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Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-04/ECHO-305-04)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03322540
Recruitment Status : Active, not recruiting
First Posted : October 26, 2017
Last Update Posted : February 7, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Incyte Corporation

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).

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Pembrolizumab Drug: Epacadostat Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 22, 2017
Actual Primary Completion Date : January 10, 2019
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Treatment 1
Pembrolizumab + epacadostat
Drug: Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Other Name: MK-3475

Drug: Epacadostat
Epacadostat administered orally twice daily.
Other Name: INCB024360

Active Comparator: Treatment 2
Pembrolizumab + matching placebo
Drug: Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Other Name: MK-3475

Drug: Placebo
Matching placebo administered orally twice daily.




Primary Outcome Measures :
  1. Objective response rate of pembrolizumab + epacadostat versus pembrolizumab + placebo [ Time Frame: Approximately 6 months ]
    Defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1.


Secondary Outcome Measures :
  1. Progression-free survival (PFS) of pembrolizumab + epacadostat versus pembrolizumab + placebo [ Time Frame: Approximately 36 months ]
    Defined as the time from randomization to the first documented progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.

  2. Overall survival (OS) of pembrolizumab + epacadostat versus pembrolizumab + placebo [ Time Frame: Up to 36 months ]
    Defined as the time from randomization to death due to any cause.

  3. Duration of response (DOR) of pembrolizumab + epacadostat versus pembrolizumab + placebo [ Time Frame: Approximately 36 months ]
    Defined as the time from the earliest date of qualifying response until earliest date of disease progression per RECIST v1.1 or death from any cause, whichever comes first.

  4. Safety and tolerability of pembrolizumab + epacadostat and pembrolizumab + placebo as measured by number of participants experiencing adverse events (AEs) [ Time Frame: Up to 37 months ]
    AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  5. Safety and tolerability of pembrolizumab + epacadostat and pembrolizumab + placebo as measured by number of participants discontinuing study drug due to AEs [ Time Frame: Up to 37 months ]
    AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322540


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Locations
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United States, California
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
Innovative Clinical Research Institute
Whittier, California, United States, 90603
United States, Florida
Florida Cancer Specialists (South Region)
Fort Myers, Florida, United States, 33916
Florida Cancer Specialists (North Region)
Saint Petersburg, Florida, United States, 33705
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Southeastern Regional Medical Center, Inc.
Newnan, Georgia, United States, 30265
United States, Illinois
Illinois Cancer Specialists
Niles, Illinois, United States, 60714
Midwestern Regional Medical Center
Zion, Illinois, United States, 60099
United States, Indiana
PPG-Oncology
Fort Wayne, Indiana, United States, 46845
United States, Maryland
Anne Arundel Health System Research Institute
Annapolis, Maryland, United States, 21401
Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, United States, 21237
Maryland Oncology Hematology, P.A.
Rockville, Maryland, United States, 20850
United States, Massachusetts
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Minnesota Oncology Hematology, PA
Coon Rapids, Minnesota, United States, 55433
United States, Nebraska
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
United States, New Jersey
John Theurer Cancer Center at Hackensack University Med Ctr
Hackensack, New Jersey, United States, 07601
United States, New York
Weill Cornell Medicine -New York Presbyterian
New York, New York, United States, 10065
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology-South Austin
Austin, Texas, United States, 78745
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Australia, Victoria
Austin Health-Austin Hospital
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
St John of God Murdoch Medical Clinic
Murdoch, Western Australia, Australia, 6150
Australia
Blacktown Hospital
Blacktown, Australia, 2148
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, New Brunswick
Moncton Hospital - Horizon Health Network
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
William Osler Health System
Brampton, Ontario, Canada, L6R 3J7
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sault Area Hospital
Sault Ste Marie, Ontario, Canada, P6B 0A8
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Regionshospitalet Herning
Herning, Denmark, 7400
Odense Universitetshospital
Odense, Denmark, 5000
Estonia
AS Ida-Tallinna Keskhaigla
Tallinn, Estonia, 11312
SA Tartu Ulikooli Kliinikum
Tartu, Estonia, 51014
Ireland
Galway University Hospital
Galway, Connacht, Ireland, H91 YR71
St Vincents University Hospital
Dublin, Ireland, Dublin 4
Israel
Soroka Medical Center
Beer Sheva, Israel, 8457108
Rambam Medical Center
Haifa, Israel, 31096
Meir Medical Center
Kfar Saba, Israel, 4428164
Rabin Medical Center
Petah Tikva, Israel, 4941492
Chaim Sheba Medical Center
Ramat Gan, Israel, 52621
Italy
IRCCS A.O.U. San Martino - IST
Genova, Italy, 16132
Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Japan
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi, Japan, 460-0001
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791-0280
Kurume University Hospital
Kurume, Fukuoka, Japan, 830-0011
Hyogo Cancer Center
Akashi, Hyogo, Japan, 673-8558
Kanazawa University Hospital
Kanazawa, Ishikawa, Japan, 920-8641
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan, 241-8515
Sendai Kousei Hospital
Sendai, Miyagi, Japan, 980-0873
Kansai Medical University Hospital
Hirakata, Osaka, Japan, 573-1191
Kindai University Hospital
Osakasayama, Osaka, Japan, 589-8511
Shizuoka Cancer Center
Nagaizumi-chō, Shizuoka Prefecture, Japan, 411-8777
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Niigata Cancer Center Hospital
Niigata, Japan, 951-8566
Okayama University Hospital
Okayama, Japan, 700-8558
National Cancer Center Hospital
Tokyo, Japan, 104-0045
Nippon Medical School Hospital
Tokyo, Japan, 113-8603
The Cancer Institute Hospital of JFCR
Tokyo, Japan, 135-8550
Showa University Hospital
Tokyo, Japan, 142-8666
Wakayama Medical University Hospital
Wakayama, Japan, 641-8509
Korea, Republic of
Chungbuk National University Hospital
Cheongju si, Chungcheongbuk Do, Korea, Republic of, 28644
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Gacheon University Gil Medical Center
Incheon, Korea, Republic of, 21565
Korea University Guro Hospital
Seoul, Korea, Republic of, 8308
Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia, 25100
Institut Kanser Negara - National Cancer Institute
Putrajaya, Wilayah Persekutuan, Malaysia, 62250
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Pantai Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
Sarawak General Hospital
Kuching, Malaysia
Poland
Mazowiecki Szpital Onkologiczny
Wieliszew, Mazowieckie, Poland, 05-135
Swietokrzyskie Centrum Onkologii SPZOZ
Kielce, Swietokrzyskie, Poland, 25-734
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
Bydgoszcz, Poland, 85-796
Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie
Gliwice, Poland, 44-101
Swietokrzyskie Centrum Onkologii SPZOZ
Kielce, Poland, 25-734
Przychodnia Lekarska Komed
Konin, Poland, 62-500
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
Olsztyn, Poland, 10-357
Wojewodzki Szpital im. Zofii z Zamoyskich Tarnowskiej w Tarnobrzegu
Tarnobrzeg, Poland, 39-400
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
Warszawa, Poland, 02-781
Russian Federation
Belgorod Regional Oncology Dispensary
Belgorod, Russian Federation, 308010
Central Clinical Hospital with polyclinic
Moscow, Russian Federation, 121359
Moscow Research Oncology Institute named after P.A. Hertsen
Moscow, Russian Federation, 125284
Ryazan Regional Clinical Oncology Dispensary
Ryazan, Russian Federation, 390046
SBHI Leningrad Regional Clinical Hospital
Saint Petersburg, Russian Federation, 194291
SBHI Samara Regional Clinical Oncology Dispensary
Samara, Russian Federation, 443031
Republican Clinical Oncology Dispensary of Republic of Bashkortostan
Ufa, Russian Federation, 450054
Spain
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Spain, 36312
Hospital General de Alicante
Alicante, Spain, 03010
Hospital del Mar
Barcelona, Spain, 8003
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Hospital Clinico de Valencia
Valencia, Spain, 46010
Switzerland
Oncological Institute of Southern Switzerland
Bellinzona, Switzerland, 6500
Inselspital Universitatsspital Bern
Bern, Switzerland, 3010
Hopitaux Universitaires de Geneve HUG.
Geneva, Switzerland, 1211
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
Universitaetsspital Zuerich
Zuerich, Switzerland, 8091
Turkey
Basken Uni. Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi
Adana, Turkey, 01120
Ankara University Medical Faculty
Ankara, Turkey, 06100
Akdeniz Universitesi Tip Fakultesi
Antalya, Turkey, 07059
Erciyes Universitesi Tip Fakultesi
Kayseri, Turkey, 38039
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi
Konya, Turkey, 42080
Ukraine
MI Kryviy Rih Center of Dnipropetrovsk Regional Council
Kryvyi Rih, Dnipropetrovsk Region, Ukraine, 50048
Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC
Dnipropetrovsk, Ukraine, 49102
Grigoriev Institute for medical Radiology NAMS of Ukraine
Kharkiv, Ukraine, 61024
PP PPC Acinus Medical and Diagnostic Centre
Kirovohrad, Ukraine, 25001
Kyiv City Clinical Oncological Center
Kyiv, Ukraine, 03115
Dobryi Prognoz
Kyiv, Ukraine, 03126
Volyn Regional Oncological Dispensary
Lutsk, Ukraine, 43018
MI Odessa Regional Oncological Centre
Odesa, Ukraine, 65055
Zaporizhzhya Regional Clinical Oncology Center
Zaporizhzhya, Ukraine, 69040
United Kingdom
Leeds Teaching Hospital NHS Trust. St. James University Hospital
Leeds, United Kingdom, LS9 7TF
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG51PB
Sponsors and Collaborators
Incyte Corporation
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Lance Leopold, MD Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03322540     History of Changes
Other Study ID Numbers: KEYNOTE-654-04/ECHO-305-04
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation:
non-small cell lung cancer
programmed cell death 1 (PD-1) inhibitor
indoleamine 2
3-dioxygenase 1 (IDO1) inhibitor

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents