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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05298423




Registration number
NCT05298423
Ethics application status
Date submitted
17/03/2022
Date registered
28/03/2022

Titles & IDs
Public title
Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006)
Scientific title
Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab With Pembrolizumab) in Combination With Concurrent Chemoradiotherapy Followed by MK-7684A Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III NSCLC
Secondary ID [1] 0 0
MK-7684A-006
Secondary ID [2] 0 0
7684A-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - pembrolizumab/vibostolimab
Treatment: Other - durvalumab
Treatment: Drugs - cisplatin
Treatment: Drugs - pemetrexed
Treatment: Drugs - etoposide
Treatment: Drugs - carboplatin
Treatment: Drugs - paclitaxel
Treatment: Other - thoracic radiotherapy

Experimental: pembrolizumab/vibostolimab coformulation+chemotherapy+radiotherapy - For the first 3 cycles, participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) intravenously (IV) on Day 1 plus 3 cycles of investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray \[Gy\] in 2 Gy fractions for 30 days total) during Cycles 2, 3. Participants receive pembrolizumab/vibostolimab for Cycles 4-20 or until discontinuation (up to \~14 months). Cycles 1-20 are 21-day cycles. Investigator's choice of chemotherapy: cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m\^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m\^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m\^2 on Day 1 of Cycle 1 and 45 mg/m\^2 on Days 1, 8, 15 of Cycles 2-3.

Active comparator: chemotherapy+radiotherapy+durvalumab - For the first 3 cycles, participants will receive investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy in 2 Gy fractions for 30 days total) during Cycles 2 and 3. Following concurrent chemoradiotherapy (cCRT), participants receive durvalumab 10 mg/kg every 2 weeks for up to an additional 26 cycles or until discontinuation (up to approximately 14 months). cCRT Cycles 1-3=21-day cycles; durvalumab Cycles 1-26=14-day cycles.

Investigator's choice of chemotherapy: cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m\^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m\^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m\^2 on Day 1 of Cycle 1 and 45 mg/m\^2 on Days 1, 8, 15 of Cycles 2-3.


Treatment: Other: pembrolizumab/vibostolimab
Administered as an intravenous (IV) infusion

Treatment: Other: durvalumab
Administered as an IV infusion

Treatment: Drugs: cisplatin
Administered as an IV infusion

Treatment: Drugs: pemetrexed
Administered as an IV infusion

Treatment: Drugs: etoposide
Administered as an IV infusion

Treatment: Drugs: carboplatin
Administered as an IV infusion

Treatment: Drugs: paclitaxel
Administered as an IV infusion

Treatment: Other: thoracic radiotherapy
Administered as an external beam radiation
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
Progression-Free Survival (PFS) For All Participants
Timepoint [1] 0 0
Up to approximately 55 months
Primary outcome [2] 0 0
Progression-Free Survival (PFS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) =1%
Timepoint [2] 0 0
Up to approximately 55 months
Primary outcome [3] 0 0
Overall Survival (OS) For All Participants
Timepoint [3] 0 0
Up to approximately 75 months
Primary outcome [4] 0 0
Overall Survival (OS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) =1%
Timepoint [4] 0 0
Up to approximately 75 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) For All Participants
Timepoint [1] 0 0
Up to approximately 75 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) =1%
Timepoint [2] 0 0
Up to approximately 75 months
Secondary outcome [3] 0 0
Number of Participants Who Experience at Least One Adverse Event (AE)
Timepoint [3] 0 0
Up to approximately 75 months
Secondary outcome [4] 0 0
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Timepoint [4] 0 0
Up to approximately 75 months
Secondary outcome [5] 0 0
Duration of Response (DOR) For All Participants
Timepoint [5] 0 0
Up to approximately 75 months
Secondary outcome [6] 0 0
Duration of Response (DOR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) =1%
Timepoint [6] 0 0
Up to approximately 75 months
Secondary outcome [7] 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) For All Participants
Timepoint [7] 0 0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Secondary outcome [8] 0 0
Change from Baseline in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS =1%
Timepoint [8] 0 0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Secondary outcome [9] 0 0
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants
Timepoint [9] 0 0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Secondary outcome [10] 0 0
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS =1%
Timepoint [10] 0 0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Secondary outcome [11] 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) For All Participants
Timepoint [11] 0 0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Secondary outcome [12] 0 0
Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS =1%
Timepoint [12] 0 0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Secondary outcome [13] 0 0
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants
Timepoint [13] 0 0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Secondary outcome [14] 0 0
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS =1%
Timepoint [14] 0 0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Secondary outcome [15] 0 0
Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants
Timepoint [15] 0 0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Secondary outcome [16] 0 0
Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS =1%
Timepoint [16] 0 0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
Secondary outcome [17] 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 For All Participants
Timepoint [17] 0 0
Up to approximately 75 months post randomization
Secondary outcome [18] 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 For Participants With PD-L1 TPS =1%
Timepoint [18] 0 0
Up to approximately 75 months post randomization
Secondary outcome [19] 0 0
Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants
Timepoint [19] 0 0
Up to approximately 75 months post randomization
Secondary outcome [20] 0 0
Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS =1%
Timepoint [20] 0 0
Up to approximately 75 months post randomization
Secondary outcome [21] 0 0
Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For All Participants
Timepoint [21] 0 0
Up to approximately 75 months post randomization
Secondary outcome [22] 0 0
Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS =1%
Timepoint [22] 0 0
Up to approximately 75 months post randomization
Secondary outcome [23] 0 0
Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants
Timepoint [23] 0 0
Up to approximately 75 months post randomization
Secondary outcome [24] 0 0
Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS =1%
Timepoint [24] 0 0
Up to approximately 75 months post randomization
Secondary outcome [25] 0 0
Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants
Timepoint [25] 0 0
Up to approximately 75 months post randomization
Secondary outcome [26] 0 0
Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS =1%
Timepoint [26] 0 0
Up to approximately 75 months post randomization

Eligibility
Key inclusion criteria
The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria

* Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC.
* Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
* Is determined to have unresectable, Stage III NSCLC as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeon
* Has no evidence of metastatic disease, indicating Stage IV NSCLC, in whole-body fluorodeoxyglucose (FDG)-positron emission tomography (PET) or FDG-PET/ computed tomography (CT) and CT or magnetic resonance imaging (MRI) scans of diagnostic quality of chest, abdomen, pelvis and brain
* Has measurable disease as defined by RECIST 1.1, with at least 1 lesion being appropriate for selection as a target lesion, as determined by local site investigator/radiology review
* Has not received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for their Stage III NSCLC
* Has provided tumor tissue sample (tissue biopsy [core, incisional, or excisional])
* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention
* Has a life expectancy of at least 6 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements. Mixed squamous/nonsquamous tumors are eligible
* Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
* Has received major surgery (with the exception of replacement of vascular access) within 4 weeks before randomization. If the participant had a major operation, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study intervention
* Is expected to require any other form of antineoplastic therapy, while on study
* Has received colony-stimulating factors (e.g., Granulocyte Colony-Stimulating Factor [G-CSF], Granulocyte Macrophage Colony-Stimulating Factor [GM-CSF], or recombinant erythropoietin) within 28 days prior to the first dose of study intervention
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
* Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
* 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 an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV ribonucleic acid [RNA] qualitative is detected) infection
* Has had an allogenic tissue/solid organ transplant

Pemetrexed-specific Criteria:

* Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose =1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed
* Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
4/09/2029
Actual
Sample size
Target
784
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,TAS,VIC
Recruitment hospital [1] 0 0
Canberra Hospital ( Site 0010) - Canberra
Recruitment hospital [2] 0 0
Icon Cancer Centre Hobart ( Site 0003) - Hobart
Recruitment hospital [3] 0 0
Ballarat Health Services-Medical Oncology ( Site 0002) - Ballarat Central
Recruitment hospital [4] 0 0
Frankston Hospital-Oncology and Haematology ( Site 0009) - Frankston
Recruitment hospital [5] 0 0
St Vincent's Hospital-Oncology Clinical Trials ( Site 0005) - Melbourne
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
7000 - Hobart
Recruitment postcode(s) [3] 0 0
3350 - Ballarat Central
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment postcode(s) [5] 0 0
3065 - Melbourne
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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
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
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Argentina
State/province [14] 0 0
Cordoba
Country [15] 0 0
Argentina
State/province [15] 0 0
Santa Fe
Country [16] 0 0
Argentina
State/province [16] 0 0
Caba
Country [17] 0 0
Brazil
State/province [17] 0 0
Rio Grande Do Sul
Country [18] 0 0
Brazil
State/province [18] 0 0
Rio de Janeiro
Country [19] 0 0
Brazil
State/province [19] 0 0
Sao Paulo
Country [20] 0 0
Chile
State/province [20] 0 0
Araucania
Country [21] 0 0
Chile
State/province [21] 0 0
Biobio
Country [22] 0 0
Chile
State/province [22] 0 0
Region M. De Santiago
Country [23] 0 0
Chile
State/province [23] 0 0
Valparaiso
Country [24] 0 0
China
State/province [24] 0 0
Beijing
Country [25] 0 0
China
State/province [25] 0 0
Chongqing
Country [26] 0 0
China
State/province [26] 0 0
Fujian
Country [27] 0 0
China
State/province [27] 0 0
Guangdong
Country [28] 0 0
China
State/province [28] 0 0
Hebei
Country [29] 0 0
China
State/province [29] 0 0
Henan
Country [30] 0 0
China
State/province [30] 0 0
Hubei
Country [31] 0 0
China
State/province [31] 0 0
Hunan
Country [32] 0 0
China
State/province [32] 0 0
Jiangsu
Country [33] 0 0
China
State/province [33] 0 0
Jilin
Country [34] 0 0
China
State/province [34] 0 0
Shandong
Country [35] 0 0
China
State/province [35] 0 0
Shanghai
Country [36] 0 0
China
State/province [36] 0 0
Shanxi
Country [37] 0 0
China
State/province [37] 0 0
Sichuan
Country [38] 0 0
China
State/province [38] 0 0
Tianjin
Country [39] 0 0
China
State/province [39] 0 0
Zhejiang
Country [40] 0 0
Costa Rica
State/province [40] 0 0
San Jose
Country [41] 0 0
Czechia
State/province [41] 0 0
Brno-mesto
Country [42] 0 0
Czechia
State/province [42] 0 0
Moravskoslezsky Kraj
Country [43] 0 0
Dominican Republic
State/province [43] 0 0
Distrito Nacional
Country [44] 0 0
Dominican Republic
State/province [44] 0 0
Santo Domingo
Country [45] 0 0
Germany
State/province [45] 0 0
Sachsen
Country [46] 0 0
Germany
State/province [46] 0 0
Schleswig-Holstein
Country [47] 0 0
Germany
State/province [47] 0 0
Berlin
Country [48] 0 0
Greece
State/province [48] 0 0
Attiki
Country [49] 0 0
Greece
State/province [49] 0 0
Irakleio
Country [50] 0 0
Greece
State/province [50] 0 0
Thessaloniki
Country [51] 0 0
Guatemala
State/province [51] 0 0
Ciudad de Guatemala
Country [52] 0 0
Guatemala
State/province [52] 0 0
Guatemala
Country [53] 0 0
Guatemala
State/province [53] 0 0
Quetzaltenango
Country [54] 0 0
Israel
State/province [54] 0 0
Haifa
Country [55] 0 0
Israel
State/province [55] 0 0
Jerusalem
Country [56] 0 0
Israel
State/province [56] 0 0
Petah Tikva
Country [57] 0 0
Israel
State/province [57] 0 0
Ramat Gan
Country [58] 0 0
Israel
State/province [58] 0 0
Tel Aviv
Country [59] 0 0
Italy
State/province [59] 0 0
Campania
Country [60] 0 0
Italy
State/province [60] 0 0
Lazio
Country [61] 0 0
Italy
State/province [61] 0 0
Lombardia
Country [62] 0 0
Italy
State/province [62] 0 0
Brescia
Country [63] 0 0
Italy
State/province [63] 0 0
Milano
Country [64] 0 0
Japan
State/province [64] 0 0
Ehime
Country [65] 0 0
Japan
State/province [65] 0 0
Fukuoka
Country [66] 0 0
Japan
State/province [66] 0 0
Hyogo
Country [67] 0 0
Japan
State/province [67] 0 0
Kanagawa
Country [68] 0 0
Japan
State/province [68] 0 0
Miyagi
Country [69] 0 0
Japan
State/province [69] 0 0
Niigata
Country [70] 0 0
Japan
State/province [70] 0 0
Osaka
Country [71] 0 0
Japan
State/province [71] 0 0
Saitama
Country [72] 0 0
Japan
State/province [72] 0 0
Tokyo
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Chungbuk
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Kyonggi-do
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Seoul
Country [76] 0 0
Malaysia
State/province [76] 0 0
Kuala Lumpur
Country [77] 0 0
Malaysia
State/province [77] 0 0
Pulau Pinang
Country [78] 0 0
Mexico
State/province [78] 0 0
Distrito Federal
Country [79] 0 0
Mexico
State/province [79] 0 0
Jalisco
Country [80] 0 0
Mexico
State/province [80] 0 0
Chihuahua
Country [81] 0 0
Mexico
State/province [81] 0 0
Oaxaca
Country [82] 0 0
Philippines
State/province [82] 0 0
National Capital Region
Country [83] 0 0
Portugal
State/province [83] 0 0
Lisboa
Country [84] 0 0
Portugal
State/province [84] 0 0
Porto
Country [85] 0 0
Romania
State/province [85] 0 0
Bucuresti
Country [86] 0 0
Romania
State/province [86] 0 0
Cluj
Country [87] 0 0
Romania
State/province [87] 0 0
Dolj
Country [88] 0 0
Romania
State/province [88] 0 0
Ilfov
Country [89] 0 0
Romania
State/province [89] 0 0
Timis
Country [90] 0 0
South Africa
State/province [90] 0 0
Eastern Cape
Country [91] 0 0
South Africa
State/province [91] 0 0
Gauteng
Country [92] 0 0
South Africa
State/province [92] 0 0
Kwazulu-Natal
Country [93] 0 0
South Africa
State/province [93] 0 0
Western Cape
Country [94] 0 0
Spain
State/province [94] 0 0
Cataluna
Country [95] 0 0
Spain
State/province [95] 0 0
La Coruna
Country [96] 0 0
Spain
State/province [96] 0 0
Madrid, Comunidad De
Country [97] 0 0
Turkey
State/province [97] 0 0
Istanbul
Country [98] 0 0
Turkey
State/province [98] 0 0
Izmir
Country [99] 0 0
Turkey
State/province [99] 0 0
Adana
Country [100] 0 0
Turkey
State/province [100] 0 0
Ankara
Country [101] 0 0
Ukraine
State/province [101] 0 0
Kirovohradska Oblast
Country [102] 0 0
Ukraine
State/province [102] 0 0
Lvivska Oblast
Country [103] 0 0
Ukraine
State/province [103] 0 0
Rivnenska Oblast
Country [104] 0 0
Ukraine
State/province [104] 0 0
Vinnytska Oblast
Country [105] 0 0
Ukraine
State/province [105] 0 0
Volynska Oblast
Country [106] 0 0
Ukraine
State/province [106] 0 0
Kyiv

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
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Trialsites@msd.com
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/NCT05298423