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

Completed · Phase 1/Phase 2

Conditions studied: Triple Negative Breast Neoplasms

In brief

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 these 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.

Key facts

Study ID

NCT03310957

Run by

Seagen Inc.

People needed

185

Starts

2018-02-27

Expected to finish

2024-09-30

Last updated by the study team

2025-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
• Part D only: Tumor tissue PD-L1 Combined Positive Score <10 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute — Los Angeles, California, United States
• Chao Family Comprehensive Cancer Center University of California Irvine — Orange, California, United States
• University of California Irvine - Newport — Orange, California, United States
• Rocky Mountain Cancer Centers - Aurora — Aurora, Colorado, United States
• The Whittingham Cancer Center / Norwalk Hospital — Norwalk, Connecticut, United States
• Helen F. Graham Cancer Center / Christiana Care Health Systems — Newark, Delaware, United States
• Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States
• AdventHealth Cancer Institute — Orlando, Florida, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Piedmont Cancer Institute — Atlanta, Georgia, United States
• Winship Cancer Institute / Emory University School of Medicine — Atlanta, Georgia, United States
• Ingalls Cancer Care / Ingalls Memorial Hospital — Harvey, Illinois, United States
• Cardinal Bernardin Cancer Center / Loyola University Medical Center — Maywood, Illinois, United States
• University of Maryland — Baltimore, Maryland, United States
• Allina Health Cancer Institute — Minneapolis, Minnesota, United States
• Saint Luke's Cancer Institute LLC — Kansas City, Missouri, United States
• Summit Medical Group — Florham Park, New Jersey, United States
• New Mexico Cancer Center — Albuquerque, New Mexico, United States
• Weill Cornell Medicine — New York, New York, United States
• University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Texas Oncology - DFW — Dallas, Texas, United States
• Texas Oncology - Houston Memorial City — Houston, Texas, United States
• Texas Oncology - San Antonio Medical Center Northeast — San Antonio, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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