Breast Cancer Clinical Trial
Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer
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 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.
Full 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-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.
Eligibility Criteria
Inclusion Criteria:
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 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
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There are 48 Locations for this study
Birmingham Alabama, 35249, United States More Info
Principal Investigator
Los Angeles California, 90048, United States More Info
Principal Investigator
Orange California, 92868, United States More Info
Principal Investigator
Orange California, 92868, United States More Info
Principal Investigator
Aurora Colorado, 80012, United States More Info
Principal Investigator
Norwalk Connecticut, 06856, United States More Info
Principal Investigator
Newark Delaware, 19713, United States More Info
Principal Investigator
Miami Florida, 33176, United States
Orlando Florida, 32804, United States More Info
Principal Investigator
Tampa Florida, 33612, United States More Info
Principal Investigator
Atlanta Georgia, 30309, United States More Info
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Atlanta Georgia, 30322, United States More Info
Principal Investigator
Harvey Illinois, 60426, United States More Info
Principal Investigator
Maywood Illinois, 60153, United States More Info
Principal Investigator
Baltimore Maryland, 21201, United States More Info
Principal Investigator
Minneapolis Minnesota, 55407, United States More Info
Principal Investigator
Kansas City Missouri, 64113, United States More Info
Principal Investigator
Florham Park New Jersey, 07932, United States More Info
Principal Investigator
Albuquerque New Mexico, 87131, United States More Info
Principal Investigator
New York New York, 10065, United States
Pittsburgh Pennsylvania, 15232, United States
Dallas Texas, 75246, United States More Info
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Houston Texas, 77024, United States More Info
Principal Investigator
San Antonio Texas, 78212, United States More Info
Principal Investigator
Charlottesville Virginia, 22903, United States More Info
Principal Investigator
Seattle Washington, 98109, United States More Info
Principal Investigator
Bonn , 53111, Germany More Info
Principal Investigator
Bottrop , 46236, Germany More Info
Principal Investigator
Erlangen , 91054, Germany More Info
Principal Investigator
Essen , 45136, Germany More Info
Principal Investigator
Muenchen , 81675, Germany
Munchen , 80337, Germany More Info
Principal Investigator
Munich , 80637, Germany
Busan , 49201, Korea, Republic of More Info
Principal Investigator
Seongnam , 13496, Korea, Republic of More Info
Principal Investigator
Seoul , 01802, Korea, Republic of More Info
Principal Investigator
Seoul , 03080, Korea, Republic of More Info
Principal Investigator
Seoul , 03722, Korea, Republic of More Info
Principal Investigator
Seoul , 49201, Korea, Republic of More Info
Principal Investigator
Barcelona , 08035, Spain More Info
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Jaen , 23007, Spain More Info
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L'Hospitalet de Llobregat , 08907, Spain More Info
Principal Investigator
La Coruna , 15006, Spain More Info
Principal Investigator
Madrid , 28033, Spain More Info
Principal Investigator
Madrid , 28034, Spain More Info
Principal Investigator
Madrid , 28041, Spain More Info
Principal Investigator
Madrid , 28050, Spain More Info
Principal Investigator
Pozuelo de Alarcón , 28223, Spain More Info
Principal Investigator
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