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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02676869




Registration number
NCT02676869
Ethics application status
Date submitted
2/02/2016
Date registered
8/02/2016

Titles & IDs
Public title
Phase 1 Study of IMP321 (Eftilagimod Alpha) Adjuvant to Anti-PD-1 Therapy in Unresectable or Metastatic Melanoma
Scientific 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
Secondary ID [1] 0 0
IMP321-P012
Universal Trial Number (UTN)
Trial acronym
TACTI-mel
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage IV Melanoma 0 0
Stage III Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IMP321 (eftilagimod alpha)
Treatment: Drugs - Pembrolizumab

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


Treatment: Drugs: 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

Treatment: Drugs: Pembrolizumab
Administered according to the approved label.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the recommended phase 2 dose
Timepoint [1] 0 0
From the time of inform consent form signature until 30 days after end of treatment
Primary outcome [2] 0 0
To asses frequency of adverse events
Timepoint [2] 0 0
From the time of inform consent form signature until 30 days after end of treatment
Primary outcome [3] 0 0
To asses severity of adverse events
Timepoint [3] 0 0
From the time of inform consent form signature until 30 days after end of treatment
Primary outcome [4] 0 0
To asses duration of adverse events
Timepoint [4] 0 0
From the time of inform consent form signature until 30 days after end of treatment
Secondary outcome [1] 0 0
Best overall response rate (ORR) to irRC and RECIST 1.1
Timepoint [1] 0 0
From the time of inform consent form signature until 30 days after end of treatment.
Secondary outcome [2] 0 0
Time to next treatment (TTNT)
Timepoint [2] 0 0
Up to 12 months
Secondary outcome [3] 0 0
Progression-free survival
Timepoint [3] 0 0
Up to 12 months
Secondary outcome [4] 0 0
Overall survival (part B only)
Timepoint [4] 0 0
Up to 12 months

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2019
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Brisbane Womens Hospital - Brisbane
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [3] 0 0
Greenslopes Private Hospital - Brisbane
Recruitment hospital [4] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [5] 0 0
Ballarat Hospital - Ballarat
Recruitment hospital [6] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
Fiona Stanley Hospital - Perth
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment postcode(s) [3] 0 0
4120 - Brisbane
Recruitment postcode(s) [4] 0 0
5042 - Adelaide
Recruitment postcode(s) [5] 0 0
3353 - Ballarat
Recruitment postcode(s) [6] 0 0
3181 - Melbourne
Recruitment postcode(s) [7] 0 0
6150 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Immutep Australia Pty. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02676869