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Clinical Trial 19603

Cancer Type:
Interventions:Pembrolizumab (Keytruda); SGN-LIV1A

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Heather Han

Call 813-745-6100
or 1-800-679-0775
Overview

Study 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

Summary

The purpose of this study is to test the safety and side effects of SGN-LIV1A and pembrolizumab when used together, as well as how well they work against triple negative breast cancer that has spread to other parts of the body. Investigators may test different doses of SGN-LIV1A to find the best one to use with pembrolizumab.

Objective

- Evaluate the safety and tolerability of the combination of SGN-LIV1A and pembrolizumab in patients with locally-advanced or metastatic, triple-negative breast cancer (LA/M TNBC). - Identify the recommended dose of SGN-LIV1A in combination with pembrolizumab in patients with LA/MTNBC. - Evaluate confirmed objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 of the combination of SGN-LIV1A and pembrolizumab in patients with LA/M TNBC.

Inclusion Criteria

  • Metastatic or locally-advanced, histologically documented triple-negative breast cancer (TNBC) (absence of human epidermal growth factor receptor 2 (HER2), and expression)
  • Have not previously received cytotoxic therapy for the treatment of unresectable locally-advanced or metastatic (LA/M) breast cancer
  • At least 6 months since prior treatment with curative intent and recurrence
  • At least 1 tumor 10 mm 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 adequate tissue obtained recently from a tumor lesion for biomarker analysis, Core needle or excisional biopsy is preferred. If neither is possible, biopsy obtained via alternative methods may be appropriate.
  • Meet baseline laboratory data criteria
  • Not pregnant. Must agree not to become pregnant until at least 6 months after ceasing study treatment.
  • Must provide written informed consent if they are able to. If the patient is unable to provide written informed consent, then written informed consent can be provide by a legally authorized representative (LAR) in accordance with local legal requirements.

    • Exclusion Criteria

  • Prior immune-oncology therapy
  • Pre-existing neuropathy of at least Grade 2
  • Radiological evidence of central nervous system (CNS) metastases
  • History of carcinomatous meningitis or active CNS metastases. Patients are eligible if CNS metastases are adequately treated and patients have neurologically returned to baseline for at least 4 weeks prior to enrollment. In addition, patients must be completely 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
  • Additional exlusions apply

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