drugset / Trial / NCT01973608

MSB0010445 and Stereotactic Body Radiation Therapy in Advanced Melanoma

NCT01973608 ↗

Phase 2 Terminated 12 enrolled EMD Serono Merck KGaA, Darmstadt, Germany · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 2a, open-label, parallel group, partly randomized dose escalation trial to assess the safety and efficacy of a low dose, an intermediate dose, and high dose MSB0010445 given by intravenous infusion to subjects with advanced (unresectable or metastatic) melanoma in combination with stereotactic body radiation therapy (SBRT).

Timeline

Start
2014-01
Primary completion
2015-04
Completion
2015-06

Outcome

Outcome not reported

Stopped: “The study is terminated prematurely as the sponsor decided to discontinue program of NHS-IL2 \[MSB0010445\]”

Drugs

EvaluationDrugModalityDoseRoute
Subject EMD 521873 Protein / enzyme biologic 0.3 mg/kg Intravenous

Indications