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

Stage IV Melanoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676869
• Other study ID #: IMP321-P012
• Status: Completed
• Phase: Phase 1
• Start date: April 2016
• Est. completion date: December 2019

Study information

• Verified date: December 2019
• Source: Immutep Australia Pty. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Stage III Melanoma
• Stage IV Melanoma

Intervention

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
• Pembrolizumab
Administered according to the approved label.

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Adelaide	South Australia
Australia	Ballarat Hospital	Ballarat	Victoria
Australia	Greenslopes Private Hospital	Brisbane	Queensland
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Royal Brisbane Womens Hospital	Brisbane	Queensland
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Perth	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Immutep Australia Pty. Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the recommended phase 2 dose		From the time of inform consent form signature until 30 days after end of treatment
Primary	To asses frequency of adverse events		From the time of inform consent form signature until 30 days after end of treatment
Primary	To asses severity of adverse events		From the time of inform consent form signature until 30 days after end of treatment
Primary	To asses duration of adverse events		From the time of inform consent form signature until 30 days after end of treatment
Secondary	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.
Secondary	Time to next treatment (TTNT)		Up to 12 months
Secondary	Progression-free survival		Up to 12 months
Secondary	Overall survival (part B only)		Up to 12 months