A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2

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Investigational drug late phase More information Active drug More information Started >3 years ago More information High burden on patient More information

Trial Details

Sponsor: Seagen, a wholly owned subsidiary of Pfizer (industry)

Phase: 2

Start date: May 3, 2022

Planned enrollment: 372

Trial ID: NCT04879329
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More trial details at ClinicalTrials.gov More info

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Investigational Drug AI Analysis

chevron Show for: disitamab vedotin (RC48, Aidixi)

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Goal: Evaluate the antitumor activity and safety of disitamab vedotin (DV; RC48-ADC), alone or combined with pembrolizumab, in HER2-expressing locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), and characterize safety and pharmacokinetics across multiple treatment settings including post-enfortumab vedotin exposure and Japan-specific cohorts.

Patients: Adults with histologically confirmed LA/mUC of the renal pelvis, ureter, bladder, or urethra and at least one measurable lesion by RECIST v1.1. HER2 expression by central testing is required (IHC 1+, 2+, or 3+). Cohorts include: previously treated patients after 1–2 prior systemic regimens including platinum (A, B); treatment-naïve patients eligible for cisplatin- or carboplatin-containing chemotherapy (C randomized and non-randomized; E in Japan); heavily pretreated Japanese patients post-platinum, PD-(L)1 inhibitor, and enfortumab vedotin (D); and patients previously treated with enfortumab vedotin ± pembrolizumab (G). ECOG 0–1 for most cohorts, up to 2 allowed in one first-line cohort. Key exclusions include prior HER2-directed therapy, prior MMAE-based ADCs for most cohorts (except those specifically post-enfortumab vedotin), uncontrolled toxicities, significant neuropathy, and relevant immunosuppression where pembrolizumab is used.

Design: Phase 2, open-label, multi-cohort, multi-center study with both randomized and non-randomized components. Randomization occurs within Cohort C, comparing DV plus pembrolizumab versus DV alone in first-line, HER2-expressing, chemotherapy-eligible LA/mUC. Other cohorts are single-arm evaluations stratified by HER2 level, prior therapy exposure, geography (Japan), and prior enfortumab vedotin use. Planned enrollment is 372 participants.

Treatments: Disitamab vedotin (DV) monotherapy and the combination of DV plus pembrolizumab. DV is an antibody-drug conjugate targeting HER2 that links a humanized anti-HER2 antibody (disitamab) to the microtubule-disrupting payload monomethyl auristatin E via a cleavable vedotin linker. Proposed mechanisms include targeted cytotoxic delivery to HER2-expressing cells, a bystander effect, immunogenic cell death, and inhibition of HER2 signaling. DV has shown activity across HER2-positive and HER2-low tumors; in metastatic urothelial carcinoma, combination with PD-1 blockade has produced high response rates in early-phase studies, and DV is approved in China for later-line HER2-overexpressing gastric cancer. Pembrolizumab is a PD-1 inhibitor with established efficacy in urothelial carcinoma across multiple lines of therapy.

Outcomes: Primary endpoints: confirmed objective response rate by blinded independent central review per RECIST v1.1 for Cohorts A, B, C, and G; and safety/PK endpoints in Japan-specific Cohorts D and E including incidence of adverse events, dose modifications, laboratory and ECG abnormalities, LVEF changes, and DV PK (AUC, Cmax, Tmax, Ctrough). Secondary endpoints include investigator-assessed ORR, duration of response, progression-free survival by BICR and investigator, disease control rate, overall survival, safety profiles, cardiac monitoring, comprehensive PK for DV (and pembrolizumab Cmax in Cohort E), and immunogenicity (anti-drug and neutralizing antibodies to DV and anti-drug antibodies to pembrolizumab where applicable).

Burden on patient: Moderate to high. Participants will undergo frequent tumor assessments by RECIST, serial safety labs, ECGs, and echocardiograms or MUGA for LVEF monitoring given HER2-targeting and ADC exposure. Several cohorts include intensive pharmacokinetic sampling for DV (and pembrolizumab in Japan), increasing visit duration and blood draws, particularly early in treatment and around dosing cycles. Central confirmation of HER2 status may require provision of archival tissue or new biopsy. Combination-therapy and randomized cohorts necessitate regular infusion visits for DV and pembrolizumab, adding clinic time and travel. Safety monitoring for neuropathy and cytopenias is routine but may trigger dose holds or modifications, leading to additional assessments. Overall, visit frequency and procedures exceed standard-of-care chemotherapy or single-agent immunotherapy due to PK, immunogenicity sampling, and cardiac monitoring typical of ADC studies.

Last updated: Oct 2025

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Arthur J.E. Child Comprehensive Cancer Centre

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Ramat Gan, 52621, Israel

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Haifa, 3109601, Israel

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Ramat Gan, 5265601, Israel

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Tel Aviv, 6423906, Israel

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Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

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Centro di Riferimento Oncologico Di Aviano

Aviano, Pordenone, 33184, Italy

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, ROME, 00168, Italy

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Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

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Terni, 05100, Italy

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Terni, 05100, Italy

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Roma, 00168, Italy

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Padua, 35128, Italy

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Milan, 20132, Italy

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National Cancer Center Hospital East

Kashiwa-shi, Chiba, 277-8577, Japan

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Sapporo, Hokkaido, 060-8543, Japan

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Osaka University Hospital

Suita-shi, Osaka, 565-0871, Japan

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Tokushima University Hospital

Tokushima, Tokushima, 770-8503, Japan

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The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-8550, Japan

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Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

Osaka, 541-8567, Japan

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Sabadell, Barcelona, 08208, Spain

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Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

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MD Anderson Cancer Center - Madrid

Madrid, 28033, Spain

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Barcelona, 08035, Spain

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MD Anderson Cancer Center Madrid

Madrid, 28033, Spain

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T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

Istanbul, 34722, Turkey (Türkiye)

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Trakya Universitesi Tip Fakultesi Hastanesi (Saglik Arastirma ve Uygulama Merkezi)

Edirne, 22030, Turkey (Türkiye)

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Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

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The Clatterbridge Cancer Centre NHS Foundation Trust, The Clatterbridge Cancer Centre - Wirral

Merseyside, CH63 4JY, United Kingdom

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London, W6 8RF, United Kingdom

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Cambridge, CB2 0QQ, United Kingdom

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Gilbert, Arizona, 85234, United States

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Baldwin Park, California, 91706, United States

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Bellflower, California, 90706, United States

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City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, 91010, United States

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Fontana, California, 92335, United States

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Harbor City, California, 90710, United States

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Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612, United States

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Irvine, California, 92618, United States

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Los Angeles, California, 90027, United States

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Los Angeles, California, 90034, United States

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Valkyrie Clinical Trials

Los Angeles, California, 90067, United States

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Los Angeles, California, 90095, United States

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UCLA Hematology Oncology

Los Angeles, California, 90095, United States

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Ontario, California, 91761, United States

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Orange, California, 92868, United States

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Panorama City, California, 91402, United States

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Riverside, California, 92505, United States

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Riverside, California, 92505, United States

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San Diego, California, 92108, United States

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San Diego, California, 92120, United States

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UCSF Mount Zion Phlebotomy

San Francisco, California, 94115, United States

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UCSF Parnassus Phlebotomy

San Francisco, California, 94143, United States

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UCSF Investigational Drugs Pharmacy

San Francisco, California, 94158, United States

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University of California, San Francisco | HDFCCC - Hematopoietic Malignancies

San Francisco, California, 94158, United States

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University of California, San Francisco

San Francisco, California, 94158, United States

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Kaiser Permanente San Marcos Medical Offices

San Marcos, California, 92078, United States

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UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, 90404, United States

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Kaiser Permanente Woodland Hills Medical Center

Woodland Hills, California, 91367, United States

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Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

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Florida Cancer Specialists

Bonita Springs, Florida, 34135, United States

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Florida Cancer Specialists

Bradenton, Florida, 34205, United States

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Florida Cancer Specialists

Bradenton, Florida, 34211, United States

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Florida Cancer Specialists

Cape Coral, Florida, 33909, United States

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Florida Cancer Specialists

Daytona Beach, Florida, 32117, United States

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Florida Cancer Specialists

Fleming Island, Florida, 32003, United States

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Florida Cancer Specialists

Fort Myers, Florida, 33905, United States

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Florida Cancer Specialists

Fort Myers, Florida, 33908, United States

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Florida Cancer Specialists

Naples, Florida, 34102, United States

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Florida Cancer Specialists

Port Charlotte, Florida, 33980, United States

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Florida Cancer Specialists

Sarasota, Florida, 34232, United States

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Florida Cancer Specialists

Sarasota, Florida, 34236, United States

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Florida Cancer Specialists

Stuart, Florida, 34994, United States

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Florida Cancer Specialists

Tallahassee, Florida, 32308, United States

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Moffitt Cancer Center McKinley Hospital

Tampa, Florida, 33612, United States

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Moffitt Cancer Center

Tampa, Florida, 33612, United States

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Florida Cancer Specialists

Venice, Florida, 34285, United States

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Florida Cancer Specialists

Venice, Florida, 34292, United States

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Florida Cancer Specialists

Vero Beach, Florida, 32960, United States

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Florida Cancer Specialists

West Palm Beach, Florida, 33401, United States

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Florida Cancer Specialists

Wellington, Florida, 33414, United States

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WellStar Paulding Hospital

Hiram, Georgia, 30141, United States

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Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica

Carrollton, Georgia, 30117, United States

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West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica

Carrollton, Georgia, 30117, United States

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Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Cartersville, Georgia, 30121, United States

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Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Douglasville, Georgia, 30134, United States

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Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Hiram, Georgia, 30141, United States

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Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Marietta, Georgia, 30060, United States

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The University of Chicago Medicine Center for Advanced Care Orland Park

Orland Park, Illinois, 60462, United States

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UChicago Medicine - River East

Chicago, Illinois, 60611, United States

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University of Chicago Medical Center

Chicago, Illinois, 60637, United States

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Accellacare - Deerfield

Deerfield, Illinois, 60015, United States

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UChicago Medicine at Ingalls - Flossmoor

Flossmoor, Illinois, 60422, United States

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UChicago Medicine Ingalls Memorial

Harvey, Illinois, 60426, United States

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University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

New Lenox, Illinois, 60451, United States

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UChicago Medicine at Ingalls - Tinley Park

Tinley Park, Illinois, 60477, United States

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UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

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University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

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Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, 48910, United States

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Cancer & Hematology Centers of Western Michigan, PC

Norton Shores, Michigan, 49444, United States

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Cancer & Hematology Centers of Western Michigan, PC

Holland, Michigan, 49424, United States

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Cancer & Hematology Centers of Western Michigan, PC- Kit Storage

Grand Rapids, Michigan, 49546, United States

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Cancer & Hematology Centers of Western Michigan, PC

Grand Rapids, Michigan, 49503, United States

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Karmanos Cancer Institute Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States

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Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)

Detroit, Michigan, 48202, United States

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Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

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MSK Monmouth

Middletown, New Jersey, 07748, United States

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MSK Bergen

Montvale, New Jersey, 07645, United States

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MSK Basking Ridge

Basking Ridge, New Jersey, 07920, United States

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Northwell Health

Lake Success, New York, 11042, United States

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Status: Recruiting

Memorial Sloan Kattering Cancer Centre- Investigational Drug Service Pharmacy

Long Island City, New York, 11101, United States

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Status: Recruiting

Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

New York, New York, 10021, United States

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Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

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Status: Recruiting

Evelyn H. Lauder Breast and Imaging Centre (BAIC)

New York, New York, 10065, United States

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Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, 10065, United States

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Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

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MSK nassau

Uniondale, New York, 11553, United States

No email / No phone

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SUNY Upstate Medical University

Syracuse, New York, 13210, United States

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Status: Active, not recruiting

MSK Commack

Commack, New York, 11725, United States

No email / No phone

Status: Recruiting

MSK Wesrchester

Harrison, New York, 10604, United States

No email / No phone

Status: Recruiting

Atrium Health University City (biopsy only)

Charlotte, North Carolina, 28262, United States

No email / No phone

Status: Recruiting

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

No email / No phone

Status: Recruiting

Carolinas Medical Center Investigational Drug Services

Charlotte, North Carolina, 28204, United States

No email / No phone

Status: Recruiting

Carolinas Medical Center (biopsy only)

Charlotte, North Carolina, 28203, United States

No email / No phone

Status: Recruiting

UNC Lineberger Comprehensive Cancer Center / University of North Carolina

Chapel Hill, North Carolina, 27599, United States

No email / No phone

Status: Not yet recruiting

Atrium Health Union (biopsy only)

Monroe, North Carolina, 28112, United States

No email / No phone

Status: Recruiting

Levine Cancer Institute- Gaston

Gastonia, North Carolina, 28054, United States

No email / No phone

Status: Recruiting

Levine Cancer Institute Concord

Concord, North Carolina, 28025, United States

No email / No phone

Status: Recruiting

Atrium Health Cabarrus (biopsy only)

Concord, North Carolina, 28025, United States

No email / No phone

Status: Recruiting

Levine Cancer Institute - Ballantyne

Charlotte, North Carolina, 28277, United States

No email / No phone

Status: Recruiting

Levine Cancer Institute University

Charlotte, North Carolina, 28262, United States

No email / No phone

Status: Recruiting

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

No email / No phone

Status: Not yet recruiting

Atrium Health Mercy (biopsy only)

Charlotte, North Carolina, 28207, United States

No email / No phone

Status: Recruiting

OSU Wexner Medical Center & James Cancer Hospital

Columbus, Ohio, 43210, United States

No email / No phone

Status: Not yet recruiting

Ohio State University

Columbus, Ohio, 43210, United States

No email / No phone

Status: Not yet recruiting

Ohio State University Hospital

Columbus, Ohio, 43210, United States

No email / No phone

Status: Not yet recruiting

James Cancer Hospital & Solove Research Institute

Columbus, Ohio, 43210, United States

No email / No phone

Status: Not yet recruiting

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

No email / No phone

Status: Recruiting

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

No email / No phone

Status: Recruiting

OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

No email / No phone

Status: Recruiting

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

No email / No phone

Status: Recruiting

Baylor Scott and White Research Institute

Dallas, Texas, 75204, United States

No email / No phone

Status: Not yet recruiting

Baylor Scott & White Medical Center - Temple

Temple, Texas, 76508, United States

No email / No phone

Status: Not yet recruiting

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

No email / No phone

Status: Recruiting

Huntsman Cancer Institute at The University of Utah

Salt Lake City, Utah, 84112, United States

No email / No phone

Status: Not yet recruiting

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

No email / No phone

Status: Recruiting

Harborview Medical Center

Seattle, Washington, 98104, United States

No email / No phone

Status: Recruiting

University of Washington Medical Center

Seattle, Washington, 98195, United States

No email / No phone

Status: Recruiting

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

No email / No phone

Status: Recruiting

Froedtert Hospital/Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

No email / No phone

Status: Recruiting

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