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

Trial Status: Active

This trial studies ladiratuzumab vedotin (LV) with pembrolizumab in patients with triple-negative breast cancer. It will find out what side effects happen when participants get these two drugs. A side effect is anything the drugs do besides treating cancer. Pembrolizumab is a drug that can be used to treat triple-negative breast cancer. The trial will also find out if the drugs work to treat this type of cancer. Participants in this study have metastatic breast cancer. This means the cancer has spread to other parts of the body.

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
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Able to provide biopsy tissue for biomarker analysis
  • Meet baseline laboratory data criteria

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

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Erica M. Stringer-Reasor
Phone: 205-975-9375

California

Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE
Contact: Hyo Sook Han
Phone: 800-456-7121

Georgia

Atlanta
Emory Saint Joseph's Hospital
Status: ACTIVE
Contact: Renee DeAundra Bent
Phone: 404-778-1900
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Renee DeAundra Bent
Phone: 404-778-1900
Emory University Hospital Midtown
Status: ACTIVE
Contact: Jane Lowe Meisel

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Nancy S. Tait
Phone: 410-328-3546
Email: ntait@umm.edu

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: ACTIVE

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: COMPLETED

Virginia

Charlottesville
University of Virginia Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

The primary goal of this study is to evaluate the combination of LV, 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 LV and pembrolizumab

during dose escalation will be monitored for frequency of dose-limiting toxicities to

determine a recommended doses for expansion cohorts. In addition to safety measures,

objective response rate, progression-free survival, overall survival, and other efficacy

outcomes will be assessed.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Seagen Inc.

  • Primary ID SGNLVA-002
  • Secondary IDs NCI-2017-02398, 2017-002289-35, KEYNOTE 721
  • Clinicaltrials.gov ID NCT03310957