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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
Date last updated
26/10/2024

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
Brazil
State/province [14] 0 0
Rio Grande Do Sul
Country [15] 0 0
Brazil
State/province [15] 0 0
Rio de Janeiro
Country [16] 0 0
Brazil
State/province [16] 0 0
Sao Paulo
Country [17] 0 0
Chile
State/province [17] 0 0
Araucania
Country [18] 0 0
Chile
State/province [18] 0 0
Biobio
Country [19] 0 0
Chile
State/province [19] 0 0
Region M. De Santiago
Country [20] 0 0
Chile
State/province [20] 0 0
Valparaiso
Country [21] 0 0
China
State/province [21] 0 0
Beijing
Country [22] 0 0
China
State/province [22] 0 0
Chongqing
Country [23] 0 0
China
State/province [23] 0 0
Fujian
Country [24] 0 0
China
State/province [24] 0 0
Guangdong
Country [25] 0 0
China
State/province [25] 0 0
Hebei
Country [26] 0 0
China
State/province [26] 0 0
Henan
Country [27] 0 0
China
State/province [27] 0 0
Hubei
Country [28] 0 0
China
State/province [28] 0 0
Hunan
Country [29] 0 0
China
State/province [29] 0 0
Jiangsu
Country [30] 0 0
China
State/province [30] 0 0
Jilin
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China
State/province [31] 0 0
Shandong
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China
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Shanghai
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China
State/province [33] 0 0
Shanxi
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China
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Sichuan
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China
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Tianjin
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China
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Zhejiang
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Costa Rica
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San Jose
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Czechia
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Brno-mesto
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Czechia
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Moravskoslezsky Kraj
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Dominican Republic
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Distrito Nacional
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Dominican Republic
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Santo Domingo
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Greece
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Attiki
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Greece
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Irakleio
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Greece
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Thessaloniki
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Guatemala
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Ciudad de Guatemala
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Guatemala
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Guatemala
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Guatemala
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Quetzaltenango
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Campania
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Brescia
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Italy
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Milano
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Niigata
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tokyo
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Korea, Republic of
State/province [70] 0 0
Chungbuk
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Seoul
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Malaysia
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Kuala Lumpur
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Malaysia
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Pulau Pinang
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Chihuahua
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Mexico
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Oaxaca
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Philippines
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National Capital Region
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Portugal
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Lisboa
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Portugal
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Porto
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Romania
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Bucuresti
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Romania
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Cluj
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Romania
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Dolj
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Romania
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Ilfov
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Romania
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Timis
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South Africa
State/province [87] 0 0
Eastern Cape
Country [88] 0 0
South Africa
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Gauteng
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South Africa
State/province [89] 0 0
Kwazulu-Natal
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South Africa
State/province [90] 0 0
Western Cape
Country [91] 0 0
Spain
State/province [91] 0 0
Cataluna
Country [92] 0 0
Spain
State/province [92] 0 0
La Coruna
Country [93] 0 0
Spain
State/province [93] 0 0
Madrid, Comunidad De
Country [94] 0 0
Turkey
State/province [94] 0 0
Istanbul
Country [95] 0 0
Turkey
State/province [95] 0 0
Izmir
Country [96] 0 0
Turkey
State/province [96] 0 0
Adana
Country [97] 0 0
Turkey
State/province [97] 0 0
Ankara
Country [98] 0 0
Ukraine
State/province [98] 0 0
Kirovohradska Oblast
Country [99] 0 0
Ukraine
State/province [99] 0 0
Lvivska Oblast
Country [100] 0 0
Ukraine
State/province [100] 0 0
Rivnenska Oblast
Country [101] 0 0
Ukraine
State/province [101] 0 0
Vinnytska Oblast
Country [102] 0 0
Ukraine
State/province [102] 0 0
Volynska Oblast
Country [103] 0 0
Ukraine
State/province [103] 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
Researchers are looking for new ways to treat people with locally advanced non-small cell lung cancer (NSCLC). The goal of this study is to learn if people who receive the combination of vibostolimab and pembrolizumab (MK-7684A) live longer without the cancer getting worse and live longer overall than people who receive durvalumab.
Trial website
https://clinicaltrials.gov/study/NCT05298423
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05298423