Study on Tisotumab Vedotin Alone and Combined with Other Cancer Drugs for Cervical Cancer

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03786081

Provider View

This clinical trial is testing the safety and effectiveness of the drug Tisotumab Vedotin, both on its own and in combination with other cancer treatments, for patients with recurrent or advanced cervical cancer.

Patient Parameters

Program Overview

This study is exploring the use of Tisotumab Vedotin, a cancer treatment, either by itself or combined with other drugs like Bevacizumab, Pembrolizumab, or Carboplatin, in patients with cervical cancer that has returned or is at an advanced stage (stage IVB). The trial has two parts: the first part determines the best dose, and the second part tests this dose in more patients.

Description

The trial is divided into two main parts. In the first part, researchers will test increasing doses of Tisotumab Vedotin combined with other drugs to find the safest and most effective dose. This part involves patients whose cervical cancer has worsened after standard treatments or who cannot take standard treatments.

In the second part, the study will expand to include more patients. Some will have never received systemic therapy for their recurrent or advanced cervical cancer, while others will have had one or two previous treatments. Participants will receive the dose of Tisotumab Vedotin found to be best in the first part of the study.

The study aims to see if these treatments can help control cervical cancer and improve patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • Have cervical cancer (squamous, adenosquamous, or adenocarcinoma) that has worsened after standard treatments or cannot be treated with standard care (for certain study groups).
  • Have cervical cancer and have not received prior systemic therapy for recurrent or advanced cancer (for other study groups).
  • Have cervical cancer that has worsened after one or two previous treatments (for specific study groups).
  • Have measurable disease based on specific medical criteria.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Not be pregnant or breastfeeding and agree to use effective contraception during and for six months after the study.
  • Agree to participate and sign an informed consent form.

Exclusion Criteria

  • Have severe kidney issues that cannot be managed with medical procedures.
  • Have symptoms of a blocked digestive tract requiring medical support.
  • Have significant bleeding issues or risks, such as recent severe bleeding or wound healing problems.
  • Have active eye surface disease or a history of certain eye conditions.
  • Have serious heart disease.
  • Require blood-thinning medication (for certain study groups).

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.