A Study to Learn More About TIVDAK in Women With Cervical Cancer That Has Come Back

Pfizer

Status and phase: Enrolling; Phase 4

Conditions: Cervical Cancer

Treatments: Drug: TIVDAK

Study type: Interventional

Funder types: Industry

Identifiers

NCT06952660

C5721005

Details and patient eligibility

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. 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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's judgment, increase the risk of study participation or make the participant inappropriate for the study.
5. Patients who are breastfeeding, pregnant, or planning to become pregnant based on criteria as indicated in the US Prescribing Information
6. Known allergies, hypersensitivity, or intolerance to Tivdak or its excipients

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Tisotumab vedotin

Experimental group

Description:

Participants will receive tisotumab vedotin by IV infusion.

Treatment:

Drug: TIVDAK