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

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

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.

Study Overview

• Status: Completed
• Conditions: Stage IV Melanoma; Stage III Melanoma
• Intervention / Treatment: Drug: IMP321 (eftilagimod alpha); Drug: Pembrolizumab

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4102
      • Princess Alexandra Hospital
    • Brisbane, Queensland, Australia, 4120
      • Greenslopes Private Hospital
    • Brisbane, Queensland, Australia, 4029
      • Royal Brisbane Womens Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5042
      • Flinders Medical Centre
  • Victoria
    • Ballarat, Victoria, Australia, 3353
      • Ballarat Hospital
    • Melbourne, Victoria, Australia, 3181
      • Alfred Hospital
  • Western Australia
    • Perth, Western Australia, Australia, 6150
      • Fiona Stanley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMP321 dose escalation; IMP321 administered fortnightly in addition to SOC pembrolizumab.	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; Other Names: Eftilagimod alpha; Drug: Pembrolizumab; Administered according to the approved label.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Immutep Australia Pty. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: February 2, 2016
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (Estimate): February 8, 2016

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Antineoplastic Agents; Antineoplastic Agents, Immunological; Pembrolizumab
• Other Study ID Numbers: IMP321-P012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided