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Carcinoma, Non-Small-Cell LungPhase 2NCT04165083

KEYMAKER-U01 Substudy 2: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Treatment-naïve Participants With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Positive Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01B/KEYMAKER-U01B)

A Phase 2 study testing Pembrolizumab, MK-4830 and MK-0482 in people with Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC at 39 sites in 7 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 purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with MK-4830 in treatment-naïve participants with advanced squamous or non-squamous NSCLC that is PD-L1 positive. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Pembrolizumab, MK-4830 and MK-0482
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
39 sitesin 7 countries
Study dates
7 Jan 2021to 31 Oct 2025
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 Stage IV squamous or non-squamous non-small cell lung cancer (NSCLC)
  • Has non-squamous NSCLC and is not eligible for an approved targeted therapy
  • Is able to provide archival tumor tissue sample collected either within 5 years or within the interval from completion of last treatment but before entering the screening period or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated obtained within 90 days of treatment initiation
  • Has not received prior systemic treatment for metastatic NSCLC
  • Has programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%
  • Is able to complete all screening procedures within the 35-day screening window.
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  • Male participants must agree to use contraception and refrain from donating sperm during the treatment period and for at least 120 days after the last dose of study treatment
  • Female participants must not be pregnant or breastfeeding, and at least one of the following conditions apply:
  • Not a woman of childbearing potential (WOCBP) OR
  • A WOCBP who agrees to use contraception during the treatment period and for at least 120 days after the last dose of study treatment
  • Has adequate organ function within 10 days of initiation of study treatment

Who cannot join

  • Has a diagnosis of small cell lung cancer
  • 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 before the first dose of study treatment
  • Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years
  • Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
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  • Has an active infection requiring systemic therapy
  • Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study treatment, or New York Heart Association Class III or IV congestive heart failure
  • Has a known history of Human Immunodeficiency Virus (HIV) infection
  • Has a known history of Hepatitis B or known active Hepatitis C virus infection
  • Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study
  • Has had major surgery <3 weeks before the first dose of study treatment
  • Has received prior radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study treatment
  • Has received any prior immunotherapy and was discontinued from that treatment due to a severe or worse immune-related adverse event (irAE)
  • Has had chemotherapy or biological cancer therapy within 4 weeks before the first dose of study treatment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the AEs due to cancer therapeutics administered more than 4 weeks before the first dose of study treatment (including participants who had previous immunomodulatory therapy with residual irAEs)
  • Has received a live vaccine within 30 days before the first dose of study treatment. Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed as long as they are messenger ribonucleic acid (mRNA) vaccines, adenoviral vaccines, or inactivated vaccines. Investigational vaccines (ie, those not licensed or approved for Emergency Use) are not allowed
  • Has received prior systemic cytotoxic chemotherapy or other targeted or biological antineoplastic therapy for metastatic disease.
  • Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or prior therapy targeting other immuno-regulatory receptors or mechanisms
  • 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 treatment
  • Has had a severe hypersensitivity reaction to treatment with monoclonal antibodies (including pembrolizumab) and/or any of their excipients
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
  • Has had an allogenic tissue/solid organ transplant

Trial locations and contacts

39 sites in 7 countries.

39 sites in 7 countries

United States18 sites

  • MedStar Franklin Square Medical Center ( Site 0033)

    Baltimore, Maryland, 21237

  • Massachusetts General Hospital ( Site 0003)

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute ( Site 0002)

    Boston, Massachusetts, 02215

  • Cleveland Clinic Main ( Site 0006)

    Cleveland, Ohio, 44195

  • Ohio State University Comprehensive Cancer Center ( Site 0015)

    Columbus, Ohio, 43210

  • City of Hope ( Site 0014)

    Duarte, California, 91010

  • Sanford Fargo Medical Center ( Site 0039)

    Fargo, North Dakota, 58102

  • Banner MD Anderson Cancer Center ( Site 0001)

    Gilbert, Arizona, 85234

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)

    Hackensack, New Jersey, 07601

  • The University of Texas MD Anderson Cancer Center ( Site 0009)

    Houston, Texas, 77030

  • Dartmouth Hitchcock Medical Center ( Site 0016)

    Lebanon, New Hampshire, 03766

  • University of Kentucky Markey Cancer Center ( Site 0019)

    Lexington, Kentucky, 40536-0293

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034)

    New York, New York, 10016

  • Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)

    Omaha, Nebraska, 68130

  • Abramson Cancer Center of the University of Pennsylvania ( Site 0010)

    Philadelphia, Pennsylvania, 19104

  • UCSF Medical Center at Mission Bay ( Site 0007)

    San Francisco, California, 94158

  • Sanford Cancer Center ( Site 0038)

    Sioux Falls, South Dakota, 57104

  • Georgetown University ( Site 0036)

    Washington D.C., District of Columbia, 20007

Other trials in United States

Israel7 sites

  • Soroka Medical Center ( Site 0072)

    Beersheba, 8457108

  • Rambam Health Care Campus-Oncology ( Site 0076)

    Haifa, 3109601

  • Shaare Zedek Medical Center ( Site 0075)

    Jerusalem, 9103102

  • Meir Medical Center ( Site 0071)

    Kfar Saba, 4428132

  • Rabin Medical Center ( Site 0074)

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center ( Site 0070)

    Ramat Gan, 5262000

  • Sourasky Medical Center ( Site 0077)

    Tel Aviv, 6423906

Other trials in Israel

Hungary3 sites

  • Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)

    Budapest, 1121

  • Petz Aladar Megyei Oktato Korhaz ( Site 0062)

    Győr, Győr-Moson-Sopron, 9024

  • Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061)

    Szolnok, Jász-Nagykun-Szolnok, 5004

Other trials in Hungary

Italy3 sites

  • Azienda Ospedaliera Universitaria Careggi ( Site 0173)

    Florence, Firenze, 50134

  • IRCCS Ospedale San Raffaele ( Site 0171)

    Milan, 20132

  • Policlinico Gemelli di Roma ( Site 0174)

    Roma, 00168

Other trials in Italy

Poland3 sites

  • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)

    Gdansk, Pomeranian Voivodeship, 80-952

  • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)

    Koszalin, West Pomeranian Voivodeship, 75-581

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

South Korea3 sites

  • Seoul National University Bundang Hospital ( Site 0081)

    Seongnam-si, Kyonggi-do, 13620

  • Severance Hospital ( Site 0080)

    Seoul, 03722

  • Samsung Medical Center ( Site 0082)

    Seoul, 06351

Other trials in South Korea

Spain2 sites

  • ICO L Hospitalet ( Site 0090)

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario Quiron Madrid ( Site 0091)

    Madrid, 28223

Other trials in Spain

About this study

Official title: KEYMAKER-U01 Substudy 2: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab in Treatment Naïve Patients With PD-L1 Positive Advanced Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with MK-4830 in treatment-naïve participants with advanced squamous or non-squamous NSCLC that is PD-L1 positive.

This study is one of three pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).

The pembrolizumab+ MK-0482 arm was added with Amendment 6.

Read the detailed description

The master screening protocol is MK-3475-U01(KEYMAKER-U01) - NCT04165798

Being tested
Pembrolizumab, MK-4830, MK-0482
Keywords
Programmed Cell Death Receptor 1 (PD-1, PD1), Programmed Cell Death Receptor Ligand 1 (PD-L1, PDL1), Programmed Cell Death Receptor Ligand 2 (PD-L2, PDL2)
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.

  • PembrolizumabBiological

    Also called KEYTRUDA®, MK-3475, SCH 900475

    IV infusion

  • MK-4830Biological

    IV infusion

  • MK-0482Biological

    IV infusion

Study groups in NCT04165083
Study groupRoleWhat they receive
Pembrolizumab + MK-4830ExperimentalOn Day 1 of each 3-week cycle, participants receive pembrolizumab 200 mg intravenously (IV) PLUS MK-4830 IV for a maximum of 35 cycles (approximately 2 years)
Receives: Biological: Pembrolizumab; Biological: MK-4830
Pembrolizumab + MK-0482ExperimentalOn Day 1 of each 3-week cycle, participants receive pembrolizumab 200 mg intravenously (IV) PLUS MK-0482 IV for a maximum of 35 cycles (approximately 2 years)
Receives: Biological: Pembrolizumab; Biological: MK-0482

What is being measured

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

  1. Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a confirmed Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) based on investigator assessment per RECIST 1.1.

    Measured: Up to approximately 56 months

Secondary outcomes (3)

  1. Progression-Free Survival (PFS) According to RECIST 1.1

    PFS was defined as the time from first dose of study treatment until either the earliest date of documented progressive disease (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 have also demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.

    Measured: Up to approximately 56 months

  2. Number of Participants Who Experienced One or More Adverse Events (AEs)

    An AE was defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

    Measured: Up to approximately 28 months

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

    An AE was defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

    Measured: Up to approximately 25 months

Timeline

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

  1. First posted15 Nov 2019
  2. Study start7 Jan 2021
  3. Primary completion31 Oct 2025
  4. Study completion31 Oct 2025

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04165083
Sponsor's protocol ID
3475-01B
Other IDs
MK-3475-01B, KEYMAKER-U01B, 2023-506933-32-00, U1111-1294-6518, 2020-001627-14, 2023
Status last verified
Oct 2026
First submitted
14 Nov 2019
Last updated
29 Oct 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab, MK-4830 and MK-0482 in people with Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC at 39 sites in 7 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 11 inclusion and 22 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Israel, Hungary, Italy, Poland and 2 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 29 Oct 2026). 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?

Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (time frame: Up to approximately 56 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 NCT04165083.

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 29 Oct 2026.

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