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

Cancer Type
Breast Cancer
Trial Phase
Phase I
Phase II
18 Years and older, Male and Female
Study Type
Protocol IDs
SGNLVA-002 (primary)
Study Sponsor
Seagen Inc.


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


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.


  1. Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
  2. Part D only: Tumor tissue PD-L1 Combined Positive Score <10 expression.
  3. Have not previously received cytotoxic therapy for the treatment of unresectable locally-advanced breast cancer or metastatic breast cancer
  4. At least 6 months since prior treatment with curative intent and recurrence
  5. At least 1 tumor 10mm in diameter or greater OR lymph node of at least 15 mm in short axis
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  7. Able to provide biopsy tissue for biomarker analysis
  8. Meet baseline laboratory data criteria
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE


Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.