Stage III Melanoma, Stage IV Melanoma
Conditions
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.
Interventions
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
DRUGPembrolizumab
Administered according to the approved label.
Sponsors
Immutep Australia Pty. Ltd.
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To asses duration of adverse events | 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 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Australia
Outcome results
None listed