Recruiting

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

Sponsor:

Pfizer

Code:

NCT06952660

Conditions

Cervical Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TIVDAK

Study Details

Brief 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.

Conditions

Cervical Cancer

Study ID

NCT06952660

Start date

May 7, 2025

Status verified date

Sep, 2026

Completion date

Dec 13, 2028

Anticipated

Primary completion date

Dec 13, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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'

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Tisotumab vedotin

Participants will receive tisotumab vedotin by IV infusion.

Interventions

TIVDAK

2 mg/kg once every 3 weeks (Q3W)

Primary outcome measure

Type, incidence and severity of ocular adverse events (AEs) [ Time Frame: 90 days after the last dose of tisotumab vedotin ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

HonorHealth Cancer Care - Biltmore - AZCCC Imaging

Recruiting

Phoenix, Arizona, United States, 85016

HonorHealth Cancer Care - Biltmore - HonorHealth Research Pharmacy

Recruiting

Phoenix, Arizona, United States, 85016

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

Recruiting

Phoenix, Arizona, United States, 85016

Sonora Quest Laboratories, LLC

Recruiting

Phoenix, Arizona, United States, 85034

South West Medical Imaging (SMIL)

Recruiting

Phoenix, Arizona, United States, 85258

Schwartz Laser Eye Center

Recruiting

Scottsdale, Arizona, United States, 85260

Virginia G. Piper Cancer Pharmacy - HonorHealth Research Pharmacy

Recruiting

Scottsdale, Arizona, United States, 85260

HonorHealth Cancer Care - Tempe - AZCCC Imaging

Recruiting

Tempe, Arizona, United States, 85284

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

Recruiting

Tempe, Arizona, United States, 85284

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

Recruiting

Duarte, California, United States, 91010

AdventHealth Hematology and Oncology Denver

Recruiting

Denver, Colorado, United States, 80210

AdventHealth Medical Group Gynecologic Oncology at Porter

Recruiting

Denver, Colorado, United States, 80210

Mount Sinai Comprehensive Cancer Center - Aventura

Recruiting

Aventura, Florida, United States, 33180

Florida Cancer Specialists

Recruiting

Bonita Springs, Florida, United States, 34135

Florida Cancer Specialists

Recruiting

Bradenton, Florida, United States, 34211

Florida Cancer Specialists

Recruiting

Cape Coral, Florida, United States, 33909

Broward Health Coral Springs

Recruiting

Coral Springs, Florida, United States, 33065

Florida Cancer Specialists

Recruiting

Daytona Beach, Florida, United States, 32117

Broward Health North

Recruiting

Deerfield Beach, Florida, United States, 33064

Florida Cancer Specialists

Recruiting

Fleming Island, Florida, United States, 32003

Broward Health Imperial Point

Recruiting

Fort Lauderdale, Florida, United States, 33308

Broward Health Medical Center

Recruiting

Fort Lauderdale, Florida, United States, 33316

Florida Cancer Specialists

Recruiting

Fort Myers, Florida, United States, 33905

Florida Cancer Specialists

Recruiting

Fort Myers, Florida, United States, 33908

HCA Mercy Hospital

Recruiting

Miami, Florida, United States, 33133

Mount Sinai Comprehensive Cancer Center

Recruiting

Miami Beach, Florida, United States, 33140

Mount Sinai Medical Center of Florida, Inc

Recruiting

Miami Beach, Florida, United States, 33140

Florida Cancer Specialists

Recruiting

N. Venice, Florida, United States, 34275

Florida Cancer Specialists

Recruiting

Naples, Florida, United States, 34102

AdventHealth

Recruiting

Orlando, Florida, United States, 32803

AdventHealth Gynecologic Oncology

Recruiting

Orlando, Florida, United States, 32804

AdventHealth Orlando Infusion Center

Recruiting

Orlando, Florida, United States, 32804

AdventHealth

Recruiting

Orlando, Florida, United States, 32804

Orlando Health Ambulatory Care Center

Recruiting

Orlando, Florida, United States, 32806

Orlando Health Cancer Institute

Recruiting

Orlando, Florida, United States, 32806

Orlando Health Orlando Regional Medical Center

Recruiting

Orlando, Florida, United States, 32806

Orlando Health Winnie Palmer Hospital for Women & Babies

Recruiting

Orlando, Florida, United States, 32806

Florida Cancer Specialists

Recruiting

Port Charlotte, Florida, United States, 33980

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34236

Florida Cancer Specialists

Recruiting

Stuart, Florida, United States, 34994

Florida Cancer Specialists

Recruiting

Wellington, Florida, United States, 33414

Florida Cancer Specialists

Recruiting

West Palm Beach, Florida, United States, 33401

Grady Health System Correll Pavilion

Recruiting

Atlanta, Georgia, United States, 30303

Grady Memorial Hospital Investigational Drug Service

Recruiting

Atlanta, Georgia, United States, 30303

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

The Emory Clinic

Recruiting

Atlanta, Georgia, United States, 30322

Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Georgia Cancer Center at Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60607

Rush University Medical Center, Ophthalmology

Recruiting

Chicago, Illinois, United States, 60612

Illinois Eye Center

Recruiting

Peoria, Illinois, United States, 61615

OSF Saint Francis Medical Center (OSF SFMC)

Recruiting

Peoria, Illinois, United States, 61637

Indiana University Health University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Sidney & Lois Eskenazi Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Norton Cancer Institute - Downtown

Recruiting

Louisville, Kentucky, United States, 40202

Norton Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Norton Cancer Institute St Matthews Campus

Recruiting

Louisville, Kentucky, United States, 40207

Norton Women's and Children's Hospital

Recruiting

Louisville, Kentucky, United States, 40207

University Medical Center - New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Trials365, LLC

Recruiting

Shreveport, Louisiana, United States, 71103

Willis Knighton Cancer Center

Recruiting

Shreveport, Louisiana, United States, 71103

Willis Knighton Physician Network - Hematology/Oncology

Recruiting

Shreveport, Louisiana, United States, 71103

Willis Knighton Physician Network/Gynecologic Oncology Associates

Recruiting

Shreveport, Louisiana, United States, 71103

WK Eye Institute North

Recruiting

Shreveport, Louisiana, United States, 71103

Willis Knighton Physician Network/Gynecologic Oncology Associates

Recruiting

Shreveport, Louisiana, United States, 71118

M Health Fairview Clinics and Specialty Center

Recruiting

Burnsville, Minnesota, United States, 55337

M Health Fairview Clinics and Surgery Center

Recruiting

Edina, Minnesota, United States, 55435

M Health Fairview Clinics and Surgery Center

Recruiting

Maple Grove, Minnesota, United States, 55369

M Health Fairview St. John's Hospital

Recruiting

Maplewood, Minnesota, United States, 55109

M Health Fairview Clinics and Surgery Center

Recruiting

Minneapolis, Minnesota, United States, 55455

M Healt Fairview - Woodwinds Hospital

Recruiting

Woodbury, Minnesota, United States, 55125

St. Dominic - Jackson Memorial Hospital

Recruiting

Jackson, Mississippi, United States, 39216

St. Dominic Gynecologic Oncology

Recruiting

Jackson, Mississippi, United States, 39216

Intermountain Health Saint Vincent Regional Hospital

Recruiting

Billings, Montana, United States, 59101

Saint Vincent Regional Hospital- Cancer Centers of Montana

Recruiting

Billings, Montana, United States, 59102

Yellowstone Eye Care

Recruiting

Billings, Montana, United States, 59102

Intermountain Health West End Clinic- Gynecologic Oncology

Recruiting

Billings, Montana, United States, 59106

Women's Cancer Center of Nevada

Recruiting

Las Vegas, Nevada, United States, 89106

MD Anderson Cancer Center at Cooper

Recruiting

Camden, New Jersey, United States, 08103

MD Anderson Cancer Center at Cooper

Recruiting

Voorhees Township, New Jersey, United States, 08043

Maimonides Medical Center

Recruiting

Brooklyn, New York, United States, 11220

Miami Valley Hospital South

Recruiting

Centerville, Ohio, United States, 45459

SCC at UH Geauga Medical Center

Recruiting

Chardon, Ohio, United States, 44024

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Cleveland Clinic Fairview Hospital

Recruiting

Cleveland, Ohio, United States, 44111

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Kettering Health Cancer Center

Recruiting

Kettering, Ohio, United States, 45429

Kettering Health Main Campus

Recruiting

Kettering, Ohio, United States, 45429

Cleveland Clinic Hillcrest Hospital

Recruiting

Mayfield Heights, Ohio, United States, 44124

SCC at Lake University (LUSCC)

Recruiting

Mentor, Ohio, United States, 44060

UH Minoff Health Center/Chagrin Highlands- Seidman Cancer Center

Recruiting

Orange, Ohio, United States, 44122

Parma - Seidman Cancer Center

Recruiting

Parma, Ohio, United States, 44129

SCC at St. John's Medical Center

Recruiting

Westlake, Ohio, United States, 44145

Oklahoma Cancer Specialists and Research Institute, LLC

Recruiting

Tulsa, Oklahoma, United States, 74146

OHSU

Recruiting

Portland, Oregon, United States, 97239

UPMC Vision Institute

Recruiting

Monroeville, Pennsylvania, United States, 15146

University Ear, Nose, & Throat Eye & Ear Institute

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

UPMC Magee-Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

UPMC Vision Institute - Mercy

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

University Ear, Nose, & Throat Specialists

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

UPMC Vision Institute Shadyside

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

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

Recruiting

Providence, Rhode Island, United States, 02905

Women & Infants Hospital of Rhode Island

Recruiting

Providence, Rhode Island, United States, 02905

Women & Infant´s Hospital Infusion Center

Recruiting

Providence, Rhode Island, United States, 02905

Texas Oncology - Central South

Recruiting

Austin, Texas, United States, 78731

Texas Oncology - Central South

Recruiting

Austin, Texas, United States, 78745

Texas Oncology - Central South

Recruiting

Austin, Texas, United States, 78758

Parkland Health & Hospital System

Recruiting

Dallas, Texas, United States, 75235

University of Texas Southwestern Medical Center - Simmons Cancer Center

Recruiting

Dallas, Texas, United States, 75235

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

Recruiting

Dallas, Texas, United States, 75390

University of Texas Southwestern Medical Center-Zale Lipshy University Hospital

Recruiting

Dallas, Texas, United States, 75390

University Of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

University of Texas Southwestern Simmons Cancer Center - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Texas Oncology - Central South

Recruiting

Harlingen, Texas, United States, 78550

Texas Oncology - Central South

Recruiting

McAllen, Texas, United States, 78503

University of Texas Southwestern Simmons Cancer Center-Richardson/Plano

Recruiting

Richardson, Texas, United States, 75080

Texas Oncology - Central South

Recruiting

Waco, Texas, United States, 76712

Texas Oncology - Central South

Recruiting

Weslaco, Texas, United States, 78596

UVA Comprehensive Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22903

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

UVA Health Cancer Care Pantops

Recruiting

Charlottesville, Virginia, United States, 22911

Carilion Clinic Gynecologic Oncology

Recruiting

Roanoke, Virginia, United States, 24016

More Information

Sponsor

Pfizer

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

Uterine Neoplasms
Genital Neoplasms
Female Urogenital Neoplasms
Neoplasms by Site
Neoplasms Uterine
Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases Uterine Cervical Neoplasms,
Tisotumab vedotin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-09-04.