A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

NCT ID: NCT04879329

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-03

Study Completion Date

2029-04-14

Brief Summary

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This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.

Detailed Description

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Conditions

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Urothelial Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Cohorts A, B, C, D, and G will enroll simultaneously. Cohort E will begin enrollment after Cohort D participants have completed the DLT evaluation period.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort A - DV monotherapy for HER2-positive tumor types

Disitamab vedotin monotherapy

Group Type EXPERIMENTAL

disitamab vedotin

Intervention Type DRUG

Given into the vein (IV; intravenous) every 2 weeks.

Cohort B - DV monotherapy for HER2-low tumor types

Disitamab vedotin monotherapy

Group Type EXPERIMENTAL

disitamab vedotin

Intervention Type DRUG

Given into the vein (IV; intravenous) every 2 weeks.

Cohort C - Non-randomized combination therapy

Disitamab vedotin + pembrolizumab

Group Type EXPERIMENTAL

disitamab vedotin

Intervention Type DRUG

Given into the vein (IV; intravenous) every 2 weeks.

pembrolizumab

Intervention Type DRUG

Given by IV on Day 1 of each 6-week cycle.

Cohort C - Randomized combination therapy

Disitamab vedotin + pembrolizumab

Group Type EXPERIMENTAL

disitamab vedotin

Intervention Type DRUG

Given into the vein (IV; intravenous) every 2 weeks.

pembrolizumab

Intervention Type DRUG

Given by IV on Day 1 of each 6-week cycle.

Cohort C - Randomized monotherapy

Disitamab vedotin monotherapy

Group Type EXPERIMENTAL

disitamab vedotin

Intervention Type DRUG

Given into the vein (IV; intravenous) every 2 weeks.

Cohort D - DV monotherapy (Japan only)

Disitamab vedotin monotherapy

Group Type EXPERIMENTAL

disitamab vedotin

Intervention Type DRUG

Given into the vein (IV; intravenous) every 2 weeks.

Cohort E - DV combination therapy (Japan only)

Disitamab vedotin + pembrolizumab

Group Type EXPERIMENTAL

disitamab vedotin

Intervention Type DRUG

Given into the vein (IV; intravenous) every 2 weeks.

pembrolizumab

Intervention Type DRUG

Given by IV on Day 1 of each 6-week cycle.

Cohort G - DV monotherapy

Disitamab vedotin

Group Type EXPERIMENTAL

disitamab vedotin

Intervention Type DRUG

Given into the vein (IV; intravenous) every 2 weeks.

Interventions

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disitamab vedotin

Given into the vein (IV; intravenous) every 2 weeks.

Intervention Type DRUG

pembrolizumab

Given by IV on Day 1 of each 6-week cycle.

Intervention Type DRUG

Other Intervention Names

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RC48-ADC KEYTRUDA®

Eligibility Criteria

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Inclusion Criteria

Cohorts A and B

* Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra
* Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of platinum-containing chemotherapy
* At least one measurable lesion by investigator assessment based on RECIST version 1.1.
* HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Cohort C

* Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra
* No prior systemic therapy for LA/mUC

* Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy
* At least one measurable lesion by investigator assessment based on RECIST v1.1.
* Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation
* HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, on the provided tumor tissue sample
* ECOG performance status of 0, 1, or 2

Cohort D

* Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra
* Based on a participant's eligibility to receive treatment with standard of care therapies in Japan, participants must have received all of the following lines of therapy for LA/mUC:

* a. One prior line of platinum-containing chemotherapy.
* b. Prior therapy with PD-(L)1 inhibitors as (neo)adjuvant therapy, first-line maintenance therapy or as second line treatment.
* c. Prior enfortumab vedotin therapy.
* At least one measurable lesion by investigator assessment based on RECIST v1.1.
* ECOG performance status of 0 or 1

Cohort E

* Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra
* No prior systemic therapy for LA/mUC

* Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy.
* At least one measurable lesion by investigator assessment based on RECIST v1.1.
* Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation
* HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample
* ECOG performance status of 0 or 1

Cohort G

* Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra
* Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of therapy containing enfortumab vedotin as monotherapy or in combination with pembrolizumab

* The last administration of enfortumab vedotin must be 90 days from the start of study treatment. Intervening therapies are allowed between the final dose of enfortumab vedotin and the start of disitamab vedotin.
* At least one measurable lesion by investigator assessment based on RECIST version 1.1.
* HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria

Cohorts A and B

* Known hypersensitivity to disitamab vedotin or any of their components
* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohorts A and B)
* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
* Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy
* Major surgery that has not fully recovered within 4 weeks prior to dose administration
* Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline

Cohort C

* Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components
* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study defined as Cycle 1 Day 1 for the single-arm part of Cohort C and as randomization date for the randomized part of Cohort C)
* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
* Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy
* Major surgery that has not fully recovered within 4 weeks prior to dose administration
* Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
* Participants who have previously received any prior treatment with an agent directed to another stimulatory or co-inhibitory T cell receptor (including but not limited to CD137 agonists, CAR-T cell therapy, CTLA-4 inhibitors, or OX-40 agonists) are excluded.

Cohort D

* Known hypersensitivity to disitamab vedotin or any of their components
* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort D)
* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
* Prior HER2-directed therapy
* Any prior history of ≥ Grade 3 non-hematological AEs related to prior therapy
* Major surgery that has not fully recovered within 4 weeks prior to dose administration
* Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline

Cohort E

* Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components
* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort E)
* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
* Any prior history of ≥ Grade 3 non-hematological AEs related to prior therapy
* Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy
* Major surgery that has not fully recovered within 4 weeks prior to dose administration
* Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug

Cohort G

* Known hypersensitivity to disitamab vedotin or any of their components
* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort G)
* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
* Prior HER2-directed therapy
* Major surgery that has not fully recovered within 4 weeks prior to dose administration
* Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Seagen, a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Banner Gateway Medical Center

Gilbert, Arizona, United States

Site Status RECRUITING

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status RECRUITING

Kaiser Permanente Anaheim Kraemer Medical Offices

Anaheim, California, United States

Site Status RECRUITING

Foothill Cardioology

Arcadia, California, United States

Site Status RECRUITING

Kaiser Permanente Baldwin Park Medical Center

Baldwin Park, California, United States

Site Status RECRUITING

Kaiser Permanente Bellflower Medical Offices

Bellflower, California, United States

Site Status RECRUITING

Beverly Hills Multi-Specialties Practice

Beverly Hills, California, United States

Site Status RECRUITING

Providence Saint Joseph Medical Center

Burbank, California, United States

Site Status RECRUITING

UCLA Burbank Cardiology

Burbank, California, United States

Site Status RECRUITING

UCLA Hematology/Oncology - Burbank

Burbank, California, United States

Site Status RECRUITING

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

Duarte, California, United States

Site Status ACTIVE_NOT_RECRUITING

UCLA Encino Specialty Care (Radiology)

Encino, California, United States

Site Status RECRUITING

UCLA Hematology/Oncoclogy-Encino

Encino, California, United States

Site Status RECRUITING

Kaiser Permanente Fontana Medical Center

Fontana, California, United States

Site Status RECRUITING

Foothill Cardiology Glendora

Glendora, California, United States

Site Status RECRUITING

Kaiser Permanente South Bay Medical center

Harbor City, California, United States

Site Status RECRUITING

Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Site Status RECRUITING

Kaiser Permanente Alton/Sand Canyon Medical Offices

Irvine, California, United States

Site Status RECRUITING

UCLA Downtown Los Angeles Primary & Specialty Care

Los Angeles, California, United States

Site Status RECRUITING

Kaiser Permanente Los Angeles Medical Offices

Los Angeles, California, United States

Site Status RECRUITING

Kaiser Permanente West Los Angeles Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Valkyrie Clinical Trials

Los Angeles, California, United States

Site Status NOT_YET_RECRUITING

Ronald Reagan UCLA Medical Center, Drug Information Center

Los Angeles, California, United States

Site Status RECRUITING

UCLA Cardiovascular Center

Los Angeles, California, United States

Site Status RECRUITING

UCLA Hematology Oncology

Los Angeles, California, United States

Site Status RECRUITING

UCLA Westwood Specialty Care

Los Angeles, California, United States

Site Status RECRUITING

UCLA Santa Monica Cardiology

Los Angeles, California, United States

Site Status RECRUITING

UCLA Montecito Primary & Specialty Care

Montecito, California, United States

Site Status RECRUITING

Newport Diagnostics Center (Radiology)

Newport Beach, California, United States

Site Status RECRUITING

Kaiser Permanente Ontario Medical Center

Ontario, California, United States

Site Status RECRUITING

UC Irvine Health

Orange, California, United States

Site Status RECRUITING

Kaiser Permanente Panorama City Medical Center, Medical Offices 3

Panorama City, California, United States

Site Status RECRUITING

Foothill Cardiology Pasadena

Pasadena, California, United States

Site Status RECRUITING

Southern California Heart Specialists

Pasadena, California, United States

Site Status RECRUITING

UCLA Hematology/ Oncology- Pasadena

Pasadena, California, United States

Site Status RECRUITING

UCLA Hematology Oncology - Porter Ranch

Porter Ranch, California, United States

Site Status RECRUITING

UCLA Porter Ranch Primary & Specialty Care

Porter Ranch, California, United States

Site Status RECRUITING

Kaiser Permanente Riverside Medical Center

Riverside, California, United States

Site Status RECRUITING

Southern California Permanente Medical Group (SCPMG)

Riverside, California, United States

Site Status RECRUITING

Kaiser Permanente San Diego Mission Road (Regulatory and Lab Supplies)

San Diego, California, United States

Site Status RECRUITING

Kaiser Permanente Zion Medical Center

San Diego, California, United States

Site Status RECRUITING

UCSF Cancer Center MZ Phlebotomy

San Francisco, California, United States

Site Status RECRUITING

UCSF Mount Zion Phlebotomy

San Francisco, California, United States

Site Status RECRUITING

UCSF Parnassus Phlebotomy

San Francisco, California, United States

Site Status RECRUITING

UCSF Investigational Drugs Pharmacy

San Francisco, California, United States

Site Status RECRUITING

University of California, San Francisco | HDFCCC - Hematopoietic Malignancies

San Francisco, California, United States

Site Status RECRUITING

University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

Diagnostic Medical Group of Southern California (Radiology)

San Gabriel, California, United States

Site Status RECRUITING

Southern California Heart Centers

San Gabriel, California, United States

Site Status RECRUITING

UCLA Hematology/Oncology - San Luis Obispo

San Luis Obispo, California, United States

Site Status RECRUITING

Sierra Vista Regional Medical Center

San Luis Obispo, California, United States

Site Status RECRUITING

Kaiser Permanente San Marcos Medical Offices

San Marcos, California, United States

Site Status RECRUITING

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, United States

Site Status RECRUITING

UCLA Simi Valley Alamo Specialty Care

Simi Valley, California, United States

Site Status RECRUITING

Twin Cities Community Hospital

Templeton, California, United States

Site Status RECRUITING

UCLA Thousand Oaks Primary & Specialty Care

Thousand Oaks, California, United States

Site Status RECRUITING

UCLA Hematology/Oncology - Torrance

Torrance, California, United States

Site Status RECRUITING

UCLA Torrance Lomita Specialty Care

Torrance, California, United States

Site Status RECRUITING

UCLA Hematology-Oncology Clinic - Santa Clarita

Valencia, California, United States

Site Status RECRUITING

UCLA Santa Clarita Primary & Specialty Care

Valencia, California, United States

Site Status RECRUITING

UCLA Hematology/Oncology - Ventura

Ventura, California, United States

Site Status RECRUITING

UCLA Ventura Cardiology

Ventura, California, United States

Site Status RECRUITING

UCLA Hematology/Oncology - Westlake

Westlake Village, California, United States

Site Status RECRUITING

Kaiser Permanente Woodland Hills Medical Center

Woodland Hills, California, United States

Site Status RECRUITING

Medstar Washington Hospital Center

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

Site Status NOT_YET_RECRUITING

Florida Cancer Specialists

Bonita Springs, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists

Bradenton, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists

Bradenton, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists

Cape Coral, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists

Daytona Beach, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Florida Cancer Specialists

Fleming Island, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists

Fort Myers, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists

Fort Myers, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists

N. Venice, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists

Naples, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists

Port Charlotte, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists

Sarasota, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists

Sarasota, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists

Stuart, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Florida Cancer Specialists

Tallahassee, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center McKinley Hospital

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists

Venice, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists

Venice, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists

Vero Beach, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Florida Cancer Specialists

Wellington, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Florida Cancer Specialists

West Palm Beach, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

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

Carrollton, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

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

Carrollton, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Cartersville, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Douglasville, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Hiram, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

WellStar Paulding Hospital

Hiram, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Marietta, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

UChicago Medicine - River East

Chicago, Illinois, United States

Site Status RECRUITING

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

Accellacare - Deerfield

Deerfield, Illinois, United States

Site Status RECRUITING

UChicago Medicine at Ingalls - Flossmoor

Flossmoor, Illinois, United States

Site Status RECRUITING

UChicago Medicine Ingalls Memorial

Harvey, Illinois, United States

Site Status RECRUITING

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

New Lenox, Illinois, United States

Site Status RECRUITING

The University of Chicago Medicine Center for Advanced Care Orland Park

Orland Park, Illinois, United States

Site Status RECRUITING

UChicago Medicine at Ingalls - Tinley Park

Tinley Park, Illinois, United States

Site Status RECRUITING

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Site Status RECRUITING

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Site Status RECRUITING

The Cancer & Hematology Centers

Big Rapids, Michigan, United States

Site Status RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)

Detroit, Michigan, United States

Site Status RECRUITING

Karmanos Cancer Institute Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Site Status RECRUITING

The Cancer & Hematology Centers

Grand Rapids, Michigan, United States

Site Status RECRUITING

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

Grand Rapids, Michigan, United States

Site Status RECRUITING

The Cancer & Hematology Centers

Grand Rapids, Michigan, United States

Site Status RECRUITING

The Cancer & Hematology Centers

Holland, Michigan, United States

Site Status RECRUITING

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, United States

Site Status RECRUITING

The Cancer & Hematology Centers

Norton Shores, Michigan, United States

Site Status RECRUITING

MSK Basking Ridge

Basking Ridge, New Jersey, United States

Site Status RECRUITING

MSK Monmouth

Middletown, New Jersey, United States

Site Status RECRUITING

MSK Bergen

Montvale, New Jersey, United States

Site Status RECRUITING

MSK Commack

Commack, New York, United States

Site Status RECRUITING

MSK Wesrchester

Harrison, New York, United States

Site Status RECRUITING

Northwell Health

Lake Success, New York, United States

Site Status RECRUITING

Memorial Sloan Kattering Cancer Centre- Investigational Drug Service Pharmacy

Long Island City, New York, United States

Site Status RECRUITING

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

New York, New York, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Evelyn H. Lauder Breast and Imaging Centre (BAIC)

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, United States

Site Status RECRUITING

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

New York, New York, United States

Site Status RECRUITING

SUNY Upstate Medical University

Syracuse, New York, United States

Site Status ACTIVE_NOT_RECRUITING

MSK nassau

Uniondale, New York, United States

Site Status RECRUITING

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status NOT_YET_RECRUITING

UNC Lineberger Comprehensive Cancer Center / University of North Carolina

Chapel Hill, North Carolina, United States

Site Status NOT_YET_RECRUITING

Carolinas Medical Center (biopsy only)

Charlotte, North Carolina, United States

Site Status RECRUITING

Carolinas Medical Center Investigational Drug Services

Charlotte, North Carolina, United States

Site Status RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status RECRUITING

Atrium Health Mercy (biopsy only)

Charlotte, North Carolina, United States

Site Status RECRUITING

Atrium Health University City (biopsy only)

Charlotte, North Carolina, United States

Site Status RECRUITING

Levine Cancer Institute University

Charlotte, North Carolina, United States

Site Status RECRUITING

Levine Cancer Institute - Ballantyne

Charlotte, North Carolina, United States

Site Status RECRUITING

Atrium Health Cabarrus (biopsy only)

Concord, North Carolina, United States

Site Status RECRUITING

Levine Cancer Institute Concord

Concord, North Carolina, United States

Site Status RECRUITING

Levine Cancer Institute- Gaston

Gastonia, North Carolina, United States

Site Status RECRUITING

Atrium Health Union (biopsy only)

Monroe, North Carolina, United States

Site Status RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

James Cancer Hospital & Solove Research Institute

Columbus, Ohio, United States

Site Status RECRUITING

Ohio State University Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

OSU Wexner Medical Center & James Cancer Hospital

Columbus, Ohio, United States

Site Status RECRUITING

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

OU Medical Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Site Status RECRUITING

Baylor Scott and White Research Institute

Dallas, Texas, United States

Site Status NOT_YET_RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Baylor Scott & White Medical Center - Temple

Temple, Texas, United States

Site Status NOT_YET_RECRUITING

Huntsman Cancer Institute at The University of Utah

Salt Lake City, Utah, United States

Site Status NOT_YET_RECRUITING

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Site Status RECRUITING

Harborview Medical Center

Seattle, Washington, United States

Site Status RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Site Status RECRUITING

University of Washington Medical Center

Seattle, Washington, United States

Site Status RECRUITING

Froedtert Hospital/Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Centro de Investigaciones Médicas y Desarrollo LC S.R.L

Buenos Aires, Buenos Aires F.D., Argentina

Site Status ACTIVE_NOT_RECRUITING

Clinica Viedma

Viedma, Río Negro Province, Argentina

Site Status RECRUITING

Hospital Aleman

Buenos Aires, , Argentina

Site Status RECRUITING

Instituto Medico Especializado Alexander Fleming

Buenos Aires, , Argentina

Site Status RECRUITING

Hospital Sirio Libanes - Buenos Aires

Buenos Aires, , Argentina

Site Status RECRUITING

Centro Medico Austral

CABA, , Argentina

Site Status RECRUITING

Centro Oncologico Korben

Caba, , Argentina

Site Status RECRUITING

Instituto Oncologico de Cordoba

Córdoba, , Argentina

Site Status RECRUITING

Cancer Care Research Pty Ltd (trading as GenesisCare)

Alexandria, New South Wales, Australia

Site Status RECRUITING

GenesisCare - North Shore

St Leonards, New South Wales, Australia

Site Status RECRUITING

Macquarie University

Sydney, New South Wales, Australia

Site Status RECRUITING

Metro South Hospital and Health Service

Brisbane, Queensland, Australia

Site Status RECRUITING

Mater Cancer Care Centre, Mater Misericordiae Limited

South Brisbane, Queensland, Australia

Site Status RECRUITING

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Victoria, Australia

Site Status RECRUITING

Lyell McEwin Hospital

Elizabeth Vale, , Australia

Site Status RECRUITING

AZ Maria Middelares

Ghent, , Belgium

Site Status ACTIVE_NOT_RECRUITING

CHU UCL Namur-Site de Saint Elisabeth

Namur, , Belgium

Site Status ACTIVE_NOT_RECRUITING

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Site Status RECRUITING

BC Cancer - Vancouver Fairmont Medical Building

Vancouver, British Columbia, Canada

Site Status RECRUITING

BC Cancer - Vancouver

Vancouver, British Columbia, Canada

Site Status RECRUITING

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Centre integre universitaire de sante et de services sociaux de l'Estrie

Sherbrooke, Quebec, Canada

Site Status ACTIVE_NOT_RECRUITING

Centro de Estudios Clínicos IC La Serena Research

La Serena, Coquimbo Region, Chile

Site Status RECRUITING

Oncovida SA

Santiago, Providencia, Chile

Site Status RECRUITING

Pontificia Universidad Catolica de Chile

Santiago, Providencia, Chile

Site Status RECRUITING

Rambam Health Care Campus

Haifa, , Israel

Site Status ACTIVE_NOT_RECRUITING

Rabin medical Center

Petah Tikva, , Israel

Site Status ACTIVE_NOT_RECRUITING

Sheba Medical Center

Ramat Gan, , Israel

Site Status ACTIVE_NOT_RECRUITING

The Chaim Sheba Medical Center

Ramat Gan, , Israel

Site Status ACTIVE_NOT_RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status ACTIVE_NOT_RECRUITING

Ospedale San Raffaele

Milan, Lombardy, Italy

Site Status ACTIVE_NOT_RECRUITING

Centro di Riferimento Oncologico Di Aviano

Aviano, Pordenone, Italy

Site Status ACTIVE_NOT_RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, ROME, Italy

Site Status ACTIVE_NOT_RECRUITING

IRCCS Ospedale San Raffaele, U.O. Farmacia Studi Clinici

Milan, , Italy

Site Status ACTIVE_NOT_RECRUITING

IOV-Istituto Oncologico Veneto IRCCS-U.O. Oncologia Medica 1-SC Farmacia

Padua, , Italy

Site Status ACTIVE_NOT_RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Site Status ACTIVE_NOT_RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, , Italy

Site Status ACTIVE_NOT_RECRUITING

Azienda Ospedaliera S. Maria di Terni

Terni, , Italy

Site Status ACTIVE_NOT_RECRUITING

S.C. Farmacia Interna

Terni, , Italy

Site Status ACTIVE_NOT_RECRUITING

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Site Status ACTIVE_NOT_RECRUITING

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Site Status ACTIVE_NOT_RECRUITING

Osaka University Hospital

Suita-shi, Osaka, Japan

Site Status ACTIVE_NOT_RECRUITING

Tokushima University Hospital

Tokushima, Tokushima, Japan

Site Status ACTIVE_NOT_RECRUITING

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

Site Status ACTIVE_NOT_RECRUITING

Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

Osaka, , Japan

Site Status ACTIVE_NOT_RECRUITING

Hospital Universitari Parc Tauli Sabadell

Sabadell, Barcelona, Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Universitari Vall d'Hebrón

Barcelona, , Spain

Site Status ACTIVE_NOT_RECRUITING

MD Anderson Cancer Center - Madrid

Madrid, , Spain

Site Status ACTIVE_NOT_RECRUITING

MD Anderson Cancer Center Madrid

Madrid, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status ACTIVE_NOT_RECRUITING

Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Arastirma ve Uygulama Hastanesi

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

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

Edirne, , Turkey (Türkiye)

Site Status RECRUITING

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

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Izmir Ekonomi Universitesi Medical Point Hastanesi

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, United Kingdom

Site Status RECRUITING

Cambridge University Hospitals NHS Foundation Trust

Cambridge, , United Kingdom

Site Status RECRUITING

Barts Health NHS Trust, St Bartholomew's Hospital

London, , United Kingdom

Site Status RECRUITING

Guy's Hospital

London, , United Kingdom

Site Status RECRUITING

Charing Cross Hospital

London, , United Kingdom

Site Status RECRUITING

The Christie NHS Foundation Trust - Christie Hospital

Manchester, , United Kingdom

Site Status NOT_YET_RECRUITING

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Site Status NOT_YET_RECRUITING

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

Merseyside, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Belgium Canada Chile Israel Italy Japan Spain Turkey (Türkiye) United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Pfizer CT.gov Call Center

Role: CONTACT

1-800-718-1021

Related Links

Access external resources that provide additional context or updates about the study.

https://pmiform.com/clinical-trial-info-request?StudyID=RC48G001

To obtain contact information for a study center near you, click here.

Other Identifiers

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C5731002

Identifier Type: OTHER

Identifier Source: secondary_id

2022-500030-28-01

Identifier Type: REGISTRY

Identifier Source: secondary_id

RC48G001

Identifier Type: -

Identifier Source: org_study_id

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