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

Sponsor
Immutep Australia Pty. Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02676869
Collaborator
(none)
24
Enrollment
7
Locations
1
Arm
44
Actual Duration (Months)
3.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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.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 :
Apr 1, 2016
Actual Primary Completion Date :
Aug 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. To assess the recommended phase 2 dose [From the time of inform consent form signature until 30 days after end of treatment]

    2. To asses frequency of adverse events [From the time of inform consent form signature until 30 days after end of treatment]

    3. To asses severity of adverse events [From the time of inform consent form signature until 30 days after end of treatment]

    4. To asses duration of adverse events [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 [From the time of inform consent form signature until 30 days after end of treatment.]

    2. Time to next treatment (TTNT) [Up to 12 months]

    3. Progression-free survival [Up to 12 months]

    4. Overall survival (part B only) [Up to 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Brisbane Womens Hospital Brisbane Queensland Australia 4029
    2 Princess Alexandra Hospital Brisbane Queensland Australia 4102
    3 Greenslopes Private Hospital Brisbane Queensland Australia 4120
    4 Flinders Medical Centre Adelaide South Australia Australia 5042
    5 Ballarat Hospital Ballarat Victoria Australia 3353
    6 Alfred Hospital Melbourne Victoria Australia 3181
    7 Fiona Stanley Hospital Perth Western Australia Australia 6150

    Sponsors and Collaborators

    • Immutep Australia Pty. Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Immutep Australia Pty. Ltd.
    ClinicalTrials.gov Identifier:
    NCT02676869
    Other Study ID Numbers:
    • IMP321-P012
    First Posted:
    Feb 8, 2016
    Last Update Posted:
    Dec 18, 2019
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Melanoma
    Pembrolizumab

    Study Results

    No Results Posted as of Dec 18, 2019