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A Trial of Pembrolizumab in Combination With Chemotherapy and Radiotherapy in Stage III NSCLC (KEYNOTE-799, MK-3475-799) (KEYNOTE-799)

Primary Purpose

Non-small Cell Lung Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab 200 mg
Paclitaxel 45 mg/m^2
Carboplatin AUC6
Cisplatin 75 mg/m^2
Pemetrexed 500 mg/m^2
Thoracic Radiation Therapy (TRT)
Paclitaxel 200 mg/m^2
Carboplatin AUC2
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

Eligibility Criteria

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

Inclusion Criteria:

  • Male/female participants, who are at least 18 years of age on the day of signing informed consent with previously untreated, unresectable, pathologically confirmed NSCLC and Stage IIIA, IIIB or IIIC NSCLC by American Joint Committee on Cancer Version 8.
  • No evidence of metastatic disease by whole body positron emission tomography/computed tomography (PET/ CT) scan, diagnostic quality CT scan, and brain imaging.
  • Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.
  • Have provided tumor tissue sample (core, incisional, or excisional biopsy).
  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Have adequate pulmonary function test (PFT)
  • Have adequate organ function
  • A male participant must agree to use contraception through the end of treatment and refrain from donating sperm during this period.
  • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and if participant is a woman of childbearing potential (WOCBP), agrees to follow the contraceptive guidance as provided in the protocol through the end of treatment.

Exclusion Criteria:

  • A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment allocation
  • Has small cell lung cancer.
  • Has had documented weight loss >10% in the preceding 3 months.
  • Participants whose radiation treatment plans are likely to encompass a volume of whole lung receiving >20 Gy in total (V20) of more than 31% of lung volume.
  • Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus or for breast cancer.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent (programmed cell death protein 1 [PD-1] and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 [PD-L2]) or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
  • Has received a live vaccine within 30 days prior to the first dose of study drug.
  • Has had an allogenic tissue/solid organ transplant.
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
  • Has severe hypersensitivity (Grade 3 or higher) to pembrolizumab and/or any of its excipients.
  • Has a known severe hypersensitivity (Grade 3 or higher) to any of the study chemotherapy agents and/or to any of their excipients.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids.
  • Has an active infection requiring systemic therapy.
  • Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
  • Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
  • Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
  • Has a known psychiatric or substance abuse disorder that would interfere with cooperating with the requirements of the study.
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study through the end of treatment.

Sites / Locations

  • St Joseph Heritage Healthcare ( Site 1403)
  • North Shore University Health System ( Site 1413)
  • Parkview Cancer Institute ( Site 1415)
  • UMass Memorial Medical Center ( Site 1417)
  • Henry Ford Hospital ( Site 1418)
  • St. Francis Cancer Treatment Center ( Site 1421)
  • Rutgers Cancer Institute of New Jersey ( Site 1422)
  • CTCA Southwestern ( Site 1428)
  • Fox Chase Cancer Center ( Site 1433)
  • Sanford Cancer Center Oncology Clinic ( Site 1434)
  • Blacktown Hospital Western Sydney Local Health District ( Site 0204)
  • MNCCI Port Macquarie Base Hospital ( Site 0200)
  • Southern Medical Day Care Centre ( Site 0201)
  • Ballarat Health Services ( Site 0206)
  • C.H. de Saint Quentin ( Site 0306)
  • Clinique Clairval ( Site 0311)
  • CHU Jean Minjoz ( Site 0301)
  • Institut du Cancer de Montpellier ( Site 0300)
  • C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0302)
  • ICO Centre Paul Papin ( Site 0309)
  • Centre Jean Perrin ( Site 0304)
  • Clinique de L'Europe ( Site 0308)
  • Institut de Cancerologie Gustave Roussy ( Site 0305)
  • Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0404)
  • Universitatsklinikum Mannheim GmbH ( Site 0413)
  • Augusta-Kranken-Anstalt Bochum ( Site 0401)
  • Bethanien Krankenhaus Moers ( Site 0406)
  • Klinikum Chemnitz gGmbH ( Site 0410)
  • LungenClinic Grosshansdorf GmbH ( Site 0408)
  • Charite Universitaetsmedizin Berlin - Campus-Virchow-Klinikum ( Site 0414)
  • Katholisches Marienkrankenhaus gGmbH ( Site 0411)
  • Chungbuk National University Hospital ( Site 1003)
  • National Cancer Center ( Site 1002)
  • Samsung Medical Center ( Site 1001)
  • Ulsan University Hospital ( Site 1000)
  • Auckland City Hospital ( Site 0700)
  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0811)
  • Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym ( Site 0802)
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0800)
  • Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 0812)
  • Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 0813)
  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0903)
  • Blokhin National Medical Oncology ( Site 0902)
  • National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0904)
  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0910)
  • Hospital Universitari Vall d Hebron ( Site 1101)
  • Hospital Clinic de Barcelona ( Site 1100)
  • Hospital Son Llatzer ( Site 1105)
  • Clinica Universitaria de Navarra ( Site 1102)
  • Hospital Universitario Virgen Macarena ( Site 1103)
  • Southampton General Hospital ( Site 1204)
  • Royal Free NHS Foundation Trust ( Site 1200)
  • Charing Cross Hospital ( Site 1208)
  • Beacon Centre ( Site 1203)
  • Leeds Teaching Hospitals NHS Trust ( Site 1209)
  • Queen's Hospital ( Site 1201)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort A

Cohort B

Arm Description

Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray [Gy] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.

Participants received 3 cycles of cisplatin 75 mg/m^2 with pemetrexed 500 mg/m^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Developed Grade 3 or Higher Pneumonitis
Pneumonitis included the MedDRA preferred terms for radiation pneumonitis are acute interstitial pneumonitis, autoimmune lung disease, interstitial lung disease, pneumonitis, idiopathic pneumonia syndrome, organizing pneumonia, and immune-mediated pneumonitis. As per common terminology criteria for Adverse Events, version 4.0, pneumonitis was graded as follows: Grade (Gr) 1- asymptomatic, clinical or diagnostic observations only; intervention not indicated; Gr 2- symptomatic, medical intervention indicated, limiting instrumental activities of daily living (ADL); Gr 3- severe symptoms; limiting self-care activities of daily living (ADL), oxygen indicated; Gr 4- life-threatening respiratory compromise; urgent intervention indicated (e.g., tracheotomy or intubation); Gr 5- death.
Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
ORR was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using modified RECIST 1.1 by blinded independent central review (BICR).

Secondary Outcome Measures

Progression Free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS was defined as the time from the first dose of study treatment to the date of the first documentation of disease progression, as determined by BICR per RECIST 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeters [mm]) in the sum of diameter of target lesions, taking as reference the smallest sum, and/or unequivocal progression of existing non-target lesions, and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using the product-limit (Kaplan-Meier) method for censored data.
Overall Survival (OS)
OS is defined as the time from enrollment to death due to any cause. OS was estimated and analyzed using the product-limit (Kaplan-Meier) method for censored data.
Number of Participants Who Experienced an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE was assessed.
Number of Participants Who Discontinued From Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued treatment due to an AE was assessed.

Full Information

First Posted
August 13, 2018
Last Updated
June 22, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03631784
Brief Title
A Trial of Pembrolizumab in Combination With Chemotherapy and Radiotherapy in Stage III NSCLC (KEYNOTE-799, MK-3475-799)
Acronym
KEYNOTE-799
Official Title
A Phase 2 Trial of Pembrolizumab (MK-3475) in Combination With Platinum Doublet Chemotherapy and Radiotherapy for Participants With Unresectable, Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-799)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 19, 2018 (Actual)
Primary Completion Date
October 18, 2021 (Actual)
Study Completion Date
March 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
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
This is a trial in adult participants with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC) treated with pembrolizumab in combination with platinum doublet chemotherapy and standard thoracic radiotherapy followed by pembrolizumab monotherapy. The primary hypothesis of the trial is that within each platinum doublet chemotherapy cohort, the percentage of participants who develop Grade 3 or higher pneumonitis is ≤10% and objective response rate (ORR) by blinded independent central review (BICR).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A
Arm Type
Experimental
Arm Description
Participants received 1 cycle of carboplatin area under the curve (AUC) 6 mg/mL/min with paclitaxel 200 mg/m^2 and pembrolizumab 200 mg on Day 1. Approximately 3 weeks later, participants received carboplatin AUC 2 mg/mL/min with paclitaxel 45 mg/ m^2 administered weekly for 6 weeks along with 2 cycles of pembrolizumab 200 mg administered every 3 weeks (Q3W) in conjunction with standard thoracic radiotherapy (TRT) (60 Gray [Gy] in 2 Gy fractions administered 5 days per week for 6 weeks). Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
Arm Title
Cohort B
Arm Type
Experimental
Arm Description
Participants received 3 cycles of cisplatin 75 mg/m^2 with pemetrexed 500 mg/m^2 and pembrolizumab 200 mg on Day 1 of each cycle. Treatment was given in conjunction with standard TRT (60 Gy in 2 Gy fractions administered 5 days per week for 6 weeks) in cycles 2 and 3. Participants then received 14 additional cycles of pembrolizumab 200 mg administered Q3W. 1 cycle=21 days.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab 200 mg
Other Intervention Name(s)
MK-3475
Intervention Description
Pembrolizumab 200 mg intravenous (IV) infusion on Days 1 of each 3-week cycle for up to 17 cycles
Intervention Type
Drug
Intervention Name(s)
Paclitaxel 45 mg/m^2
Intervention Description
Paclitaxel 45 mg/m^2 IV infusion on Days 1, 8, 15 of each 3-week cycle for Cycles 2, and 3 during radiation therapy.
Intervention Type
Drug
Intervention Name(s)
Carboplatin AUC6
Intervention Description
Carboplatin AUC6 IV infusion on Day 1 of the 21-day cycle for Cycle 1.
Intervention Type
Drug
Intervention Name(s)
Cisplatin 75 mg/m^2
Intervention Description
Cisplatin 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle for Cycles 1, 2, 3.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed 500 mg/m^2
Intervention Description
Pemetrexed 500 mg/m^2 IV infusion on Day 1 of each 21-day cycle for Cycles 1, 2, and 3.
Intervention Type
Radiation
Intervention Name(s)
Thoracic Radiation Therapy (TRT)
Intervention Description
The target total dose of TRT will be 60 Gy in 30 daily fractions of 2 Gy, prescribed to the planning target volume.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel 200 mg/m^2
Intervention Description
Paclitaxel 200 mg/m^2 IV infusion on Day 1 of the 21-day cycle of Cycle 1.
Intervention Type
Drug
Intervention Name(s)
Carboplatin AUC2
Intervention Description
Carboplatin AUC2 IV infusion on Day 1, 8, 15 for Cycles 2 and 3 during radiation therapy.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Developed Grade 3 or Higher Pneumonitis
Description
Pneumonitis included the MedDRA preferred terms for radiation pneumonitis are acute interstitial pneumonitis, autoimmune lung disease, interstitial lung disease, pneumonitis, idiopathic pneumonia syndrome, organizing pneumonia, and immune-mediated pneumonitis. As per common terminology criteria for Adverse Events, version 4.0, pneumonitis was graded as follows: Grade (Gr) 1- asymptomatic, clinical or diagnostic observations only; intervention not indicated; Gr 2- symptomatic, medical intervention indicated, limiting instrumental activities of daily living (ADL); Gr 3- severe symptoms; limiting self-care activities of daily living (ADL), oxygen indicated; Gr 4- life-threatening respiratory compromise; urgent intervention indicated (e.g., tracheotomy or intubation); Gr 5- death.
Time Frame
Up to approximately 3 years
Title
Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Description
ORR was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using modified RECIST 1.1 by blinded independent central review (BICR).
Time Frame
Up to approximately 3 years
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Description
PFS was defined as the time from the first dose of study treatment to the date of the first documentation of disease progression, as determined by BICR per RECIST 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeters [mm]) in the sum of diameter of target lesions, taking as reference the smallest sum, and/or unequivocal progression of existing non-target lesions, and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using the product-limit (Kaplan-Meier) method for censored data.
Time Frame
Up to approximately 5 years
Title
Overall Survival (OS)
Description
OS is defined as the time from enrollment to death due to any cause. OS was estimated and analyzed using the product-limit (Kaplan-Meier) method for censored data.
Time Frame
Up to approximately 5 years
Title
Number of Participants Who Experienced an Adverse Event (AE)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE was assessed.
Time Frame
Up to approximately 1 1/4 years
Title
Number of Participants Who Discontinued From Study Treatment Due to an AE
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued treatment due to an AE was assessed.
Time Frame
Up to approximately 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male/female participants, who are at least 18 years of age on the day of signing informed consent with previously untreated, unresectable, pathologically confirmed NSCLC and Stage IIIA, IIIB or IIIC NSCLC by American Joint Committee on Cancer Version 8. No evidence of metastatic disease by whole body positron emission tomography/computed tomography (PET/ CT) scan, diagnostic quality CT scan, and brain imaging. Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. Have provided tumor tissue sample (core, incisional, or excisional biopsy). Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Have adequate pulmonary function test (PFT) Have adequate organ function A male participant must agree to use contraception through the end of treatment and refrain from donating sperm during this period. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and if participant is a woman of childbearing potential (WOCBP), agrees to follow the contraceptive guidance as provided in the protocol through the end of treatment. Exclusion Criteria: A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment allocation Has small cell lung cancer. Has had documented weight loss >10% in the preceding 3 months. Participants whose radiation treatment plans are likely to encompass a volume of whole lung receiving >20 Gy in total (V20) of more than 31% of lung volume. Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus or for breast cancer. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent (programmed cell death protein 1 [PD-1] and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 [PD-L2]) or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137). Has received a live vaccine within 30 days prior to the first dose of study drug. Has had an allogenic tissue/solid organ transplant. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Has severe hypersensitivity (Grade 3 or higher) to pembrolizumab and/or any of its excipients. Has a known severe hypersensitivity (Grade 3 or higher) to any of the study chemotherapy agents and/or to any of their excipients. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids. Has an active infection requiring systemic therapy. Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority. Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Has a known history of active tuberculosis (TB; Bacillus tuberculosis). Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. Has a known psychiatric or substance abuse disorder that would interfere with cooperating with the requirements of the study. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study through the end of treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
St Joseph Heritage Healthcare ( Site 1403)
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
North Shore University Health System ( Site 1413)
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Parkview Cancer Institute ( Site 1415)
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
UMass Memorial Medical Center ( Site 1417)
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Henry Ford Hospital ( Site 1418)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
St. Francis Cancer Treatment Center ( Site 1421)
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey ( Site 1422)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
CTCA Southwestern ( Site 1428)
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Fox Chase Cancer Center ( Site 1433)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Sanford Cancer Center Oncology Clinic ( Site 1434)
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Blacktown Hospital Western Sydney Local Health District ( Site 0204)
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
MNCCI Port Macquarie Base Hospital ( Site 0200)
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Southern Medical Day Care Centre ( Site 0201)
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Ballarat Health Services ( Site 0206)
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
C.H. de Saint Quentin ( Site 0306)
City
Saint Quentin
State/Province
Aisne
ZIP/Postal Code
02321
Country
France
Facility Name
Clinique Clairval ( Site 0311)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13009
Country
France
Facility Name
CHU Jean Minjoz ( Site 0301)
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25000
Country
France
Facility Name
Institut du Cancer de Montpellier ( Site 0300)
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34298
Country
France
Facility Name
C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0302)
City
Rennes.
State/Province
Ille-et-Vilaine
ZIP/Postal Code
35033
Country
France
Facility Name
ICO Centre Paul Papin ( Site 0309)
City
Angers
State/Province
Maine-et-Loire
ZIP/Postal Code
49055
Country
France
Facility Name
Centre Jean Perrin ( Site 0304)
City
Clermont Ferrand
State/Province
Puy-de-Dome
ZIP/Postal Code
63011
Country
France
Facility Name
Clinique de L'Europe ( Site 0308)
City
Amiens
State/Province
Somme
ZIP/Postal Code
80000
Country
France
Facility Name
Institut de Cancerologie Gustave Roussy ( Site 0305)
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
Facility Name
Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0404)
City
Heidelberg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Universitatsklinikum Mannheim GmbH ( Site 0413)
City
Mannheim
State/Province
Baden-Wurttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Augusta-Kranken-Anstalt Bochum ( Site 0401)
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44791
Country
Germany
Facility Name
Bethanien Krankenhaus Moers ( Site 0406)
City
Moers
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47441
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH ( Site 0410)
City
Chemnitz
State/Province
Sachsen
ZIP/Postal Code
09113
Country
Germany
Facility Name
LungenClinic Grosshansdorf GmbH ( Site 0408)
City
Grosshansdorf
State/Province
Schleswig-Holstein
ZIP/Postal Code
22927
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus-Virchow-Klinikum ( Site 0414)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Katholisches Marienkrankenhaus gGmbH ( Site 0411)
City
Hamburg
ZIP/Postal Code
22087
Country
Germany
Facility Name
Chungbuk National University Hospital ( Site 1003)
City
Cheongju si
State/Province
Chungcheongbuk-do [Chungbuk]
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
National Cancer Center ( Site 1002)
City
Goyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 1001)
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Ulsan University Hospital ( Site 1000)
City
Ulsan
State/Province
Ulsan-Kwangyokshi
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
Auckland City Hospital ( Site 0700)
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0811)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym ( Site 0802)
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0800)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 0812)
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 0813)
City
Koszalin
State/Province
Zachodniopomorskie
ZIP/Postal Code
75-581
Country
Poland
Facility Name
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0903)
City
Ufa
State/Province
Baskortostan, Respublika
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Blokhin National Medical Oncology ( Site 0902)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0904)
City
St. Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0910)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Hospital Universitari Vall d Hebron ( Site 1101)
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona ( Site 1100)
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Son Llatzer ( Site 1105)
City
Palma de Mallorca
State/Province
Illes Balears [Islas Baleares]
ZIP/Postal Code
07198
Country
Spain
Facility Name
Clinica Universitaria de Navarra ( Site 1102)
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena ( Site 1103)
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Southampton General Hospital ( Site 1204)
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Free NHS Foundation Trust ( Site 1200)
City
London
State/Province
London, City Of
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Charing Cross Hospital ( Site 1208)
City
London
State/Province
London, City Of
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Beacon Centre ( Site 1203)
City
Taunton
State/Province
Somerset
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust ( Site 1209)
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Queen's Hospital ( Site 1201)
City
Rom Valley
ZIP/Postal Code
RM7 0AG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
34086039
Citation
Jabbour SK, Lee KH, Frost N, Breder V, Kowalski DM, Pollock T, Levchenko E, Reguart N, Martinez-Marti A, Houghton B, Paoli JB, Safina S, Park K, Komiya T, Sanford A, Boolell V, Liu H, Samkari A, Keller SM, Reck M. Pembrolizumab Plus Concurrent Chemoradiation Therapy in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer: The Phase 2 KEYNOTE-799 Nonrandomized Trial. JAMA Oncol. 2021 Jun 4;7(9):1-9. doi: 10.1001/jamaoncol.2021.2301. Online ahead of print.
Results Reference
result
Links:
URL
http://merckoncologyclinicaltrials.com
Description
Merck Oncology Clinical Trials Information

Learn more about this trial

A Trial of Pembrolizumab in Combination With Chemotherapy and Radiotherapy in Stage III NSCLC (KEYNOTE-799, MK-3475-799)

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