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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03631784




Registration number
NCT03631784
Ethics application status
Date submitted
13/08/2018
Date registered
15/08/2018

Titles & IDs
Public title
A Trial of Pembrolizumab in Combination With Chemotherapy and Radiotherapy in Stage III NSCLC (KEYNOTE-799, MK-3475-799)
Scientific 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)
Secondary ID [1] 0 0
MK-3475-799
Secondary ID [2] 0 0
3475-799
Universal Trial Number (UTN)
Trial acronym
KEYNOTE-799
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pembrolizumab 200 mg
Treatment: Drugs - Paclitaxel 45 mg/m^2
Treatment: Drugs - Carboplatin AUC6
Treatment: Drugs - Cisplatin 75 mg/m^2
Treatment: Drugs - Pemetrexed 500 mg/m^2
Treatment: Other - Thoracic Radiation Therapy (TRT)
Treatment: Drugs - Paclitaxel 200 mg/m^2
Treatment: Drugs - Carboplatin AUC2

Experimental: Cohort A - 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.

Experimental: Cohort B - 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.


Treatment: Drugs: Pembrolizumab 200 mg
Pembrolizumab 200 mg intravenous (IV) infusion on Days 1 of each 3-week cycle for up to 17 cycles

Treatment: Drugs: Paclitaxel 45 mg/m^2
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.

Treatment: Drugs: Carboplatin AUC6
Carboplatin AUC6 IV infusion on Day 1 of the 21-day cycle for Cycle 1.

Treatment: Drugs: Cisplatin 75 mg/m^2
Cisplatin 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle for Cycles 1, 2, 3.

Treatment: Drugs: Pemetrexed 500 mg/m^2
Pemetrexed 500 mg/m\^2 IV infusion on Day 1 of each 21-day cycle for Cycles 1, 2, and 3.

Treatment: Other: Thoracic Radiation Therapy (TRT)
The target total dose of TRT will be 60 Gy in 30 daily fractions of 2 Gy, prescribed to the planning target volume.

Treatment: Drugs: Paclitaxel 200 mg/m^2
Paclitaxel 200 mg/m\^2 IV infusion on Day 1 of the 21-day cycle of Cycle 1.

Treatment: Drugs: Carboplatin AUC2
Carboplatin AUC2 IV infusion on Day 1, 8, 15 for Cycles 2 and 3 during radiation therapy.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Developed Grade 3 or Higher Pneumonitis
Timepoint [1] 0 0
Up to approximately 3 years
Primary outcome [2] 0 0
Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [1] 0 0
Progression Free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
Number of Participants Who Experienced an Adverse Event (AE)
Timepoint [3] 0 0
Up to approximately 1 1/4 years
Secondary outcome [4] 0 0
Number of Participants Who Discontinued From Study Treatment Due to an AE
Timepoint [4] 0 0
Up to approximately 1 year

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/03/2024
Sample size
Target
Accrual to date
Final
217
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Blacktown Hospital Western Sydney Local Health District ( Site 0204) - Blacktown
Recruitment hospital [2] 0 0
MNCCI Port Macquarie Base Hospital ( Site 0200) - Port Macquarie
Recruitment hospital [3] 0 0
Southern Medical Day Care Centre ( Site 0201) - Wollongong
Recruitment hospital [4] 0 0
Ballarat Health Services ( Site 0206) - Ballarat
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
3350 - Ballarat
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
South Dakota
Country [11] 0 0
France
State/province [11] 0 0
Aisne
Country [12] 0 0
France
State/province [12] 0 0
Bouches-du-Rhone
Country [13] 0 0
France
State/province [13] 0 0
Doubs
Country [14] 0 0
France
State/province [14] 0 0
Herault
Country [15] 0 0
France
State/province [15] 0 0
Ille-et-Vilaine
Country [16] 0 0
France
State/province [16] 0 0
Maine-et-Loire
Country [17] 0 0
France
State/province [17] 0 0
Puy-de-Dome
Country [18] 0 0
France
State/province [18] 0 0
Somme
Country [19] 0 0
France
State/province [19] 0 0
Val-de-Marne
Country [20] 0 0
Germany
State/province [20] 0 0
Baden-Wurttemberg
Country [21] 0 0
Germany
State/province [21] 0 0
Nordrhein-Westfalen
Country [22] 0 0
Germany
State/province [22] 0 0
Sachsen
Country [23] 0 0
Germany
State/province [23] 0 0
Schleswig-Holstein
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Hamburg
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Chungcheongbuk-do [Chungbuk]
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Kyonggi-do
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Seoul-teukbyeolsi [Seoul]
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Ulsan-Kwangyokshi
Country [30] 0 0
New Zealand
State/province [30] 0 0
Auckland
Country [31] 0 0
Poland
State/province [31] 0 0
Kujawsko-pomorskie
Country [32] 0 0
Poland
State/province [32] 0 0
Malopolskie
Country [33] 0 0
Poland
State/province [33] 0 0
Mazowieckie
Country [34] 0 0
Poland
State/province [34] 0 0
Pomorskie
Country [35] 0 0
Poland
State/province [35] 0 0
Zachodniopomorskie
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Baskortostan, Respublika
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Moskva
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Sankt-Peterburg
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Tatarstan, Respublika
Country [40] 0 0
Spain
State/province [40] 0 0
Barcelona [Barcelona]
Country [41] 0 0
Spain
State/province [41] 0 0
Illes Balears [Islas Baleares]
Country [42] 0 0
Spain
State/province [42] 0 0
Madrid
Country [43] 0 0
Spain
State/province [43] 0 0
Sevilla
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Hampshire
Country [45] 0 0
United Kingdom
State/province [45] 0 0
London, City Of
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Somerset
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Leeds
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Rom Valley

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Jabbour SK, Lee KH, Frost N, Breder V, Kowalski DM... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT03631784