Cervical Cancer
Conditions
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
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 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.
Interventions
DRUGTIVDAK
2 mg/kg once every 3 weeks (Q3W)
Sponsors
Pfizer
Genmab
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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'
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type, incidence and severity of ocular adverse events (AEs) | 90 days after the last dose of tisotumab vedotin |
Secondary
| Measure | Time frame |
|---|---|
| Time to resolution of ocular AEs | 90 days after the last dose of tisotumab vedotin |
| Time to onset of ocular AEs | 90 days after the last dose of tisotumab vedotin |
| Incidence of serious adverse events (SAEs) | 90 days after the last dose of tisotumab vedotin |
| AEs leading to dose modifications including treatment discontinuation | 90 days after the last dose of tisotumab vedotin |
Countries
Puerto Rico, United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed