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Clinical Trial 19758

Cancer Type: Gynecological Tumor
Interventions:Tisotumab Vedotin

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Hye Sook Chon

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Open Label Phase 2 Study of Tisotumab Vedotin for Patients with Platinum-Resistant Ovarian Cancer with a Safety Run-in of a Dose-Dense Regimen

Summary

Objective

Evaluate safety and tolerability of a dose-dense regimen of tisotumab vedotin Evaluate antitumor activity of tisotumab vedotin Evaluate the safety and tolerability of tisotumab vedotin Evaluate preliminary antitumor activity of tisotumab vedotin Evaluate antitumor activity of tisotumab vedotin Evaluate durability of response in patients who respond to tisotumab vedotin Evaluate stability and control of disease Evaluate the timing of responses Evaluate progression-free survival (PFS) of patients treated with tisotumab vedotin Evaluate survival of patients treated with tisotumab vedotin Assess pharmacokinetics of tisotumab vedotin Assess immunogenicity of tisotumab vedotin Evaluate Tissue Factor expression-response relationship Assess biomarkers of biological activity and resistance and predictive biomarkers of response Patient-reported outcomes

Inclusion Criteria

  • Histologic documentation of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
  • If eligible, patients must have received previous treatment with a bevacizumab-containing regimen for ovarian cancer.
  • Safety run-in only: Patients with platinum-resistant ovarian cancer (PROC) who have received up to 5 prior systemic treatment regimens for ovarian cancer
  • Phase 2 only: Patients with PROC who have received at most 1 prior cytotoxic chemotherapy regimen in the PROC setting
  • Measureable disease according to RECIST v1.1 as assessed by the investigator
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Life expectancy of at least 3 months
  • Able to provide fresh tissue for biomarker analysis from a newly obtained core or excisional biopsy of a tumor lesion. Some exceptions may apply, in which case archival tissue will be used.

  • Exclusion Criteria

  • Primary platinum-refractory disease, defined as disease progression within 2 months of completion of first line platinum-based therapy
  • Patients with clinical symptoms or signs of gastrointestinal obstruction with the past 6 months or who currently require parenteral nutrition
  • Hematological: Known past or current coagulation defects leading to an increased risk of bleeding, diffuse alveolar hemorrhage from vasculitis, known bleeding diathesis, ongoing major bleeding, or trauma with increased risk of life-threatening bleeding within 8 weeks of trial entry
  • Cardiovascular: Clinically significant cardiac disease including uncontrolled hypertension, unstable angina, acute myocardial infarction with 6 months of screening, serious cardiac arrhythmia requiring medication, medical history of congestive heart failure, or medical history of decreased cardiac ejection fraction of > Ophthalmological: Active ocular surface disease at baseline or prior episode of cicatricial conjunctivitis or Steven Johnson syndrome
  • Prior treatment with MMAE-derived drugs
  • Inflammatory bowel disease including Crohn's disease and ulcerative colitis
  • Ongoing, acute, or chronic inflammatory skin disease
  • Uncontrolled tumor-related pain
  • Inflammatory lung disease requiring chronic medical therapy
  • Grade 3 or higher pulmonary disease unrelated to underlying malignancy
  • Uncontrolled pleural or pericardial effusions
  • Grade >1 peripheral neuropathy
  • Patients who are pregnant or breastfeeding