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)

January 19, 2022 updated by: Incyte Corporation

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

233

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Blacktown Hospital
      • Camperdown, New South Wales, Australia, 2050
        • Chris OBrien Lifehouse
      • Westmead, New South Wales, Australia, 2145
        • The Crown Princess Mary Cancer Centre Westmead
      • Wollongong, New South Wales, Australia, 2500
        • Southern Medical Day Care Centre
    • New South Wales (Australia)
      • Port Macquarie, New South Wales (Australia), Australia, 2444
        • MNCCI Port Macquarie Base Hospital
    • Queensland
      • Cairns, Queensland, Australia, 4870
        • Cairns Base Hospital
  • Canada
      • Quebec, Canada, G1R 2J6
        • CHU de Quebec - Hotel-Dieu de Quebec
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • BCCA-Cancer Centre of the Southern Interior
      • North Vancouver, British Columbia, Canada, V7L 2L7
        • Lions Gate Hospital
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • CISSS de la Monteregie-Centre
      • Laval, Quebec, Canada, H7M 3L9
        • CSSS de Laval- Hopital de la Cite de la Sante
      • Montréal, Quebec, Canada, H3T 1M5
        • CIUSSS Ouest de l'Ile - St-Mary's Hospital
      • Montréal, Quebec, Canada, H4J 1C5
        • CIUSSS du Nord-de-l'ILe-de-Montreal Hopital du Sacre-Coeur de Montreal
      • Trois-Rivières, Quebec, Canada, G8Z 3R9
        • CIUSSS de la Mauricie-et-du-Centre-du-Quebec
  • Hungary
      • Budapest, Hungary, 1121
        • Orszagos Koranyi TBC es Pulmonologiai Intezet
      • Farkasgyepű, Hungary, 8582
        • Veszprem Megyei Tudogyogyintezet
      • Gyula, Hungary, 5700
        • Bekes Megyei Pandy Kalman Korhaz
      • Miskolc, Hungary, 3529
        • CRU Hungary Kft.
      • Szolnok, Hungary, 5004
        • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
    • Zalaegerszeg
      • Pozva, Zalaegerszeg, Hungary, 8900
        • Zala Megyei Korhaz Pozvai Telephely
  • Ireland
      • Dublin, Ireland, Dublin 4
        • St Vincents University Hospital
  • Israel
      • Afula, Israel, 1834111
        • Ha Emek Medical Center
      • Be'er Sheva, Israel, 8457108
        • Soroka Medical Center
      • Haifa, Israel, 3525408
        • Rambam Medical Center
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
      • Petah Tikva, Israel, 5262000
        • Rabin Medical Center
      • Ramat Gan, Israel, 52621
        • Chaim Sheba Medcal Center
  • Italy
      • Aviano, Italy, 33081
        • Centro di Riferimento Oncologico
      • Catania, Italy, 95123
        • A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico
      • Milano, Italy, 20133
        • Fondazione Irccs Istituto Nazionale Dei Tumori
      • Milano, Italy, 20141
        • Istituto Europeo di Oncologia
      • Monza, Italy, 20900
        • Ospedale San Gerardo - Asst Monza
  • Korea, Republic of
      • Goyang-si, Korea, Republic of, 10408
        • National Cancer Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
  • Mexico
      • Oaxaca, Mexico, 68000
        • Oaxaca Site Management Organization S.C.
      • Veracruz, Mexico, 91900
        • FAICIC Clínical Research
    • Yucatan
      • Mérida, Yucatan, Mexico, 97070
        • Medical Care Research S.A. de C.V.
  • Russian Federation
      • Belgorod, Russian Federation, 308010
        • Belgorod Regional Oncology Dispensary
      • Izhevsk, Russian Federation, 426067
        • Udmurtia Republic Regional Clinical Oncology Dispensary
      • Kazan, Russian Federation, 420029
        • Republican Clinical Oncology Dispensary of Tatarstan MoH
      • Moscow, Russian Federation, 121359
        • Central Clinical Hospital with Polyclinic
      • Moscow, Russian Federation, 125284
        • Moscow Research Oncology Institute
      • Pyatigorsk, Russian Federation, 357502
        • SBI of Stavropol region Pyatigorskiy Oncologic dispensary
      • Saint Petersburg, Russian Federation, 194291
        • SBHI Leningrad Regional Clinical Hospital
      • Samara, Russian Federation, 443031
        • SBHI Samara Regional Clinical Oncology Dispensary
      • Sochi, Russian Federation, 354057
        • Oncological Dispensary #2 of Ministry of Health of Krasnodar region
      • Tomsk, Russian Federation, 634028
        • Tomsk Scientific Research Institute of Oncology
  • Spain
      • Huelva, Spain, 21005
        • Hospital Juan Ramón Jimenez
      • L'Hospitalet De Llobregat, Spain, 08980
        • Institut Catala Oncologia de Bellvitge - ICO
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Valencia, Spain, 46026
        • Hospital Universitario La Fe
      • Zaragoza, Spain, 50009
        • Hospital Clínico Universitario Lozano Blesa
    • Gran Canaria
      • Las Palmas De Gran Canaria, Gran Canaria, Spain, 35016
        • Hospital Universitario Insular de Gran Canaria
  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Chang Gung Medical Foundation, Kaohsiung Branch
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 70457
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 33305
        • Chang Gung medical Foundation, Linkou Branch
  • Turkey
      • Adana, Turkey, 01120
        • Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi
      • Adana, Turkey, 01330
        • Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi
      • Ankara, Turkey, 06100
        • Hacettepe Universitesi Tip Fakultesi Hastanesi
      • Bursa, Turkey, 16059
        • Uludag Universitesi Tip Fakultesi
      • Denizli, Turkey, 20070
        • Pamukkale Unv. Tip Fak
      • Istanbul, Turkey, 34098
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi
      • Samsun, Turkey, 55200
        • Samsun Medical Park Hastanesi
      • Tekirdağ, Turkey, 59030
        • Namık Kemal University Medical Faculty
    • Bornova
      • İzmir, Bornova, Turkey, 35100
        • Ege Universitesi Tip Fakultesi Hastanesi
  • United Kingdom
      • Edinburgh, United Kingdom, EH42XU
        • Western General Hospital
      • London, United Kingdom, N18 1QX
        • North Middlesex Hospital
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre
  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • Southern Cancer Center, PC
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Western Regional Medical Center, Inc.
      • Tucson, Arizona, United States, 85704
        • Arizona Oncology Associates PC- HOPE
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Lynn Cancer Institute
      • Fort Myers, Florida, United States, 33901-8101
        • Florida Cancer Specialists (South Region)
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists (North Region)
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • PPG-Oncology
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • MMCORC
    • Montana
      • Billings, Montana, United States, 59102
        • St. Vincent Healthcare Frontier Cancer Center
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology P.C
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care, Inc.
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Southwestern Regional Medical Center, Inc.
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18045
        • St. Luke's Hospital - Anderson Campus
      • Pittsburgh, Pennsylvania, United States, 15224
        • Allegheny General Hospital
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
    • Texas
      • Denton, Texas, United States, 76210
        • Texas Oncology-Denton South
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care
      • Charlottesville, Virginia, United States, 22908
        • Emily Couric Clinical Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Other Names:
  • MK-3475
Drug: Epacadostat
Epacadostat administered orally twice daily.
Other Names:
  • INCB024360
Drug: Platinum-based chemotherapy
Investigator selected one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin, depending on histology.
Experimental: 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).
Drug: Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Other Names:
  • MK-3475
Drug: Platinum-based chemotherapy
Investigator selected one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin, depending on histology.
Drug: Placebo
Matching placebo administered orally twice daily.
Experimental: 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.
Drug: Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.
Other Names:
  • MK-3475
Drug: Epacadostat
Epacadostat administered orally twice daily.
Other Names:
  • INCB024360

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
Time Frame: Assessed every 12 weeks up to 24 months
ORR is defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) based on blinded independent central review (BICR).
Assessed every 12 weeks up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
Time Frame: Up to 24 months
Defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.
Up to 24 months
Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
Time Frame: Up to 24 months
Defined as the time from randomization to death due to any cause.
Up to 24 months
Duration of Response of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
Time Frame: Up to 24 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.
Up to 24 months
Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to 25 months
An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Up to 25 months
Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Discontinuing Study Drug Due to AEs
Time Frame: Up to 25 months
An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of any study drug, whether or not considered related to the study drug.
Up to 25 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2018

Primary Completion (Actual)

December 13, 2018

Study Completion (Actual)

October 16, 2020

Study Registration Dates

First Submitted

October 24, 2017

First Submitted That Met QC Criteria

October 24, 2017

First Posted (Actual)

October 26, 2017

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEYNOTE-715-06/ECHO-306-06
  • 2017-001810-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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