Clinical Trials /

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

NCT03310957

Description:

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 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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: SGNLVA-002
  • SECONDARY ID: KEYNOTE 721
  • SECONDARY ID: 2017-002289-35
  • NCT ID: NCT03310957

Conditions

  • Breast Neoplasms

Interventions

DrugSynonymsArms
ladiratuzumab vedotinLV, SGN-LIV1ALV plus pembrolizumab
PembrolizumabKeytrudaLV plus pembrolizumab

Purpose

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 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 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.
    

Trial Arms

NameTypeDescriptionInterventions
LV plus pembrolizumabExperimentalLV + pembrolizumab
  • ladiratuzumab vedotin
  • Pembrolizumab

Eligibility Criteria

        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

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Confirmed objective response rate
Time Frame:Up to 18 weeks following last dose; approximately 1 year
Safety Issue:
Description:Confirmed ORR as determined by investigator according to RECIST v 1.1

Secondary Outcome Measures

Measure:Duration of response
Time Frame:Up to 2.5 years following last dose
Safety Issue:
Description:DOR as determined by investigator according to RECIST v 1.1
Measure:Disease control rate
Time Frame:Up to 2.5 years following last dose
Safety Issue:
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
Measure:Progression-free survival
Time Frame:Up to 2.5 years following last dose
Safety Issue:
Description:PFS as determined by investigator according to RECIST v 1.1
Measure:Overall survival
Time Frame:Up to 2.5 years following last dose
Safety Issue:
Description:OS is defined as the time from start of study treatment to date of death due to any cause.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Seagen Inc.

Trial 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

Last Updated

April 13, 2021