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

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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Pfizer (industry)

Phase: 3

Start date: Dec. 11, 2025

Planned enrollment: 800

Trial ID: NCT07222800
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More trial details at ClinicalTrials.gov More info

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Investigational Drug AI Analysis

chevron Show for: PF-08634404 (SSGJ-707)

TrialFetch AI Analysis

Goal: To determine whether adding the investigational PD-1/VEGF bispecific antibody PF-08634404 to standard first-line chemotherapy improves clinical outcomes versus bevacizumab plus the same chemotherapy in previously untreated metastatic colorectal cancer, while characterizing safety, pharmacokinetics, immunogenicity, and patient-reported quality of life.

Patients: Adults (≥18 years) with histologically/cytologically confirmed metastatic (stage IV) colorectal adenocarcinoma, ECOG performance status 0–1, at least one RECIST 1.1 measurable lesion, and adequate organ function. Key exclusions include locally confirmed BRAF V600E mutation, MSI-high/dMMR disease, active symptomatic CNS metastases, significant bleeding risk or recent grade ≥3 hemorrhage, recent major surgery/trauma, significant cardiovascular disease within 6 months, active autoimmune disease requiring systemic therapy within 2 years, and noninfectious/drug-induced ILD/pneumonitis.

Design: Phase 3, double-blind, randomized, active-controlled, multicenter study with planned enrollment of approximately 800 participants. Treatment is delivered in repeating IV cycles and may continue until disease progression, unacceptable toxicity, or discontinuation. Disease assessments include blinded independent central review (BICR) for key efficacy endpoints, with long-term follow-up for survival and subsequent therapy outcomes (overall follow-up up to ~4 years).

Treatments: Experimental arm: PF-08634404 administered intravenously in combination with standard chemotherapy for metastatic colorectal cancer (specific regimen not provided in the trial description). PF-08634404 (also known as SSGJ-707) is a bispecific antibody targeting PD-1 and VEGF, intended to couple immune checkpoint inhibition with anti-angiogenic effects. Early-phase experience has been reported mainly in first-line NSCLC, where combination with platinum chemotherapy showed higher objective response rates than a PD-1 inhibitor plus chemotherapy in a phase 2 report, with grade ≥3 treatment-related adverse events in the ~40% range; efficacy and safety in mCRC remain investigational and are being tested here against an established anti-VEGF standard. Comparator arm: bevacizumab (anti-VEGF monoclonal antibody) administered intravenously in combination with standard chemotherapy.

Outcomes: Co-primary endpoints are progression-free survival by BICR per RECIST 1.1 and overall survival. Key secondary endpoints include objective response rate and duration of response (each assessed by BICR and by investigator), investigator-assessed PFS, PFS2 (time to second progression after next-line therapy), treatment-emergent adverse events/serious adverse events, clinical laboratory abnormalities, pharmacokinetics of PF-08634404, anti-drug antibodies, and patient-reported outcomes (EORTC QLQ-C30 global health status/QoL, EORTC QLQ-CR29 symptom/function scales, and time to definitive deterioration).

Burden on patient: Moderate burden. Treatment requires regular on-site IV infusions consistent with standard first-line mCRC therapy, plus protocol-mandated efficacy imaging and assessments over a prolonged period (up to approximately 4 years) with blinded central review. Additional study-specific procedures include pharmacokinetic sampling and immunogenicity testing (anti-drug antibodies) over roughly the first 21 months, routine safety labs, and repeated quality-of-life questionnaires; follow-up continues every 12 weeks after treatment discontinuation, which adds ongoing visits or contact beyond typical care in some settings. No mandatory biopsies are described in the provided information.

Last updated: Jan 2026

Eligibility More information

Caution: ClinicalTrials.gov appears to have newer eligibility criteria than the version saved here. Review the current criteria in ClinicalTrials.gov.

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Sites (156)

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Icon Cancer Centre Wesley

Auchenflower, Queensland, 4066, Australia

No email / No phone

Status: Recruiting

Icon Cancer Centre Hobart

Hobart, Tasmania, 7000, Australia

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Status: Recruiting

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

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Status: Recruiting

Centro de Oncologia - CEON+ - Unidade São Caetano do Sul

São Caetano do Sul, São Paulo, 09541-270, Brazil

No email / No phone

Status: Recruiting

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

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Status: Recruiting

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

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Status: Recruiting

Kyushu University Hospital

Fukuoka, 812-8582, Japan

No email / No phone

Status: Recruiting

National Hospital Organization Osaka Medical Center

Osaka, 540-0006, Japan

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Status: Recruiting

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, 464-8681, Japan

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Status: Recruiting

Chiba cancer center

Chiba, Chiba, 260-8717, Japan

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Status: Recruiting

Kanagawa cancer center

Yokohama, Kanagawa, 241-8515, Japan

No email / No phone

Status: Recruiting

Saitama Medical University International Medical Center

Hidaka, Saitama, 350-1298, Japan

No email / No phone

Status: Recruiting

Saitama Prefectural Cancer Center

Kitaadachi-gun, Saitama, 362-0806, Japan

No email / No phone

Status: Recruiting

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, 411-8777, Japan

No email / No phone

Status: Recruiting

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-8550, Japan

No email / No phone

Status: Recruiting

Pan American Center for Oncology Trials - Mayaguez

Mayagüez, 00680, Puerto Rico

No email / No phone

Status: Recruiting

Pan American Center for Oncology Trials, LLC

San Juan, 00909, Puerto Rico

No email / No phone

Status: Recruiting

Pan American Center for Oncology Trials, LLC

Rio Piedras, 00935, Puerto Rico

No email / No phone

Status: Recruiting

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Scottsdale, Arizona, 85260, United States

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Phoenix, Arizona, 85028, United States

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Mesa, Arizona, 85206, United States

No email / No phone

Status: Recruiting

Ironwood Cancer & Research Centers

Chandler, Arizona, 85224, United States

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Status: Recruiting

Ironwood Cancer & Research Centers

Mesa, Arizona, 85202, United States

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Status: Recruiting

Ironwood Cancer & Research Centers

Goodyear, Arizona, 85395, United States

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Status: Recruiting

Ironwood Cancer & Research Centers

Glendale, Arizona, 85306, United States

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Status: Recruiting

Ironwood Cancer & Research Centers

Gilbert, Arizona, 85297, United States

No email / No phone

Status: Recruiting

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

No email / No phone

Status: Recruiting

Highlands Oncology Group

Rogers, Arkansas, 72758, United States

No email / No phone

Status: Recruiting

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

No email / No phone

Status: Recruiting

Rocky Mountain Cancer Centers - Boulder

Boulder, Colorado, 80303, United States

No email / No phone

Status: Recruiting

BRCR Global - Coral Springs

Coral Springs, Florida, 33065, United States

No email / No phone

Status: Recruiting

Cancer Care Centers of Brevard, Inc.

Melbourne, Florida, 32935, United States

No email / No phone

Status: Recruiting

Cancer Care Centers of Brevard, Inc.

Palm Bay, Florida, 32909, United States

No email / No phone

Status: Recruiting

Cancer Care Centers of Brevard, Inc.

Rockledge, Florida, 32955, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Fort Myers, Florida, 33905, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Bonita Springs, Florida, 34135, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Bradenton, Florida, 34211, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Cape Coral, Florida, 33909, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Fort Myers, Florida, 33908, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

N. Venice, Florida, 34275, United States

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Status: Recruiting

Florida Cancer Specialists

Naples, Florida, 34102, United States

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Status: Recruiting

Florida Cancer Specialists

Port Charlotte, Florida, 33980, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Sarasota, Florida, 34236, United States

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Status: Recruiting

Mid Florida Hematology and Oncology Center

Orange City, Florida, 32763, United States

No email / No phone

Status: Recruiting

Hope and Healing Cancer Services

New Lenox, Illinois, 60451, United States

No email / No phone

Status: Recruiting

Hope and Healing Cancer Services

Hinsdale, Illinois, 60521, United States

No email / No phone

Status: Recruiting

Illinois Cancer Care

Peoria, Illinois, 61615, United States

No email / No phone

Status: Recruiting

Illinois Cancer Specialists

Niles, Illinois, 60714, United States

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Status: Recruiting

Illinois Cancer Specialists

Arlington Heights, Illinois, 60005, United States

No email / No phone

Status: Recruiting

Illinois Cancer Specialists

Chicago, Illinois, 60631, United States

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Status: Recruiting

Illinois CancerCare - Bloomington

Bloomington, Illinois, 61704, United States

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Status: Recruiting

Illinois CancerCare - Galesburg

Galesburg, Illinois, 61401, United States

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Status: Recruiting

Illinois CancerCare-Ottawa-Fox River Cancer Center

Ottawa, Illinois, 61350, United States

No email / No phone

Status: Recruiting

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

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Status: Recruiting

Illinois CancerCare-Peru - Valley Regional Cancer Center

Peru, Illinois, 61354, United States

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Status: Recruiting

Illinois CancerCare-Washington

Washington, Illinois, 61571, United States

No email / No phone

Status: Recruiting

The Cancer & Hematology Centers

Norton Shores, Michigan, 49444, United States

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Status: Recruiting

The Cancer & Hematology Centers

Holland, Michigan, 49424, United States

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Status: Recruiting

The Cancer & Hematology Centers

Big Rapids, Michigan, 49307, United States

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Status: Recruiting

The Cancer & Hematology Centers

Grand Rapids, Michigan, 49503, United States

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Status: Recruiting

The Cancer & Hematology Centers

Grand Rapids, Michigan, 49546, United States

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Status: Recruiting

Avera Cancer Institute- Marshall

Marshall, Minnesota, 56258, United States

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Status: Recruiting

Cancer Partners of Nebraska

Lincoln, Nebraska, 68516, United States

No email / No phone

Status: Recruiting

Renown Regional Medical Center

Reno, Nevada, 89502, United States

No email / No phone

Status: Recruiting

Hematology Oncology Associates of Rockland

Nyack, New York, 10960, United States

No email / No phone

Status: Recruiting

Hematology-Oncology Associates of Central New York, PC

East Syracuse, New York, 13057, United States

No email / No phone

Status: Recruiting

Hematology-Oncology Associates of Central New York, PC

Camillus, New York, 13031, United States

No email / No phone

Status: Recruiting

Oncology Hematology Care - Eastgate

Cincinnati, Ohio, 45245, United States

No email / No phone

Status: Recruiting

Oncology Hematology Care Clinical Trials, LLC

Fairfield, Ohio, 45014, United States

No email / No phone

Status: Recruiting

Oncology Associates of Oregon, P.C.

Eugene, Oregon, 97401, United States

No email / No phone

Status: Recruiting

Oncology Associates of Oregon, P.C.

Corvallis, Oregon, 97330, United States

No email / No phone

Status: Recruiting

Oncology Associates of Oregon, P.C.

Albany, Oregon, 97321, United States

No email / No phone

Status: Recruiting

Oncology Associates of Oregon, P.C.

Springfield, Oregon, 97477, United States

No email / No phone

Status: Recruiting

AMG Oncology & Hematology -Yankton

Yankton, South Dakota, 57078, United States

No email / No phone

Status: Recruiting

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

No email / No phone

Status: Recruiting

Avera Cancer Institute- Aberdeen

Aberdeen, South Dakota, 57401, United States

No email / No phone

Status: Recruiting

Avera Cancer Institute- Mitchell

Mitchell, South Dakota, 57301, United States

No email / No phone

Status: Recruiting

Avera Cancer Institute- Pierre

Pierre, South Dakota, 57501, United States

No email / No phone

Status: Recruiting

Oncology Consultants P.A.

Houston, Texas, 77024, United States

No email / No phone

Status: Recruiting

Oncology Consultants P.A.

Houston, Texas, 77030, United States

No email / No phone

Status: Recruiting

Oncology Consultants P.A.

Houston, Texas, 77008, United States

No email / No phone

Status: Recruiting

Radnet/Houston Medical Imaging

Houston, Texas, 77098, United States

No email / No phone

Status: Recruiting

Texas Oncology - Gulf Coast

Houston, Texas, 77024, United States

No email / No phone

Status: Recruiting

Texas Oncology - Gulf Coast

Houston, Texas, 77054, United States

No email / No phone

Status: Recruiting

Texas Oncology - Gulf Coast

Houston, Texas, 77070, United States

No email / No phone

Status: Recruiting

Texas Oncology - Gulf Coast

Humble, Texas, 77338, United States

No email / No phone

Status: Recruiting

Texas Oncology - Gulf Coast

Pearland, Texas, 77584, United States

No email / No phone

Status: Recruiting

Texas Oncology - Gulf Coast

Sugar Land, Texas, 77479, United States

No email / No phone

Status: Recruiting

Texas Oncology - Gulf Coast

The Woodlands, Texas, 77380, United States

No email / No phone

Status: Recruiting

Texas Oncology - Gulf Coast

Beaumont, Texas, 77702, United States

No email / No phone

Status: Recruiting

Texas Oncology - Northeast Texas

Longview, Texas, 75601, United States

No email / No phone

Status: Recruiting

Texas Oncology - Northeast Texas

Tyler, Texas, 75702, United States

No email / No phone

Status: Recruiting

Texas Oncology - Northeast Texas

Flower Mound, Texas, 75028, United States

No email / No phone

Status: Recruiting

Texas Oncology - Northeast Texas

Denton, Texas, 76201, United States

No email / No phone

Status: Recruiting

Texas Oncology - Northeast Texas

Denison, Texas, 75020, United States

No email / No phone

Status: Recruiting

Texas Oncology - West Texas

Amarillo, Texas, 79124, United States

No email / No phone

Status: Recruiting

Texas Oncology - West Texas

Midland, Texas, 79701, United States

No email / No phone

Status: Recruiting

Texas Oncology - West Texas

Odessa, Texas, 79761, United States

No email / No phone

Status: Recruiting

Texas Oncology - West Texas

Wichita Falls, Texas, 76310, United States

No email / No phone

Status: Recruiting

Texas Oncology - West Texas

El Paso, Texas, 79938, United States

No email / No phone

Status: Recruiting

Texas Oncology - West Texas

El Paso, Texas, 79915, United States

No email / No phone

Status: Recruiting

Texas Oncology - West Texas

El Paso, Texas, 79902, United States

No email / No phone

Status: Recruiting

Texas Oncology - West Texas

Abilene, Texas, 79606, United States

No email / No phone

Status: Recruiting

US Oncology Investigational Products Center

Irving, Texas, 75063, United States

No email / No phone

Status: Recruiting

US Oncology Investigational Products Center (IPC)

Irving, Texas, 75063, United States

No email / No phone

Status: Recruiting

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Wytheville, Virginia, 24382, United States

No email / No phone

Status: Recruiting

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Salem, Virginia, 24153, United States

No email / No phone

Status: Recruiting

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Roanoke, Virginia, 24014, United States

No email / No phone

Status: Recruiting

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Low Moor, Virginia, 24457, United States

No email / No phone

Status: Recruiting

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Blacksburg, Virginia, 24060, United States

No email / No phone

Status: Recruiting

Virginia Cancer Specialists, PC

Woodbridge, Virginia, 22191, United States

No email / No phone

Status: Recruiting

Virginia Cancer Specialists, PC

Reston, Virginia, 20190, United States

No email / No phone

Status: Recruiting

Virginia Cancer Specialists, PC

Manassas, Virginia, 20110, United States

No email / No phone

Status: Recruiting

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

No email / No phone

Status: Recruiting

Virginia Cancer Specialists, PC

Arlington, Virginia, 22201, United States

No email / No phone

Status: Recruiting

AZ Sint-Lucas

Ghent, 9000, Belgium

No email / No phone

Status: Not yet recruiting

Grand Hôpital de Charleroi

Charleroi, Hainaut, 6060, Belgium

No email / No phone

Status: Not yet recruiting

CHU Brest, Hopital La Cavale Blanche

Brest, 29200, France

No email / No phone

Status: Not yet recruiting

Hôpital Européen Georges Pompidou

Paris, 75015, France

No email / No phone

Status: Not yet recruiting

Institut Gustave Roussy

Villejuif, 94800, France

No email / No phone

Status: Not yet recruiting

Henri Mondor Hospital

Créteil, Île-de-France Region, 94000, France

No email / No phone

Status: Not yet recruiting

Asklepios Altona

Hamburg, 22763, Germany

No email / No phone

Status: Not yet recruiting

DRK Kliniken Berlin - Köpenick

Berlin, 12559, Germany

No email / No phone

Status: Not yet recruiting

Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf

Dresden, 01307, Germany

No email / No phone

Status: Not yet recruiting

Rabin Medical Center

Petah Tikva, HA Merkaz, 4941492, Israel

No email / No phone

Status: Not yet recruiting

Hadassah Medical Center

Jerusalem, Jerusalem, 9112001, Israel

No email / No phone

Status: Not yet recruiting

Sourasky Medical Center

Tel Aviv, TELL ABĪB, 6423906, Israel

No email / No phone

Status: Not yet recruiting

Pia Fondazione Di Culto E Di Religione Card. G. Panico

Tricase, Lecce, 73039, Italy

No email / No phone

Status: Not yet recruiting

Pratia Poznań

Poznan, 60-192, Poland

No email / No phone

Status: Not yet recruiting

SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu

Opole, 45-061, Poland

No email / No phone

Status: Not yet recruiting

Pratia Onkologia Katowice

Katowice, Silesian Voivodeship, 40-519, Poland

No email / No phone

Status: Not yet recruiting

CETIR

Barcelona, 08029, Spain

No email / No phone

Status: Not yet recruiting

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

No email / No phone

Status: Not yet recruiting

Hospital Regional Universitario de Malaga (Hospital Civil)

Málaga, 29011, Spain

No email / No phone

Status: Not yet recruiting

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

No email / No phone

Status: Not yet recruiting

Clínica Radiológica HLA Mario Gallegos

Málaga, Andalusia, 29016, Spain

No email / No phone

Status: Not yet recruiting

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona], 08035, Spain

No email / No phone

Status: Not yet recruiting

Hospital Jerez de la Frontera

Jerez de la Frontera, Cádiz, 11407, Spain

No email / No phone

Status: Not yet recruiting

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, 333, Taiwan

No email / No phone

Status: Not yet recruiting

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung City, 83301, Taiwan

No email / No phone

Status: Not yet recruiting

National Cheng Kung University Hospital

Tainan, 704, Taiwan

No email / No phone

Status: Not yet recruiting

National Taiwan University Hospital

Taipei, 10002, Taiwan

No email / No phone

Status: Not yet recruiting

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

No email / No phone

Status: Not yet recruiting

Intermountain Health Cancer Center Saint Joseph

Denver, Colorado, 80218, United States

No email / No phone

Status: Not yet recruiting

Intermountain Health Saint Joseph Hospital

Denver, Colorado, 80218, United States

No email / No phone

Status: Not yet recruiting

Intermountain Health Saint Joseph Hospital - Research Office

Denver, Colorado, 80218, United States

No email / No phone

Status: Not yet recruiting

Kaiser Permanente Interstate Medical Office Central

Portland, Oregon, 97227, United States

No email / No phone

Status: Not yet recruiting

Kaiser Permanente Sunnyside Medical Center

Clackamas, Oregon, 97015, United States

No email / No phone

Status: Not yet recruiting

Kaiser Permanente Westside Medical Center

Hillsboro, Oregon, 97124, United States

No email / No phone

Status: Not yet recruiting

Henry-Joyce Cancer Clinic

Nashville, Tennessee, 37232, United States

No email / No phone

Status: Not yet recruiting

Virginia Cancer Institute

Richmond, Virginia, 23235, United States

No email / No phone

Status: Not yet recruiting

Virginia Cancer Institute

Richmond, Virginia, 23229, United States

No email / No phone

Status: Not yet recruiting

Virginia Cancer Institute

Petersburg, Virginia, 23805, United States

No email / No phone

Status: Not yet recruiting

Virginia Cancer Institute

Midlothian, Virginia, 23112, United States

No email / No phone

Status: Not yet recruiting

Virginia Cancer Institute

Mechanicsville, Virginia, 23116, United States

No email / No phone

Status: Not yet recruiting

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