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

NCT02676869 | Completed Phase 1 DMC

• 1 other identifier: IMP321-P012
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

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.

Conditions

Stage IV Melanoma; Stage III Melanoma

Outcome Measures

Primary Outcomes (4)

• To assess the recommended phase 2 dose

  From the time of inform consent form signature until 30 days after end of treatment

• To asses frequency of adverse events

  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 Outcomes (4)

• 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.

• Time to next treatment (TTNT)

  Up to 12 months

• Progression-free survival

  Up to 12 months

• Overall survival (part B only)

  Up to 12 months

Study Arms (1)

IMP321 dose escalation

EXPERIMENTAL

IMP321 administered fortnightly in addition to SOC pembrolizumab.

Drug: IMP321 (eftilagimod alpha); Drug: Pembrolizumab

Interventions

IMP321 (eftilagimod alpha) 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

Also known as: Eftilagimod alpha

IMP321 dose escalation

Pembrolizumab DRUG

Administered according to the approved label.

IMP321 dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Immutep Australia Pty. Ltd.: lead

Study Sites (7)

Royal Brisbane Womens Hospital

Brisbane, Queensland, 4029, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Greenslopes Private Hospital

Brisbane, Queensland, 4120, Australia

Location

Flinders Medical Centre

Adelaide, South Australia, 5042, Australia

Location

Ballarat Hospital

Ballarat, Victoria, 3353, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3181, Australia

Location

Fiona Stanley Hospital

Perth, Western Australia, 6150, Australia

Location

MeSH Terms

Conditions

Melanoma

Interventions

soluble LAG-3 protein, human; pembrolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 8, 2016
• Study Start: April 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Locations

AU (7)