Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Immutep Australia Pty. Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
