Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer
- Conditions
- Triple Negative Breast Neoplasms
- Interventions
- Registration Number
- NCT03310957
- Lead Sponsor
- Seagen Inc.
- 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 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.
- 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-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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 186
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LV + pembrolizumab Pembrolizumab LV + pembrolizumab LV + pembrolizumab ladiratuzumab vedotin LV + pembrolizumab
- Primary Outcome Measures
Name Time Method Confirmed objective response rate Up to 18 weeks following last dose; approximately 1 year Confirmed ORR as determined by investigator according to RECIST v 1.1
Incidence of laboratory abnormalities Through 1 month following last dose; approximately 10 months Incidence of adverse events Through 1 month following last dose; approximately 10 months Incidence of dose-limiting toxicities Through 1 month following last dose; approximately 10 months
- Secondary Outcome Measures
Name Time Method Duration of response Up to 2.5 years following last dose DOR as determined by investigator according to RECIST v 1.1
Progression-free survival Up to 2.5 years following last dose PFS as determined by investigator according to RECIST v 1.1
Overall survival Up to 2.5 years following last dose OS is defined as the time from start of study treatment to date of death due to any cause.
Disease control rate Up to 2.5 years following last dose Proportion of patients with complete response (CR), partial response (PR), or stable disease (SD) as determined by investigator according to RECIST v 1.1
Trial Locations
- Locations (50)
Marien Hospital Bottrop
🇩🇪Bottrop, Other, Germany
Klinikum der Universitat Munchen
🇩🇪Munchen, Other, Germany
Samsung Medical Center
🇰🇷Seoul, Other, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Other, Korea, Republic of
Complejo Hospitalario de Jaen
🇪🇸Jaen, Other, Spain
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
🇺🇸Los Angeles, California, United States
The Whittingham Cancer Center / Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
Winship Cancer Institute / Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Texas Oncology - DFW
🇺🇸Dallas, Texas, United States
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Other, Spain
University of California Irvine - Newport
🇺🇸Orange, California, United States
Chao Family Comprehensive Cancer Center University of California Irvine
🇺🇸Orange, California, United States
Helen F. Graham Cancer Center / Christiana Care Health Systems
🇺🇸Newark, Delaware, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Piedmont Cancer Institute
🇺🇸Atlanta, Georgia, United States
Ingalls Cancer Care / Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Summit Medical Group
🇺🇸Florham Park, New Jersey, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
🇺🇸Seattle, Washington, United States
Stadtisches Klinikum Dessau
🇩🇪Dessau, Other, Germany
Universitatsklinikum Erlangen
🇩🇪Erlangen, Other, Germany
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Klinikum Rechts der Isar der Technischen Universitaet Muenchen
🇩🇪Muenchen, Other, Germany
Kliniken Essen-Mitte - Evang. Huyssens-Stiftung
🇩🇪Essen, Other, Germany
Gynakologisches Zentrum Bonn Friedensplatz
🇩🇪Bonn, Other, Germany
Rotkreuzklinikum Munich
🇩🇪Munich, Other, Germany
Pusan National University Hospital
🇰🇷Busan, Other, Korea, Republic of
CHA Bundang Medical Center
🇰🇷Seongnam, Other, Korea, Republic of
Hospital del Mar
🇪🇸Barcelona, Other, Spain
Complejo Hospitalario Universitario La Coruna
🇪🇸La Coruna, Other, Spain
L'Institut Catala d'Oncologia
🇪🇸L'Hospitalet de Llobregat, Other, Spain
MD Anderson Cancer Center - Madrid
🇪🇸Madrid, Other, Spain
Hospital Ruber Internacional
🇪🇸Madrid, Other, Spain
HM Centro Integral Oncologico Clara Campal
🇪🇸Madrid, Other, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Other, Spain
Hospital Universitario Quironsalud Madrid
🇪🇸Pozuelo de Alarcon, Other, Spain
Korea Cancer Center Hospital
🇰🇷Seoul, Other, Korea, Republic of
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Seoul National University Hospital
🇰🇷Seoul, Other, Korea, Republic of
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Rocky Mountain Cancer Centers - Aurora
🇺🇸Aurora, Colorado, United States
Miami Cancer Institute at Baptist Health, Inc.
🇺🇸Miami, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
AdventHealth Cancer Institute
🇺🇸Orlando, Florida, United States
Allina Health Cancer Institute
🇺🇸Minneapolis, Minnesota, United States
Texas Oncology - Houston Memorial City
🇺🇸Houston, Texas, United States
Texas Oncology - San Antonio Medical Center Northeast
🇺🇸San Antonio, Texas, United States
Saint Luke's Cancer Institute LLC
🇺🇸Kansas City, Missouri, United States