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NCT03358472 · ClinicalTrials.gov registry record · Phase 3

Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)

A Phase 3 study, sponsored by Incyte Corporation.

Completed
Registry status
Phase 3
Development phase
89
Enrollment target

NCT03358472 is a Phase 3 study that has completed, run by Incyte Corporation. The registered enrollment target is 89 participants.

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The verdict

NCT03358472, a Phase 3 study, has completed, sponsored by Incyte Corporation.

COMPLETED
Registry status
Phase 3
Development phase
89 participants
Enrollment target

Study Summary

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the EXTREME regimen (cetuximab + cisplatin or carboplatin + 5-fluorouracil) as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Interventions

  • DRUG Pembrolizumab
  • DRUG Carboplatin
  • DRUG Cisplatin
  • DRUG Epacadostat
  • DRUG Cetuximab

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2017-12-01
Est. Completion 2025-10-30
Phase Phase 3

Sponsor

Incyte Corporation

239 total trials

What the Registry Record Tells You About NCT03358472

The ClinicalTrials.gov registry entry for NCT03358472 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incyte Corporation, which has 239 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT03358472 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03358472 about?

NCT03358472 is a clinical study titled "Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)". The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the EXTREME regimen (cetuximab + cisplatin or carboplatin + 5-fluorouracil) as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (H...

What is the current status of trial NCT03358472?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 89 participants. The study started on 2017-12-01. Estimated completion is 2025-10-30.

What interventions are being tested in trial NCT03358472?

The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Cisplatin (DRUG), Epacadostat (DRUG), Cetuximab (DRUG).

Who is sponsoring clinical trial NCT03358472?

This trial is sponsored by Incyte Corporation, which has 239 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.