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AzTrials

Metastatic Non Small Cell Lung CancerPhase 2NCT04725188

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)

A Phase 2 study testing Pembrolizumab/Vibostolimab coformulation and Docetaxel in people with Metastatic Non Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 95 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Non Small Cell Lung Cancer
What is being tested?
Pembrolizumab/Vibostolimab coformulation and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
255 participants
Where
95 sitesin 20 countries
Study dates
20 Apr 2021to 17 Oct 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

95 sites in 20 countries.

95 sites in 20 countries

United States10 sites

  • University of Maryland ( Site 2528)

    Baltimore, Maryland, 21201

  • University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 2526)

    Cincinnati, Ohio, 45219

  • St Francis Cancer Center-Research Office ( Site 2531)

    Greenville, South Carolina, 29607

  • Hattiesburg Clinic Hematology/Oncology ( Site 2511)

    Hattiesburg, Mississippi, 39401

  • Baptist Health Lexington-Research ( Site 2502)

    Lexington, Kentucky, 40503

  • Cedars-Sinai Medical Center ( Site 2522)

    Los Angeles, California, 90048

  • Illinois Cancer Care ( Site 2534)

    Peoria, Illinois, 61615

  • Mercy Research - Cancer and Hematology Center ( Site 2535)

    Springfield, Missouri, 65804

  • Mercy Research - David C. Pratt Cancer Center ( Site 2532)

    St Louis, Missouri, 63109

  • Montefiore- Einstein Center for Cancer Care-Oncology ( Site 2509)

    The Bronx, New York, 10461

Other trials in United States

France9 sites

  • Centre Hospitalier d'Avignon-Service d'Oncologie médicale et d'hématologie clinique ( Site 1004)

    Avignon, Vaucluse, 84000

  • Clinique Ambroise Paré ( Site 1007)

    Beuvry, Pas-de-Calais, 62660

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1009)

    Bordeaux, Aquitaine, 33000

  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1006)

    Caen, Calvados, 14033

  • Centre Hospitalier du Mans ( Site 1002)

    Le Mans, Sarthe, 72037

  • Nouvel Hôpital Civil (NHC) ( Site 1000)

    Strasbourg, Alsace, 67000

  • HIA Sainte Anne ( Site 1003)

    Toulon, Var, 83800 Cedex 9

  • CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 1008)

    Toulouse, Haute-Garonne, 31059

  • Gustave Roussy ( Site 1005)

    Villejuif, Val-de-Marne, 94800

Other trials in France

Russia9 sites

  • Moscow Clinical Research Center-Chemotherapy department ( Site 1910)

    Moscow, Moscow, 111123

  • Central Clinical Hospital of the Presidential Administrative Department ( Site 1902)

    Moscow, Moscow, 121359

  • Hadassah Medical-Oncology department ( Site 1912)

    Moscow, Moscow Oblast, 121205

  • Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 1909)

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603081

  • Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary ( Site 1908)

    Omsk, Omsk Oblast, 644013

  • Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (

    Saint Petersburg, Leningradskaya Oblast', 190020

  • Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1911)

    Saint Petersburg, Leningradskaya Oblast', 198255

  • GBUZ LOKB-Oncology department #1 ( Site 1905)

    Saint Petersburg, Sankt-Peterburg, 194291

  • N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( S

    Saint Petersburg, Sankt-Peterburg, 197758

Other trials in Russia

Italy8 sites

  • CRO-IRCCS-medical oncology ( Site 1304)

    Aviano, Pordenone, 33081

  • Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1306)

    Florence, Tuscany, 50134

  • Ospedale San Raffaele-Oncologia Medica ( Site 1305)

    Milan, 20132

  • Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1301)

    Milan, 20141

  • Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1308)

    Naples, Napoli, 80131

  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga-Oncologia Polmonare ( Site 1300)

    Orbassano, Torino, 10043

  • Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1303)

    Roma, 00168

  • Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1307)

    Rome, Lazio, 00184

Other trials in Italy

Argentina6 sites

  • Centro de Oncología e Investigación de Buenos Aires ( Site 0008)

    Berazategui, Buenos Aires, B1884BBF

  • Hospital Privado Universitario de Córdoba ( Site 0001)

    Córdoba, 5016

  • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0005)

    La Rioja, F5300COE

  • Hospital Privado de Comunidad ( Site 0004)

    Mar del Plata, Buenos Aires, 7600

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0002)

    Mar del Plata, Buenos Aires, 7600

  • Instituto de Oncología de Rosario ( Site 0003)

    Rosario, Santa Fe Province, S2000KZE

Other trials in Argentina

Belgium5 sites

  • UZ Brussel ( Site 0336)

    Brussels, Bruxelles-Capitale, Region de, 1090

  • Grand Hôpital de Charleroi-Oncology & Hematology ( Site 0337)

    Charleroi, Hainaut, 6000

  • Jessa Ziekenhuis-Pulmonology & Thoracic Oncology ( Site 0338)

    Hasselt, Limburg, 3500

  • AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0333)

    Mechelen, Antwerpen, 2800

  • AZ Nikolaas ( Site 0334)

    Sint-Niklaas, Oost-Vlaanderen, 1932

Other trials in Belgium

Germany5 sites

  • Helios Klinikum Emil von Behring Berlin-Zehlendorf ( Site 1106)

    Berlin, 14165

  • Universitätsklinikum Bonn ( Site 1111)

    Bonn, North Rhine-Westphalia, 53127

  • Klinikverbund Allgaeu gGmbH ( Site 1109)

    Immenstadt im Allgäu, Bavaria, 87509

  • Onkologie Ravensburg ( Site 1104)

    Ravensburg, Baden-Wurttemberg, 88212

  • Helios Dr. Horst Schmidt Kliniken ( Site 1108)

    Wiesbaden, Hesse, 65199

Other trials in Germany

Taiwan5 sites

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 2303)

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301

  • Taichung Veterans General Hospital-Chest ( Site 2307)

    Taichung, 40705

  • NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 2302)

    Tainan, 704

  • National Taiwan University Hospital-Oncology ( Site 2304)

    Taipei, 10002

  • Mackay Memorial Hospital-Chest Medicine ( Site 2305)

    Taipei, 10449

Other trials in Taiwan

Brazil4 sites

  • Hospital Nossa Senhora da Conceição ( Site 0403)

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Centro de Tratamento de Tumores Botafogo - CTTB-Pesquisa Clínica ( Site 0402)

    Rio de Janeiro, 22250-905

  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0400)

    São Paulo, São Paulo, 01246-000

  • Hospital Paulistano ( Site 0406)

    São Paulo, 01321-000

Other trials in Brazil

Finland4 sites

  • Oulun yliopistollinen sairaala ( Site 0902)

    Oulu, North Ostrobothnia, 90220

  • Tampereen yliopistollinen sairaala-Oncology ( Site 0906)

    Tampere, Pirkanmaa, 33520

  • Turku University Hospital-The Department of Pulmonary Medicine ( Site 0905)

    Turku, Southwest Finland, 20520

  • Vaasan Keskussairaala ( Site 0903)

    Vaasa, Pohjanmaa, 65130

Other trials in Finland

Israel4 sites

  • Soroka Medical Center ( Site 1202)

    Beersheba, 8410101

  • Rambam Health Care Campus-Oncology ( Site 1203)

    Haifa, 3109601

  • Shaare Zedek Medical Center-Oncology ( Site 1206)

    Jerusalem, 9103102

  • Sourasky Medical Center ( Site 1205)

    Tel Aviv, 6423906

Other trials in Israel

Malaysia4 sites

  • Hospital Sultan Ismail ( Site 1503)

    Johor Bahru, Johor, 81100

  • Hospital Tengku Ampuan Afzan ( Site 1500)

    Kuantan, Pahang, 25100

  • University Malaya Medical Centre ( Site 1501)

    Lembah Pantai, Kuala Lumpur, 59100

  • Beacon Hospital Sdn Bhd ( Site 1504)

    Petaling Jaya, Selangor, 46050

Other trials in Malaysia

South Korea4 sites

  • Chungbuk National University Hospital-Internal medicine ( Site 2004)

    Cheongju-si, North Chungcheong, 28644

  • Seoul National University Bundang Hospital ( Site 2003)

    Seongnam, Kyonggi-do, 13620

  • Asan Medical Center-Oncology ( Site 2000)

    Songpagu, Seoul, 05505

  • The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2005)

    Suwon, Kyonggi-do, 16247

Other trials in South Korea

Spain4 sites

  • HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit

    Barcelona, Catalonia, 08036

  • Hospital de la Santa Creu i Sant Pau-Oncología Médica ( Site 2102)

    Barcelona, Catalonia, 08041

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2101)

    Madrid, 28009

  • Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 2103)

    Seville, 41014

Other trials in Spain

Australia3 sites

  • Canberra Hospital ( Site 0104)

    Canberra, Australian Capital Territory, 2605

  • Fiona Stanley Hospital-Medical Oncology ( Site 0102)

    Murdoch, Western Australia, 6150

  • Gold Coast University Hospital-Clinical Trials Service ( Site 0106)

    Southport, Queensland, 4215

Other trials in Australia

Austria3 sites

  • Medizinische Universität Graz ( Site 0201)

    Graz, Styria, 8036

  • Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0203)

    Linz, Upper Austria, 4020

  • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0204)

    Vienna, 1210

Other trials in Austria

Denmark3 sites

  • Rigshospitalet ( Site 0702)

    Copenhagen, Capital Region, 2100

  • Odense Universitetshospital ( Site 0700)

    Odense, Region Syddanmark, 5000

  • Sygehus Soenderjylland-Kraeftambulatoriet ( Site 0705)

    Sønderborg, Region Syddanmark, 6400

Other trials in Denmark

Poland2 sites

  • Przychodnia Lekarska KOMED ( Site 1704)

    Konin, Greater Poland Voivodeship, 62-500

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Thailand2 sites

  • Chulalongkorn University ( Site 2403)

    Bangkok, Bangkok, 10330

  • Faculty of Medicine Siriraj Hospital ( Site 2400)

    Bangkok, Bangkok, 10700

Other trials in Thailand

Switzerland1 site

  • Ospedale Regionale Bellinzona e Valli ( Site 2203)

    Bellinzona, Canton Ticino, 6500

Other trials in Switzerland

About this study

Official 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

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).

Read the detailed description

Participants may receive additional 17 cycles of pembrolizumab/vibostolimab (each cycle length = 21 days) for an additional 1 year of treatment as second course phase at investigator's discretion.

Being tested
Pembrolizumab/Vibostolimab coformulation, Docetaxel, Placebo
Keywords
Programmed Cell Death Receptor 1 (PD-1), Programmed Cell Death Receptor Ligand 1 (PD-L1), Programmed Cell Death Receptor Ligand 2 (PD-L2), PD-1, PDL1, PD-L1, PD-L2
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab/Vibostolimab coformulationBiological

    Also called MK-7684A

    Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years.

  • DocetaxelDrug

    Also called Taxotere

    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.

  • PlaceboDrug

    Normal saline IV infusion Q3W up to approximately 2 years

Study groups in NCT04725188
Study groupRoleWhat they receive
Arm 1: Pembrolizumab/Vibostolimab coformulation + DocetaxelExperimentalParticipants 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.
Receives: Biological: Pembrolizumab/Vibostolimab coformulation; Drug: Docetaxel
Arm 2: Pembrolizumab/Vibostolimab coformulationExperimentalParticipants 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.
Receives: Biological: Pembrolizumab/Vibostolimab coformulation
Arm 3: Placebo + DocetaxelActive comparatorParticipants 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.
Receives: Drug: Docetaxel; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) Assessment

    PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR is presented.

    Measured: Up to approximately 21 months

Secondary outcomes (5)

  1. Objective Response Rate (ORR) Per RECIST 1.1 by BICR Assessment

    ORR is defined as the percentage of participants who have a confirmed complete response (CR: Disappearance of all target lesions) or a partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by BICR based on RECIST 1.1 is presented.

    Measured: Up to approximately 21 months

  2. Overall Survival (OS)

    OS is defined as the time from randomization to the date of death due to any cause.

    Measured: Up to approximately 21 months

  3. Duration of Response (DOR) Per RECIST 1.1 by BICR Assessment

    For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The DOR as assessed by BICR is presented.

    Measured: Up to approximately 21 months

  4. Number of Participants Who Experienced an Adverse Event (AE)

    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced an AE is reported here.

    Measured: Up to approximately 39 months

  5. Number of Participants Who Discontinued Study Treatment Due to an AE

    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE is reported here.

    Measured: Up to approximately 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2021
  2. Study start20 Apr 2021
  3. Primary completion26 Jan 2023
  4. Study completion17 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04725188
Sponsor's protocol ID
7684A-002
Other IDs
MK-7684A-002, KEYVIBE-002, 2022-501252-28-00, U1111-1275-8661, 2020-004034-38
Status last verified
Jul 2025
First submitted
25 Jan 2021
Last updated
15 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab/Vibostolimab coformulation and Docetaxel in people with Metastatic Non Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 95 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, France, Russia, Italy, Argentina and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) Assessment (time frame: Up to approximately 21 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04725188.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.

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