NCT06952660 · Pfizer
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
TIVDAK
2 mg/kg once every 3 weeks (Q3W)
Primary outcome measures
Type, incidence and severity of ocular adverse events (AEs)
Time frame: 90 days after the last dose of tisotumab vedotin
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
Where
- Phoenix, Arizona
- Scottsdale, Arizona
- Tempe, Arizona
- Aventura, Florida
- Bonita Springs, Florida
- Bradenton, Florida
- Cape Coral, Florida
- Coral Springs, Florida
- Daytona Beach, Florida
- Deerfield Beach, Florida
- Fleming Island, Florida
- Fort Lauderdale, Florida
And 43 more locations — see the full list below.
Collaborators
Genmab
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2026 · Source of record for eligibility and locations