Status:
RECRUITING
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Genmab
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 ki...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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'
Exclusion
Key Trial Info
Start Date :
May 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 13 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06952660
Start Date
May 7 2025
End Date
December 13 2028
Last Update
December 12 2025
Active Locations (42)
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1
Mount Sinai Comprehensive Cancer Center - Aventura
Aventura, Florida, United States, 33180
2
Broward Health Coral Springs
Coral Springs, Florida, United States, 33065
3
Broward Health North
Deerfield Beach, Florida, United States, 33064
4
Broward Health Imperial Point
Fort Lauderdale, Florida, United States, 33308