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Study on Tisotumab Vedotin, Bevacizumab, Carboplatin, and Pembrolizumab for Patients with Recurrent or Stage IVB 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 recurrent or stage IVB cervical cancer. The study involves a medication called tisotumab vedotin, also known by its code name HuMax-TF-ADC. This medication is being tested both on its own and in combination with other treatments. The other treatments being studied in combination with tisotumab vedotin include bevacizumab, carboplatin, and pembrolizumab. Bevacizumab is a type of medication known as a recombinant humanized monoclonal antibody, carboplatin is a chemotherapy medication, and pembrolizumab is another type of monoclonal antibody.

The purpose of the study is to determine the best dose of tisotumab vedotin when used in combination with other treatments and to evaluate its effectiveness in treating cervical cancer. The study will begin with a phase called dose escalation, where different doses of the medication are tested to find the highest dose that can be given safely. After this, the study will move to a phase called dose expansion, where the focus will be on understanding how well the medication works in treating the cancer.

Participants in the study will receive the medication as a solution for infusion, which means it will be given through a vein. The study will monitor the safety of the treatments and any side effects that may occur. The trial aims to provide valuable information about the potential benefits and risks of using tisotumab vedotin, alone or in combination, for treating advanced cervical cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, the patient will be informed about the study's purpose and procedures. An informed consent form must be signed to confirm understanding and willingness to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying the type of cervical cancer and previous treatments, as well as ensuring the patient is not pregnant or breastfeeding.

  3. Step 3

    Treatment phase

    The treatment involves the administration of tisotumab vedotin alone or in combination with other medications such as bevacizumab, carboplatin, and pembrolizumab. All medications are given as a concentrate for solution for infusion.

    The specific combination and dosage will depend on the patient's treatment arm and previous medical history. The goal is to determine the maximum tolerated dose and evaluate the antitumor activity.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, the patient will be monitored for any side effects or adverse events. Regular assessments will be conducted to evaluate the response to treatment and overall health.

    The trial aims to assess the objective response rate, duration of response, time to response, progression-free survival, and overall survival.

  5. Step 5

    End of trial

    The trial is expected to conclude by January 31, 2025. Upon completion, a final assessment will be conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

6 criteria

  • Must have a type of cervical cancer called squamous, adenosquamous, or adenocarcinoma and have either worsened after standard treatments or cannot tolerate them for **recurrent or stage IVB cervical cancer**. This applies to certain groups in the study.
  • For other groups, must have the same types of cervical cancer but must not have received any previous systemic therapy for **recurrent or stage IVB cervical cancer**.
  • For another set of groups, must have the same types of cervical cancer and have worsened after at least one but no more than two previous systemic therapies for **recurrent or stage IVB cervical cancer**.
  • Must have an **ECOG performance status** of 0 or 1, which means the patient is fully active or has some symptoms but can still carry out light work.
  • Must not be pregnant, breastfeeding, or planning to have children during the study and for at least 6 months after the last treatment. Women of childbearing potential must agree to use effective birth control during the study and for 6 months after the last treatment.
  • Must sign an **informed consent form**, which means the patient understands the purpose and procedures of the study and agrees to participate.

Who cannot join the trial?

3 criteria

  • Patients with medical conditions other than recurrent or stage IVB cervical cancer cannot participate. This means if the cancer has not come back or is not at stage IVB, they are not eligible.
  • Only female patients are eligible for this study. Male patients cannot participate.
  • Patients who are considered part of a vulnerable population are not eligible. This generally refers to groups who may need special protection or care.
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Investigated drugs

Tisotumab Vedotin: This medication is being tested as a treatment for cervical cancer. It is used alone or in combination with other treatments. The goal is to find the best dose that patients can tolerate and to see how well it works against the cancer. Tisotumab Vedotin is designed to target and kill cancer cells, helping to reduce the size of tumors and slow the progression of the disease.

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 recurrent or stage IVB cervical cancer. It is in the investigational stage, with ongoing research to determine its safety and efficacy. Tisotumab Vedotin is designed to target and destroy cancer cells by delivering a toxic agent directly to them, utilizing an antibody-drug conjugate mechanism. It falls under the pharmacological classification of targeted cancer therapies, specifically antibody-drug conjugates.

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 develops slowly over time, beginning with precancerous changes in the cervical cells. These changes can progress to cancer if not detected and treated early. In advanced stages, such as stage IVB, the cancer has spread to distant organs beyond the pelvis. Recurrent cervical cancer refers to cancer that has returned after treatment. The progression of cervical cancer can vary, but it typically involves the growth and spread of abnormal cells that can invade nearby tissues and organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-508832-68-00Protocol codeGCT1015-05Estimated enrolment158 patientsSponsorGenmab A/S

sourced from the EU Clinical Trials Register and site verification

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