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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05224141




Registration number
NCT05224141
Ethics application status
Date submitted
25/01/2022
Date registered
4/02/2022

Titles & IDs
Public title
Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008, KEYVIBE-008)
Scientific title
A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination With Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination With Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer
Secondary ID [1] 0 0
MK-7684A-008
Secondary ID [2] 0 0
7684A-008
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab/Vibostolimab Co-Formulation
Treatment: Drugs - Saline placebo
Treatment: Drugs - Etoposide
Treatment: Drugs - Cisplatin
Treatment: Other - Atezolizumab
Treatment: Drugs - Carboplatin

Experimental: Pembrolizumab/Vibostolimab - Participants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W), in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve (AUC) 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of MK-7684A Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.

Active comparator: Atezolizumab - Participants will receive 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of atezolizumab Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.


Treatment: Other: Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg fixed dose coformulation administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.

Treatment: Drugs: Saline placebo
Saline solution administered via IV infusion on Cycle 1 (and Q3W as needed beyond Cycle 1)

Treatment: Drugs: Etoposide
Etoposide 100 mg/m\^2 administered via IV infusion Q3W on Days 1 2, 3 of each cycle for up to 4 cycles

Treatment: Drugs: Cisplatin
Cisplatin 75 mg/m\^2 administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

Treatment: Other: Atezolizumab
Atezolizumab 1200 mg administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.

Treatment: Drugs: Carboplatin
Carboplatin AUC 5 mg/mL/min administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 37 months
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 26 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to approximately 37 months
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Up to approximately 37 months
Secondary outcome [4] 0 0
Percentage of Participants Who Experienced an Adverse Event (AE)
Timepoint [4] 0 0
Up to approximately 60 months
Secondary outcome [5] 0 0
Percentage of Participants Who Discontinued Study Treatment Due to an AE
Timepoint [5] 0 0
Up to approximately 60 months
Secondary outcome [6] 0 0
Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Timepoint [6] 0 0
Baseline and up to approximately 37 months
Secondary outcome [7] 0 0
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Timepoint [7] 0 0
Baseline and up to approximately 37 months
Secondary outcome [8] 0 0
Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30
Timepoint [8] 0 0
Baseline and up to approximately 37 months
Secondary outcome [9] 0 0
Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)
Timepoint [9] 0 0
Baseline and up to approximately 37 months
Secondary outcome [10] 0 0
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
Timepoint [10] 0 0
Baseline and up to approximately 37 months
Secondary outcome [11] 0 0
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30
Timepoint [11] 0 0
Baseline and up to approximately 37 months
Secondary outcome [12] 0 0
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Timepoint [12] 0 0
Baseline and up to approximately 37 months
Secondary outcome [13] 0 0
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30
Timepoint [13] 0 0
Baseline and up to approximately 37 months
Secondary outcome [14] 0 0
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13
Timepoint [14] 0 0
Baseline and up to approximately 37 months
Secondary outcome [15] 0 0
TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
Timepoint [15] 0 0
Baseline and up to approximately 37 months

Eligibility
Key inclusion criteria
* Has histologically or cytologically confirmed diagnosis of ES-SCLC in need of first-line therapy
* Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
* Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse
* Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse
* Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
* Has a predicted life expectancy of >3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease
* Has received prior treatment for Small Cell Lung Cancer (SCLC)
* Is expected to require any other form of antineoplastic therapy for SCLC while on study
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has a history of severe hypersensitivity reaction (=Grade 3) to any study intervention and/or any of its excipients
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has a known history of, or active, neurologic paraneoplastic syndrome
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of Hepatitis B or known active Hepatitis C virus infection
* Has had an allogenic tissue/solid organ transplant
* Has had major surgery within prior 3 weeks or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study intervention
* Has symptomatic ascites or pleural effusion

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/06/2027
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Nepean Hospital ( Site 2700) - Penrith
Recruitment hospital [2] 0 0
Calvary Mater Newcastle ( Site 2703) - Waratah
Recruitment hospital [3] 0 0
Frankston Hospital-Oncology and Haematology ( Site 2702) - Frankston
Recruitment hospital [4] 0 0
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701) - St Albans
Recruitment postcode(s) [1] 0 0
2747 - Penrith
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Argentina
State/province [10] 0 0
Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Caba
Country [12] 0 0
Argentina
State/province [12] 0 0
Santa Fe
Country [13] 0 0
Austria
State/province [13] 0 0
Oberosterreich
Country [14] 0 0
Austria
State/province [14] 0 0
Steiermark
Country [15] 0 0
Austria
State/province [15] 0 0
Wien
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
China
State/province [17] 0 0
Anhui
Country [18] 0 0
China
State/province [18] 0 0
Beijing
Country [19] 0 0
China
State/province [19] 0 0
Fujian
Country [20] 0 0
China
State/province [20] 0 0
Heilongjiang
Country [21] 0 0
China
State/province [21] 0 0
Henan
Country [22] 0 0
China
State/province [22] 0 0
Hubei
Country [23] 0 0
China
State/province [23] 0 0
Hunan
Country [24] 0 0
China
State/province [24] 0 0
Jiangsu
Country [25] 0 0
China
State/province [25] 0 0
Jilin
Country [26] 0 0
China
State/province [26] 0 0
Shaanxi
Country [27] 0 0
China
State/province [27] 0 0
Shanghai
Country [28] 0 0
China
State/province [28] 0 0
Sichuan
Country [29] 0 0
China
State/province [29] 0 0
Zhejiang
Country [30] 0 0
Finland
State/province [30] 0 0
Pohjanmaa
Country [31] 0 0
Finland
State/province [31] 0 0
Pohjois-Pohjanmaa
Country [32] 0 0
Finland
State/province [32] 0 0
Varsinais-Suomi
Country [33] 0 0
France
State/province [33] 0 0
Bouches-du-Rhone
Country [34] 0 0
France
State/province [34] 0 0
Haute-Garonne
Country [35] 0 0
France
State/province [35] 0 0
Haute-Vienne
Country [36] 0 0
Germany
State/province [36] 0 0
Baden-Wurttemberg
Country [37] 0 0
Germany
State/province [37] 0 0
Hessen
Country [38] 0 0
Germany
State/province [38] 0 0
Niedersachsen
Country [39] 0 0
Germany
State/province [39] 0 0
Schleswig-Holstein
Country [40] 0 0
Germany
State/province [40] 0 0
Thuringen
Country [41] 0 0
Greece
State/province [41] 0 0
Attiki
Country [42] 0 0
Greece
State/province [42] 0 0
Irakleio
Country [43] 0 0
Greece
State/province [43] 0 0
Thessaloniki
Country [44] 0 0
Hungary
State/province [44] 0 0
Bacs-Kiskun
Country [45] 0 0
Hungary
State/province [45] 0 0
Gyor-Moson-Sopron
Country [46] 0 0
Hungary
State/province [46] 0 0
Pest
Country [47] 0 0
Hungary
State/province [47] 0 0
Somogy
Country [48] 0 0
Ireland
State/province [48] 0 0
Dublin
Country [49] 0 0
Israel
State/province [49] 0 0
Haifa
Country [50] 0 0
Israel
State/province [50] 0 0
Jerusalem
Country [51] 0 0
Israel
State/province [51] 0 0
Ramat Gan
Country [52] 0 0
Italy
State/province [52] 0 0
Campania
Country [53] 0 0
Italy
State/province [53] 0 0
Lombardia
Country [54] 0 0
Italy
State/province [54] 0 0
Milano
Country [55] 0 0
Italy
State/province [55] 0 0
Roma
Country [56] 0 0
Japan
State/province [56] 0 0
Aichi
Country [57] 0 0
Japan
State/province [57] 0 0
Chiba
Country [58] 0 0
Japan
State/province [58] 0 0
Ehime
Country [59] 0 0
Japan
State/province [59] 0 0
Fukuoka
Country [60] 0 0
Japan
State/province [60] 0 0
Hokkaido
Country [61] 0 0
Japan
State/province [61] 0 0
Ishikawa
Country [62] 0 0
Japan
State/province [62] 0 0
Kanagawa
Country [63] 0 0
Japan
State/province [63] 0 0
Miyagi
Country [64] 0 0
Japan
State/province [64] 0 0
Niigata
Country [65] 0 0
Japan
State/province [65] 0 0
Osaka
Country [66] 0 0
Japan
State/province [66] 0 0
Shizuoka
Country [67] 0 0
Japan
State/province [67] 0 0
Tokyo
Country [68] 0 0
Japan
State/province [68] 0 0
Okayama
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Jeonranamdo
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Taegu-Kwangyokshi
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Taejon-Kwangyokshi
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Seoul
Country [73] 0 0
Lithuania
State/province [73] 0 0
Klaipedos Miestas
Country [74] 0 0
Lithuania
State/province [74] 0 0
Vilniaus Miestas
Country [75] 0 0
Lithuania
State/province [75] 0 0
Kaunas
Country [76] 0 0
Mexico
State/province [76] 0 0
Distrito Federal
Country [77] 0 0
Mexico
State/province [77] 0 0
Jalisco
Country [78] 0 0
Mexico
State/province [78] 0 0
Nuevo Leon
Country [79] 0 0
Mexico
State/province [79] 0 0
Oaxaca
Country [80] 0 0
Netherlands
State/province [80] 0 0
Fryslan
Country [81] 0 0
Netherlands
State/province [81] 0 0
Gelderland
Country [82] 0 0
Netherlands
State/province [82] 0 0
Limburg
Country [83] 0 0
Netherlands
State/province [83] 0 0
Noord-Brabant
Country [84] 0 0
Netherlands
State/province [84] 0 0
Overijssel
Country [85] 0 0
Netherlands
State/province [85] 0 0
Zuid-Holland
Country [86] 0 0
Netherlands
State/province [86] 0 0
Groningen
Country [87] 0 0
Poland
State/province [87] 0 0
Mazowieckie
Country [88] 0 0
Poland
State/province [88] 0 0
Podkarpackie
Country [89] 0 0
Poland
State/province [89] 0 0
Pomorskie
Country [90] 0 0
Poland
State/province [90] 0 0
Slaskie
Country [91] 0 0
Poland
State/province [91] 0 0
Wielkopolskie
Country [92] 0 0
Portugal
State/province [92] 0 0
Lisboa
Country [93] 0 0
Portugal
State/province [93] 0 0
Porto
Country [94] 0 0
Romania
State/province [94] 0 0
Bucuresti
Country [95] 0 0
Romania
State/province [95] 0 0
Cluj
Country [96] 0 0
Romania
State/province [96] 0 0
Dolj
Country [97] 0 0
Romania
State/province [97] 0 0
Timis
Country [98] 0 0
Spain
State/province [98] 0 0
Madrid, Comunidad De
Country [99] 0 0
Spain
State/province [99] 0 0
Malaga
Country [100] 0 0
Spain
State/province [100] 0 0
Barcelona
Country [101] 0 0
Spain
State/province [101] 0 0
Sevilla
Country [102] 0 0
Turkey
State/province [102] 0 0
Izmir
Country [103] 0 0
Turkey
State/province [103] 0 0
Adana
Country [104] 0 0
Turkey
State/province [104] 0 0
Ankara
Country [105] 0 0
Turkey
State/province [105] 0 0
Istanbul
Country [106] 0 0
United Kingdom
State/province [106] 0 0
England
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Hillingdon
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Birmingham

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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05224141