancer Center
Kitaadachi-gun, Saitama, 362-0806, Japan
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, 411-8777, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
National Hospital Organization Osaka Medical Center
Osaka, 540-0006, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka, 541-8567, Japan
Pratia Onkologia Katowice
Katowice, Silesian Voivodeship, 40-519, Poland
Pratia MCM Krakow
Krakow, 30-727, Poland
SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
Opole, 45-061, Poland
Pratia Poznań
Poznan, 60-192, Poland
Pan American Center for Oncology Trials - Mayaguez
Mayagüez, 00680, Puerto Rico
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935, Puerto Rico
Pan American Center for Oncology Trials, LLC - Centro Europa Office
San Juan, 00907, Puerto Rico
Pan American Center for Oncology Trials, LLC
San Juan, 00909, Puerto Rico
Clínica Radiológica HLA Mario Gallegos
Málaga, Andalusia, 29016, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035, Spain
Hospital Jerez de la Frontera
Jerez de la Frontera, Cádiz, 11407, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, 28034, Spain
CETIR
Barcelona, 08029, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Regional Universitario de Malaga (Hospital Civil)
Málaga, 29011, Spain
Instituto Valenciano de Oncología (IVO)
Valencia, 46009, Spain
Zentro Diagnostico Avanzado
Zaragoza, 50006, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung City, 83301, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2025
First Posted
October 30, 2025
Study Start
December 11, 2025
Primary Completion (Estimated)
March 29, 2030
Study Completion (Estimated)
August 1, 2031
Last Updated
June 4, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.