Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors

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Status: Active

Description

This trial will study tisotumab vedotin to find out whether it is an effective treatment for certain solid tumors and what side effects (unwanted effects) may occur. The treatment will be given to patients every three weeks.

Eligibility Criteria

Inclusion Criteria

  • Relapsed, locally-advanced or metastatic colorectal or pancreatic cancer, squamous NSCLC, or SCCHN patients who are not candidates for standard therapy.
  • All patients must have experienced disease progression on or after their most recent systemic therapy.
  • Baseline measurable disease as measured by RECIST v1. 1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Colorectal cancer patients must have received prior therapy with each of following agents, if eligible: a fluoropyrimidine, oxaliplatin, irinotecan, and/or bevacizumab. Patients should have received no more than 3 systemic regimens in the metastatic setting.
  • Patients with NSCLC must have predominant squamous histology. Patients must have received prior therapy with a platinum-based treatment and a checkpoint inhibitor (CPI), if eligible. Patients should have received no more than 2 systemic regimens in the metastatic setting.
  • Patients eligible for a tyrosine kinase inhibitor should have received such therapy. These patients should have received no more than 3 systemic regimens in the metastatic setting.
  • Patients with exocrine pancreatic adenocarcinoma must have predominant adenocarcinoma histology. Patients must have received prior therapy with a gemcitabine-based or 5FU-based regimen, if eligible, and should have received no more than 1 systemic regimen in the unresectable or metastatic setting.
  • Patients with SCCHN must have received prior therapy with a platinum-based regimen and a checkpoint inhibitor (CPI), if eligible, and should have received no more than 3 systemic regimens in the recurrent/metastatic setting.

Exclusion Criteria

  • Active bleeding conditions
  • Ocular surface disease at the time of enrollment (Note: cataract is not considered active ocular surface disease for this protocol)
  • Pulmonary disease requiring chronic medical therapy, unrelated to underlying cancer
  • Uncontrolled tumor-related pain
  • Peripheral neuropathy greater than or equal to Grade 2
  • History of another malignancy within 3 years of the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.
  • Active or previous brain metastasis
  • Patients who are breastfeeding, pregnant, or planning to become pregnant from the time of informed consent until 6 months after the final study dose is administered
  • For patients with SCCHN or NSCLC, ongoing anticoagulant therapy

Locations & Contacts

California

Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Name Not Available
San Jose
Stanford Cancer Center South Bay
Status: Active
Name Not Available

Connecticut

New Haven
Yale University
Status: Active
Contact: Kamil Sadowski
Phone: 203-785-6661
Email: kamil.sadowski@yale.edu

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Name Not Available

Kansas

Fairway
University of Kansas Clinical Research Center
Status: Active
Name Not Available
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: Active
Name Not Available

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: Active
Name Not Available

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Name Not Available
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Name Not Available

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

The primary goal of this global, open label, multicenter trial is to assess the activity, safety, and tolerability of tisotumab vedotin for the treatment of selected solid tumors. Patients will be treated with single agent tisotumab vedotin every three weeks. Patients who meet eligibility criteria will be enrolled into one of 4 cohorts of tumor types known to express Tissue Factor. These include colorectal cancer, squamous non-small cell lung cancer (NSCLC), exocrine pancreatic adenocarcinoma, and squamous cell carcinoma of the head and neck (SCCHN).

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Seattle Genetics

Trial IDs

Primary ID SGNTV-001
Secondary IDs NCI-2018-00676, 2017-005076-26
Clinicaltrials.gov ID NCT03485209