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Spots Global Cancer Trial Database for Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05)

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Trial Identification

Brief Title: Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05)

Official Title: A Phase 2, Randomized, Double-Blind Study of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) Versus Pembrolizumab Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer Expressing High Levels of PD-L1

Study ID: NCT03322540

Conditions

Lung Cancer

Study Description

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) expressing high levels of programmed cell death ligand 1 (PD-L1).

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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), Saint 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, Beer Sheva, , 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, Japan

National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan

Kurume University Hospital, Kurume, Fukuoka, Japan

Kanazawa University Hospital, Kanazawa, Ishikawa, Japan

Kanagawa Cancer Center, Yokohama, Kanagawa, Japan

Sendai Kousei Hospital, Sendai, Miyagi, Japan

Kansai Medical University Hospital, Hirakata, Osaka, Japan

Kindai University Hospital, Osakasayama, Osaka, Japan

Shizuoka Cancer Center, Nagaizumi-chō, Shizuoka Prefecture, 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

Chungbuk National University Hospital, Cheongju si, Chungcheongbuk Do, Korea, Republic of

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of

Gacheon University Gil Medical Center, Incheon, , Korea, Republic of

Hospital Tengku Ampuan Afzan, Kuantan, Pahang, Malaysia

Institut Kanser Negara - National Cancer Institute, Putrajaya, Wilayah Persekutuan, Malaysia

University Malaya Medical Centre, Kuala Lumpur, , Malaysia

Pantai Hospital Kuala Lumpur, Kuala Lumpur, , Malaysia

Sarawak General Hospital, Kuching, , Malaysia

Swietokrzyskie Centrum Onkologii SPZOZ, Kielce, Swietokrzyskie, Poland

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, Warszawa, , Poland

Belgorod Regional Oncology Dispensary, Belgorod, , Russian Federation

Central Clinical Hospital with polyclinic, Moscow, , Russian Federation

Moscow Research Oncology Institute named after P.A. Hertsen, Moscow, , Russian Federation

SBHI Leningrad Regional Clinical Hospital, Saint Petersburg, , Russian Federation

SBHI Samara Regional Clinical Oncology Dispensary, Samara, , Russian Federation

Republican Clinical Oncology Dispensary of Republic of Bashkortostan, Ufa, , Russian Federation

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, Sevilla, , 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, Zuerich, , Switzerland

Basken Uni. Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi, Adana, , Turkey

Ankara University Medical Faculty, Ankara, , Turkey

Akdeniz Universitesi Tip Fakultesi, Antalya, , Turkey

Erciyes Universitesi Tip Fakultesi, Kayseri, , Turkey

Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi, Konya, , Turkey

MI Kryviy Rih Center of Dnipropetrovsk Regional Council, Kryvyi Rih, Dnipropetrovsk Region, 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

Contact Details

Name: Lance Leopold, MD

Affiliation: Incyte Corporation

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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