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NCT03798639 · ClinicalTrials.gov registry record · Phase 1
Nivolumab and Radiation Therapy or Ipilimumab as Adjuvant Therapy in Treating Patients With Merkel Cell Cancer
A Phase 1 study of Merkel Cell Carcinoma and Pathologic Stage IIIA Merkel Cell Carcinoma AJCC v8, sponsored by Claire Verschraegen.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT03798639: Completed Phase 1 study of Merkel Cell Carcinoma and Pathologic Stage IIIA Merkel Cell Carcinoma AJCC v8, sponsored by Claire Verschraegen.
NCT03798639 is a Phase 1 study of Merkel Cell Carcinoma and Pathologic Stage IIIA Merkel Cell Carcinoma AJCC v8 that has completed, run by Claire Verschraegen. The registered enrollment target is 7 participants, below the 51-participant average among 26 other Merkel Cell Carcinoma trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03798639, a Phase 1 study of Merkel Cell Carcinoma and Pathologic Stage IIIA Merkel Cell Carcinoma AJCC v8, has completed, sponsored by Claire Verschraegen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and how well nivolumab works when given together with radiation therapy or ipilimumab as adjuvant therapy in treating patients with Merkel cell cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, gamma rays, neutrons, protons or other sources to kill tumor cells and shrink tumors. Giving nivolumab with radiation therapy or ipilimumab after surgery may kill any remaining tumor cells.
Primary Outcome
Will be estimated along with the 95% confidence interval for each arm based on the binomial distribution.
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-01-07 |
| Est. Completion | 2022-12-02 |
| Phase | Phase 1 |
What the finished NCT03798639 record still lists
NCT03798639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 51-participant average among 26 other Merkel Cell Carcinoma trials with a reported enrollment target (86% lower).
The record links to 3 conditions, with Merkel Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Radiation Therapy is the first listed.
NCT03798639 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT03798639 about?
NCT03798639 is a clinical study titled "Nivolumab and Radiation Therapy or Ipilimumab as Adjuvant Therapy in Treating Patients With Merkel Cell Cancer". This phase I trial studies the side effects and how well nivolumab works when given together with radiation therapy or ipilimumab as adjuvant therapy in treating patients with Merkel cell cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body?s immune s...
What is the current status of trial NCT03798639?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2019-01-07. Estimated completion is 2022-12-02.
What conditions does trial NCT03798639 study?
This clinical trial studies the following conditions: Merkel Cell Carcinoma, Pathologic Stage IIIA Merkel Cell Carcinoma AJCC v8, Pathologic Stage IIIB Merkel Cell Carcinoma AJCC v8.
What interventions are being tested in trial NCT03798639?
The interventions under investigation include: Radiation Therapy (RADIATION), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03798639?
This trial is sponsored by Claire Verschraegen, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03798639 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Merkel Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03798639's enrollment target sits among peer trials
7 26th of 26 the lowest of 26 other Merkel Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Merkel Cell Carcinoma 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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