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

Purpose

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.

Condition

  • Cervical Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tisotumab vedotin 		Participants will receive tisotumab vedotin by IV infusion.
  • Drug: TIVDAK
    2 mg/kg once every 3 weeks (Q3W)

Recruiting Locations

HonorHealth Cancer Care - Biltmore - AZCCC Imaging
Phoenix, Arizona 85016

HonorHealth Cancer Care - Biltmore - HonorHealth Research Pharmacy
Phoenix, Arizona 85016

Sonora Quest Laboratories, LLC
Phoenix, Arizona 85034

South West Medical Imaging (SMIL)
Phoenix, Arizona 85258

Schwartz Laser Eye Center
Scottsdale, Arizona 85260

Virginia G. Piper Cancer Pharmacy - HonorHealth Research Pharmacy
Scottsdale, Arizona 85260

HonorHealth Cancer Care - Tempe - AZCCC Imaging
Tempe, Arizona 85284

Mount Sinai Comprehensive Cancer Center - Aventura
Aventura, Florida 33180

Florida Cancer Specialists
Bonita Springs, Florida 34135

Florida Cancer Specialists
Bradenton, Florida 34211

Florida Cancer Specialists
Cape Coral, Florida 33909

Broward Health Coral Springs
Coral Springs, Florida 33065

Florida Cancer Specialists
Daytona Beach, Florida 32117

Broward Health North
Deerfield Beach, Florida 33064

Florida Cancer Specialists
Fleming Island, Florida 32003

Broward Health Imperial Point
Fort Lauderdale, Florida 33308

Broward Health Medical Center
Fort Lauderdale, Florida 33316

Florida Cancer Specialists
Fort Myers, Florida 33905

Florida Cancer Specialists
Fort Myers, Florida 33908

HCA Mercy Hospital
Miami, Florida 33133

Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140

Mount Sinai Medical Center of Florida, Inc
Miami Beach, Florida 33140

Florida Cancer Specialists
N. Venice, Florida 34275

Florida Cancer Specialists
Naples, Florida 34102

Orlando Health Cancer Institute
Orlando, Florida 32806

Orlando Health Orlando Regional Medical Center
Orlando, Florida 32806

Orlando Health Winnie Palmer Hospital for Women & Babies
Orlando, Florida 32806

Florida Cancer Specialists
Port Charlotte, Florida 33980

Florida Cancer Specialists
Sarasota, Florida 34236

Florida Cancer Specialists
Stuart, Florida 34994

Florida Cancer Specialists
Wellington, Florida 33414

Florida Cancer Specialists
West Palm Beach, Florida 33401

Grady Health System Correll Pavilion
Atlanta, Georgia 30303

Grady Memorial Hospital Investigational Drug Service
Atlanta, Georgia 30303

Emory University Hospital Midtown
Atlanta, Georgia 30308

Emory University Hospital
Atlanta, Georgia 30322

The Emory Clinic
Atlanta, Georgia 30322

Winship Cancer Institute
Atlanta, Georgia 30322

Georgia Cancer Center at Augusta University
Augusta, Georgia 30912

Rush University Medical Center
Chicago, Illinois 60607

Rush University Medical Center, Ophthalmology
Chicago, Illinois 60612

Illinois Eye Center
Peoria, Illinois 61615

OSF Saint Francis Medical Center (OSF SFMC)
Peoria, Illinois 61637

Indiana University Health University Hospital
Indianapolis, Indiana 46202

Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana 46202

Sidney & Lois Eskenazi Hospital
Indianapolis, Indiana 46202

Norton Cancer Institute - Downtown
Louisville, Kentucky 40202

Norton Hospital
Louisville, Kentucky 40202

Norton Cancer Institute St Matthews Campus
Louisville, Kentucky 40207

Norton Women's and Children's Hospital
Louisville, Kentucky 40207

University Medical Center - New Orleans
New Orleans, Louisiana 70112

Trials365, LLC
Shreveport, Louisiana 71103

Willis Knighton Cancer Center
Shreveport, Louisiana 71103

Willis Knighton Physician Network - Hematology/Oncology
Shreveport, Louisiana 71103

Willis Knighton Physician Network/Gynecologic Oncology Associates
Shreveport, Louisiana 71103

WK Eye Institute North
Shreveport, Louisiana 71103

Willis Knighton Physician Network/Gynecologic Oncology Associates
Shreveport, Louisiana 71118

M Health Fairview Clinics and Specialty Center
Burnsville, Minnesota 55337

M Health Fairview Clinics and Surgery Center
Edina, Minnesota 55435

M Health Fairview Clinics and Surgery Center
Maple Grove, Minnesota 55369

M Health Fairview St. John's Hospital
Maplewood, Minnesota 55109

M Health Fairview Clinics and Surgery Center
Minneapolis, Minnesota 55455

M Healt Fairview - Woodwinds Hospital
Woodbury, Minnesota 55125

St. Dominic - Jackson Memorial Hospital
Jackson, Mississippi 39216

St. Dominic Gynecologic Oncology
Jackson, Mississippi 39216

Intermountain Health Saint Vincent Regional Hospital
Billings, Montana 59101

Saint Vincent Regional Hospital- Cancer Centers of Montana
Billings, Montana 59102

Yellowstone Eye Care
Billings, Montana 59102

Intermountain Health West End Clinic- Gynecologic Oncology
Billings, Montana 59106

Women's Cancer Center of Nevada
Las Vegas, Nevada 89106

MD Anderson Cancer Center at Cooper
Camden, New Jersey 08103

MD Anderson Cancer Center at Cooper
Voorhees Township, New Jersey 08043

Maimonides Medical Center
Brooklyn, New York 11220

Miami Valley Hospital South
Centerville, Ohio 45459

Kettering Health Cancer Center
Kettering, Ohio 45429

Kettering Health Main Campus
Kettering, Ohio 45429

Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma 74146

Women & Infants Hospital of Rhode Island/The Program in Women´s Oncology - Clinic
Providence, Rhode Island 02905

Women & Infants Hospital of Rhode Island
Providence, Rhode Island 02905

Texas Oncology - Central South
Austin, Texas 78731

Texas Oncology - Central South
Austin, Texas 78745

Texas Oncology - Central South
Austin, Texas 78758

Texas Oncology - Central South
Harlingen, Texas 78550

Texas Oncology - Central South
McAllen, Texas 78503

Texas Oncology - Central South
Waco, Texas 76712

Texas Oncology - Central South
Weslaco, Texas 78596

University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia 22903

University of Virginia
Charlottesville, Virginia 22908

UVA Health Cancer Care Pantops
Charlottesville, Virginia 22911

Carilion Clinic Gynecologic Oncology
Roanoke, Virginia 24016

Puerto Rico Cancer Specialists Clinical Trials
San Juan, Puerto Rico 00917-5027

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com