Clinical trial NCT02676869: Phase 1 Study of IMP321 (Eftilagimod Alpha) Adjuvant to Anti-PD-1 Therapy in Unresectable or Metastatic Melanoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stage IV Melanoma
Stage III Melanoma
Lead sponsor: Immutep Australia Pty. Ltd.
Sponsor class: INDUSTRY
First posted: 2016-02-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To assess the recommended phase 2 dose
timeFrame: From the time of inform consent form signature until 30 days after end of treatment
measure: To asses frequency of adverse events
timeFrame: From the time of inform consent form signature until 30 days after end of treatment
measure: To asses severity of adverse events
timeFrame: From the time of inform consent form signature until 30 days after end of treatment
measure: To asses duration of adverse events
timeFrame: From the time of inform consent form signature until 30 days after end of treatment
Secondary outcomes:
measure: Best overall response rate (ORR) to irRC and RECIST 1.1
timeFrame: From the time of inform consent form signature until 30 days after end of treatment.
measure: Time to next treatment (TTNT)
timeFrame: Up to 12 months
measure: Progression-free survival
timeFrame: Up to 12 months
measure: Overall survival (part B only)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Royal Brisbane Womens Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Ballarat
country: Australia
facility: Ballarat Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Perth
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
Study officials:
References: