ClinicalTrials.gg
RecruitingNCT06952660Updated Nov 5, 2026

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

A Phase 4 interventional study of TIVDAK in Cervical Cancer, sponsored by Pfizer. Recruiting at 135 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Pfizer · Phase 4, Interventional, and Other

From the registry’s dates

  • Started May 2025; still recruiting 1 year 6 months later.
Updated Nov 5, 20266 sites added1 site removedGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.
02

Conditions studied

  • Cervical Cancer

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
03

In context

Uterine Cervical Neoplasms

2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Must have recurrent or 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 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 according to the US Prescribing Information

Exclusion criteria

Exclusion criteria:

  1. Active ocular disease at baseline per investigator assessment
  2. Previous treatment with Tivdak
  3. Previous administration of an 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'
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Tisotumab vedotin

    Participants will receive tisotumab vedotin by IV infusion.

    Drug: TIVDAK

Interventions

  • DrugTIVDAK

    2 mg/kg once every 3 weeks (Q3W)

06

What researchers measure

Primary outcomes

  1. Type, incidence and severity of ocular adverse events (AEs)

    Time frame: 90 days after the last dose of tisotumab vedotin

Secondary outcomes

  1. Time to resolution of ocular AEs

    Time frame: 90 days after the last dose of tisotumab vedotin

  2. Time to onset of ocular AEs

    Time frame: 90 days after the last dose of tisotumab vedotin

  3. Incidence of serious adverse events (SAEs)

    Time frame: 90 days after the last dose of tisotumab vedotin

  4. AEs leading to dose modifications including treatment discontinuation

    Time frame: 90 days after the last dose of tisotumab vedotin

07

Study locations

130 of 135 sites recruiting
  • HonorHealth Cancer Care - Biltmore - AZCCC Imaging
    Phoenix, Arizona 85016, United States
    Recruiting
  • HonorHealth Cancer Care - Biltmore - HonorHealth Research Pharmacy
    Phoenix, Arizona 85016, United States
    Recruiting
  • HonorHealth Research Institute (Arizona Center for Cancer Care) - HonorHealth Cancer Care -Biltmore
    Phoenix, Arizona 85016, United States
    Recruiting
  • Sonora Quest Laboratories, LLC
    Phoenix, Arizona 85034, United States
    Recruiting
  • South West Medical Imaging (SMIL)
    Phoenix, Arizona 85258, United States
    Recruiting
  • Schwartz Laser Eye Center
    Scottsdale, Arizona 85260, United States
    Recruiting
  • Virginia G. Piper Cancer Pharmacy - HonorHealth Research Pharmacy
    Scottsdale, Arizona 85260, United States
    Recruiting
  • HonorHealth Cancer Care - Tempe - AZCCC Imaging
    Tempe, Arizona 85284, United States
    Recruiting
  • HonorHealth Research Institute (Arizona Center for Cancer Care) - HonorHealth Cancer Care - Tempe
    Tempe, Arizona 85284, United States
    Recruiting
  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
    Duarte, California 91010, United States
    Recruiting
  • AdventHealth Hematology and Oncology Denver
    Denver, Colorado 80210, United States
    Recruiting
  • AdventHealth Medical Group Gynecologic Oncology at Porter
    Denver, Colorado 80210, United States
    Recruiting
  • Mount Sinai Comprehensive Cancer Center - Aventura
    Aventura, Florida 33180, United States
    Recruiting
  • Florida Cancer Specialists
    Bonita Springs, Florida 34135, United States
    Recruiting
  • Florida Cancer Specialists
    Bradenton, Florida 34211, United States
    Recruiting
  • Florida Cancer Specialists
    Cape Coral, Florida 33909, United States
    Recruiting
  • Broward Health Coral Springs
    Coral Springs, Florida 33065, United States
    Recruiting
  • Florida Cancer Specialists
    Daytona Beach, Florida 32117, United States
    Recruiting
  • Broward Health North
    Deerfield Beach, Florida 33064, United States
    Recruiting
  • Florida Cancer Specialists
    Fleming Island, Florida 32003, United States
    Recruiting
  • Broward Health Imperial Point
    Fort Lauderdale, Florida 33308, United States
    Recruiting
  • Broward Health Medical Center
    Fort Lauderdale, Florida 33316, United States
    Recruiting
  • Florida Cancer Specialists
    Fort Myers, Florida 33905, United States
    Recruiting
  • Florida Cancer Specialists
    Fort Myers, Florida 33908, United States
    Recruiting
  • HCA Mercy Hospital
    Miami, Florida 33133, United States
    Recruiting
  • Mount Sinai Comprehensive Cancer Center
    Miami Beach, Florida 33140, United States
    Recruiting
  • Mount Sinai Medical Center of Florida, Inc
    Miami Beach, Florida 33140, United States
    Recruiting
  • Florida Cancer Specialists
    N. Venice, Florida 34275, United States
    Recruiting
  • Florida Cancer Specialists
    Naples, Florida 34102, United States
    Recruiting
  • AdventHealth
    Orlando, Florida 32803, United States
    Recruiting
  • AdventHealth Gynecologic Oncology
    Orlando, Florida 32804, United States
    Recruiting
  • AdventHealth Orlando Infusion Center
    Orlando, Florida 32804, United States
    Recruiting
  • AdventHealth
    Orlando, Florida 32804, United States
    Recruiting
  • Orlando Health Ambulatory Care Center
    Orlando, Florida 32806, United States
    Recruiting
  • Orlando Health Cancer Institute
    Orlando, Florida 32806, United States
    Recruiting
  • Orlando Health Orlando Regional Medical Center
    Orlando, Florida 32806, United States
    Recruiting
  • Orlando Health Winnie Palmer Hospital for Women & Babies
    Orlando, Florida 32806, United States
    Recruiting
  • Florida Cancer Specialists
    Palm Beach Gardens, Florida 33410, United States
    Recruiting
  • Florida Cancer Specialists
    Port Charlotte, Florida 33980, United States
    Recruiting
  • Florida Cancer Specialists
    Sarasota, Florida 34236, United States
    Recruiting
  • Florida Cancer Specialists
    Sebring, Florida 33870, United States
    Recruiting
  • Florida Cancer Specialists
    Wellington, Florida 33414, United States
    Recruiting
  • Florida Cancer Specialists
    West Palm Beach, Florida 33401, United States
    Recruiting
  • Grady Health System Correll Pavilion
    Atlanta, Georgia 30303, United States
    Recruiting
  • Grady Memorial Hospital Investigational Drug Service
    Atlanta, Georgia 30303, United States
    Recruiting
  • Emory University Hospital Midtown
    Atlanta, Georgia 30308, United States
    Recruiting
  • Emory University Hospital
    Atlanta, Georgia 30322, United States
    Recruiting
  • The Emory Clinic
    Atlanta, Georgia 30322, United States
    Recruiting
  • Winship Cancer Institute
    Atlanta, Georgia 30322, United States
    Recruiting
  • Georgia Cancer Center at Augusta University
    Augusta, Georgia 30912, United States
    Recruiting
  • Rush University Medical Center
    Chicago, Illinois 60607, United States
    Recruiting
  • Rush University Medical Center, Ophthalmology
    Chicago, Illinois 60612, United States
    Recruiting
  • Illinois Eye Center
    Peoria, Illinois 61615, United States
    Recruiting
  • OSF Saint Francis Medical Center (OSF SFMC)
    Peoria, Illinois 61637, United States
    Recruiting
  • Indiana University Health University Hospital
    Indianapolis, Indiana 46202, United States
    Recruiting
  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center
    Indianapolis, Indiana 46202, United States
    Recruiting
  • Sidney & Lois Eskenazi Hospital
    Indianapolis, Indiana 46202, United States
    Recruiting
  • Norton Cancer Institute - Downtown
    Louisville, Kentucky 40202, United States
    Recruiting
  • Norton Hospital
    Louisville, Kentucky 40202, United States
    Recruiting
  • Norton Cancer Institute St Matthews Campus
    Louisville, Kentucky 40207, United States
    Recruiting
  • Norton Women's and Children's Hospital
    Louisville, Kentucky 40207, United States
    Recruiting
  • University Medical Center - New Orleans
    New Orleans, Louisiana 70112, United States
    Recruiting
  • Trials365, LLC
    Shreveport, Louisiana 71103, United States
    Recruiting
  • Willis Knighton Cancer Center
    Shreveport, Louisiana 71103, United States
    Recruiting
  • Willis Knighton Physician Network - Hematology/Oncology
    Shreveport, Louisiana 71103, United States
    Recruiting
  • Willis Knighton Physician Network/Gynecologic Oncology Associates
    Shreveport, Louisiana 71103, United States
    Recruiting
  • WK Eye Institute North
    Shreveport, Louisiana 71103, United States
    Recruiting
  • Willis Knighton Physician Network/Gynecologic Oncology Associates
    Shreveport, Louisiana 71118, United States
    Recruiting
  • M Health Fairview Clinics and Specialty Center
    Burnsville, Minnesota 55337, United States
    Recruiting
  • M Health Fairview Clinics and Surgery Center
    Edina, Minnesota 55435, United States
    Recruiting
  • M Health Fairview Clinics and Surgery Center
    Maple Grove, Minnesota 55369, United States
    Recruiting
  • M Health Fairview St. John's Hospital
    Maplewood, Minnesota 55109, United States
    Recruiting
  • M Health Fairview Clinics and Surgery Center
    Minneapolis, Minnesota 55455, United States
    Recruiting
  • M Healt Fairview - Woodwinds Hospital
    Woodbury, Minnesota 55125, United States
    Recruiting
  • St. Dominic - Jackson Memorial Hospital
    Jackson, Mississippi 39216, United States
    Recruiting
  • St. Dominic Gynecologic Oncology
    Jackson, Mississippi 39216, United States
    Recruiting
  • Intermountain Health Saint Vincent Regional Hospital
    Billings, Montana 59101, United States
    Recruiting
  • Saint Vincent Regional Hospital- Cancer Centers of Montana
    Billings, Montana 59102, United States
    Recruiting
  • Yellowstone Eye Care
    Billings, Montana 59102, United States
    Recruiting
  • Intermountain Health West End Clinic- Gynecologic Oncology
    Billings, Montana 59106, United States
    Recruiting
  • Women's Cancer Center of Nevada
    Las Vegas, Nevada 89106, United States
    Recruiting
  • MD Anderson Cancer Center at Cooper
    Camden, New Jersey 08103, United States
    Recruiting
  • MD Anderson Cancer Center at Cooper
    Voorhees Township, New Jersey 08043, United States
    Recruiting
  • Maimonides Medical Center
    Brooklyn, New York 11220, United States
    Recruiting
  • Columbia University Medical Center - Herbert Irving Pavilion
    New York, New York 10032, United States
    Not yet recruiting
  • IP Address: Columbia University Medical Center/New York Presbyterian Hospital Research Pharmacy
    New York, New York 10032, United States
    Not yet recruiting
  • Miami Valley Hospital South
    Centerville, Ohio 45459, United States
    Recruiting
  • SCC at UH Geauga Medical Center
    Chardon, Ohio 44024, United States
    Recruiting
  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio 44106, United States
    Recruiting
  • Cleveland Clinic Fairview Hospital
    Cleveland, Ohio 44111, United States
    Recruiting
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
    Recruiting
  • Ohio Health Arthur G.H. Bing - MD Cancer Center
    Columbus, Ohio 43214, United States
    Not yet recruiting
  • OhioHealth Research Institute
    Columbus, Ohio 43214, United States
    Not yet recruiting
  • Riverside Methodist Hospital
    Columbus, Ohio 43214, United States
    Not yet recruiting
  • Kettering Health Cancer Center
    Kettering, Ohio 45429, United States
    Recruiting
  • Kettering Health Main Campus
    Kettering, Ohio 45429, United States
    Recruiting
  • Cleveland Clinic Hillcrest Hospital
    Mayfield Heights, Ohio 44124, United States
    Recruiting
  • SCC at Lake University (LUSCC)
    Mentor, Ohio 44060, United States
    Recruiting
  • UH Minoff Health Center/Chagrin Highlands- Seidman Cancer Center
    Orange, Ohio 44122, United States
    Recruiting
  • Parma - Seidman Cancer Center
    Parma, Ohio 44129, United States
    Recruiting

Showing the first 100 of 135 sites across 2 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: 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.

Data sharing details ↗ · www.pfizer.com

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2025 (actual). Primary completion is estimated for Dec 2028, 43 months after the start.

Of 19 phase 4 interventional studies under Uterine Cervical Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 86. This study's planned 43 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 15, 2025
First posted
May 1, 2025
StartActual
May 7, 2025
Primary completionEst.
Dec 13, 2028
CompletionEst.
Dec 13, 2028
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
6 sites added, 1 site removed
Show 6 added (6 United States)
  • Texas Oncology - DFW · Arlington, United States
  • Texas Oncology - Gulf Coast · Houston, United States
  • Florida Cancer Specialists · Palm Beach Gardens, United States
  • Florida Cancer Specialists · Sebring, United States
  • UPMC Hillman Cancer Center-Erie · Erie, United States
  • PinnacleHealth Women´s Cancer Center (Ortenzio Cancer Center) · Mechanicsburg, United States
Show 1 removed
  • Florida Cancer Specialists · Stuart, United States
across 2 updates, Sep 25, 2026 – Nov 5, 2026
Show all 3 updates
  1. Nov 5, 2026
    4 sites added, 1 site removed
    Show 4 added (4 United States)
    • Florida Cancer Specialists · Palm Beach Gardens, United States
    • Florida Cancer Specialists · Sebring, United States
    • UPMC Hillman Cancer Center-Erie · Erie, United States
    • PinnacleHealth Women´s Cancer Center (Ortenzio Cancer Center) · Mechanicsburg, United States
    Show 1 removed
    • Florida Cancer Specialists · Stuart, United States
    + 1 other change: verification date
  2. Oct 13, 2026
    Minor edits only
    + 1 other change: verification date
  3. Sep 25, 2026
    2 sites added
    Show 2 added (2 United States)
    • Texas Oncology - DFW · Arlington, United States
    • Texas Oncology - Gulf Coast · Houston, United States

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06952660
Lead sponsor
Pfizer
Collaborators
Genmab
Responsible party
Sponsor
First posted
May 1, 2025
Start date
May 7, 2025
Primary completion
Dec 13, 2028 (estimated)
Completion
Dec 13, 2028 (estimated)
Last update
Nov 5, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Tisotumab vedotin

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