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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04725188




Registration number
NCT04725188
Ethics application status
Date submitted
25/01/2021
Date registered
26/01/2021
Date last updated
2/04/2024

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
Other interventions - 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.


Other interventions: 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
Other interventions
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
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California
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Illinois
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Kentucky
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Maryland
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Mississippi
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Missouri
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New York
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Ohio
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United States of America
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South Carolina
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Cordoba
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Argentina
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La Rioja
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Austria
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Oberosterreich
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Austria
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Steiermark
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Austria
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Wien
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Belgium
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Antwerpen
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Belgium
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Bruxelles-Capitale, Region De
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Belgium
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Hainaut
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Belgium
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Limburg
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Belgium
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Oost-Vlaanderen
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Rio Grande Do Sul
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Sao Paulo
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Rio de Janeiro
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Denmark
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Hovedstaden
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Syddanmark
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Finland
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Pirkanmaa
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Finland
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Pohjanmaa
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Finland
State/province [29] 0 0
Pohjois-Pohjanmaa
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Finland
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Varsinais-Suomi
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France
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Alsace
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France
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Aquitaine
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France
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Calvados
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France
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Haute-Garonne
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France
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Pas-de-Calais
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Sarthe
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France
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France
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Var
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France
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Vaucluse
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Germany
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Baden-Wurttemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Nordrhein-Westfalen
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Germany
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Berlin
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Be'er Sheva
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Israel
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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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Lazio
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Napoli
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Pordenone
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Milano
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Roma
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Korea, Republic of
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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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Johor
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Malaysia
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Kuala Lumpur
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Malaysia
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Pahang
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Malaysia
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Selangor
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Poland
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Mazowieckie
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Poland
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Wielkopolskie
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Russian Federation
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Leningradskaya Oblast
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Russian Federation
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Moskovskaya Oblast
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Russian Federation
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Moskva
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Russian Federation
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Nizhegorodskaya Oblast
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Russian Federation
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Omskaya Oblast
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Russian Federation
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Sankt-Peterburg
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Spain
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Cataluna
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Spain
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Madrid
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Spain
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Sevilla
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Switzerland
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Ticino
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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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
The main purpose of this study is to compare pembrolizumab/vibostolimab coformulation
(MK-7684A) plus docetaxel or pembrolizumab/vibostolimab coformulation to normal saline
placebo plus docetaxel. Participants with metastatic non-small cell lung cancer (NSCLC) and
progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior
anti- programmed cell death 1 (PD-1)/ programmed cell death ligand 1(PD-L1) monoclonal
antibody (mAb). MK-7684A is a coformulation product of pembrolizumab/vibostolimab. The dual
primary hypotheses of the study are pembrolizumab/vibostolimab coformulation plus docetaxel
and pembrolizumab/vibostolimab coformulation is superior to normal saline placebo plus
docetaxel with respect to progression free survival (PFS) per Response Evaluation Criteria in
Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04725188
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04725188