Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
A PROSPECTIVE LOW-INTERVENTIONAL PHASE 4 SINGLE ARM STUDY OF OCULAR ASSESSMENTS IN PATIENTS TREATED WITH TIVDAK® IN RECURRENT OR METASTATIC CERVICAL CANCER
- Cervical Cancer
At a glance
- Phase
- Phase 4
- Study type
- Interventional
- Sponsor
- Pfizer
- Enrolment target
- 100
- Started
- 7 May 2025
- Main results due
- 13 December 2028
- Study sites
- 132
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Women only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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'
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(132)
HonorHealth Cancer Care - Biltmore - AZCCC Imaging
Phoenix, Arizona, United States
Recruiting
HonorHealth Cancer Care - Biltmore - HonorHealth Research Pharmacy
Phoenix, Arizona, United States
Recruiting
HonorHealth Research Institute (Arizona Center for Cancer Care) - HonorHealth Cancer Care -Biltmore
Phoenix, Arizona, United States
Recruiting
Sonora Quest Laboratories, LLC
Phoenix, Arizona, United States
Recruiting
South West Medical Imaging (SMIL)
Phoenix, Arizona, United States
Recruiting
Schwartz Laser Eye Center
Scottsdale, Arizona, United States
Recruiting
Virginia G. Piper Cancer Pharmacy - HonorHealth Research Pharmacy
Scottsdale, Arizona, United States
Recruiting
HonorHealth Cancer Care - Tempe - AZCCC Imaging
Tempe, Arizona, United States
Recruiting
HonorHealth Research Institute (Arizona Center for Cancer Care) - HonorHealth Cancer Care - Tempe
Tempe, Arizona, United States
Recruiting
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
Recruiting
AdventHealth Hematology and Oncology Denver
Denver, Colorado, United States
Recruiting
AdventHealth Medical Group Gynecologic Oncology at Porter
Denver, Colorado, United States
Recruiting
Mount Sinai Comprehensive Cancer Center - Aventura
Aventura, Florida, United States
Recruiting
Florida Cancer Specialists
Bonita Springs, Florida, United States
Recruiting
Florida Cancer Specialists
Bradenton, Florida, United States
Recruiting
Florida Cancer Specialists
Cape Coral, Florida, United States
Recruiting
Broward Health Coral Springs
Coral Springs, Florida, United States
Recruiting
Florida Cancer Specialists
Daytona Beach, Florida, United States
Recruiting
Broward Health North
Deerfield Beach, Florida, United States
Recruiting
Florida Cancer Specialists
Fleming Island, Florida, United States
Recruiting
Broward Health Imperial Point
Fort Lauderdale, Florida, United States
Recruiting
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Recruiting
Florida Cancer Specialists
Fort Myers, Florida, United States
Recruiting
Florida Cancer Specialists
Fort Myers, Florida, United States
Recruiting
HCA Mercy Hospital
Miami, Florida, United States
Recruiting
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Recruiting
Mount Sinai Medical Center of Florida, Inc
Miami Beach, Florida, United States
Recruiting
Florida Cancer Specialists
N. Venice, Florida, United States
Recruiting
Florida Cancer Specialists
Naples, Florida, United States
Recruiting
AdventHealth
Orlando, Florida, United States
Recruiting
AdventHealth Gynecologic Oncology
Orlando, Florida, United States
Recruiting
AdventHealth Orlando Infusion Center
Orlando, Florida, United States
Recruiting
AdventHealth
Orlando, Florida, United States
Recruiting
Orlando Health Ambulatory Care Center
Orlando, Florida, United States
Recruiting
Orlando Health Cancer Institute
Orlando, Florida, United States
Recruiting
Orlando Health Orlando Regional Medical Center
Orlando, Florida, United States
Recruiting
Orlando Health Winnie Palmer Hospital for Women & Babies
Orlando, Florida, United States
Recruiting
Florida Cancer Specialists
Port Charlotte, Florida, United States
Recruiting
Florida Cancer Specialists
Sarasota, Florida, United States
Recruiting
Florida Cancer Specialists
Stuart, Florida, United States
Recruiting
Florida Cancer Specialists
Wellington, Florida, United States
Recruiting
Florida Cancer Specialists
West Palm Beach, Florida, United States
Recruiting
Grady Health System Correll Pavilion
Atlanta, Georgia, United States
Recruiting
Grady Memorial Hospital Investigational Drug Service
Atlanta, Georgia, United States
Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, United States
Recruiting
Emory University Hospital
Atlanta, Georgia, United States
Recruiting
The Emory Clinic
Atlanta, Georgia, United States
Recruiting
Winship Cancer Institute
Atlanta, Georgia, United States
Recruiting
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
Recruiting
Rush University Medical Center
Chicago, Illinois, United States
Recruiting
Rush University Medical Center, Ophthalmology
Chicago, Illinois, United States
Recruiting
Illinois Eye Center
Peoria, Illinois, United States
Recruiting
OSF Saint Francis Medical Center (OSF SFMC)
Peoria, Illinois, United States
Recruiting
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Recruiting
Sidney & Lois Eskenazi Hospital
Indianapolis, Indiana, United States
Recruiting
Norton Cancer Institute - Downtown
Louisville, Kentucky, United States
Recruiting
Norton Hospital
Louisville, Kentucky, United States
Recruiting
Norton Cancer Institute St Matthews Campus
Louisville, Kentucky, United States
Recruiting
Norton Women's and Children's Hospital
Louisville, Kentucky, United States
Recruiting
Showing 60 of 132 sites — filter to narrow it down. 127 of the 132 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06952660. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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