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

Primary Purpose

Triple Negative Breast Neoplasms

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ladiratuzumab vedotin
Pembrolizumab
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple Negative Breast Neoplasms focused on measuring Breast cancer, Breast carcinoma, Triple negative breast cancer, Locally-advanced breast cancer, Metastatic breast cancer, Tumors, breast, Breast tumors, pembrolizumab, LIV-1 protein, human, Ladiratuzumab vedotin, hLIV22-vcMMAE, Seattle Genetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
  • Chao Family Comprehensive Cancer Center University of California Irvine
  • University of California Irvine - Newport
  • Rocky Mountain Cancer Centers - Aurora
  • The Whittingham Cancer Center / Norwalk Hospital
  • Helen F. Graham Cancer Center / Christiana Care Health Systems
  • Miami Cancer Institute at Baptist Health, Inc.
  • AdventHealth Cancer Institute
  • H. Lee Moffitt Cancer Center and Research Institute
  • Piedmont Cancer Institute
  • Winship Cancer Institute / Emory University School of Medicine
  • Ingalls Cancer Care / Ingalls Memorial Hospital
  • Cardinal Bernardin Cancer Center / Loyola University Medical Center
  • University of Maryland
  • Allina Health Cancer Institute
  • Saint Luke's Cancer Institute LLC
  • Summit Medical Group
  • University of New Mexico Cancer Center
  • Weill Cornell Medicine
  • University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
  • Texas Oncology - Baylor Sammons Cancer Center
  • Texas Oncology - Houston Memorial City
  • Texas Oncology - San Antonio Medical Center Northeast
  • University of Virginia
  • Seattle Cancer Care Alliance / University of Washington
  • Gynakologisches Zentrum Bonn Friedensplatz
  • Marien Hospital Bottrop
  • Stadtisches Klinikum Dessau
  • Universitatsklinikum Erlangen
  • Kliniken Essen-Mitte - Evang. Huyssens-Stiftung
  • Klinikum Rechts der Isar der Technischen Universitaet Muenchen
  • Klinikum der Universitat Munchen
  • Rotkreuzklinikum Munich
  • Pusan National University Hospital
  • CHA Bundang Medical Center
  • Korea Cancer Center Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • Hospital del Mar
  • Hospital Universitario Vall d'Hebron
  • Complejo Hospitalario de Jaen
  • L'Institut Catala d'Oncologia
  • Complejo Hospitalario Universitario La Coruna
  • Centro Oncologico MD Anderson
  • Hospital Ruber Internacional
  • Hospital Universitario 12 de Octubre
  • HM Centro Integral Oncologico Clara Campal
  • Hospital Universitario Quironsalud Madrid

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LV + pembrolizumab

Arm Description

LV + pembrolizumab

Outcomes

Primary Outcome Measures

Confirmed objective response rate
Confirmed ORR as determined by investigator according to RECIST v 1.1
Incidence of adverse events
Incidence of laboratory abnormalities
Incidence of dose-limiting toxicities

Secondary Outcome Measures

Duration of response
DOR as determined by investigator according to RECIST v 1.1
Disease control rate
Proportion of patients with complete response (CR), partial response (PR), or stable disease (SD) as determined by investigator according to RECIST v 1.1
Progression-free survival
PFS as determined by investigator according to RECIST v 1.1
Overall survival
OS is defined as the time from start of study treatment to date of death due to any cause.

Full Information

First Posted
October 11, 2017
Last Updated
July 12, 2023
Sponsor
Seagen Inc.
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03310957
Brief Title
Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer
Official Title
Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination With Pembrolizumab for First-Line Treatment of Patients With Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 27, 2018 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Neoplasms
Keywords
Breast cancer, Breast carcinoma, Triple negative breast cancer, Locally-advanced breast cancer, Metastatic breast cancer, Tumors, breast, Breast tumors, pembrolizumab, LIV-1 protein, human, Ladiratuzumab vedotin, hLIV22-vcMMAE, Seattle Genetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LV + pembrolizumab
Arm Type
Experimental
Arm Description
LV + pembrolizumab
Intervention Type
Drug
Intervention Name(s)
ladiratuzumab vedotin
Other Intervention Name(s)
LV, SGN-LIV1A
Intervention Description
Given into the vein (IV; intravenously)
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda
Intervention Description
IV infusion every 3 weeks
Primary Outcome Measure Information:
Title
Confirmed objective response rate
Description
Confirmed ORR as determined by investigator according to RECIST v 1.1
Time Frame
Up to 18 weeks following last dose; approximately 1 year
Title
Incidence of adverse events
Time Frame
Through 1 month following last dose; approximately 10 months
Title
Incidence of laboratory abnormalities
Time Frame
Through 1 month following last dose; approximately 10 months
Title
Incidence of dose-limiting toxicities
Time Frame
Through 1 month following last dose; approximately 10 months
Secondary Outcome Measure Information:
Title
Duration of response
Description
DOR as determined by investigator according to RECIST v 1.1
Time Frame
Up to 2.5 years following last dose
Title
Disease control rate
Description
Proportion of patients with complete response (CR), partial response (PR), or stable disease (SD) as determined by investigator according to RECIST v 1.1
Time Frame
Up to 2.5 years following last dose
Title
Progression-free survival
Description
PFS as determined by investigator according to RECIST v 1.1
Time Frame
Up to 2.5 years following last dose
Title
Overall survival
Description
OS is defined as the time from start of study treatment to date of death due to any cause.
Time Frame
Up to 2.5 years following last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon Croft, PharmD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zejing Wang, MD, PhD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center University of California Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California Irvine - Newport
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
The Whittingham Cancer Center / Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Helen F. Graham Cancer Center / Christiana Care Health Systems
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Miami Cancer Institute at Baptist Health, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
AdventHealth Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Piedmont Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Winship Cancer Institute / Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Ingalls Cancer Care / Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Cardinal Bernardin Cancer Center / Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Allina Health Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Saint Luke's Cancer Institute LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64113
Country
United States
Facility Name
Summit Medical Group
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Texas Oncology - Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology - Houston Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Texas Oncology - San Antonio Medical Center Northeast
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Seattle Cancer Care Alliance / University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Gynakologisches Zentrum Bonn Friedensplatz
City
Bonn
ZIP/Postal Code
53111
Country
Germany
Facility Name
Marien Hospital Bottrop
City
Bottrop
ZIP/Postal Code
46236
Country
Germany
Facility Name
Stadtisches Klinikum Dessau
City
Dessau
ZIP/Postal Code
06847
Country
Germany
Facility Name
Universitatsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Kliniken Essen-Mitte - Evang. Huyssens-Stiftung
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Klinikum Rechts der Isar der Technischen Universitaet Muenchen
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinikum der Universitat Munchen
City
Munchen
ZIP/Postal Code
80337
Country
Germany
Facility Name
Rotkreuzklinikum Munich
City
Munich
ZIP/Postal Code
80637
Country
Germany
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center
City
Seongnam
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Korea Cancer Center Hospital
City
Seoul
ZIP/Postal Code
01802
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Complejo Hospitalario de Jaen
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
L'Institut Catala d'Oncologia
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Complejo Hospitalario Universitario La Coruna
City
La Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Centro Oncologico MD Anderson
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Ruber Internacional
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
HM Centro Integral Oncologico Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Quironsalud Madrid
City
Pozuelo de Alarcón
ZIP/Postal Code
28223
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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