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Study Comparing Tisotumab Vedotin with Chemotherapy for Patients with Recurrent or Metastatic Cervical Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for cervical cancer that has returned or spread to other parts of the body after initial treatment. The study will compare a new treatment called Tisotumab Vedotin with other chemotherapy options chosen by the doctors involved in the study. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells. The purpose of the study is to see if Tisotumab Vedotin can improve the effectiveness of treatment for patients with this type of cancer.

Participants in the study will receive either Tisotumab Vedotin or one of the chemotherapy drugs, which may include Vinorelbine, Topotecan, Irinotecan, Pemetrexed, or Gemcitabine. These medications are given through an infusion, which means they are delivered directly into the bloodstream through a vein. The study will also involve the use of eye drops, such as Brimonidine Tartrate and Dexamethasone, which are used for different purposes related to eye health. The trial will monitor the overall survival of participants, which means the length of time they live after starting the treatment, as well as other factors like how long the cancer stays under control and any side effects experienced.

The study is designed to help researchers understand if Tisotumab Vedotin can provide better outcomes for patients with recurrent or metastatic cervical cancer compared to the standard chemotherapy options. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to gather important information about the effectiveness of the treatments being tested. The trial aims to provide valuable insights that could lead to improved treatment options for patients with this challenging condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be required to sign an informed consent form. This indicates understanding of the trial's purpose and procedures.

    A fresh or archival biopsy must be provided before the first treatment, unless deemed unfeasible after medical review.

  2. Step 2

    Initial assessments

    Initial assessments will include a review of medical history and a physical examination.

    Laboratory tests will be conducted to ensure acceptable values for kidney and liver function, as well as blood health.

    A pregnancy test will be conducted for women of reproductive potential.

  3. Step 3

    Randomization

    The patient will be randomly assigned to receive either tisotumab vedotin or a chemotherapy regimen chosen by the investigator.

  4. Step 4

    Treatment administration

    If assigned to tisotumab vedotin, the patient will receive the medication through intravenous administration.

    If assigned to chemotherapy, the patient may receive one of the following medications: vinorelbine, topotecan, irinotecan, pemetrexed, or gemcitabine, all administered intravenously.

    The specific dosage and frequency will be determined by the healthcare provider based on the patient's condition.

  5. Step 5

    Ongoing assessments

    Regular assessments will be conducted to monitor the patient's response to treatment.

    These assessments will include imaging tests to measure disease progression and laboratory tests to monitor health status.

  6. Step 6

    Completion of treatment

    The treatment will continue until disease progression, unacceptable side effects, or the patient's decision to withdraw from the study.

    After completing the treatment, follow-up assessments will be conducted to evaluate overall survival and quality of life.

Who can join the trial?

13 criteria

  • Must be at least 18 years old or considered an adult by local rules at the time of giving consent.
  • Must agree not to breastfeed or donate eggs, starting from the time of giving consent and continuing for 6 months after the last dose of the study drug.
  • If required by local health authorities, must have negative tests for hepatitis B and C. Hepatitis is a liver infection caused by viruses.
  • Must provide a recent or past tissue sample (biopsy) before the first planned treatment, unless it's not possible after a medical review.
  • Must be willing and able to follow the rules and restrictions of the study.
  • Must sign a consent form indicating understanding of the trial's purpose and procedures and willingness to participate before any trial-related activities.
  • Must have recurrent or metastatic cervical cancer, which means the cancer has returned or spread to other parts of the body. The cancer type should be squamous cell, adenocarcinoma, or adenosquamous. Must have experienced disease progression during or after standard treatments, received 1 or 2 prior treatments for this cancer, and not be a candidate for curative treatments like certain surgeries or radiotherapy.
  • Must have measurable disease according to specific medical guidelines assessed by the study doctor.
  • Must have acceptable laboratory test results, including kidney, liver, and blood health.
  • Must have an ECOG PS of 0 or 1 before randomization. ECOG PS is a scale used to assess how a disease affects a patient's daily living abilities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Must have a life expectancy of at least 3 months.
  • Must have a negative pregnancy test for women who can have children. Women who are postmenopausal or permanently sterilized are not considered to have reproductive potential.
  • Women who can have children must agree to use effective birth control during the study and for 6 months after the last treatment.

Who cannot join the trial?

4 criteria

  • Patients who are not female cannot participate in the study.
  • Patients who do not have second- or third-line recurrent or metastatic cervical cancer cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
  • Patients who are considered part of a vulnerable population may not be eligible. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.
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Investigated drugs

  • Tisotumab Vedotin

    is a medication being studied for its effectiveness in treating cervical cancer that has returned or spread after previous treatments. It is designed to target and deliver a cancer-fighting agent directly to the cancer cells, potentially improving treatment outcomes.

  • Chemotherapy

    refers to a group of cancer-fighting drugs that are used in this trial as a comparison to Tisotumab Vedotin. These drugs work by killing or slowing the growth of cancer cells and are chosen by the investigator based on the patient's specific condition and treatment history.

What is already known about the treatment

Tisotumab Vedotin – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating second- or third-line recurrent or metastatic cervical cancer. It is an investigational drug, meaning it is not yet approved for general medical use but is being evaluated for its potential benefits. Tisotumab Vedotin works by targeting cancer cells and delivering a toxic substance directly to them, which helps to kill the cancer cells while minimizing damage to normal cells. It is classified as an antibody-drug conjugate, combining a monoclonal antibody with a cytotoxic agent to enhance its therapeutic effect.

Investigated diseases

Cervical Cancer – Cervical cancer is a type of cancer that occurs in the cells of the cervix, which is the lower part of the uterus connecting to the vagina. It often progresses slowly and may not show symptoms in the early stages. As the disease advances, it can spread to nearby tissues and organs, leading to more noticeable symptoms such as abnormal bleeding, pelvic pain, or pain during intercourse. The progression of cervical cancer is typically categorized into stages, with recurrent or metastatic cases indicating that the cancer has returned or spread to other parts of the body after initial treatment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503813-31-01Protocol codeC5721002 / SGNTV-003Estimated enrolment480 patientsSponsorSeagen Inc.

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