Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
EMD Serono
With
Merck KGaA, Darmstadt, Germany
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Advanced unresectable or metastatic melanoma, previously treated with ipilimumab; anti-melanoma treatments, including anti-PD/PD-L1 or any other immunotherapy, are allowed provided no treatment from last dose of that treatment to trial enrolment
Subjects need to have
* one lesion that can be irradiated
* at least 1 measurable lesion outside the radiation field, different from the lesion that will be irradiated
* one lesion that can be biopsied before treatment with SBRT and MSB0010445
* one lesion outside the radiation field that can be biopsied while on treatment with MSB0010445
The lesion that is biopsied at Baseline can be the lesion that will be irradiated
The lesion that will be biopsied while on treatment should not be a lesion that has been irradiated or biopsied at Baseline
Signed written informed consent
Male and female subjects at least 18 years of age
Life expectancy greater than or equal to (\>=) 4 months
Eastern cooperative oncology group (ECOG) performance status of 0 or 1
You may not be if
Active central nervous system metastasis
Treatment with systemic anti-cancer therapy within the 30 days before the first dose of SBRT
Pre-existing pericardial effusion or history of Grade \>=2 pleural effusion or ascites within 3 months before first dose of SBRT
Concurrent systemic therapy with steroids or other immunosuppressive agents except short-term systemic steroids for allergic reactions
Clareo Health | MSB0010445 and Stereotactic Body Radiation Therapy in Advanced Melanoma
