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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02676869
Recruitment Status : Completed
First Posted : February 8, 2016
Last Update Posted : December 18, 2019
Information provided by (Responsible Party):
Immutep Australia Pty. Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stage IV Melanoma Stage III Melanoma Drug: IMP321 (eftilagimod alpha) Drug: Pembrolizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Study is an open label, dose finding study consisting of 2 parts. In part A, the dose is escalated following the protocol-defined safety observation period of the previous cohort. Patients will receive 9 cycles Pembrolizumab in combination with IMP321. In part B, the dose was defined based on the dose escalation. The treatment duration will be expanded to 19 cycles in the combined treatment.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 2016
Actual Primary Completion Date : August 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

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 Name: Eftilagimod alpha

Drug: Pembrolizumab
Administered according to the approved label.

Primary Outcome Measures :
  1. To assess the recommended phase 2 dose [ Time Frame: From the time of inform consent form signature until 30 days after end of treatment ]
  2. To asses frequency of adverse events [ Time Frame: From the time of inform consent form signature until 30 days after end of treatment ]
  3. To asses severity of adverse events [ Time Frame: From the time of inform consent form signature until 30 days after end of treatment ]
  4. To asses duration of adverse events [ Time Frame: From the time of inform consent form signature until 30 days after end of treatment ]

Secondary Outcome Measures :
  1. 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. ]
  2. Time to next treatment (TTNT) [ Time Frame: Up to 12 months ]
  3. Progression-free survival [ Time Frame: Up to 12 months ]
  4. Overall survival (part B only) [ Time Frame: Up to 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02676869

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Australia, Queensland
Royal Brisbane Womens Hospital
Brisbane, Queensland, Australia, 4029
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Greenslopes Private Hospital
Brisbane, Queensland, Australia, 4120
Australia, South Australia
Flinders Medical Centre
Adelaide, South Australia, Australia, 5042
Australia, Victoria
Ballarat Hospital
Ballarat, Victoria, Australia, 3353
Alfred Hospital
Melbourne, Victoria, Australia, 3181
Australia, Western Australia
Fiona Stanley Hospital
Perth, Western Australia, Australia, 6150
Sponsors and Collaborators
Immutep Australia Pty. Ltd.
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Responsible Party: Immutep Australia Pty. Ltd.
ClinicalTrials.gov Identifier: NCT02676869    
Other Study ID Numbers: IMP321-P012
First Posted: February 8, 2016    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action