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



Status:Recruiting
Conditions:Lung Cancer, Colorectal Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:June 25, 2018
End Date:April 2021
Contact:Seattle Genetics Trial Information Support
Email:clinicaltrials@seagen.com
Phone:8663337436

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Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors

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.

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).

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, irinotecean, 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, a tyrosine kinase inhibitor,
and a checkpoint inhibitor (CPI), if eligible. Patients should have received no more
than 2 systemic regimens in the locally advanced or 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 2
systemic regimens in the recurrent/metastatic setting.

Exclusion Criteria:

- Active bleeding conditions

- Ocular surface disease at the time of enrollment

- 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
We found this trial at
19
sites
Gainesville, Florida 32610
Principal Investigator: Thomas George, MD
Phone: 352-265-0680
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Matthew Taylor, MD
Phone: 503-494-1617
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Howard Safran
Phone: 401-444-6217
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Atlanta, Georgia 30322
Principal Investigator: Conor Steuer
Phone: 404-778-1900
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Geoffrey Shapiro
Phone: 617-632-6623
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Matthew Reilley
Phone: 434-924-9496
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Dallas, Texas 75246
Principal Investigator: Carlos Becerra
Phone: 214-818-8472
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Fort Collins, Colorado 80528
Principal Investigator: Steven Schuster
Phone: 970-297-6154
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Fort Collins, CO
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1 Ingalls Drive
Harvey, Illinois 60426
Principal Investigator: Danielle Sterrenberg, MD
Phone: 708-339-4800
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Houston, Texas 77030
Principal Investigator: David Hong
Phone: 713-745-4367
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Louisville, Kentucky 40207
Principal Investigator: John Hamm, MD
Phone: 502-629-4267
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Lubbock, Texas 79410
Principal Investigator: Isaac Tafur, MD
Phone: 806-725-7993
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LYON cedex 08, 69008
Principal Investigator: Jerome Fayette
Phone: 866-333-7436
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Principal Investigator: Jill Lacy, MD
Phone: 203-737-4645
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
Principal Investigator: May Cho
Phone: 916-734-8512
University of California-Davis As we begin our second century, UC Davis is poised to become...
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1665 Utica Avenue South
Saint Louis Park, Minnesota 55426
Principal Investigator: Daniel Anderson, MD
Phone: 952-993-6071
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Stanford, California 94305
Principal Investigator: Omid Tehrani
Phone: 669-233-2816
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Westwood, Kansas 66205
Principal Investigator: Anwaar Saeed
Phone: 913-945-7547
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Winston-Salem, North Carolina 27157
Principal Investigator: Lowell Hart
Phone: 336-713-7035
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