ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : December 3, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
This trial studies SGN-LIV1A in combination with pembrolizumab to find out what their side effects are and if they work for patients with triple-negative breast cancer that has spread to other parts of the body. Patients will be given both experimental drugs every 3 weeks.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: SGN-LIV1A Drug: Pembrolizumab Phase 1 Phase 2

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 in Part A will be monitored for frequency of dose-limiting toxicities to determine if SGN-LIV1A dosing should be de-escalated before opening the expansion in Part B. In addition to safety measures, objective response rate, progression-free survival, overall survival, and other efficacy outcomes will be assessed.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: SGN-LIV1A plus pembrolizumab
SGN-LIV1A followed by pembrolizumab.
Drug: SGN-LIV1A
IV infusion every 3 weeks

Drug: Pembrolizumab
IV infusion every 3 weeks
Other Name: Keytruda




Primary Outcome Measures :
  1. 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

  2. Incidence of adverse events [ Time Frame: Through 1 month following last dose ]
  3. Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ]
  4. Incidence of dose-limiting toxicities [ Time Frame: Through 1 month following last dose ]

Secondary Outcome Measures :
  1. Duration of response [ Time Frame: Up to 2.5 years following last dose ]
    DOR as determined by investigator according to RECIST v 1.1

  2. 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

  3. Progression-free survival [ Time Frame: Up to 2.5 years following last dose ]
    PFS as determined by investigator according to RECIST v 1.1

  4. Overall survival [ Time Frame: Up to 2.5 years following last dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
  • Have not previously received 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.
  • Active autoimmune disease requiring systemic treatment within the past 2 years
  • History of interstitial lung disease
  • Current pneumonitis or history of pneumonitis requiring steroids

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310957


Contacts
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

  Show 20 Study Locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Merck Sharp & Dohme Corp.
Investigators
Study Director: Zejing Wang, MD, PhD Seattle Genetics, Inc.

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT03310957     History of Changes
Other Study ID Numbers: SGNLVA-002
KEYNOTE 721 ( Other Identifier: Merck and Co., Inc )
2017-002289-35 ( EudraCT Number )
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 29, 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seattle Genetics, Inc.:
Breast cancer
Breast carcinoma
Triple negative breast cancer
Locally-advanced breast cancer
Metastatic breast cancer
Tumors, breast
Breast tumors
pembrolizumab
LIV-1 protein, human

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pembrolizumab
Immunoconjugates
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs