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New drug combo shows promise in head and neck cancer battle

NCT ID NCT03358472

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding an experimental drug (epacadostat) to an immunotherapy (pembrolizumab) works better than standard chemotherapy for people with advanced head and neck cancer that has come back or spread. 89 adults took part. The main goal was to see how many patients' tumors shrank or disappeared. The study also tracked side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

89 people

The number who actually took part.

Started

Dec 2017

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Measurable disease based on RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function per protocol-defined criteria. * Documentation of results from testing of human papilloma virus (HPV) status for oropharyngeal cancer. * Baseline archival tumor specimen available or willing to undergo a prestudy treatment tumor core or excisional biopsy of a tumor lesion not previously irradiated, to obtain the specimen. Exclusion Criteria: * Carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous histologies as primary tumors. * Disease progression within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC. * Use of protocol-defined prior/concomitant therapy. * Known additional malignancy that is progressing or has required active treatment within the past 3 years. * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Active autoimmune disease that has required systemic treatment in past 2 years. * Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority. * Known history of or is positive for active hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (defined as HCV RNA \[qualitative\] is detected).

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck cancer

Contacts and locations

Locations

  • Adana Sehir Hastanesi

    Adana, 01370, Turkey (Türkiye)

  • Allgemeines Krankenhaus der Stadt Wien

    Vienna, 1090, Austria

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Baptist Health

    Louisville, Kentucky, 40223, United States

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526, Hungary

  • CHU de Quebec-Universite Laval-Hotel Dieu de Quebec

    Québec, Quebec, G1R 3S1, Canada

  • Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria

    Lisbon, 1649-035, Portugal

  • Chang Gung Medical Foundation. Linkou

    Taoyuan, 33305, Taiwan

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35040, Turkey (Türkiye)

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100, Turkey (Türkiye)

  • Hiroshima University Hospital

    Hiroshima, 734-8551, Japan

  • Hokkaido University Hospital

    Hokkaido, 060-8648, Japan

  • Hospital Clinico Lozano Blesa

    Zaragoza, 50009, Spain

  • Hospital General Universitari Vall d Hebron

    Barcelona, 08035, Spain

  • Hospital Germans Trias i Pujol. ICO de Badalona

    Badalona, 08916, Spain

  • Hospital Infanta Cristina

    Madrid, 28981, Spain

  • Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital de Nuestra Senora de Valme

    Seville, 41014, Spain

  • Huntsman Cancer Institute Univ of Utah

    Salt Lake City, Utah, 19026, United States

  • Hyogo Cancer Center

    Akashi, 673-8558, Japan

  • IRRCS Instituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Inonu Universitesi Turgut Ozal Tip Merkezi

    Malatya, 44280, Turkey (Türkiye)

  • Inst. Portugues de Oncologia de Coimbra Frencisco Gentil EPE

    Coimbra, 3000-075, Portugal

  • Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE

    Lisbon, 1099-023, Portugal

  • Inst. Portugues de Oncologia de Porto Francisco Gentil EPE

    Porto, 4200-072, Portugal

  • Istanbul Universitesi Onkoloji Enstitusu

    Istanbul, 34093, Turkey (Türkiye)

  • Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet

    Szolnok, 5000, Hungary

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Juravinski Cancer Center Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2, Canada

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515, Japan

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Kindai University Hospital

    Sayama, 589-8511, Japan

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047, Japan

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • Landeskrankenhaus Salzburg

    Salzburg, 5020, Austria

  • Macquarie University Hospital

    North Ryde, New South Wales, 2109, Australia

  • Mazowiecki Szpital Onkologiczny

    Wieliszew, Masovian Voivodeship, 05-135, Poland

  • Medipol Hastanesi

    Istanbul, 34214, Turkey (Türkiye)

  • Miyagi Cancer Center

    Natori-shi, Miyagi, 981-1293, Japan

  • Musgrove Park Hospital

    Taunton, TA1 5DA, United Kingdom

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital

    Tainan, 70457, Taiwan

  • National Taiwan University Hospital

    Taipei, 10048, Taiwan

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico, 87106, United States

  • North Middlesex Hospital

    London, N18 1QX, United Kingdom

  • Northwest Georgia Oncology Centers PC

    Douglasville, Georgia, 30134, United States

  • Oklahoma Cancer Specialists and Research

    Tulsa, Oklahoma, 74146, United States

  • Pacific Cancer Medical Center

    Anaheim, California, 19026, United States

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Providence Portland Med Center

    Portland, Oregon, 97213, United States

  • Przychodnia Lekarska Komed

    Konin, 62-500, Poland

  • Royal Brisbane & Women s Hospital

    Herston, Queensland, 4029, Australia

  • Saitama Cancer Center

    Saitama, 362-0806, Japan

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Shizuoka Cancer Center Hospital and Research Institute

    Shizuoka, 411-8777, Japan

  • St. Joseph Heritage Healthcare

    Santa Rosa, California, 95403, United States

  • St. Vincent Healthcare Cancer Ctr

    Billings, Montana, 59102, United States

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550, Japan

  • The Royal Marsden Foundation Trust

    London, SW3 6JJ, United Kingdom

  • The Royal Marsden Nhs Foundation Trust - Chelsea

    London, SW3 6JJ, United Kingdom

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • Trakya Universitesi Tip Fakultesi

    Edirne, 22030, Turkey (Türkiye)

  • U of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University College London Hospitals (UCLH)

    London, NW1 2PG, United Kingdom

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045, United States

  • Viginia Mason Med Ctr

    Seattle, Washington, 98101, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06520, United States

  • Zachodniopomorskie Centrum Onkologii

    Szczecin, 71-730, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.