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

NCT02676869 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-12-18

No results posted yet for this study

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.

Conditions

  • Stage IV Melanoma
  • Stage III Melanoma

Interventions

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

DRUG

Pembrolizumab

Administered according to the approved label.

Sponsors & Collaborators

  • Immutep Australia Pty. Ltd.

    lead INDUSTRY

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-08-31
Completion
2019-12-31

Countries

  • Australia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02676869 on ClinicalTrials.gov