Status:
COMPLETED
Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer
Lead Sponsor:
Seagen Inc.
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Triple Negative Breast Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
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-adv...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT03310957
Start Date
February 27 2018
End Date
September 30 2024
Last Update
December 12 2025
Active Locations (50)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
3
Chao Family Comprehensive Cancer Center University of California Irvine
Orange, California, United States, 92868
4
University of California Irvine - Newport
Orange, California, United States, 92868