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NCT01935921 · ClinicalTrials.gov registry record · Phase 1

Ipilimumab, Cetuximab, and Intensity-Modulated Radiation Therapy in Treating Patients With Previously Untreated Stage III-IVB Head and Neck Cancer

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
19
Enrollment target

NCT01935921: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT01935921 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01935921, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
19 participants
Enrollment target

Study Summary

This phase Ib trial studies the side effects and best dose of ipilimumab when given together with cetuximab and intensity-modulated radiation therapy (IMRT) in treating patients with previously untreated stage III-IVB head and neck cancer. Monoclonal antibodies, such as ipilimumab and cetuximab, may block tumor growth in different ways by targeting certain cells. Specialized radiation therapy, such as IMRT, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving ipilimumab together with cetuximab and IMRT may kill more tumor cells.

Interventions

  • BIOLOGICAL Cetuximab
  • OTHER Laboratory Biomarker Analysis
  • RADIATION Intensity-Modulated Radiation Therapy
  • BIOLOGICAL Ipilimumab

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2013-04-09
Est. Completion 2018-07-06
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01935921

The ClinicalTrials.gov registry entry for NCT01935921 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Cetuximab is the first listed.

NCT01935921 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01935921 about?

NCT01935921 is a clinical study titled "Ipilimumab, Cetuximab, and Intensity-Modulated Radiation Therapy in Treating Patients With Previously Untreated Stage III-IVB Head and Neck Cancer". This phase Ib trial studies the side effects and best dose of ipilimumab when given together with cetuximab and intensity-modulated radiation therapy (IMRT) in treating patients with previously untreated stage III-IVB head and neck cancer. Monoclonal antibodies, such as ipilimumab and cetuximab, may...

What is the current status of trial NCT01935921?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2013-04-09. Estimated completion is 2018-07-06.

What interventions are being tested in trial NCT01935921?

The interventions under investigation include: Cetuximab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Intensity-Modulated Radiation Therapy (RADIATION), Ipilimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT01935921?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

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

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, the data changelog, or report a data error.