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NCT02124850 · ClinicalTrials.gov registry record · Phase 1
A Phase Ib Study of Neoadjuvant of Cetuximab Plus Motolimod and Cetuximab Plus Motolimod Plus Nivolumab
A Phase 1 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02124850 is a Phase 1 study that was terminated before completion, run by Celgene. The registered enrollment target is 18 participants.
The verdict
NCT02124850, a Phase 1 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Protocol VRXP-A106 will enroll patients with Stage II-IVA head and neck cancer patients who will be treated with surgical resection. Cetuximab and motolimod (Cohort 1); and cetuximab, motolimod, and nivolumab (Cohort 2) will be administered for a 3-4 week period before surgery. The primary objective of the study is to determine the extent to which the administration of neoadjuvant motolimod plus cetuximab and motolimod plus cetuximab and nivolumab modulates immune biomarkers (NK, mDC and T cell activation as well as tumor infiltration and serum cytokines) in peripheral blood and head and neck cancer tumors. An exploratory objective of the study is to assess whether modulation of biomarkers as described above can predict anti-tumor response.
Interventions
- DRUG Nivolumab
- DRUG Cetuximab
- DRUG Motolimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2014-10-28 |
| Est. Completion | 2016-10-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02124850
The ClinicalTrials.gov registry entry for NCT02124850 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT02124850 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02124850 about?
NCT02124850 is a clinical study titled "A Phase Ib Study of Neoadjuvant of Cetuximab Plus Motolimod and Cetuximab Plus Motolimod Plus Nivolumab". Protocol VRXP-A106 will enroll patients with Stage II-IVA head and neck cancer patients who will be treated with surgical resection. Cetuximab and motolimod (Cohort 1); and cetuximab, motolimod, and nivolumab (Cohort 2) will be administered for a 3-4 week period before surgery. The primary objective...
What is the current status of trial NCT02124850?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2014-10-28. Estimated completion is 2016-10-31.
What interventions are being tested in trial NCT02124850?
The interventions under investigation include: Nivolumab (DRUG), Cetuximab (DRUG), Motolimod (DRUG).
Who is sponsoring clinical trial NCT02124850?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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