TIVDAK for Cervical Cancer
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.12345Why 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.26789
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TIVDAK once every 3 weeks as an infusion
Follow-up
Participants are monitored monthly for 3 months after stopping TIVDAK
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?
1
Treatment groups
Experimental Treatment
Participants will receive tisotumab vedotin by IV infusion.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
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
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
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.
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 ...
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.
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.
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, ...
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, ...
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 ...
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 ...
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