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

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ClinicalTrials.gov Identifier: NCT03310957
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : June 7, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: SGN-LIV1A Drug: Pembrolizumab Phase 1 Phase 2

Detailed Description:

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 if SGN-LIV1A dosing should be de-escalated before opening the expansion in Part B. In addition to safety measures, objective response rate, progression-free survival, overall survival, and other efficacy outcomes will be assessed.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: SGN-LIV1A plus pembrolizumab
SGN-LIV1A followed by pembrolizumab.
Drug: SGN-LIV1A
IV infusion every 3 weeks

Drug: Pembrolizumab
IV infusion every 3 weeks
Other Name: Keytruda




Primary Outcome Measures :
  1. Confirmed objective response rate [ Time Frame: Up to 18 weeks following last dose ]
    Confirmed ORR as determined by investigator according to RECIST v 1.1

  2. Incidence of adverse events [ Time Frame: Through 1 month following last dose ]
  3. Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ]
  4. Incidence of dose-limiting toxicities [ Time Frame: Through 1 month following last dose ]

Secondary Outcome Measures :
  1. Duration of response [ Time Frame: Up to 2.5 years following last dose ]
    DOR as determined by investigator according to RECIST v 1.1

  2. Disease control rate [ Time Frame: Up to 2.5 years following last dose ]
    Proportion of patients with complete response (CR), partial response (PR), or stable disease (SD) as determined by investigator according to RECIST v 1.1

  3. Progression-free survival [ Time Frame: Up to 2.5 years following last dose ]
    PFS as determined by investigator according to RECIST v 1.1

  4. Overall survival [ Time Frame: Up to 2.5 years following last dose ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
  • Have not previously received therapy for the treatment of unresectable LA/M breast cancer
  • At least 12 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
  • Radiological evidence of CNS metastases
  • Active autoimmune disease requiring systemic treatment within the past 2 years
  • History of interstitial lung disease
  • Current pneumonitis or history of pneumonitis requiring steroids

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310957


Contacts
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
United States, California
Chao Family Comprehensive Cancer Center University of California Irvine Recruiting
Orange, California, United States, 92868
Contact: Ritesh Parajuli    714-456-8614    rparajul@uci.edu   
Principal Investigator: Ritesh Parajuli         
University of California Irvine - Newport Recruiting
Orange, California, United States, 92868
Contact: Michelle Dich    714-456-8614    mdich@uci.edu   
Principal Investigator: Ritesh Parajuli         
United States, Delaware
Helen F. Graham Cancer Center / Christiana Care Health Systems Recruiting
Newark, Delaware, United States, 19713
Contact: Denise DeMaio    302-623-4500    denise.a.demaio@christianacare.org   
Principal Investigator: Michael Guarino         
United States, Florida
Cancer Institute of Florida Recruiting
Orlando, Florida, United States, 32804
Contact: Susan Coakley    407-303-2070    susan.coakley@flhosp.org   
Contact: Sara Guyler    407-303-2024    sara.guyler@flhosp.org   
Principal Investigator: Carlos Alemany         
United States, Georgia
Winship Cancer Institute / Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Renee Bent    404-778-1900    renee.bent@emory.edu   
Principal Investigator: Jane Meisel         
United States, Illinois
Ingalls Cancer Care / Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Contact: Margaret Marriott    703-339-4800    mmarriott@ingalls.org   
Contact: Amber Kindt    703-339-4800    akindt@ingalls.org   
Principal Investigator: Danielle Sterrenberg         
Cardinal Bernardin Cancer Center / Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Mary Beth Bartolotta    708-327-3148    mbartolotta@luc.edu   
Contact: Gaye Moran    708-327-3229    gwmoran@luc.edu   
Principal Investigator: Kathy Albain         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Nancy Tait    410-328-2703    ntait@umm.edu   
Contact: Lindsey Vacovsky    410-328-2703    lindsey.vacovsky@umm.edu   
Principal Investigator: Katherine H. R. Tkaczuk         
United States, Minnesota
Virginia Piper Cancer Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Jacquelyn Underhill    612-863-4633    jacquelyn.underhill@allina.com   
Contact: Lori Green    612-863-4633    lori.green@allina.com   
Principal Investigator: Michaela Tsai         
United States, New Jersey
Summit Medical Group Recruiting
Florham Park, New Jersey, United States, 07932
Contact: Michelle Mackenzie    973-436-1755    mmackenzie@smgnj.com   
Principal Investigator: Steven Papish         
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Karwyn Gustafson, MD    505-272-4946    ksgustafson@salud.unm.edu   
Principal Investigator: Ursa Brown-Glaberman, MD         
United States, Pennsylvania
Hillman Cancer Center / University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Shannon Cieply    412-647-2811    cieplysl2@upmc.edu   
Principal Investigator: Adam Brufsky         
United States, Texas
Texas Oncology - Houston Memorial City Recruiting
Houston, Texas, United States, 77024
Contact: Francine Whittington    713-467-1722    francine.whittington@usoncology.com   
Contact: Rowena Martinez    713-467-1722    rowena.martinez@usoncology.com   
Principal Investigator: Michelina Cairo         
Sponsors and Collaborators
Seattle Genetics, Inc.
Merck Sharp & Dohme Corp.
Investigators
Study Director: Hong Ren, MD, MS Seattle Genetics, Inc.

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT03310957     History of Changes
Other Study ID Numbers: SGNLVA-002
KEYNOTE 721 ( Other Identifier: Merck and Co., Inc )
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 5, 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seattle Genetics, Inc.:
Breast cancer
Breast carcinoma
Triple negative breast cancer
Locally-advanced breast cancer
Metastatic breast cancer
Tumors, breast
Breast tumors
pembrolizumab
LIV-1 protein, human

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pembrolizumab
Immunoconjugates
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs