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NCT06952660PHASE4Recruiting

Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer

Pfizer

Start Date

5/7/2025

Completion Date

12/13/2028

Summary

TIVDAK is used for the treatment of cervical cancer that has come back after chemotherapy. Chemotherapy is a treatment that uses medicines to stop the growth of cancer cells. This is done either by killing the cells or by stopping them from growing. The purpose of this study is to learn about possible side effects of TIVDAK, specially to any side effect that is related to the eye. A side effect is anything a medicine does to your body that is not part of how the medicine treats disease. * This study is seeking for participants who: Are willing to take all the required eye tests * Have not received TIVDAK before * Do not have any active eye issues. Participants will receive TIVDAK once every 3 weeks as an infusion that will be injected into the vein. Participants will visit an eye care provider at 3 stages: * before starting the treatment, * before each of the first 9 infusions * then monthly for 3 months after they stop taking TIVDAK. Treatment with TIVDAK will continue until it is not working anymore against the participant's cancer.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion criteria: 1. Must have recurrent or metastatic cervical cancer with disease progression on or after chemotherapy 2. Treating physician has determined that treatment with Tivdak is appropriate for the participant according to US Prescribing Information 3. Must sign an informed consent form indicating that the participant understands the purpose and procedures required for the study and are willing to participate 4. Must be willing to undergo repeated ocular assessments as required by the study and regular clinic visits according to local standard practice of the study site 5. Must agree to use effective contraception according to the US Prescribing Information Exclusion criteria: 1. Active ocular disease at baseline per investigator assessment 2. Previous treatment with Tivdak 3. Previous administration of an investigational drug within 30 days 4. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may, in the investigator'

Interventions

DRUG

TIVDAK

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Cervical Cancer

Locations

HonorHealth Cancer Care - Biltmore - AZCCC Imaging

Phoenix, Arizona 85016

United States

HonorHealth Cancer Care - Biltmore - HonorHealth Research Pharmacy

Phoenix, Arizona 85016

United States

HonorHealth Research Institute (Arizona Center for Cancer Care) - HonorHealth Cancer Care -Biltmore

Phoenix, Arizona 85016

United States

Sonora Quest Laboratories, LLC

Phoenix, Arizona 85034

United States

South West Medical Imaging (SMIL)

Phoenix, Arizona 85258

United States

Schwartz Laser Eye Center

Scottsdale, Arizona 85260

United States

Virginia G. Piper Cancer Pharmacy - HonorHealth Research Pharmacy

Scottsdale, Arizona 85260

United States

HonorHealth Cancer Care - Tempe - AZCCC Imaging

Tempe, Arizona 85284

United States

HonorHealth Research Institute (Arizona Center for Cancer Care) - HonorHealth Cancer Care - Tempe

Tempe, Arizona 85284

United States

AdventHealth Hematology and Oncology Denver

Denver, Colorado 80210

United States

AdventHealth Medical Group Gynecologic Oncology at Porter

Denver, Colorado 80210

United States

Mount Sinai Comprehensive Cancer Center - Aventura

Aventura, Florida 33180

United States

Florida Cancer Specialists

Bonita Springs, Florida 34135

United States

Florida Cancer Specialists

Bradenton, Florida 34211

United States

Florida Cancer Specialists

Cape Coral, Florida 33909

United States

Broward Health Coral Springs

Coral Springs, Florida 33065

United States

Florida Cancer Specialists

Daytona Beach, Florida 32117

United States

Broward Health North

Deerfield Beach, Florida 33064

United States

Florida Cancer Specialists

Fleming Island, Florida 32003

United States

Broward Health Imperial Point

Fort Lauderdale, Florida 33308

United States

Broward Health Medical Center

Fort Lauderdale, Florida 33316

United States

Florida Cancer Specialists

Fort Myers, Florida 33905

United States

Florida Cancer Specialists

Fort Myers, Florida 33908

United States

HCA Mercy Hospital

Miami, Florida 33133

United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida 33140

United States

Mount Sinai Medical Center of Florida, Inc

Miami Beach, Florida 33140

United States

Florida Cancer Specialists

N. Venice, Florida 34275

United States

Florida Cancer Specialists

Naples, Florida 34102

United States

AdventHealth

Orlando, Florida 32803

United States

AdventHealth Gynecologic Oncology

Orlando, Florida 32804

United States

AdventHealth Orlando Infusion Center

Orlando, Florida 32804

United States

AdventHealth

Orlando, Florida 32804

United States

Orlando Health Ambulatory Care Center

Orlando, Florida 32806

United States

Orlando Health Cancer Institute

Orlando, Florida 32806

United States

Orlando Health Orlando Regional Medical Center

Orlando, Florida 32806

United States

Orlando Health Winnie Palmer Hospital for Women & Babies

Orlando, Florida 32806

United States

Florida Cancer Specialists

Port Charlotte, Florida 33980

United States

Florida Cancer Specialists

Sarasota, Florida 34236

United States

Florida Cancer Specialists

Stuart, Florida 34994

United States

Florida Cancer Specialists

Wellington, Florida 33414

United States

Florida Cancer Specialists

West Palm Beach, Florida 33401

United States

Grady Health System Correll Pavilion

Atlanta, Georgia 30303

United States

Grady Memorial Hospital Investigational Drug Service

Atlanta, Georgia 30303

United States

Emory University Hospital Midtown

Atlanta, Georgia 30308

United States

Emory University Hospital

Atlanta, Georgia 30322

United States

The Emory Clinic

Atlanta, Georgia 30322

United States

Winship Cancer Institute

Atlanta, Georgia 30322

United States

Georgia Cancer Center at Augusta University

Augusta, Georgia 30912

United States

Rush University Medical Center

Chicago, Illinois 60607

United States

Rush University Medical Center, Ophthalmology

Chicago, Illinois 60612

United States

Illinois Eye Center

Peoria, Illinois 61615

United States

OSF Saint Francis Medical Center (OSF SFMC)

Peoria, Illinois 61637

United States

Indiana University Health University Hospital

Indianapolis, Indiana 46202

United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana 46202

United States

Sidney & Lois Eskenazi Hospital

Indianapolis, Indiana 46202

United States

Norton Cancer Institute - Downtown

Louisville, Kentucky 40202

United States

Norton Hospital

Louisville, Kentucky 40202

United States

Norton Cancer Institute St Matthews Campus

Louisville, Kentucky 40207

United States

Norton Women's and Children's Hospital

Louisville, Kentucky 40207

United States

University Medical Center - New Orleans

New Orleans, Louisiana 70112

United States

Trials365, LLC

Shreveport, Louisiana 71103

United States

Willis Knighton Cancer Center

Shreveport, Louisiana 71103

United States

Willis Knighton Physician Network - Hematology/Oncology

Shreveport, Louisiana 71103

United States

Willis Knighton Physician Network/Gynecologic Oncology Associates

Shreveport, Louisiana 71103

United States

WK Eye Institute North

Shreveport, Louisiana 71103

United States

Willis Knighton Physician Network/Gynecologic Oncology Associates

Shreveport, Louisiana 71118

United States

M Health Fairview Clinics and Specialty Center

Burnsville, Minnesota 55337

United States

M Health Fairview Clinics and Surgery Center

Edina, Minnesota 55435

United States

M Health Fairview Clinics and Surgery Center

Maple Grove, Minnesota 55369

United States

M Health Fairview St. John's Hospital

Maplewood, Minnesota 55109

United States

M Health Fairview Clinics and Surgery Center

Minneapolis, Minnesota 55455

United States

M Healt Fairview - Woodwinds Hospital

Woodbury, Minnesota 55125

United States

St. Dominic - Jackson Memorial Hospital

Jackson, Mississippi 39216

United States

St. Dominic Gynecologic Oncology

Jackson, Mississippi 39216

United States

Intermountain Health Saint Vincent Regional Hospital

Billings, Montana 59101

United States

Saint Vincent Regional Hospital- Cancer Centers of Montana

Billings, Montana 59102

United States

Yellowstone Eye Care

Billings, Montana 59102

United States

Intermountain Health West End Clinic- Gynecologic Oncology

Billings, Montana 59106

United States

Women's Cancer Center of Nevada

Las Vegas, Nevada 89106

United States

MD Anderson Cancer Center at Cooper

Camden, New Jersey 08103

United States

MD Anderson Cancer Center at Cooper

Voorhees Township, New Jersey 08043

United States

Maimonides Medical Center

Brooklyn, New York 11220

United States

Columbia University Medical Center - Herbert Irving Pavilion

New York, New York 10032

United States

IP Address: Columbia University Medical Center/New York Presbyterian Hospital Research Pharmacy

New York, New York 10032

United States

Miami Valley Hospital South

Centerville, Ohio 45459

United States

SCC at UH Geauga Medical Center

Chardon, Ohio 44024

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Cleveland Clinic Fairview Hospital

Cleveland, Ohio 44111

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Ohio Health Arthur G.H. Bing - MD Cancer Center

Columbus, Ohio 43214

United States

OhioHealth Research Institute

Columbus, Ohio 43214

United States

Riverside Methodist Hospital

Columbus, Ohio 43214

United States

Kettering Health Cancer Center

Kettering, Ohio 45429

United States

Kettering Health Main Campus

Kettering, Ohio 45429

United States

Cleveland Clinic Hillcrest Hospital

Mayfield Heights, Ohio 44124

United States

SCC at Lake University (LUSCC)

Mentor, Ohio 44060

United States

UH Minoff Health Center/Chagrin Highlands- Seidman Cancer Center

Orange, Ohio 44122

United States

Parma - Seidman Cancer Center

Parma, Ohio 44129

United States

SCC at St. John's Medical Center

Westlake, Ohio 44145

United States

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma 74146

United States

OHSU

Portland, Oregon 97239

United States

UPMC Vision Institute

Monroeville, Pennsylvania 15146

United States

University Ear, Nose, & Throat Eye & Ear Institute

Pittsburgh, Pennsylvania 15213

United States

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania 15213

United States

UPMC Vision Institute - Mercy

Pittsburgh, Pennsylvania 15219

United States

University Ear, Nose, & Throat Specialists

Pittsburgh, Pennsylvania 15232

United States

UPMC Vision Institute Shadyside

Pittsburgh, Pennsylvania 15232

United States

Women & Infants Hospital of Rhode Island/The Program in Women´s Oncology - Clinic

Providence, Rhode Island 02905

United States

Women & Infants Hospital of Rhode Island

Providence, Rhode Island 02905

United States

Women & Infant´s Hospital Infusion Center

Providence, Rhode Island 02905

United States

Texas Oncology - Central South

Austin, Texas 78731

United States

Texas Oncology - Central South

Austin, Texas 78745

United States

Texas Oncology - Central South

Austin, Texas 78758

United States

Parkland Health & Hospital System

Dallas, Texas 75235

United States

University of Texas Southwestern Medical Center - Simmons Cancer Center

Dallas, Texas 75235

United States

University of Texas Southwestern Medical Center-William P. Clements Jr. University Hospital

Dallas, Texas 75390

United States

University of Texas Southwestern Medical Center-Zale Lipshy University Hospital

Dallas, Texas 75390

United States

University Of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

University of Texas Southwestern Simmons Cancer Center - Fort Worth

Fort Worth, Texas 76104

United States

Texas Oncology - Central South

Harlingen, Texas 78550

United States

Texas Oncology - Central South

McAllen, Texas 78503

United States

University of Texas Southwestern Simmons Cancer Center-Richardson/Plano

Richardson, Texas 75080

United States

Texas Oncology - Central South

Waco, Texas 76712

United States

Texas Oncology - Central South

Weslaco, Texas 78596

United States

UVA Comprehensive Cancer Center

Charlottesville, Virginia 22903

United States

University of Virginia

Charlottesville, Virginia 22908

United States

UVA Health Cancer Care Pantops

Charlottesville, Virginia 22911

United States

Carilion Clinic Gynecologic Oncology

Roanoke, Virginia 24016

United States

Puerto Rico Cancer Specialists Clinical Trials

San Juan, 00917-5027

Puerto Rico