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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: Clinical Trial Phase 2 study, sponsored by EMD Serono.
NCT01973608 is a Phase 2 study that was terminated before completion, run by EMD Serono. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
DLT was defined as any Grade\>= 3 toxicity related to drug, occurring during 21 days post first dose of drug except Grade 3 infusion-related adverse reaction resolving within 6 hours and Transient (\<=6 hours) Grade 3 flu-like symptoms/fever controlled with medical management; Transient (\<= 24 hours) Grade 3 fatigue, local reactions, headache, nausea, emesis that resolved to \<= Grade 1; Grade 3 skin toxicity ,Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 8 x upper limit of
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 |
Why NCT01973608 stopped before completion
NCT01973608 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 5 interventions - of which Stereotactic Body Radiation Therapy (SBRT) is the first listed.
NCT01973608 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01973608's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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