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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 : May 3, 2023
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Seagen Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Triple Negative Breast Neoplasms Drug: ladiratuzumab vedotin Drug: Pembrolizumab Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 211 participants
Allocation: N/A
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 : April 30, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: LV + pembrolizumab
LV + pembrolizumab
 Drug: ladiratuzumab vedotin
Given into the vein (IV; intravenously)
Other Names:
  • LV
  • SGN-LIV1A

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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Incidence of adverse events [ Time Frame: Through 1 month following last dose; approximately 10 months ]
  3. Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose; approximately 10 months ]
  4. Incidence of dose-limiting toxicities [ Time Frame: Through 1 month following last dose; approximately 10 months ]

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 ]
    OS is defined as the time from start of study treatment to date of death due to any cause.


Eligibility Criteria
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Information from the National Library of Medicine

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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)

    • 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
Contacts and Locations
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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
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Contact: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
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Sponsors and Collaborators
Seagen Inc.
Merck Sharp & Dohme LLC
Investigators
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Study Director: Brandon Croft, PharmD Seagen Inc.
Study Director: Zejing Wang, MD, PhD Seagen Inc.
More Information
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT03310957    
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: May 3, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen 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
Ladiratuzumab vedotin
hLIV22-vcMMAE
Seattle Genetics
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pembrolizumab
SGN-LIV1A
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs