A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)
NCT ID: NCT03322566
Last Updated: 2022-01-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
233 participants
INTERVENTIONAL
2018-01-09
2020-10-16
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 + Chemotherapy + Epacadostat
Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Epacadostat
Epacadostat administered orally twice daily.
Platinum-based chemotherapy
Investigator selected one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin, depending on histology.
Pembrolizumab + Chemotherapy + Placebo
Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Platinum-based chemotherapy
Investigator selected one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin, depending on histology.
Placebo
Matching placebo administered orally twice daily.
Pembrolizumab + Epacadostat
Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles.
Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Epacadostat
Epacadostat administered orally twice daily.
Interventions
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Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Epacadostat
Epacadostat administered orally twice daily.
Platinum-based chemotherapy
Investigator selected one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin, depending on histology.
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
* 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.
* Provide tumor tissue sample.
Exclusion Criteria
* History of (non-infectious) 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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Southern Cancer Center, PC
Daphne, Alabama, United States
Western Regional Medical Center, Inc.
Goodyear, Arizona, United States
Arizona Oncology Associates PC- HOPE
Tucson, Arizona, United States
Lynn Cancer Institute
Boca Raton, Florida, United States
Florida Cancer Specialists (South Region)
Fort Myers, Florida, United States
Florida Cancer Specialists (North Region)
St. Petersburg, Florida, United States
PPG-Oncology
Fort Wayne, Indiana, United States
University of Michigan
Ann Arbor, Michigan, United States
MMCORC
Saint Louis Park, Minnesota, United States
St. Vincent Healthcare Frontier Cancer Center
Billings, Montana, United States
New York Oncology Hematology P.C
Albany, New York, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States
Southwestern Regional Medical Center, Inc.
Tulsa, Oklahoma, United States
St. Luke's Hospital - Anderson Campus
Easton, Pennsylvania, 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-Denton South
Denton, Texas, United States
Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, United States
Emily Couric Clinical Cancer Center
Charlottesville, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Blacktown Hospital
Blacktown, New South Wales, Australia
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia
The Crown Princess Mary Cancer Centre Westmead
Westmead, New South Wales, Australia
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia
MNCCI Port Macquarie Base Hospital
Port Macquarie, New South Wales (Australia), Australia
Cairns Base Hospital
Cairns, Queensland, Australia
BCCA-Cancer Centre of the Southern Interior
Kelowna, British Columbia, Canada
Lions Gate Hospital
North Vancouver, British Columbia, Canada
CISSS de la Monteregie-Centre
Greenfield Park, Quebec, Canada
CSSS de Laval- Hopital de la Cite de la Sante
Laval, Quebec, Canada
CIUSSS Ouest de l'Ile - St-Mary's Hospital
Montreal, Quebec, Canada
CIUSSS du Nord-de-l'ILe-de-Montreal Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
CHU de Quebec - Hotel-Dieu de Quebec
Québec, Quebec, Canada
CIUSSS de la Mauricie-et-du-Centre-du-Quebec
Trois-Rivières, Quebec, Canada
Zala Megyei Korhaz Pozvai Telephely
Pózva, Zalaegerszeg, Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest, , Hungary
Veszprem Megyei Tudogyogyintezet
Farkasgyepű, , Hungary
Bekes Megyei Pandy Kalman Korhaz
Gyula, , Hungary
CRU Hungary Kft.
Miskolc, , Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
Szolnok, , Hungary
St Vincents University Hospital
Dublin, , Ireland
Ha Emek Medical Center
Afula, , Israel
Soroka Medical Center
Beersheba, , Israel
Rambam Medical Center
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Chaim Sheba Medcal Center
Ramat Gan, , Israel
Centro Di Riferimento Oncologico
Aviano, , Italy
A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico
Catania, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Ospedale San Gerardo - ASST Monza
Monza, , Italy
Medical Care Research S.A. de C.V.
Mérida, Yucatán, Mexico
Oaxaca Site Management Organization S.C.
Oaxaca City, , Mexico
FAICIC Clinical Research
Veracruz, , Mexico
Belgorod Regional Oncology Dispensary
Belgorod, , Russia
Udmurtia Republic Regional Clinical Oncology Dispensary
Izhevsk, , Russia
Republican Clinical Oncology Dispensary of Tatarstan MoH
Kazan', , Russia
Central Clinical Hospital with polyclinic
Moscow, , Russia
Moscow Research Oncology Institute
Moscow, , Russia
SBI of Stavropol region Pyatigorskiy Oncologic dispensary
Pyatigorsk, , Russia
SBHI Leningrad Regional Clinical Hospital
Saint Petersburg, , Russia
SBHI Samara Regional Clinical Oncology Dispensary
Samara, , Russia
Oncological Dispensary #2 of Ministry of Health of Krasnodar region
Sochi, , Russia
Tomsk Scientific Research Institute of Oncology
Tomsk, , Russia
National Cancer Center
Goyang-si, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Gran Canaria, Spain
Hospital Juan Ramón Jimenez
Huelva, , Spain
Institut Catala Oncologia de Bellvitge - ICO
L'Hospitalet de Llobregat, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Chang Gung Medical Foundation, Kaohsiung Branch
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation, Linkou Branch
Taoyuan District, , Taiwan
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, Bornova, Turkey (Türkiye)
Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi
Adana, , Turkey (Türkiye)
Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi
Adana, , Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, , Turkey (Türkiye)
Uludag Universitesi Tip Fakultesi
Bursa, , Turkey (Türkiye)
Pamukkale Unv. Tip Fak
Denizli, , Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, , Turkey (Türkiye)
Samsun Medical Park Hastanesi
Samsun, , Turkey (Türkiye)
Namık Kemal University Medical Faculty
Tekirdağ, , Turkey (Türkiye)
Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
North Middlesex Hospital
London, , United Kingdom
Freeman Hospital Newcastle upon Tyne Foundation NHS Trust
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Boyer M, Hui R, Urban D, Clingan P, Su WC, Devaux C, Gadgeel S, Garassino M, Leopold L, Daniel J, Munteanu MC, Samkari A, Luo Y, Abreu DR. Pembrolizumab with platinum-based chemotherapy with or without epacadostat as first-line treatment for metastatic non-small cell lung cancer: a randomized, partially double-blind, placebo-controlled phase II study. BMC Cancer. 2024 Jul 25;23(Suppl 1):1250. doi: 10.1186/s12885-022-10427-4.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-001810-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KEYNOTE-715-06/ECHO-306-06
Identifier Type: -
Identifier Source: org_study_id
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