TIVDAK for Cervical Cancer

Recruiting at 6 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Pfizer

Disqualifiers: Active ocular disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: Until disease progression

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for women with cervical cancer that has returned after chemotherapy. Participants must not have used TIVDAK before, agree to effective contraception, and be willing to take regular eye tests as well as sign an informed consent form.

Inclusion Criteria

I am willing to have regular eye exams and clinic visits as the study requires.

I am willing to sign a consent form and participate in the study.

I agree to use birth control as advised.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive TIVDAK once every 3 weeks as an infusion

Until disease progression

1 visit before starting treatment, 9 visits before each infusion

Follow-up

Participants are monitored monthly for 3 months after stopping TIVDAK

3 months

3 visits (monthly)

Treatment Details

Interventions

• TIVDAK

Trial Overview TIVDAK is being tested for its effectiveness in treating recurrent cervical cancer. Women will receive it through an infusion every three weeks and undergo frequent eye exams to monitor any vision-related side effects.

Participant Groups

Group I: Tisotumab vedotin Experimental Treatment 1 Intervention

Participants will receive tisotumab vedotin by IV infusion.

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Genmab

Industry Sponsor

Trials

76

Recruited

15,300+

Dr. Jan van de Winkel

Genmab

Chief Executive Officer since 2010

PhD in Immunology, University of Utrecht

Dr. Judith Klimovsky

Genmab

Chief Medical Officer since 2019

MD, University of Copenhagen