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

Phase 1

Completed

• Conditions: Stage IV Melanoma; Stage III Melanoma
• Interventions: Drug: IMP321 (eftilagimod alpha); Drug: Pembrolizumab

• Registration Number: NCT02676869
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-02
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-08
• Study Start: 2016-04
• Primary Completion: 2019-08
• Status Verified: 2019-12
• Study Completion: 2019-12
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
IMP321 dose escalation	IMP321 (eftilagimod alpha)	IMP321 administered fortnightly in addition to SOC pembrolizumab.
IMP321 dose escalation	Pembrolizumab	IMP321 administered fortnightly in addition to SOC pembrolizumab.

Primary Outcome Measures

Name	Time	Method
To asses frequency of adverse events	From the time of inform consent form signature until 30 days after end of treatment
To assess the recommended phase 2 dose	From the time of inform consent form signature until 30 days after end of treatment
To asses severity of adverse events	From the time of inform consent form signature until 30 days after end of treatment
To asses duration of adverse events	From the time of inform consent form signature until 30 days after end of treatment

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Up to 12 months
Time to next treatment (TTNT)	Up to 12 months
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.
Overall survival (part B only)	Up to 12 months

Trial Locations

Locations (7)

Princess Alexandra Hospital; 🇦🇺 Brisbane, Queensland, Australia

Fiona Stanley Hospital; 🇦🇺 Perth, Western Australia, Australia

Ballarat Hospital; 🇦🇺 Ballarat, Victoria, Australia

Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Royal Brisbane Womens Hospital; 🇦🇺 Brisbane, Queensland, Australia

Greenslopes Private Hospital; 🇦🇺 Brisbane, Queensland, Australia

Flinders Medical Centre; 🇦🇺 Adelaide, South Australia, Australia