drugset / Trial / NCT01973608
MSB0010445 and Stereotactic Body Radiation Therapy in Advanced Melanoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EMD 521873 | Protein / enzyme biologic | 0.3 mg/kg | Intravenous |