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

Phase 4

Not yet recruiting

• Conditions: Cervical Cancer
• Interventions: Drug: TIVDAK

• Registration Number: NCT06952660
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-04-28
• Last Update Submitted: 2025-04-28
• Study First Posted: 2025-05-01
• Last Update Posted: 2025-05-01
• Study Start: 2025-05-09
• Primary Completion: 2028-12-13
• Study Completion: 2028-12-13

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tisotumab vedotin	TIVDAK	Participants will receive tisotumab vedotin by IV infusion.

Primary Outcome Measures

Name	Time	Method
Type, incidence and severity of ocular adverse events (AEs)	90 days after the last dose of tisotumab vedotin

Secondary Outcome Measures

Name	Time	Method
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