Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer



Status:Recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:February 27, 2018
End Date:May 2022
Contact:Seattle Genetics Trial Information Support
Email:clinicaltrials@seagen.com
Phone:866-333-7436

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Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination With Pembrolizumab for First-Line Treatment of Patients With Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer

This trial studies SGN-LIV1A in combination with pembrolizumab to find out what their side
effects are and if they work for patients with triple-negative breast cancer that has spread
to other parts of the body. Patients will be given both experimental drugs every 3 weeks.

The primary goal of this study is to evaluate the combination of SGN-LIV1A, which targets
LIV-1- expressing tumor cells, with the checkpoint inhibitor pembrolizumab for patients with
unresectable locally-advanced or metastatic triple-negative breast cancer. These two drugs
act through distinct and possibly complementary modes of action.

This is a single-arm, open-label, multicenter trial. Patients given SGN-LIV1A and
pembrolizumab in Part A will be monitored for frequency of dose-limiting toxicities to
determine a recommended phase 2 dose for expansion in Part B. In addition to safety measures,
objective response rate, progression-free survival, overall survival, and other efficacy
outcomes will be assessed.

Inclusion Criteria:

- Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER,
and PR expression)

- Have not previously received cytotoxic therapy for the treatment of unresectable
locally-advanced breast cancer or metastatic breast cancer

- At least 6 months since prior treatment with curative intent and recurrence

- At least 1 tumor 10mm in diameter or greater OR lymph node of at least 15 mm in short
axis

- ECOG performance status of 0 or 1

- Able to provide biopsy tissue for biomarker analysis

- Meet baseline laboratory data criteria

- Not pregnant. Must agree not to become pregnant until at least 6 months after ceasing
study treatment

Exclusion Criteria:

- Prior immune-oncology therapy

- Pre-existing neuropathy of at least Grade 2

- History of carcinomatous meningitis or active central nervous system (CNS) metastases.
Patients are eligible if CNS metastases are adequately treated and patients have
neurologically returned to baseline (except for residual signs or symptoms related to
the CNS treatment) for at least 4 weeks prior to enrollment. Patients must be off
corticosteroids.

- Received prior radiotherapy within 2 weeks of start of study treatment or have not
adequately recovered from prior radiotherapy

- Active autoimmune disease requiring systemic treatment within the past 2 years

- History of interstitial lung disease

- Current pneumonitis or history of pneumonitis requiring steroids
We found this trial at
25
sites
Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Katherine H. R. Tkaczuk
Phone: 410-328-3546
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: Ursa Brown-Glaberman, MD
Phone: 505-272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Erica Stringer-Reasor
Phone: 205-975-2618
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Hyo Heather Han
Phone: 813-745-4673
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Atlanta, Georgia 30322
Principal Investigator: Jane Meisel
Phone: 404-778-1900
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Atlanta, Georgia 30318
Principal Investigator: Rajni Sinha
Phone: 404-350-9853
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Aurora, Colorado 80012
Principal Investigator: Sami Diab
Phone: 303-418-7639
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Bonn, 53111
Principal Investigator: Christian Kurbacher
Phone: 866-333-7436
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Patrick Dillon
Phone: 434-924-0211
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Dallas, Texas 75246
Principal Investigator: Joyce O'Shaughnessy
Phone: 214-370-1000
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Florham Park, New Jersey 07932
Principal Investigator: Steven Papish
Phone: 973-436-1755
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1 Ingalls Drive
Harvey, Illinois 60426
Principal Investigator: Danielle Sterrenberg
Phone: 708-339-4800
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Houston, Texas 77024
Principal Investigator: Michelina Cairo
Phone: 713-467-1722
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4321 Washington Street #4000
Kansas City, Missouri 64111
(816) 932-3300
Principal Investigator: Timothy Pluard
Phone: 816-932-1370
Saint Luke's Cancer Institute Hope is an important part of the arsenal that helps patients...
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Los Angeles, California 90048
Principal Investigator: Reva Basho
Phone: 310-945-8127
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2160 S. First Ave.
Maywood, Illinois 60153
888-584-7888
Principal Investigator: Kathy Albain
Phone: 708-327-3148
Cardinal Bernardin Cancer Center at Loyola University Medical Center The Cardinal Bernardin Cancer Center is...
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Maywood, IL
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Minneapolis, Minnesota 55408
Principal Investigator: Michaela Tsai
Phone: 612-863-4633
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New York, New York 10021
Principal Investigator: Eleni Andreopoulou
Phone: 646-962-2064
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Newark, Delaware 19713
Principal Investigator: Michael Guarino
Phone: 302-623-4500
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Newark, DE
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Norwalk, Connecticut 06856
Principal Investigator: Linda Vahdat
Phone: 203-852-2996
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Orange, California 92868
Principal Investigator: Ritesh Parajuli
Phone: 714-456-8614
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Orange, California 92868
Principal Investigator: Ritesh Parajuli
Phone: 714-456-8614
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Orlando, Florida 32804
Principal Investigator: Carlos Alemany
Phone: 407-303-2070
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5115 Centre Avenue
Pittsburgh, Pennsylvania 15232
Principal Investigator: Adam Brufsky
Phone: 412-647-2811
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San Antonio, Texas 78212
Principal Investigator: Sharon Wilks
Phone: 210-224-3820
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