Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With 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.
- Breast Neoplasms
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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
- 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
- Phase 1/Phase 2
- Study Type
- Intervention Model
- Single Group Assignment
- Primary Purpose
- None (Open Label)
SGN-LIV1A plus pembrolizumab
|SGN-LIV1A followed by pembrolizumab.||
- NCT ID
- Seattle Genetics, Inc.
Study ContactSeattle Genetics Trial Information Support
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.