A safety study for MSB0010445 in combination with Stereotactic Body Radiation in advanced melanoma subjects following prior treatment with ipilimumab

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A safety study for MSB0010445 in combination with Stereotactic Body Radiation in advanced melanoma subjects following prior treatment with ipilimumab

The primary objective of the trial is as follows:
- To determine the maximum tolerated dose (MTD) of MSB0010445 in combination with Stereotactic Body Radiation Therapy (SBRT) in subjects with advanced melanoma
The exploratory objectives of the trial are as follows:
- To establish that MSB0010445 in combination with SBRT is clinically active through the observation of best overall response assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
- To further characterize the safety of MSB0010445 in combination with SBRT
- To characterize the immunogenicity of MSB0010445
- To characterize the pharmacokinetics (PK) of MSB0010445
- To propose that MSB0010445 in combination with SBRT is biologically active by observing modifications of the tumor microenvironment (by infiltration of CD8+ T cells and of regulatory T cell [Treg] in the tumor)
- To evaluate potential biomarkers of immune response correlated with clinical activity by analysis of tumor and peripheral blood samples
- To establish that MSB0010445 is clinically active through the observation of best overall response assessed by modified immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
- To evaluate the pharmacodynamic activity of MSB0010445 in combination with radiotherapy in peripheral blood

Protocol Number091312
Principal InvestigatorHoward Kaufman
PhasePhase II
ScopeNational
Applicable Disease SitesMelanoma, skin
Therapies InvolvedRadiotherapy
Chemotherapy single agent systemic
Drugs InvolvedMSB0010445
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.