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

NCT ID: NCT02676869

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Stage IV Melanoma Stage III Melanoma

Study Design

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Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IMP321 dose escalation

IMP321 administered fortnightly in addition to SOC pembrolizumab.

Group Type EXPERIMENTAL

IMP321 (eftilagimod alpha)

Intervention Type DRUG

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

Intervention Type DRUG

Administered according to the approved label.

Interventions

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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

Intervention Type DRUG

Pembrolizumab

Administered according to the approved label.

Intervention Type DRUG

Other Intervention Names

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Eftilagimod alpha

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Immutep Australia Pty. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Royal Brisbane Womens Hospital

Brisbane, Queensland, Australia

Site Status

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Site Status

Greenslopes Private Hospital

Brisbane, Queensland, Australia

Site Status

Flinders Medical Centre

Adelaide, South Australia, Australia

Site Status

Ballarat Hospital

Ballarat, Victoria, Australia

Site Status

Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Fiona Stanley Hospital

Perth, Western Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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IMP321-P012

Identifier Type: -

Identifier Source: org_study_id