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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.

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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

FieldValue
Enrollment Target 18 participants
Start Date 2014-10-28
Est. Completion 2016-10-31
Phase Phase 1

Sponsor

Celgene

308 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.