Study on Tisotumab Vedotin, Bevacizumab, Carboplatin, and Pembrolizumab for Patients with Recurrent or Stage IVB Cervical Cancer

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centre hospitalier universitaire de Liege Liege Belgium
Hospital Universitario 12 De Octubre Madrid Spain
University Hospital Waterford Waterford Ireland
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
University Hospital Olomouc Olomouc Czechia
University Hospital Ostrava Ostrava Czechia
Csuy Uqavmarkoy Hhzocaxl Cork Ireland
Cqvteyhjw Uzdetpqnwhoeps Sopvoteag Woluwe-Saint-Lambert Belgium
Afyuszfsp Utt Amsterdam The Netherlands
Spnvvehsh Roihpfu Uyuxpsdsbp Mfhjbrw Cqdobw Nijmegen The Netherlands
Ejjbbgg Uhphbhrgyxns Mflzxpg Clgewop Raepxlmvb (hcoiifk Mph Rotterdam The Netherlands
Hdsqokog Vkpv dkvylkrb Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
28.03.2019
Czechia Czechia
Not recruiting
28.03.2019
Ireland Ireland
Not recruiting
28.03.2019
Italy Italy
Not recruiting
28.03.2019
Spain Spain
Not recruiting
28.03.2019
The Netherlands The Netherlands
Not recruiting
28.03.2019

Trial locations

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.

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 ID:
2023-508832-68-00
Protocol code:
GCT1015-05
NCT ID:
NCT03786081
Trial Phase:
Human Pharmacology (Phase I) – Other

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