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NCT03071406 · ClinicalTrials.gov registry record · Phase 2
Randomized Study of Nivolumab+Ipilimumab+/- SBRT for Metastatic Merkel Cell Carcinoma
A Phase 2 study of Skin Cancer and Merkel Cell Carcinoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 2
- Study locations
NCT03071406: Active Phase 2 study of Skin Cancer and Merkel Cell Carcinoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03071406 is a Phase 2 study of Skin Cancer and Merkel Cell Carcinoma that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 50 participants, below the 463-participant average among 40 other Skin Cancer trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03071406, a Phase 2 study of Skin Cancer and Merkel Cell Carcinoma, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to test the effectiveness, safety, and tolerability of the drugs nivolumab plus ipilimumab with or without the addition of stereotactic body radiation therapy (SBRT). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will stimulate the body's immune system to work against tumor cells. This study will test an investigational use of nivolumab.
Primary Outcome
Overall response according to Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) including Complete Response (CR) + Partial Response (PR).
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- RADIATION Stereotactic Body Radiation Therapy (SBRT)
Study Locations (2)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-03-14 |
| Est. Completion | 2026-09-19 |
| Phase | Phase 2 |
What the registry record for NCT03071406 still lists
NCT03071406 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 463-participant average among 40 other Skin Cancer trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Skin Cancer appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT03071406 reports a single indexed study location in Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT03071406 about?
NCT03071406 is a clinical study titled "Randomized Study of Nivolumab+Ipilimumab+/- SBRT for Metastatic Merkel Cell Carcinoma". The purpose of this study is to test the effectiveness, safety, and tolerability of the drugs nivolumab plus ipilimumab with or without the addition of stereotactic body radiation therapy (SBRT). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will stimulate the ...
What is the current status of trial NCT03071406?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2017-03-14. Estimated completion is 2026-09-19.
What conditions does trial NCT03071406 study?
This clinical trial studies the following conditions: Skin Cancer, Merkel Cell Carcinoma.
What interventions are being tested in trial NCT03071406?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Stereotactic Body Radiation Therapy (SBRT) (RADIATION).
Who is sponsoring clinical trial NCT03071406?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03071406 being conducted?
This trial has 2 study locations across Florida, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03071406's enrollment target sits among peer trials
50 23rd of 40 higher than 18 of 40 other Skin Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Skin Cancer 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.
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