Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05)
NCT ID: NCT03322540
Last Updated: 2025-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
154 participants
INTERVENTIONAL
2017-12-15
2020-11-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pembrolizumab + Epacadostat
Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Epacadostat
Epacadostat administered orally twice daily.
Pembrolizumab + Placebo
Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Placebo
Matching placebo administered orally twice daily.
Interventions
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Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Epacadostat
Epacadostat administered orally twice daily.
Placebo
Matching placebo administered orally twice daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease based on RECIST 1.1.
* Tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥ 50% of tumor cells (tumor proportion score \[TPS\] ≥ 50%) as assessed by immunohistochemistry at a central laboratory.
* Life expectancy of at least 3 months.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function per protocol-defined criteria.
Exclusion Criteria
* History of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
* Symptomatic ascites or pleural effusion.
* Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
* Active autoimmune disease that has required systemic treatment in past 2 years.
* Has had an allogeneic tissue/solid organ transplant.
* Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
* Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
* History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
* Use of protocol-defined prior/concomitant therapy.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Lance Leopold, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Pacific Cancer Medical Center, Inc.
Anaheim, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Florida Cancer Specialists (South Region)
Fort Myers, Florida, United States
Florida Cancer Specialists (North Region)
St. Petersburg, Florida, United States
Southeastern Regional Medical Center, Inc.
Newnan, Georgia, United States
Anne Arundel Health System Research Institute
Annapolis, Maryland, United States
Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, United States
Maryland Oncology Hematology, P.A.
Rockville, Maryland, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Minnesota Oncology Hematology, PA
Coon Rapids, Minnesota, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
Chattanooga, Tennessee, United States
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology-South Austin
Austin, Texas, United States
Austin Health-Austin Hospital
Heidelberg, Victoria, Australia
St John of God Murdoch Medical Clinic
Murdoch, Western Australia, Australia
Cross Cancer Institute
Edmonton, Alberta, Canada
Moncton Hospital - Horizon Health Network
Moncton, New Brunswick, Canada
William Osler Health System
Brampton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Sault Area Hospital
Sault Ste. Marie, Ontario, Canada
Rigshospitalet
Copenhagen, , Denmark
Regionshospitalet Herning
Herning, , Denmark
Odense Universitetshospital
Odense, , Denmark
SA Tartu Ulikooli Kliinikum
Tartu, , Estonia
Galway University Hospital
Galway, Connacht, Ireland
St Vincents University Hospital
Dublin, , Ireland
Soroka Medical Center
Beersheba, , Israel
Rambam Medical Center
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
IRCCS A.O.U. San Martino - IST
Genova, , Italy
Policlinico Universitario Agostino Gemelli
Roma, , Italy
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Kansai Medical University Hospital
Hirakata, Osaka, Japan
Kindai University Hospital
Sayama, Osaka, Japan
Shizuoka Cancer Center
Nagaizumi-chō, Shizuoka, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Okayama University Hospital
Okayama, , Japan
National Cancer Center Hospital
Tokyo, , Japan
Nippon Medical School Hospital
Tokyo, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Wakayama Medical University Hospital
Wakayama, , Japan
Institut Kanser Negara - National Cancer Institute
Putrajaya, Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Pantai Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
Sarawak General Hospital
Kuching, , Malaysia
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
Bydgoszcz, , Poland
Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie
Gliwice, , Poland
Swietokrzyskie Centrum Onkologii SPZOZ
Kielce, , Poland
Przychodnia Lekarska Komed
Konin, , Poland
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
Olsztyn, , Poland
Wojewodzki Szpital im. Zofii z Zamoyskich Tarnowskiej w Tarnobrzegu
Tarnobrzeg, , Poland
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
Warsaw, , Poland
Swietokrzyskie Centrum Onkologii SPZOZ
Kielce, Świętokrzyskie Voivodeship, Poland
Belgorod Regional Oncology Dispensary
Belgorod, , Russia
Central Clinical Hospital with polyclinic
Moscow, , Russia
Moscow Research Oncology Institute named after P.A. Hertsen
Moscow, , Russia
SBHI Leningrad Regional Clinical Hospital
Saint Petersburg, , Russia
SBHI Samara Regional Clinical Oncology Dispensary
Samara, , Russia
Republican Clinical Oncology Dispensary of Republic of Bashkortostan
Ufa, , Russia
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Gacheon University Gil Medical Center
Incheon, , South Korea
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital General de Alicante
Alicante, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Clinico de Valencia
Valencia, , Spain
Oncological Institute of Southern Switzerland
Bellinzona, , Switzerland
Inselspital Universitatsspital Bern
Bern, , Switzerland
Hopitaux Universitaires de Geneve HUG.
Geneva, , Switzerland
Kantonsspital Winterthur
Winterthur, , Switzerland
Universitaetsspital Zuerich
Zurich, , Switzerland
Basken Uni. Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi
Adana, , Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Akdeniz Universitesi Tip Fakultesi
Antalya, , Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi
Kayseri, , Turkey (Türkiye)
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi
Konya, , Turkey (Türkiye)
MI Kryviy Rih Center of Dnipropetrovsk Regional Council
Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine
Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC
Dnipropetrovsk, , Ukraine
Grigoriev Institute for medical Radiology NAMS of Ukraine
Kharkiv, , Ukraine
PP PPC Acinus Medical and Diagnostic Centre
Kirovohrad, , Ukraine
Kyiv City Clinical Oncological Center
Kyiv, , Ukraine
Dobryi Prognoz
Kyiv, , Ukraine
Volyn Regional Oncological Dispensary
Lutsk, , Ukraine
MI Odessa Regional Oncological Centre
Odesa, , Ukraine
Zaporizhzhya Regional Clinical Oncology Center
Zaporizhzhya, , Ukraine
Leeds Teaching Hospital NHS Trust. St. James University Hospital
Leeds, , United Kingdom
Countries
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References
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Tokito T, Kolesnik O, Sorensen J, Artac M, Quintela ML, Lee JS, Hussein M, Pless M, Paz-Ares L, Leopold L, Daniel J, Munteanu M, Samkari A, Xu L, Butts C. Epacadostat plus pembrolizumab versus placebo plus pembrolizumab as first-line treatment for metastatic non-small cell lung cancer with high levels of programmed death-ligand 1: a randomized, double-blind phase 2 study. BMC Cancer. 2024 Jul 25;23(Suppl 1):1251. doi: 10.1186/s12885-023-11203-8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-001841-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KEYNOTE-654-05/ECHO-305-05
Identifier Type: -
Identifier Source: org_study_id
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