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 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.

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
  • NCT ID: NCT03310957

Conditions

  • Breast Neoplasms

Interventions

DrugSynonymsArms
SGN-LIV1ASGN-LIV1A plus pembrolizumab
PembrolizumabKeytrudaSGN-LIV1A plus pembrolizumab

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
SGN-LIV1A plus pembrolizumabExperimentalSGN-LIV1A followed by pembrolizumab.
  • SGN-LIV1A
  • Pembrolizumab

Eligibility 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 LA/M breast
             cancer

          -  At least 12 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

          -  Radiological evidence of CNS metastases

          -  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
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:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Seattle Genetics, 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

Last Updated

April 30, 2018