Cervical CancerPhase 4NCT06952660
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
A Phase 4 study testing TIVDAK in people with Cervical Cancer, run by Pfizer at 132 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- TIVDAK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 132 sitesin 2 countries
- Study dates
- 7 May 2025to 13 Dec 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
- Treating physician has determined that treatment with Tivdak is appropriate for the participant according to US Prescribing Information
- Must sign an informed consent form indicating that the participant understands the purpose and procedures required for the study and are willing to participate
- 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
- Must agree to use effective contraception according to the US Prescribing Information
Who cannot join
- Active ocular disease at baseline per investigator assessment
- Previous treatment with Tivdak
- Previous administration of an investigational drug within 30 days
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may, in the investigator'
Trial locations and contacts
132 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
132 sites in 2 countries
United States131 sites, 131 recruiting
- Recruiting
Texas Oncology - DFW
Arlington, Texas, 76012
- Recruiting
Grady Health System Correll Pavilion
Atlanta, Georgia, 30303
- Recruiting
Grady Memorial Hospital Investigational Drug Service
Atlanta, Georgia, 30303
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
- Recruiting
The Emory Clinic
Atlanta, Georgia, 30322
- Recruiting
Winship Cancer Institute
Atlanta, Georgia, 30322
- Recruiting
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
- Recruiting
Texas Oncology - Central South
Austin, Texas, 78731
- Recruiting
Texas Oncology - Central South
Austin, Texas, 78745
- Recruiting
Texas Oncology - Central South
Austin, Texas, 78758
- Recruiting
Mount Sinai Comprehensive Cancer Center - Aventura
Aventura, Florida, 33180
- Recruiting
Intermountain Health Saint Vincent Regional Hospital
Billings, Montana, 59101
- Recruiting
Saint Vincent Regional Hospital- Cancer Centers of Montana
Billings, Montana, 59102
- Recruiting
Yellowstone Eye Care
Billings, Montana, 59102
- Recruiting
Intermountain Health West End Clinic- Gynecologic Oncology
Billings, Montana, 59106
- Recruiting
Florida Cancer Specialists
Bonita Springs, Florida, 34135
- Recruiting
Florida Cancer Specialists
Bradenton, Florida, 34211
- Recruiting
Maimonides Medical Center
Brooklyn, New York, 11220
- Recruiting
M Health Fairview Clinics and Specialty Center
Burnsville, Minnesota, 55337
- Recruiting
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103
- Recruiting
Florida Cancer Specialists
Cape Coral, Florida, 33909
- Recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
- Recruiting
SCC at UH Geauga Medical Center
Chardon, Ohio, 44024
- Recruiting
UVA Comprehensive Cancer Center
Charlottesville, Virginia, 22903
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
- Recruiting
UVA Health Cancer Care Pantops
Charlottesville, Virginia, 22911
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60607
- Recruiting
Rush University Medical Center, Ophthalmology
Chicago, Illinois, 60612
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Recruiting
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Not yet recruiting
Ohio Health Arthur G.H. Bing - MD Cancer Center
Columbus, Ohio, 43214
- Not yet recruiting
OhioHealth Research Institute
Columbus, Ohio, 43214
- Not yet recruiting
Riverside Methodist Hospital
Columbus, Ohio, 43214
- Recruiting
Broward Health Coral Springs
Coral Springs, Florida, 33065
- Recruiting
Parkland Health & Hospital System
Dallas, Texas, 75235
- Recruiting
University of Texas Southwestern Medical Center - Simmons Cancer Center
Dallas, Texas, 75235
- Recruiting
University of Texas Southwestern Medical Center-William P. Clements Jr. University Hospital
Dallas, Texas, 75390
- Recruiting
University of Texas Southwestern Medical Center-Zale Lipshy University Hospital
Dallas, Texas, 75390
- Recruiting
University Of Texas Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
Florida Cancer Specialists
Daytona Beach, Florida, 32117
- Recruiting
Broward Health North
Deerfield Beach, Florida, 33064
- Recruiting
AdventHealth Hematology and Oncology Denver
Denver, Colorado, 80210
- Recruiting
AdventHealth Medical Group Gynecologic Oncology at Porter
Denver, Colorado, 80210
- Recruiting
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010
- Recruiting
M Health Fairview Clinics and Surgery Center
Edina, Minnesota, 55435
- Recruiting
Florida Cancer Specialists
Fleming Island, Florida, 32003
- Recruiting
Broward Health Imperial Point
Fort Lauderdale, Florida, 33308
- Recruiting
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
- Recruiting
Florida Cancer Specialists
Fort Myers, Florida, 33905
- Recruiting
Florida Cancer Specialists
Fort Myers, Florida, 33908
- Recruiting
University of Texas Southwestern Simmons Cancer Center - Fort Worth
Fort Worth, Texas, 76104
- Recruiting
Texas Oncology - Central South
Harlingen, Texas, 78550
- Recruiting
Texas Oncology - Gulf Coast
Houston, Texas, 77054
- Recruiting
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
- Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
- Recruiting
Sidney & Lois Eskenazi Hospital
Indianapolis, Indiana, 46202
- Recruiting
St. Dominic - Jackson Memorial Hospital
Jackson, Mississippi, 39216
- Recruiting
St. Dominic Gynecologic Oncology
Jackson, Mississippi, 39216
- Recruiting
Kettering Health Cancer Center
Kettering, Ohio, 45429
- Recruiting
Kettering Health Main Campus
Kettering, Ohio, 45429
- Recruiting
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89106
- Recruiting
Norton Cancer Institute - Downtown
Louisville, Kentucky, 40202
- Recruiting
Norton Hospital
Louisville, Kentucky, 40202
- Recruiting
Norton Cancer Institute St Matthews Campus
Louisville, Kentucky, 40207
- Recruiting
Norton Women's and Children's Hospital
Louisville, Kentucky, 40207
- Recruiting
M Health Fairview Clinics and Surgery Center
Maple Grove, Minnesota, 55369
- Recruiting
M Health Fairview St. John's Hospital
Maplewood, Minnesota, 55109
- Recruiting
Cleveland Clinic Hillcrest Hospital
Mayfield Heights, Ohio, 44124
- Recruiting
Texas Oncology - Central South
McAllen, Texas, 78503
- Recruiting
SCC at Lake University (LUSCC)
Mentor, Ohio, 44060
- Recruiting
HCA Mercy Hospital
Miami, Florida, 33133
- Recruiting
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
- Recruiting
Mount Sinai Medical Center of Florida, Inc
Miami Beach, Florida, 33140
- Recruiting
M Health Fairview Clinics and Surgery Center
Minneapolis, Minnesota, 55455
- Recruiting
UPMC Vision Institute
Monroeville, Pennsylvania, 15146
- Recruiting
Florida Cancer Specialists
N. Venice, Florida, 34275
- Recruiting
Florida Cancer Specialists
Naples, Florida, 34102
- Recruiting
University Medical Center - New Orleans
New Orleans, Louisiana, 70112
- Not yet recruiting
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, 10032
- Not yet recruiting
IP Address: Columbia University Medical Center/New York Presbyterian Hospital Research Pharmacy
New York, New York, 10032
- Recruiting
UH Minoff Health Center/Chagrin Highlands- Seidman Cancer Center
Orange, Ohio, 44122
- Recruiting
AdventHealth
Orlando, Florida, 32803
- Recruiting
AdventHealth Gynecologic Oncology
Orlando, Florida, 32804
- Recruiting
AdventHealth Orlando Infusion Center
Orlando, Florida, 32804
- Recruiting
AdventHealth
Orlando, Florida, 32804
- Recruiting
Orlando Health Ambulatory Care Center
Orlando, Florida, 32806
- Recruiting
Orlando Health Cancer Institute
Orlando, Florida, 32806
- Recruiting
Orlando Health Orlando Regional Medical Center
Orlando, Florida, 32806
- Recruiting
Orlando Health Winnie Palmer Hospital for Women & Babies
Orlando, Florida, 32806
- Recruiting
Parma - Seidman Cancer Center
Parma, Ohio, 44129
- Recruiting
Illinois Eye Center
Peoria, Illinois, 61615
- Recruiting
OSF Saint Francis Medical Center (OSF SFMC)
Peoria, Illinois, 61637
- Recruiting
HonorHealth Cancer Care - Biltmore - AZCCC Imaging
Phoenix, Arizona, 85016
- Recruiting
HonorHealth Cancer Care - Biltmore - HonorHealth Research Pharmacy
Phoenix, Arizona, 85016
- Recruiting
HonorHealth Research Institute (Arizona Center for Cancer Care) - HonorHealth Cancer Care -Biltmore
Phoenix, Arizona, 85016
- Recruiting
Sonora Quest Laboratories, LLC
Phoenix, Arizona, 85034
- Recruiting
South West Medical Imaging (SMIL)
Phoenix, Arizona, 85258
- Recruiting
University Ear, Nose, & Throat Eye & Ear Institute
Pittsburgh, Pennsylvania, 15213
- Recruiting
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
- Recruiting
UPMC Vision Institute - Mercy
Pittsburgh, Pennsylvania, 15219
- Recruiting
University Ear, Nose, & Throat Specialists
Pittsburgh, Pennsylvania, 15232
- Recruiting
UPMC Vision Institute Shadyside
Pittsburgh, Pennsylvania, 15232
- Recruiting
Florida Cancer Specialists
Port Charlotte, Florida, 33980
- Recruiting
OHSU
Portland, Oregon, 97239
- Recruiting
Women & Infants Hospital of Rhode Island/The Program in Women´s Oncology - Clinic
Providence, Rhode Island, 02905
- Recruiting
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
- Recruiting
Women & Infant´s Hospital Infusion Center
Providence, Rhode Island, 02905
- Recruiting
University of Texas Southwestern Simmons Cancer Center-Richardson/Plano
Richardson, Texas, 75080
- Recruiting
Carilion Clinic Gynecologic Oncology
Roanoke, Virginia, 24016
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34236
- Recruiting
Schwartz Laser Eye Center
Scottsdale, Arizona, 85260
- Recruiting
Virginia G. Piper Cancer Pharmacy - HonorHealth Research Pharmacy
Scottsdale, Arizona, 85260
- Recruiting
Trials365, LLC
Shreveport, Louisiana, 71103
- Recruiting
Willis Knighton Cancer Center
Shreveport, Louisiana, 71103
- Recruiting
Willis Knighton Physician Network - Hematology/Oncology
Shreveport, Louisiana, 71103
- Recruiting
Willis Knighton Physician Network/Gynecologic Oncology Associates
Shreveport, Louisiana, 71103
- Recruiting
WK Eye Institute North
Shreveport, Louisiana, 71103
- Recruiting
Willis Knighton Physician Network/Gynecologic Oncology Associates
Shreveport, Louisiana, 71118
- Recruiting
Florida Cancer Specialists
Stuart, Florida, 34994
- Recruiting
HonorHealth Cancer Care - Tempe - AZCCC Imaging
Tempe, Arizona, 85284
- Recruiting
HonorHealth Research Institute (Arizona Center for Cancer Care) - HonorHealth Cancer Care - Tempe
Tempe, Arizona, 85284
- Recruiting
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, 74146
- Recruiting
MD Anderson Cancer Center at Cooper
Voorhees Township, New Jersey, 08043
- Recruiting
Texas Oncology - Central South
Waco, Texas, 76712
- Recruiting
Florida Cancer Specialists
Wellington, Florida, 33414
- Recruiting
Texas Oncology - Central South
Weslaco, Texas, 78596
- Recruiting
Florida Cancer Specialists
West Palm Beach, Florida, 33401
- Recruiting
SCC at St. John's Medical Center
Westlake, Ohio, 44145
- Recruiting
M Healt Fairview - Woodwinds Hospital
Woodbury, Minnesota, 55125
Puerto Rico1 site, 1 recruiting
- Recruiting
Puerto Rico Cancer Specialists Clinical Trials
San Juan, 00917-5027
About this study
Official title: A PROSPECTIVE LOW-INTERVENTIONAL PHASE 4 SINGLE ARM STUDY OF OCULAR ASSESSMENTS IN PATIENTS TREATED WITH TIVDAK® IN RECURRENT OR METASTATIC CERVICAL CANCER
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.
Read more
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
- Being tested
- TIVDAK
- 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
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Neoplasms, Neoplasms by Site, Uterine Cervical Diseases, Uterine Diseases, Genital Diseases, Female, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIVDAKDrug
2 mg/kg once every 3 weeks (Q3W)
| Study group | Role | What they receive |
|---|---|---|
| Tisotumab vedotin | Experimental | Participants will receive tisotumab vedotin by IV infusion. Receives: Drug: TIVDAK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, incidence and severity of ocular adverse events (AEs)
Measured: 90 days after the last dose of tisotumab vedotin
Secondary outcomes (4)
Time to resolution of ocular AEs
Measured: 90 days after the last dose of tisotumab vedotin
Time to onset of ocular AEs
Measured: 90 days after the last dose of tisotumab vedotin
Incidence of serious adverse events (SAEs)
Measured: 90 days after the last dose of tisotumab vedotin
AEs leading to dose modifications including treatment discontinuation
Measured: 90 days after the last dose of tisotumab vedotin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start7 May 2025
- Primary completion13 Dec 2028 (estimated)
- Study completion13 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952660
- Sponsor's protocol ID
- C5721005
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.