Phase 1 Study of IMP321 (Eftilagimod Alpha) Adjuvant to Anti-PD-1 Therapy in Unresectable or Metastatic Melanoma

Overview

The purpose of this study is to determine the safety, tolerability and recommended phase 2 dose of a new drug, known as IMP321, in combination with pembrolizumab when given to patients with unresectable or metastatic melanoma.

Full Title of Study: “A Multicentre, Open Label, Dose Escalation, Phase 1 Study in Patients With Unresectable or Metastatic Melanoma Receiving IMP321 (LAG-3Ig Fusion Protein-eftilagimod Alpha) as an Adjunctive Therapy to Anti-PD-1 Therapy With Pembrolizumab”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2019

Interventions

  • Drug: IMP321 (eftilagimod alpha)
    • Part A: Single subcutaneous injections of 1 mg (cohort 1), 6 mg (cohort 2) or 30 mg (cohort 3) of IMP321 administered every 2 weeks Part B: Single subcutaneous injections of 30 mg of IMP321 administered every 2 weeks
  • Drug: Pembrolizumab
    • Administered according to the approved label.

Arms, Groups and Cohorts

  • Experimental: IMP321 dose escalation
    • IMP321 administered fortnightly in addition to SOC pembrolizumab.

Clinical Trial Outcome Measures

Primary Measures

  • To assess the recommended phase 2 dose
    • Time Frame: From the time of inform consent form signature until 30 days after end of treatment
  • To asses frequency of adverse events
    • Time Frame: From the time of inform consent form signature until 30 days after end of treatment
  • To asses severity of adverse events
    • Time Frame: From the time of inform consent form signature until 30 days after end of treatment
  • To asses duration of adverse events
    • Time Frame: From the time of inform consent form signature until 30 days after end of treatment

Secondary Measures

  • Best overall response rate (ORR) to irRC and RECIST 1.1
    • Time Frame: From the time of inform consent form signature until 30 days after end of treatment.
  • Time to next treatment (TTNT)
    • Time Frame: Up to 12 months
  • Progression-free survival
    • Time Frame: Up to 12 months
  • Overall survival (part B only)
    • Time Frame: Up to 12 months

Participating in This Clinical Trial

Main Inclusion Criteria

  • Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma
  • Currently receiving anti-PD-1 therapy with pembrolizumab and after 3 cycles achieved asymptomatic irPD (slowly progressive, not requiring urgent intervention, and stable performance status) or sub-optimal response (irSD, irPR) as demonstrated in imaging assessments performed within 6 weeks prior to study start
  • Female or male 18 years of age or above
  • ECOG performance status 0-1
  • Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 10. Adequate Laboratory criteria

Main Exclusion Criteria

  • More than four prior lines of therapies for advanced or metastatic disease.
  • Prior PD-1/PDL-1 targeted therapy
  • Currently receiving treatment with another investigational drug, or less than 4 weeks since ending treatment on another investigational drug
  • Currently receiving systemic chemotherapy, targeted small molecule therapy, radiotherapy, or biological cancer therapy (other than pembrolizumab) or less than 4 weeks since completion of these therapies and first dose of study treatment
  • History of irAEs from ipilimumab of CTCAE Grade 4 requiring steroid treatment
  • Known cerebral or leptomeningeal metastases
  • Serious intercurrent infection within 4 weeks prior to first dose of study treatment
  • Active acute or chronic infection
  • History or evidence of interstitial lung disease or active non-infectious pneumonitis
  • Active auto-immune disease requiring immunosuppressive therapy
  • HIV positivity, active hepatitis B or hepatitis C
  • Continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Immutep Australia Pty. Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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