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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04725188




Registration number
NCT04725188
Ethics application status
Date submitted
25/01/2021
Date registered
26/01/2021

Titles & IDs
Public title
Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002)
Scientific title
A Phase 2, Multicenter, Randomized Study to Compare the Efficacy and Safety of MK-7684A or MK-7684A Plus Docetaxel Versus Docetaxel Monotherapy in the Treatment of Participants With Metastatic Non-small Cell Lung Cancer With Progressive Disease After Treatment With a Platinum Doublet Chemotherapy and Immunotherapy
Secondary ID [1] 0 0
MK-7684A-002
Secondary ID [2] 0 0
7684A-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic 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: Other - Pembrolizumab/Vibostolimab coformuation
Treatment: Drugs - Docetaxel
Treatment: Drugs - Placebo

Experimental: Arm 1: Pembrolizumab/Vibostolimab coformulation + Docetaxel - Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle will be 21 days.

Experimental: Arm 2: Pembrolizumab/Vibostolimab coformulation - Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W for up to 35 cycles up to approximately 2 years. Each cycle will be 21 days.

Active comparator: Arm 3: Placebo + Docetaxel - Participants receive normal saline placebo via IV infusion Q3W for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 IV infusion Q3W. Each cycle will be 21 days.


Treatment: Other: Pembrolizumab/Vibostolimab coformuation
Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years.

Treatment: Drugs: Docetaxel
Docetaxel 75 mg\^m2 IV infusion Q3W until discontinuation due to progressive disease or unacceptable toxicity. Docetaxel will serve as part of an experimental treatment in Arm 1, and as an active comparator in Arm 3.

Treatment: Drugs: Placebo
Normal saline IV infusion Q3W up to approximately 2 years
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) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) Assessment
Timepoint [1] 0 0
Up to approximately 21 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) Per RECIST 1.1 by BICR Assessment
Timepoint [1] 0 0
Up to approximately 21 months
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 21 months
Secondary outcome [3] 0 0
Duration of Response (DOR) Per RECIST 1.1 by BICR Assessment
Timepoint [3] 0 0
Up to approximately 21 months
Secondary outcome [4] 0 0
Number of Participants Who Experienced an Adverse Event (AE)
Timepoint [4] 0 0
Up to approximately 21 months
Secondary outcome [5] 0 0
Number of Participants Who Discontinued Study Treatment Due to an AE
Timepoint [5] 0 0
Up to approximately 18 months

Eligibility
Key inclusion criteria
* Has a histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)
* Has confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or reactive oxygen species (ROS) 1 directed therapy is not indicated as primary therapy
* Has progressive disease (PD) on treatment with one prior anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies

* Retreatment with the same anti-PD-L1/PD-L1 mAb is acceptable in the overall course of treatment
* Has PD as determined by the investigator after platinum doublet chemotherapy for metastatic disease
* Has measurable disease defined as at least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI), based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
* Has provided tumor tissue for PD-L1 biomarker analysis from an archival sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
* Has a life expectancy of at least 3 months
* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days prior to randomization
* Male participants randomized to docetaxel are eligible to participant if they agree to refrain from donating sperm, and either 1) be abstinent from heterosexual intercourse; or 2) must agree to follow contraceptive guidance as per study protocol unless confirmed to be azoospermic during the intervention period and for at least 180 days after the last dose of docetaxel
* Female participants must be not pregnant, not breastfeeding, and not be a woman of child-bearing potential (WOCBP). A WOCBP is eligible is she agrees to either use contraception, or be abstinent from heterosexual intercourse during the intervention period and for =120 days after the last dose of study intervention. If a WOCBP is randomized to docetaxel, she agrees not to donate eggs and either uses contraception or be abstinent from heterosexual intercourse during the treatment period and for =180 days after the last dose of docetaxel
* Has adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy
* Has received docetaxel as monotherapy or in combination with other therapies
* Has received previous treatment with another agent targeting the T-cell immunoreceptor with immunoglobulin [Ig] and immunoreceptor tyrosine-based inhibitory motif [ITIM] domains (TIGIT) pathway
* Has received radiotherapy within 2 weeks of start of study intervention. One week washout is permitted for palliative radiation to non-CNS disease
* 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 severe hypersensitivity (=Grade 3) to docetaxel or pembrolizumab/vibostolimab coformulation and/or any of its excipients
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention
* Has interstitial lung disease, or history of pneumonitis requiring steroids for treatment
* Has known history of active human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
* Has had an allogenic tissue/solid organ transplant
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/08/2027
Actual
Sample size
Target
Accrual to date
Final
255
Recruitment in Australia
Recruitment state(s)
ACT,QLD,WA
Recruitment hospital [1] 0 0
Canberra Hospital ( Site 0104) - Canberra
Recruitment hospital [2] 0 0
Gold Coast University Hospital-Clinical Trials Service ( Site 0106) - Southport
Recruitment hospital [3] 0 0
Fiona Stanley Hospital-Medical Oncology ( Site 0102) - Murdoch
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
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
Kentucky
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United States of America
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Maryland
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United States of America
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Mississippi
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United States of America
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Missouri
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United States of America
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New York
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United States of America
State/province [8] 0 0
Ohio
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United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
Argentina
State/province [10] 0 0
Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Santa Fe
Country [12] 0 0
Argentina
State/province [12] 0 0
Cordoba
Country [13] 0 0
Argentina
State/province [13] 0 0
La Rioja
Country [14] 0 0
Austria
State/province [14] 0 0
Oberosterreich
Country [15] 0 0
Austria
State/province [15] 0 0
Steiermark
Country [16] 0 0
Austria
State/province [16] 0 0
Wien
Country [17] 0 0
Belgium
State/province [17] 0 0
Antwerpen
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Belgium
State/province [18] 0 0
Bruxelles-Capitale, Region De
Country [19] 0 0
Belgium
State/province [19] 0 0
Hainaut
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Belgium
State/province [20] 0 0
Limburg
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Belgium
State/province [21] 0 0
Oost-Vlaanderen
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Brazil
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Rio Grande Do Sul
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Brazil
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Sao Paulo
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Brazil
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Rio de Janeiro
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Denmark
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Hovedstaden
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Denmark
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Syddanmark
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Finland
State/province [27] 0 0
Pirkanmaa
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Finland
State/province [28] 0 0
Pohjanmaa
Country [29] 0 0
Finland
State/province [29] 0 0
Pohjois-Pohjanmaa
Country [30] 0 0
Finland
State/province [30] 0 0
Varsinais-Suomi
Country [31] 0 0
France
State/province [31] 0 0
Alsace
Country [32] 0 0
France
State/province [32] 0 0
Aquitaine
Country [33] 0 0
France
State/province [33] 0 0
Calvados
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France
State/province [34] 0 0
Haute-Garonne
Country [35] 0 0
France
State/province [35] 0 0
Pas-de-Calais
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France
State/province [36] 0 0
Sarthe
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France
State/province [37] 0 0
Val-de-Marne
Country [38] 0 0
France
State/province [38] 0 0
Var
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France
State/province [39] 0 0
Vaucluse
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Germany
State/province [40] 0 0
Baden-Wurttemberg
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Germany
State/province [41] 0 0
Bayern
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Germany
State/province [42] 0 0
Hessen
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Germany
State/province [43] 0 0
Nordrhein-Westfalen
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Germany
State/province [44] 0 0
Berlin
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Israel
State/province [45] 0 0
Be'er Sheva
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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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Tel Aviv
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Italy
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Lazio
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Italy
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Napoli
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Italy
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Pordenone
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Italy
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Torino
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Italy
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Toscana
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Italy
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Milano
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Italy
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Roma
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Korea, Republic of
State/province [56] 0 0
Chungbuk
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Korea, Republic of
State/province [57] 0 0
Kyonggi-do
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Seoul
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Malaysia
State/province [59] 0 0
Johor
Country [60] 0 0
Malaysia
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Kuala Lumpur
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Malaysia
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Pahang
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Malaysia
State/province [62] 0 0
Selangor
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Poland
State/province [63] 0 0
Mazowieckie
Country [64] 0 0
Poland
State/province [64] 0 0
Wielkopolskie
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Leningradskaya Oblast
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Moskovskaya Oblast
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Moskva
Country [68] 0 0
Russian Federation
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Nizhegorodskaya Oblast
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Omskaya Oblast
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Sankt-Peterburg
Country [71] 0 0
Spain
State/province [71] 0 0
Cataluna
Country [72] 0 0
Spain
State/province [72] 0 0
Madrid
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Spain
State/province [73] 0 0
Sevilla
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Switzerland
State/province [74] 0 0
Ticino
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Taiwan
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Kaohsiung
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Taiwan
State/province [76] 0 0
Taichung
Country [77] 0 0
Taiwan
State/province [77] 0 0
Tainan
Country [78] 0 0
Taiwan
State/province [78] 0 0
Taipei
Country [79] 0 0
Thailand
State/province [79] 0 0
Krung Thep Maha Nakhon

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

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04725188