TIVDAK for Cervical Cancer

Recruiting at 24 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called TIVDAK, an antibody-drug conjugate, for cervical cancer that has returned after chemotherapy. The main goal is to identify any side effects, particularly those affecting the eyes. Participants will receive the treatment through an IV every three weeks and will undergo regular eye exams. Suitable candidates for this trial are individuals with cervical cancer that has recurred after chemotherapy and who currently have no eye issues. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the safety track record for TIVDAK?

Research has shown that TIVDAK (tisotumab vedotin) generally has a safety profile that most people can handle. In earlier studies, patients tolerated TIVDAK well, with most not experiencing severe side effects that would prevent them from continuing treatment.

Some side effects did occur, with common ones being tiredness, nausea, and hair loss. Eye-related side effects are particularly important, so this study includes regular eye exams.

The FDA has already approved the drug for treating certain types of cervical cancer. This approval indicates that TIVDAK meets safety standards for cancer treatment, but the study aims to learn more about specific side effects, especially those affecting the eyes. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for cervical cancer, which typically include chemotherapy, radiation therapy, and surgery, Tisotumab vedotin (TIVDAK) is unique because it combines an antibody with a cancer-killing agent. This innovative approach specifically targets cancer cells by binding to tissue factor, a protein commonly overexpressed in cervical cancer, and delivering the cytotoxic payload directly into the cancer cells. Researchers are excited about Tisotumab vedotin because this targeted mechanism may lead to fewer side effects compared to traditional chemotherapy, which affects both healthy and cancerous cells. This new method of action holds promise for more effective and tolerable treatment options for patients with cervical cancer.

What is the effectiveness track record for TIVDAK in treating cervical cancer?

Research has shown that TIVDAK may effectively treat recurrent cervical cancer. In studies, 17.8% of patients treated with TIVDAK experienced cancer shrinkage or disappearance, compared to 5.2% of those who received standard chemotherapy. Additionally, TIVDAK extended the time patients lived without their cancer worsening. These results suggest that TIVDAK outperforms chemotherapy for this condition. ^{2 6 7 8 9}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. tivdakhcp.com tivdakhcp.com/efficacy/

Efficacy | Tivdak® (tisotumab vedotin-tftv) HCP Site TIVDAK (tisotumab vedotin-tftv) treated patients had a 17.8% overall response rate compared to a 5.2% overall response rate with IC chemotherapy.

2. tivdak.com tivdak.com/study-results/

Study Results for Tivdak® (tisotumab vedotin-tftv) In this trial, about half of the patients were treated with Tivdak (N=253), and about half of the patients were treated with chemotherapy (N=249). One of the ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38959480/

Tisotumab Vedotin as Second- or Third-Line Therapy for ... In patients with recurrent cervical cancer, second- or third-line treatment with tisotumab vedotin resulted in significantly greater efficacy than chemotherapy.

4. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2313811

Tisotumab Vedotin as Second- or Third-Line Therapy for ... In patients with recurrent cervical cancer, second- or third-line treatment with tisotumab vedotin resulted in significantly greater efficacy than chemotherapy.

5. nature.com nature.com/articles/s41571-024-00929-4

Tisotumab vedotin effective in recurrent cervical cancer This observation was supported by a significant improvement in progression-free survival (median 4.2 months versus 2.9 months; HR 0.67, 95% CI, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12127362/

The efficacy and safety of Tisotumab vedotin in ... The meta-analysis results revealed that the median OS, median PFS, ORR, and DCR were 11.83 months, 4.22 months, 29.9%, and 75.1%, respectively, ...

7. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00056-5/fulltext

Efficacy and safety of tisotumab vedotin in previously ... Tisotumab vedotin showed clinically meaningful and durable antitumour activity with a manageable and tolerable safety profile in women with ...

8. fda.gov fda.gov/drugs/resources-information-approved-drugs/fda-approves-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical-cancer

FDA approves tisotumab vedotin-tftv for recurrent or ... Confirmed ORR was 17.8% (95% CI: 13.3, 23.1) and 5.2% (95% CI: 2.8, 8.8) in the respective arms (p-value <0.0001). This trial's results fulfill ...

9. ir.zailaboratory.com ir.zailaboratory.com/zh-hant/news-releases/news-release-details/tivdakr-tisotumab-vedotin-tftv-significantly-prolonged-overall/

TIVDAK® (tisotumab vedotin-tftv) Significantly Prolonged ... TIVDAK demonstrated superior overall survival, progression-free survival and objective response rate compared to chemotherapy in late-breaking results ...