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
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
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