My cervical cancer may be back, but I won’t stop fighting.
Learn about a clinical trial for recurrent or metastatic cervical cancer.
About the innovaTV 301 study
The innovaTV 301 study is testing a study drug, tisotumab vedotin, for people with cervical cancer that has spread or has come back after treatment. During the study, participants will receive either the study drug or chemotherapy treatment for cervical cancer. This study drug works in a new way and is designed to target cervical cancer cells.
How do I qualify?
You may qualify if you have been diagnosed with cervical cancer that has spread (metastasized) or come back (recurrent) after your treatment.
The study doctor can discuss any additional criteria with you.
Why take part?
You will get the following at no extra cost:
- Either the study drug or standard chemotherapy (with a 50/50 chance of receiving one or the other)
- All study-related medical exams
- Close monitoring of your cancer and overall health by doctors who specialize in cervical cancer
You may be paid back for some of your travel and lodging costs.
Your safety is the highest priority while participating. If you have questions or concerns at any point throughout the study, a study staff member is available. Your participation is voluntary, and you are free to withdraw at any time and for any reason. Your privacy will be maintained throughout the study.
About Cervical Cancer
Cervical cancer is a type of cancer that occurs in the cells of the cervix — the lower part of the uterus that connects to the vagina.1 It is the fourth most common cancer in women. In 2018, an estimated 570,000 women were diagnosed with cervical cancer worldwide.2 Treatments for cervical cancer may include surgery, radiation, and drug therapies. Depending on the type and stage of your cancer, you may have already had 1 or more of these treatments.3
Frequently Asked Questions
About the innovaTV 301 study
Why is the innovaTV 301 study being conducted?
Who is conducting the innovaTV 301 study?
The innovaTV 301 study is being done to find out if the study drug, tisotumab vedotin, works better than other chemotherapy treatments that are used for cervical cancer. During the study, participants will receive either the study drug or standard chemotherapy.
How do I decide if this clinical trial is right for me?
Seagen is conducting the innovaTV 301 study. Seagen is a global biotechnology company located in Bothell, Washington. Seagen is dedicated to making sure that all patients are represented in our clinical trials. It is important to Seagen that the therapies we make improve the lives of all people with cancer, including those who have been historically underrepresented due to their sex, race, ethnicity, or age.
Do I have to pay for anything to take part in this study?
Deciding to take part in a clinical trial is an important and personal decision. Before you agree to take part, the study team will review all aspects of the clinical trial with you. You will be given a document called an Informed Consent Form that provides, in writing, the clinical trial’s purpose, assessments, procedures, benefits, risks, and precautions. You will have the opportunity to ask questions and are encouraged to speak with your own doctor to decide if taking part is right for you.
Is there a placebo in this study?
All study-related medical care and the study drug or standard chemotherapy will be provided at no extra cost. You may be paid back for some of your travel and lodging costs.
What is a study drug?
There is no placebo in this study. There are 2 groups. One group will get the study drug, tisotumab vedotin. The other group will get standard chemotherapy, which is what you might get even if you were not in this study. There is a 50/50 chance of receiving one or the other.
Your group will be chosen randomly, like tossing a coin. This means that you might get tisotumab vedotin or you might get standard chemotherapy. Your study doctor will tell you which group you’re in.
Will my personal information be kept private?
A study drug is a medication that has not been approved by regulatory or health authorities (eg, the US Food and Drug Administration [FDA], European Medicines Agency [EMA], or appropriate regulatory authorities in each country) for prescription use.
Does my doctor need to give me permission to take part in this study?
Yes, the information you provide will not be shared with anyone who is not directly associated with this clinical trial without your permission, except as required by law or as set forth in the informed consent.
Can I withdraw from the study after I start?
No, your doctor does not have to give you permission to take part. However, feel free to talk to your doctor about participating. With your permission, the study doctor will keep your regular doctor updated about your condition during the study.
Yes, taking part in any clinical trial is completely voluntary. If you decide to take part in a clinical trial, you are free to withdraw at any time for any reason without any penalty or effect on your future medical care. If you are in the study and decide to leave it, you should talk to your study doctor about leaving the study so that they can schedule a final evaluation.
About Clinical Trials
What is a clinical trial?
Who oversees clinical trials?
A clinical trial is a research study in which people agree to test a new treatment to prevent or improve a disease or medical condition. A clinical trial also looks at how participants react to the new treatment and if any unwanted side effects occur. This helps to determine if the new treatment works, if it is safe, and if it is better than those already available.
It is only through the completion of clinical trials that study drugs can be evaluated and, if proven safe and effective, approved for a particular use. Different regulatory bodies in different countries will provide this approval after a thorough review. Prescription medications in use today were first proven safe and effective during clinical trials.
Who can take part in a clinical trial?
The study doctor is responsible for and oversees the trial at their study site. To help make sure that a clinical trial is ethical, and that participants’ rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review study protocols.
Only patients who meet all required eligibility criteria for a clinical trial may take part. The study team at the study doctor’s office will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to take part in the clinical trial. You may also be asked to provide information from your medical records to help the study team determine whether you may be eligible.