Back to resultsPhase 1 Study of IMP321 (Eftilagimod Alpha) Adjuvant to Anti-PD-1 Therapy in Unresectable or Metastatic Melanoma (TACTI-mel)
Primary Purpose
Stage IV Melanoma, Stage III Melanoma
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
IMP321 (eftilagimod alpha)
Pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Stage IV Melanoma
Eligibility Criteria
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
Sites / Locations
- Royal Brisbane Womens Hospital
- Princess Alexandra Hospital
- Greenslopes Private Hospital
- Flinders Medical Centre
- Ballarat Hospital
- Alfred Hospital
- Fiona Stanley Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMP321 dose escalation
Arm Description
IMP321 administered fortnightly in addition to SOC pembrolizumab.
Outcomes
Primary Outcome Measures
To assess the recommended phase 2 dose
To asses frequency of adverse events
To asses severity of adverse events
To asses duration of adverse events
Secondary Outcome Measures
Best overall response rate (ORR) to irRC and RECIST 1.1
Time to next treatment (TTNT)
Progression-free survival
Overall survival (part B only)
Full Information
NCT ID
NCT02676869
First Posted
February 2, 2016
Last Updated
December 17, 2019
Sponsor
Immutep Australia Pty. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02676869
Brief Title
Phase 1 Study of IMP321 (Eftilagimod Alpha) Adjuvant to Anti-PD-1 Therapy in Unresectable or Metastatic Melanoma
Acronym
TACTI-mel
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immutep Australia Pty. Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Melanoma, Stage III Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
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)
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMP321 dose escalation
Arm Type
Experimental
Arm Description
IMP321 administered fortnightly in addition to SOC pembrolizumab.
Intervention Type
Drug
Intervention Name(s)
IMP321 (eftilagimod alpha)
Other Intervention Name(s)
Eftilagimod alpha
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Administered according to the approved label.
Primary Outcome Measure Information:
Title
To assess the recommended phase 2 dose
Time Frame
From the time of inform consent form signature until 30 days after end of treatment
Title
To asses frequency of adverse events
Time Frame
From the time of inform consent form signature until 30 days after end of treatment
Title
To asses severity of adverse events
Time Frame
From the time of inform consent form signature until 30 days after end of treatment
Title
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 Measure Information:
Title
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.
Title
Time to next treatment (TTNT)
Time Frame
Up to 12 months
Title
Progression-free survival
Time Frame
Up to 12 months
Title
Overall survival (part B only)
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Royal Brisbane Womens Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Greenslopes Private Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Flinders Medical Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Ballarat Hospital
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3353
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Phase 1 Study of IMP321 (Eftilagimod Alpha) Adjuvant to Anti-PD-1 Therapy in Unresectable or Metastatic Melanoma
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