A Trial of Tisotumab Vedotin in Cervical Cancer

• Status: Active, not recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: Female

Summary

A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genmab; Seagen Inc.
• Collaborators: Belgian Gynaecological Oncology Group; European Network of Gynaecological Oncological Trial Groups (ENGOT); Genmab; Gynecologic Oncology Group; Seattle Genetics, Inc.
• Treatments: Tisotumab vedotin

Criteria

Inclusion Criteria

• Patients with extra-pelvic metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology who have experienced disease progressed on standard of care chemotherapy in combination with bevacizumab, if eligible.

• Measurable disease according to RECIST v1.1 as assessed by IRC.

• Age ≥ 18 years.

• Acceptable renal function

• Acceptable liver function

• Acceptable hematological status

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• A negative serum pregnancy test for patients of reproductive potential.

• All patients must provide a fresh or archival biopsy during screening.

• Following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out.

Exclusion Criteria

• Have received no more than 2 prior systemic treatment regimens for recurrent or metastatic cervical cancer.

• Known past or current coagulation defects leading to an increased risk of bleeding;

• Ongoing major bleeding

• Active ocular surface disease

• Known past or current malignancy other than the inclusion diagnosis.

• Peripheral neuropathy grade ≥ 2