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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Epacadostat
Placebo
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring non-small cell lung cancer, programmed cell death 1 (PD-1) inhibitor, indoleamine 2, 3-dioxygenase 1 (IDO1) inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pacific Cancer Medical Center, Inc.
  • Innovative Clinical Research Institute
  • Florida Cancer Specialists (South Region)
  • Florida Cancer Specialists (North Region)
  • Southeastern Regional Medical Center, Inc.
  • Anne Arundel Health System Research Institute
  • Weinberg Cancer Institute at Franklin Square
  • Maryland Oncology Hematology, P.A.
  • UMass Memorial Medical Center
  • Minnesota Oncology Hematology, PA
  • Nebraska Cancer Specialists
  • Allegheny General Hospital
  • Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
  • Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
  • Texas Oncology-South Austin
  • Austin Health-Austin Hospital
  • St John of God Murdoch Medical Clinic
  • Cross Cancer Institute
  • Moncton Hospital - Horizon Health Network
  • William Osler Health System
  • Cancer Centre of Southeastern Ontario at Kingston General Hospital
  • Sault Area Hospital
  • Rigshospitalet
  • Regionshospitalet Herning
  • Odense Universitetshospital
  • SA Tartu Ulikooli Kliinikum
  • Galway University Hospital
  • St Vincents University Hospital
  • Soroka Medical Center
  • Rambam Medical Center
  • Meir Medical Center
  • Rabin Medical Center
  • Chaim Sheba Medical Center
  • IRCCS A.O.U. San Martino - IST
  • Policlinico Universitario Agostino Gemelli
  • National Hospital Organization Nagoya Medical Center
  • National Hospital Organization Shikoku Cancer Center
  • Kurume University Hospital
  • Kanazawa University Hospital
  • Kanagawa Cancer Center
  • Sendai Kousei Hospital
  • Kansai Medical University Hospital
  • Kindai University Hospital
  • Shizuoka Cancer Center
  • National Hospital Organization Kyushu Cancer Center
  • Kyushu University Hospital
  • Niigata Cancer Center Hospital
  • Okayama University Hospital
  • National Cancer Center Hospital
  • Nippon Medical School Hospital
  • The Cancer Institute Hospital of JFCR
  • Wakayama Medical University Hospital
  • Chungbuk National University Hospital
  • Seoul National University Bundang Hospital
  • Gacheon University Gil Medical Center
  • Hospital Tengku Ampuan Afzan
  • Institut Kanser Negara - National Cancer Institute
  • University Malaya Medical Centre
  • Pantai Hospital Kuala Lumpur
  • Sarawak General Hospital
  • Swietokrzyskie Centrum Onkologii SPZOZ
  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka
  • Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie
  • Swietokrzyskie Centrum Onkologii SPZOZ
  • Przychodnia Lekarska Komed
  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
  • Wojewodzki Szpital im. Zofii z Zamoyskich Tarnowskiej w Tarnobrzegu
  • Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
  • Belgorod Regional Oncology Dispensary
  • Central Clinical Hospital with polyclinic
  • Moscow Research Oncology Institute named after P.A. Hertsen
  • SBHI Leningrad Regional Clinical Hospital
  • SBHI Samara Regional Clinical Oncology Dispensary
  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan
  • Hospital Alvaro Cunqueiro
  • Hospital General de Alicante
  • Hospital del Mar
  • Hospital Clinico San Carlos
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Virgen Macarena
  • Hospital Clinico de Valencia
  • Oncological Institute of Southern Switzerland
  • Inselspital Universitatsspital Bern
  • Hopitaux Universitaires de Geneve HUG.
  • Kantonsspital Winterthur
  • Universitaetsspital Zuerich
  • Basken Uni. Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi
  • Ankara University Medical Faculty
  • Akdeniz Universitesi Tip Fakultesi
  • Erciyes Universitesi Tip Fakultesi
  • Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi
  • MI Kryviy Rih Center of Dnipropetrovsk Regional Council
  • Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC
  • Grigoriev Institute for medical Radiology NAMS of Ukraine
  • PP PPC Acinus Medical and Diagnostic Centre
  • Kyiv City Clinical Oncological Center
  • Dobryi Prognoz
  • Volyn Regional Oncological Dispensary
  • MI Odessa Regional Oncological Centre
  • Zaporizhzhya Regional Clinical Oncology Center
  • Leeds Teaching Hospital NHS Trust. St. James University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pembrolizumab + Epacadostat

Pembrolizumab + Placebo

Arm Description

Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.

Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) of Pembrolizumab Plus Epacadostat Versus Pembrolizumab Plus Placebo
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 based on blinded independent central review (BICR).

Secondary Outcome Measures

Progression-free Survival (PFS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
PFS is defined as the time from randomization to the first documented progressive disease per RECIST v1.1 based on BICR or death due to any cause, whichever occurs first.
Overall Survival (OS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
OS is defined as the time from randomization to death due to any cause.
Duration of Response (DOR) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
DOR is 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.
Number of Participants With Adverse Events (AEs)
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.
Number of Participants Who Discontinued Study Drug Due to AEs
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.

Full Information

First Posted
October 24, 2017
Last Updated
January 19, 2022
Sponsor
Incyte Corporation
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03322540
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 Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
November 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
non-small cell lung cancer, programmed cell death 1 (PD-1) inhibitor, indoleamine 2, 3-dioxygenase 1 (IDO1) inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
With the implementation of Amendment 05 the study is no longer blinded.
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab + Epacadostat
Arm Type
Experimental
Arm Description
Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
Arm Title
Pembrolizumab + Placebo
Arm Type
Active Comparator
Arm Description
Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475
Intervention Description
Pembrolizumab administered intravenously every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Epacadostat
Other Intervention Name(s)
INCB024360
Intervention Description
Epacadostat administered orally twice daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo administered orally twice daily.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) of Pembrolizumab Plus Epacadostat Versus Pembrolizumab Plus Placebo
Description
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 based on blinded independent central review (BICR).
Time Frame
Up to approximately 6 months
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
Description
PFS is defined as the time from randomization to the first documented progressive disease per RECIST v1.1 based on BICR or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 36 months
Title
Overall Survival (OS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 36 months
Title
Duration of Response (DOR) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
Description
DOR is 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.
Time Frame
Up to approximately 36 months
Title
Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
Up to 37 months
Title
Number of Participants Who Discontinued Study Drug Due to AEs
Description
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.
Time Frame
Up to 37 months

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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