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

Active: No
Cancer Type: Breast Cancer NCT ID: NCT03310957
Trial Phases: Phase I
Phase II 		Protocol IDs: SGNLVA-002 (primary)
NCI-2017-02398
KEYNOTE 721
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Seagen Inc.
NCI Full Details: http://clinicaltrials.gov/show/NCT03310957

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.

Objectives

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.

Treatment Sites in Georgia

Piedmont Cancer Institute - Atlanta
1800 Howell Mill Road
Suite 800
Atlanta, GA 30318
678-298-3238
www.piedmontcancerinstitute.com



Piedmont Cancer Institute - Fayetteville
1267 Highway 54 West
Suite 4200
Fayetteville, GA 30214
678-298-3238
www.piedmontcancerinstitute.com



Piedmont Cancer Institute - Newnan
775 Poplar Road
Suite 310
Newnan, GA 30265
678-298-3238
www.piedmontcancerinstitute.com



Piedmont Cancer Institute - Stockbridge
1240 Eagles Landing Parkway
Suite 260
Stockbridge, GA 30281
678-298-3238
www.piedmontcancerinstitute.com



Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**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.