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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03310957
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : April 28, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Tracking Information
First Submitted Date  ICMJE October 11, 2017
First Posted Date  ICMJE October 16, 2017
Last Update Posted Date April 28, 2020
Actual Study Start Date  ICMJE February 27, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • Confirmed objective response rate [ Time Frame: Up to 18 weeks following last dose; approximately 1 year ]
    Confirmed ORR as determined by investigator according to RECIST v 1.1
  • Incidence of adverse events [ Time Frame: Through 1 month following last dose; approximately 10 months ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose; approximately 10 months ]
  • Incidence of dose-limiting toxicities [ Time Frame: Through 1 month following last dose; approximately 10 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 11, 2017)
  • Confirmed objective response rate [ Time Frame: Up to 18 weeks following last dose ]
    Confirmed ORR as determined by investigator according to RECIST v 1.1
  • Incidence of adverse events [ Time Frame: Through 1 month following last dose ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ]
  • Incidence of dose-limiting toxicities [ Time Frame: Through 1 month following last dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2017)
  • Duration of response [ Time Frame: Up to 2.5 years following last dose ]
    DOR as determined by investigator according to RECIST v 1.1
  • Disease control rate [ Time Frame: 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
  • Progression-free survival [ Time Frame: Up to 2.5 years following last dose ]
    PFS as determined by investigator according to RECIST v 1.1
  • Overall survival [ Time Frame: Up to 2.5 years following last dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer
Official Title  ICMJE 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
Brief Summary This trial studies SGN-LIV1A 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 the 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 SGN-LIV1A, 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 SGN-LIV1A 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: SGN-LIV1A
    IV infusion
  • Drug: Pembrolizumab
    IV infusion every 3 weeks
    Other Name: Keytruda
Study Arms  ICMJE Experimental: SGN-LIV1A plus pembrolizumab
SGN-LIV1A + pembrolizumab
Interventions:
  • Drug: SGN-LIV1A
  • Drug: Pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2020)
122
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2017)
72
Estimated Study Completion Date  ICMJE March 31, 2023
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER, and PR 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
  • ECOG performance status of 0 or 1
  • Able to provide biopsy tissue for biomarker analysis
  • Meet baseline laboratory data criteria
  • Not pregnant. Must agree not to become pregnant until at least 6 months after ceasing study treatment

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com
Listed Location Countries  ICMJE Germany,   Korea, Republic of,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03310957
Other Study ID Numbers  ICMJE SGNLVA-002
KEYNOTE 721 ( Other Identifier: Merck and Co., Inc )
2017-002289-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seattle Genetics, Inc.
Study Sponsor  ICMJE Seattle Genetics, Inc.
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Study Director: Zejing Wang, MD, PhD Seattle Genetics, Inc.
PRS Account Seattle Genetics, Inc.
Verification Date April 24, 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP