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NCT04862650 · ClinicalTrials.gov registry record · Phase 2

Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by Marcelo Bonomi.

Active
Registry status
Phase 2
Development phase
46
Enrollment target
1
Study location

NCT04862650 is a Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma that is active but no longer recruiting, run by Marcelo Bonomi. The registered enrollment target is 46 participants, below the 125-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04862650, a Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Marcelo Bonomi.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
46 participants
Enrollment target
1
Study location

Study Summary

This phase II trial studies the effect of cemiplimab in combination with low-dose paclitaxel and carboplatin in treating patients with squamous cell carcinoma of the head and neck that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as cemiplimab , may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, like paclitaxel and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cemiplimab in combination with paclitaxel and carboplatin may work better in treating recurrent or metastatic squamous cell carcinoma of the head and neck.

Interventions

  • DRUG Carboplatin
  • DRUG Paclitaxel
  • BIOLOGICAL Cemiplimab

Study Locations (1)

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2021-11-30
Est. Completion 2026-12-31
Phase Phase 2

Sponsor

Marcelo Bonomi

1 total trials

What the Registry Record Tells You About NCT04862650

The ClinicalTrials.gov registry entry for NCT04862650 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 125-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (63% lower). The listed sponsor is Marcelo Bonomi, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Metastatic Head-and-neck Squamous-cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Carboplatin is the first listed.

NCT04862650 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT04862650 about?

NCT04862650 is a clinical study titled "Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck". This phase II trial studies the effect of cemiplimab in combination with low-dose paclitaxel and carboplatin in treating patients with squamous cell carcinoma of the head and neck that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibod...

What is the current status of trial NCT04862650?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2021-11-30. Estimated completion is 2026-12-31.

What conditions does trial NCT04862650 study?

This clinical trial studies the following conditions: Metastatic Head-and-neck Squamous-cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8.

What interventions are being tested in trial NCT04862650?

The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Cemiplimab (BIOLOGICAL).

Who is sponsoring clinical trial NCT04862650?

This trial is sponsored by Marcelo Bonomi, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04862650 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.