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NCT01973608 · ClinicalTrials.gov registry record · Phase 2
MSB0010445 and Stereotactic Body Radiation Therapy in Advanced Melanoma
A Phase 2 study, sponsored by EMD Serono.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01973608 is a Phase 2 study that was terminated before completion, run by EMD Serono. The registered enrollment target is 12 participants.
The verdict
NCT01973608, a Phase 2 study, was terminated before completion, sponsored by EMD Serono.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study 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).
Interventions
- RADIATION Stereotactic Body Radiation Therapy (SBRT)
- DRUG MSB0010445 (0.3 milligram per kilogram [mg/kg])
- DRUG MSB0010445 (1.0 mg/kg)
- DRUG MSB0010445 (1.8 mg/kg)
- DRUG MSB0010445 (2.4 mg/kg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2014-01 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01973608
The ClinicalTrials.gov registry entry for NCT01973608 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Stereotactic Body Radiation Therapy (SBRT) is the first listed.
NCT01973608 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01973608 about?
NCT01973608 is a clinical study titled "MSB0010445 and Stereotactic Body Radiation Therapy in Advanced Melanoma". 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 st...
What is the current status of trial NCT01973608?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2014-01. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01973608?
The interventions under investigation include: Stereotactic Body Radiation Therapy (SBRT) (RADIATION), MSB0010445 (0.3 milligram per kilogram [mg/kg]) (DRUG), MSB0010445 (1.0 mg/kg) (DRUG), MSB0010445 (1.8 mg/kg) (DRUG), MSB0010445 (2.4 mg/kg) (DRUG).
Who is sponsoring clinical trial NCT01973608?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
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