A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)

A Phase 2 Precision Oncology Study of Biomarker-Directed, Pembrolizumab-(MK-3475, SCH 900475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (KEYNOTE-495; KeyImPaCT)

This study will investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile [GEP] and tumor mutational burden [TMB]) will be randomized to receive pembrolizumab in combination with quavonlimab (MK-1308), favezelimab (MK-4280), or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either quavonlimab, favezelimab, or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with low GEP and high TMB, 3) greater than 20% among participants with high GEP and low TMB, and 4) greater than 45% among participants with high GEP and high TMB.

Study Overview

• Status: Completed
• Conditions: Advanced Non-Small Cell Lung Cancer
• Intervention / Treatment: Biological: Pembrolizumab; Drug: Quavonlimab; Biological: Favezelimab; Drug: Lenvatinib

Detailed Description

After Amendment 5, participants can receive 800 mg of favezelimab every 3 weeks (Q3W)

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Blacktown Hospital Western Sydney Local Health District ( Site 0200)
  • Queensland
    • Brisbane, Queensland, Australia, 4120
      • Gallipoli Medical Research Foundation ( Site 0202)
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital ( Site 0201)
• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital ( Site 0306)
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Science Centre ( Site 0304)
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre ( Site 0309)
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • CIUSSS du Saguenay-Lac-St-Jean ( Site 0305)
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital ( Site 0307)
    • Montreal, Quebec, Canada, H3T 1M5
      • CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0310)
• Hong Kong
  • Hong Kong, Hong Kong, 000
    • Prince of Wales Hospital ( Site 1801)
  • Hong Kong, Hong Kong
    • Queen Mary Hospital ( Site 1800)
• Ireland
  • Dublin, Ireland, D08 K0Y5
    • St James Hospital ( Site 2200)
  • Limerick, Ireland, V94 YVH0
    • Mid Western Cancer Centre ( Site 2201)
• Italy
  • Messina, Italy, 98158
    • Azienda Ospedaliera Papardo ( Site 0706)
  • Naples, Italy, 80131
    • Seconda Universita degli Studi di Napoli ( Site 0704)
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli ( Site 0703)
  • Siena, Italy, 53100
    • Azienda Ospedaliera Universitaria Senese ( Site 0705)
  • Emilia-Romagna
    • Meldola, Emilia-Romagna, Italy, 47014
      • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0702)
  • Lombardy
    • Rozzano, Lombardy, Italy, 20089
      • Istituto Clinico Humanitas Research Hospital ( Site 0700)
  • Torino
    • Orbassano, Torino, Italy, 10043
      • AOU San Luigi Gonzaga di Orbassano ( Site 0707)
  • Verona
    • Legnago, Verona, Italy, 37045
      • AULSS21 Regione Veneto Ospedale Mater Salutis - Legnago ( Site 0701)
• Japan
  • Tokyo, Japan, 104-0045
    • National Cancer Center Hospital ( Site 2001)
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital of JFCR ( Site 2000)
• Poland
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-693
      • MED-POLONIA Sp. z o.o. ( Site 0907)
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 53-413
      • Dolnoslaskie Centrum Onkologii. ( Site 0993)
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-781
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
• Russia
  • Baskortostan, Respublika
    • Ufa, Baskortostan, Respublika, Russia, 450054
      • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1003)
  • Moscow
    • Moscow, Moscow, Russia, 111123
      • The Loginov Moscow Clinical Scientific Center ( Site 1008)
    • Moscow, Moscow, Russia, 115478
      • N.N. Blokhin NMRCO ( Site 1000)
  • Omsk Oblast
    • Omsk, Omsk Oblast, Russia, 644013
      • Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 194291
      • SBHI Leningrad Regional Clinical Hospital ( Site 1001)
    • Saint Petersburg, Sankt-Peterburg, Russia, 198255
      • St Petersburg City Clinical Oncology Dispensary ( Site 1002)
  • Tatarstan, Respublika
    • Kazan', Tatarstan, Respublika, Russia, 420029
      • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1005)
• Singapore
  • Central Singapore
    • Singapore, Central Singapore, Singapore, 169610
      • National Cancer Centre Singapore ( Site 1900)
  • South West
    • Singapore, South West, Singapore, 119074
      • National University Hospital ( Site 1901)
• South Africa
  • Gauteng
    • Groenkloof Pretoria, Gauteng, South Africa, 0181
      • MPOC ( Site 2310)
    • Parktown-Johannesburg, Gauteng, South Africa, 2193
      • Wits Clinical Research ( Site 2313)
    • Pretoria, Gauteng, South Africa, 0002
      • Univ. Pretoria and Steve Biko Academic Hospitals ( Site 2315)
    • Sandton, Gauteng, South Africa, 2196
      • Sandton Oncology Medical Group PTY LTD ( Site 2316)
    • Vereeniging, Gauteng, South Africa, 1939
      • Vaal Triangle Oncology Centre ( Site 2314)
  • KwaZulu-Natal
    • Umhlanga, KwaZulu-Natal, South Africa, 4320
      • Umhlanga Oncolgy Center ( Site 2311)
  • Western Cape
    • Kraaifontein, Western Cape, South Africa, 7570
      • Cape Town Oncology Trials Pty Ltd ( Site 2312)
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital ( Site 0800)
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System ( Site 0802)
  • Seoul, South Korea, 06351
    • Samsung Medical Center ( Site 0805)
  • Kyonggi-do
    • Seongnam-si, Kyonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital ( Site 0803)
  • Seoul
    • Songpa-gu, Seoul, South Korea, 05505
      • Asan Medical Center ( Site 0801)
• Spain
  • Barcelona, Spain, 08035
    • Hospital General Universitari Vall d Hebron ( Site 1100)
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal ( Site 1101)
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre ( Site 1102)
• Switzerland
  • Canton of Aargau
    • Saint Gallen, Canton of Aargau, Switzerland, 9007
      • Kantonsspital St. Gallen ( Site 2102)
  • Canton of Basel-City
    • Basel, Canton of Basel-City, Switzerland, 4031
      • Universitaetsspital Basel ( Site 2104)
  • Canton of Geneva
    • Geneva, Canton of Geneva, Switzerland, 1211
      • Hopitaux Universitaires de Geneve HUG ( Site 2106)
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8091
      • Universitaetsspital Zuerich ( Site 2100)
  • Kanton Graubünden
    • Chur, Kanton Graubünden, Switzerland, 7000
      • Kantonsspital Graubuenden ( Site 2103)
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital ( Site 1203)
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital ( Site 1202)
  • Taipei, Taiwan, 10048
    • National Taiwan University Hospital ( Site 1200)
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital ( Site 1204)
• United Kingdom
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital ( Site 1301)
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Cambridge University Hospitals NHS Trust ( Site 1306)
  • London, City of
    • London, London, City of, United Kingdom, NW1 2PG
      • University College London Hospital NHS Foundation Trust ( Site 1308)
• United States
  • Arizona
    • Tempe, Arizona, United States, 85284
      • Arizona Oncology Associates, PC- HAL ( Site 8001)
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis Comprehensive Cancer Center ( Site 0137)
    • San Francisco, California, United States, 94143
      • University of California San Francisco ( Site 0111)
    • Santa Monica, California, United States, 90404
      • UCLA Hematology/Oncology -Santa Monica ( Site 0108)
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine ( Site 0100)
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida ( Site 0115)
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland ( Site 0136)
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester - St. Mary's Hospital ( Site 0117)
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0112)
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center ( Site 0113)
    • New York, New York, United States, 10065
      • Weill Cornell Medical College ( Site 0138)
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care ( Site 8005)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania ( Site 0132)
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Cancer Center/Hillman Cancer Center ( Site 0104)
  • Texas
    • Houston, Texas, United States, 77024
      • Texas Oncology-Memorial City ( Site 8006)
    • Tyler, Texas, United States, 75702
      • Texas Oncology-Tyler ( Site 8003)
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Emily Couric Clinical Cancer Center ( Site 0134)
  • Washington
    • Vancouver, Washington, United States, 98684
      • Northwest Cancer Specialists, P.C. ( Site 8000)
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin- Madison Carbone Cancer Center ( Site 0130)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Has a histologically- or cytologically-confirmed diagnosis of Stage IV (American Joint Committee on Cancer [AJCC] v 8) NSCLC and has not had prior systemic therapy for advanced disease
• Has confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), c-ros oncogene 1- (ROS1-), or B isoform of rapidly accelerated fibrosarcoma- (B-Raf-) directed therapy is not indicated as primary therapy (documentation of absence of tumor activating EGFR mutations, B-Raf mutations, ALK gene rearrangements, and ROS1 gene rearrangements)
• Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
• Male participants must agree to use contraception during the treatment period and for ≥120 days, after the last dose of study treatment and refrain from donating sperm during this period. Male participants with pregnant partners must agree to use a condom
• Female participants eligible to participate if not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees to follow contraceptive guidance during the treatment period and for ≥120 days after the last dose of study treatment
• Provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Has adequate organ function

Exclusion Criteria:

• Has significant cardiovascular impairment within 12 months of the first dose of study drug: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA) stroke, or cardiac arrhythmia associated with hemodynamic instability, significant cardiovascular impairment, or a left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram
• Prolongation of QTc interval to >480 milliseconds (ms)
• Has symptomatic ascites or pleural effusion
• Has had an allogenic tissue/solid organ transplant
• WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study treatment
• Has not recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy, or has had major surgery within 3 weeks prior to first dose of study intervention
• Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
• Radiographic evidence of major blood vessel invasion/infiltration
• Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug
• Has received prior systemic chemotherapy treatment for metastatic/recurrent NSCLC
• Has current NSCLC disease that can be treated with curative intent with surgical resection, localized radiotherapy, or chemoradiation
• Is expected to require any other form of systemic or localized antineoplastic therapy while on study (including maintenance therapy with another agent for NSCLC, radiation therapy, and/or surgical resection)
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor
• Has received previous treatment with another agent targeting the Lymphocyte-activation gene 3 (LAG-3) receptor
• Has received previous treatment with another agent targeting vascular endothelial growth factor (VEGF) or the VEGF receptor
• Has received prior anticancer therapy including investigational agents within 4 weeks prior to randomization
• Has received prior radiotherapy within 2 weeks of start of study treatment or received lung radiation therapy of >30 Gy within 6 months 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 treatment
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
• 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 the first dose of study treatment
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has severe hypersensitivity (≥Grade 3) to pembrolizumab, favezelimab, or lenvatinib and/or any of its excipients
• Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)
• Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
• 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 RNA [qualitative] is detected) infection
• Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
• Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study
• 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 (females and males) after the last dose of study treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pembrolizumab + Lenvatinib; Participants received pembrolizumab 200 mg every 3 weeks (Q3W) intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.	Biological: Pembrolizumab; 200 mg pembrolizumab solution for intravenous (IV) infusion administered Q3W; Other Names: MK-3475; Drug: Lenvatinib; 20 mg lenvatinib capsules administered orally once daily; Other Names: MK-7902
Experimental: Pembrolizumab + Quavonlimab; Participants received pembrolizumab 200 mg Q3W IV plus quavonlimab 25 mg every 6 weeks (Q6W) IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).	Biological: Pembrolizumab; 200 mg pembrolizumab solution for intravenous (IV) infusion administered Q3W; Other Names: MK-3475; Drug: Quavonlimab; Quavonlimab solution for IV infusion administered at the RP2D (dose and schedule based on study NCT03179436); Other Names: MK-1308
Experimental: Pembrolizumab + Favezelimab 200 mg; Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).	Biological: Pembrolizumab; 200 mg pembrolizumab solution for intravenous (IV) infusion administered Q3W; Other Names: MK-3475; Biological: Favezelimab; 200 mg or 800 mg favezelimab solution for IV infusion administered Q3W; Other Names: MK-4280
Experimental: Pembrolizumab + Favezelimab 800 mg; Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).	Biological: Pembrolizumab; 200 mg pembrolizumab solution for intravenous (IV) infusion administered Q3W; Other Names: MK-3475; Biological: Favezelimab; 200 mg or 800 mg favezelimab solution for IV infusion administered Q3W; Other Names: MK-4280

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	ORR was defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by local site radiologic review. The percentage of participants who experience CR or PR as assessed by local site radiologic review with confirmatory assessment per RECIST 1.1 is presented. Participants were assigned to 1 of 4 biomarker-defined groups (GEP low/TMB low, GEP low/TMB high, GEP high/TMB low, and GEP high/TMB high) and randomized within-group to receive a combination treatment of study interventions. Per protocol, no participants within GEP Low/TMB Low biomarker group were assigned to receive Pembrolizumab + Favezelimab 800 mg.	Up to approximately 80 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	PFS was defined as the time from allocation to the first documented progressive disease (PD) or death due to any cause, whichever occurs first according to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by local site radiologic review. PD was 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. The PFS for all participants is presented. Participants were assigned to 1 of 4 biomarker-defined groups (GEP low/TMB low, GEP low/TMB high, GEP high/TMB low, and GEP high/TMB high) and randomized within-group to receive a combination treatment of study interventions. Per protocol, no participants within GEP Low/TMB Low biomarker group were assigned to receive Pembrolizumab + Favezelimab 800 mg.	Up to approximately 80 months
Overall Survival (OS)	OS was defined as the time from the date of allocation to death due to any cause. The OS for all participants is presented. Participants were assigned to 1 of 4 biomarker-defined groups (GEP low/TMB low, GEP low/TMB high, GEP high/TMB low, and GEP high/TMB high) and randomized within-group to receive a combination treatment of study interventions. Per protocol, no participants within GEP Low/TMB Low biomarker group were assigned to receive Pembrolizumab + Favezelimab 800 mg.	Up to approximately 80 months
Number of Participants Experiencing Adverse Events (AEs)	An AE was defined as any untoward medical occurrence in participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants in each treatment arm experiencing an AE is reported.	Up to approximately 80 months
Number of Participants Discontinuing Study Drug Due to AEs	An AE was defined as any untoward medical occurrence in participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants in each treatment arm that discontinued study drug due to an AE is reported.	Up to approximately 39 months

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Gutierrez M, Lam WS, Hellmann MD, Gubens MA, Aggarwal C, Tan DSW, Felip E, Chiu JWY, Lee JS, Yang JC, Garon EB, Finocchiaro G, Ahn MJ, Luft A, Landers GA, Basso A, Ma H, Kobie J, Palcza J, Cristescu R, Fong L, Snyder A, Yuan J, Herbst RS. Biomarker-directed, pembrolizumab-based combination therapy in non-small cell lung cancer: phase 2 KEYNOTE-495/KeyImPaCT trial interim results. Nat Med. 2023 Jul;29(7):1718-1727. doi: 10.1038/s41591-023-02385-6. Epub 2023 Jul 10.

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): June 13, 2025
• Study Completion (Actual): June 13, 2025

Study Registration Dates

• First Submitted: April 27, 2018
• First Submitted That Met QC Criteria: April 27, 2018
• First Posted (Actual): May 7, 2018

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; pembrolizumab; lenvatinib
• Other Study ID Numbers: 3475-495; MK-3475-495 (Other Identifier: MSD Protocol Number); 194621 (Registry Identifier: Japic-CTI); KEYNOTE-495 (Other Identifier: MSD); 2022-500990-16-00 (Registry Identifier: EU CT Number); 2017-003134-85 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No