Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma

NCT04671667 · View on ClinicalTrials.gov ↗

Study Summary

This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy \[cisplatin and carboplatin\] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is also in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.

Interventions

  • DRUG Carboplatin
  • PROCEDURE Computed Tomography
  • DRUG Cisplatin
  • PROCEDURE Magnetic Resonance Imaging
  • RADIATION Intensity-Modulated Radiation Therapy

Study Locations (20)

California

  • Kaiser Permanente-Anaheim — Anaheim
  • Kaiser Permanente-Bellflower — Bellflower
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine
  • UC San Diego Moores Cancer Center — La Jolla
  • Kaiser Permanente Los Angeles Medical Center — Los Angeles
  • Kaiser Permanente-Ontario — Ontario
  • UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange
  • Sutter Cancer Centers Radiation Oncology Services-Roseville — Roseville
  • Sutter Roseville Medical Center — Roseville
  • California Protons Cancer Therapy Center — San Diego

Connecticut

  • Smilow Cancer Center/Yale-New Haven Hospital — New Haven
  • Yale University — New Haven
  • Smilow Cancer Hospital Care Center-Trumbull — Trumbull
  • Smilow Cancer Hospital Care Center - Waterford — Waterford

Florida

  • UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach
  • UF Health Cancer Institute - Gainesville — Gainesville

Alabama

  • University of Alabama at Birmingham Cancer Center — Birmingham

Arkansas

  • University of Arkansas for Medical Sciences — Little Rock

District of Columbia

  • MedStar Washington Hospital Center — Washington D.C.

Trial Details

FieldValue
Enrollment Target 188 participants
Start Date 2021-04-27
Est. Completion 2029-06-30
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04671667

The ClinicalTrials.gov registry entry for NCT04671667 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 188 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 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Recurrent Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which Carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04671667 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Connecticut, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04671667 about?

NCT04671667 is a clinical study titled "Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma". This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy \[cisplatin and carboplatin\] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head...

What is the current status of trial NCT04671667?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 188 participants. The study started on 2021-04-27. Estimated completion is 2029-06-30.

What conditions does trial NCT04671667 study?

This clinical trial studies the following conditions: Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04671667?

The interventions under investigation include: Carboplatin (DRUG), Computed Tomography (PROCEDURE), Cisplatin (DRUG), Magnetic Resonance Imaging (PROCEDURE), Intensity-Modulated Radiation Therapy (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04671667?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04671667 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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