Clinical trial NCT03322566: 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)
Official title: A Randomized Phase 2 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: Non-small cell lung cancer
programmed cell death 1 (PD-1) inhibitor
indoleamine 2
3-dioxygenase 1 (IDO1) inhibitor
chemotherapy
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-10-26
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation
* 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:

* Known untreated central nervous system metastases and/or carcinomatous meningitis
* 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.

Primary outcomes:
measure: Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
timeFrame: Assessed every 12 weeks up to 24 months
Secondary outcomes:
measure: Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
timeFrame: Up to 24 months
measure: Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
timeFrame: Up to 24 months
measure: Duration of Response of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
timeFrame: Up to 24 months
measure: Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to 25 months
measure: Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Discontinuing Study Drug Due to AEs
timeFrame: Up to 25 months
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Southern Cancer Center, PC
state: Alabama
city: Goodyear
country: United States
facility: Western Regional Medical Center, Inc.
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates PC- HOPE
state: Arizona
city: Boca Raton
country: United States
facility: Lynn Cancer Institute
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists (South Region)
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists (North Region)
state: Florida
city: Fort Wayne
country: United States
facility: PPG-Oncology
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis Park
country: United States
facility: MMCORC
state: Minnesota
city: Billings
country: United States
facility: St. Vincent Healthcare Frontier Cancer Center
state: Montana
city: Albany
country: United States
facility: New York Oncology Hematology P.C
state: New York
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Tulsa
country: United States
facility: Southwestern Regional Medical Center, Inc.
state: Oklahoma
city: Easton
country: United States
facility: St. Luke's Hospital - Anderson Campus
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Chattanooga
country: United States
facility: Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
state: Tennessee
city: Denton
country: United States
facility: Texas Oncology-Denton South
state: Texas
city: Blacksburg
country: United States
facility: Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care
state: Virginia
city: Charlottesville
country: United States
facility: Emily Couric Clinical Cancer Center
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Port Macquarie
country: Australia
facility: MNCCI Port Macquarie Base Hospital
state: New South Wales (Australia)
city: Blacktown
country: Australia
facility: Blacktown Hospital
state: New South Wales
city: Camperdown
country: Australia
facility: Chris OBrien Lifehouse
state: New South Wales
city: Westmead
country: Australia
facility: The Crown Princess Mary Cancer Centre Westmead
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Centre
state: New South Wales
city: Cairns
country: Australia
facility: Cairns Base Hospital
state: Queensland
city: Kelowna
country: Canada
facility: BCCA-Cancer Centre of the Southern Interior
state: British Columbia
city: North Vancouver
country: Canada
facility: Lions Gate Hospital
state: British Columbia
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie-Centre
state: Quebec
city: Laval
country: Canada
facility: CSSS de Laval- Hopital de la Cite de la Sante
state: Quebec
city: Montréal
country: Canada
facility: CIUSSS Ouest de l'Ile - St-Mary's Hospital
state: Quebec
city: Montréal
country: Canada
facility: CIUSSS du Nord-de-l'ILe-de-Montreal Hopital du Sacre-Coeur de Montreal
state: Quebec
city: Trois-Rivières
country: Canada
facility: CIUSSS de la Mauricie-et-du-Centre-du-Quebec
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec - Hotel-Dieu de Quebec
city: Pozva
country: Hungary
facility: Zala Megyei Korhaz Pozvai Telephely
state: Zalaegerszeg
city: Budapest
country: Hungary
facility: Orszagos Koranyi TBC es Pulmonologiai Intezet
city: Farkasgyepű
country: Hungary
facility: Veszprem Megyei Tudogyogyintezet
city: Gyula
country: Hungary
facility: Bekes Megyei Pandy Kalman Korhaz
city: Miskolc
country: Hungary
facility: CRU Hungary Kft.
city: Szolnok
country: Hungary
facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
city: Dublin
country: Ireland
facility: St Vincents University Hospital
city: Afula
country: Israel
facility: Ha Emek Medical Center
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medcal Center
city: Aviano
country: Italy
facility: Centro Di Riferimento Oncologico
city: Catania
country: Italy
facility: A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Monza
country: Italy
facility: Ospedale San Gerardo - ASST Monza
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Mérida
country: Mexico
facility: Medical Care Research S.A. de C.V.
state: Yucatan
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization S.C.
city: Veracruz
country: Mexico
facility: FAICIC Clinical Research
city: Belgorod
country: Russian Federation
facility: Belgorod Regional Oncology Dispensary
city: Izhevsk
country: Russian Federation
facility: Udmurtia Republic Regional Clinical Oncology Dispensary
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Tatarstan MoH
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital with polyclinic
city: Moscow
country: Russian Federation
facility: Moscow Research Oncology Institute
city: Pyatigorsk
country: Russian Federation
facility: SBI of Stavropol region Pyatigorskiy Oncologic dispensary
city: Saint Petersburg
country: Russian Federation
facility: SBHI Leningrad Regional Clinical Hospital
city: Samara
country: Russian Federation
facility: SBHI Samara Regional Clinical Oncology Dispensary
city: Sochi
country: Russian Federation
facility: Oncological Dispensary #2 of Ministry of Health of Krasnodar region
city: Tomsk
country: Russian Federation
facility: Tomsk Scientific Research Institute of Oncology
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran Canaria
state: Gran Canaria
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jimenez
city: L'Hospitalet De Llobregat
country: Spain
facility: Institut Catala Oncologia de Bellvitge - ICO
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation, Kaohsiung Branch
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation, Linkou Branch
city: İzmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi
state: Bornova
city: Adana
country: Turkey
facility: Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi
city: Adana
country: Turkey
facility: Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi
city: Bursa
country: Turkey
facility: Uludag Universitesi Tip Fakultesi
city: Denizli
country: Turkey
facility: Pamukkale Unv. Tip Fak
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi
city: Samsun
country: Turkey
facility: Samsun Medical Park Hastanesi
city: Tekirdağ
country: Turkey
facility: Namık Kemal University Medical Faculty
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
state: Middlesex
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: London
country: United Kingdom
facility: North Middlesex Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital Newcastle upon Tyne Foundation NHS Trust
Study officials:
affiliation: Incyte Corporation
name: Lance Leopold, MD
role: STUDY_DIRECTOR
References: