A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
After Amendment 5, participants can receive 800 mg of favezelimab every 3 weeks (Q3W)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GEP low TMB low: Pembrolizumab + Quavonlimab Participants receive pembrolizumab 200 mg Q3W plus quavonlimab at the Recommended Phase 2 Dose ([RP2D], dose and schedule based on study NCT03179436) 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:
Drug: Quavonlimab
Quavonlimab solution for IV infusion administered at the RP2D (dose and schedule based on study NCT03179436)
Other Names:
|
| Experimental: GEP low TMB low: Pembrolizumab + Favezelimab Participants receive pembrolizumab 200 mg Q3W plus favezelimab 200 mg or 800 mg Q3W 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:
Biological: Favezelimab
200 mg or 800 mg favezelimab solution for IV infusion administered Q3W
Other Names:
|
| Experimental: GEP low TMB low: Pembrolizumab + Lenvatinib Participants receive pembrolizumab 200 mg Q3W plus lenvatinib 20 mg 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:
Drug: Lenvatinib
20 mg lenvatinib capsules administered orally once daily
Other Names:
|
| Experimental: GEP low TMB hi: Pembrolizumab + Quavonlimab Participants receive pembrolizumab 200 mg Q3W plus quavonlimab at the RP2D (dose and schedule based on study NCT03179436) 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:
Drug: Quavonlimab
Quavonlimab solution for IV infusion administered at the RP2D (dose and schedule based on study NCT03179436)
Other Names:
|
| Experimental: GEP low TMB hi: Pembrolizumab + Favezelimab Participants receive pembrolizumab 200 mg Q3W plus favezelimab 200 mg or 800 mg Q3W 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:
Biological: Favezelimab
200 mg or 800 mg favezelimab solution for IV infusion administered Q3W
Other Names:
|
| Experimental: GEP low TMB hi: Pembrolizumab + Lenvatinib Participants receive pembrolizumab 200 mg Q3W plus lenvatinib 20 mg 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:
Drug: Lenvatinib
20 mg lenvatinib capsules administered orally once daily
Other Names:
|
| Experimental: GEP hi TMB low: Pembrolizumab + Quavonlimab Participants receive pembrolizumab 200 mg Q3W plus quavonlimab at the RP2D (dose and schedule based on study NCT03179436) 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:
Drug: Quavonlimab
Quavonlimab solution for IV infusion administered at the RP2D (dose and schedule based on study NCT03179436)
Other Names:
|
| Experimental: GEP hi TMB low: Pembrolizumab + Favezelimab Participants receive pembrolizumab 200 mg Q3W plus favezelimab 200 mg or 800 mg Q3W 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:
Biological: Favezelimab
200 mg or 800 mg favezelimab solution for IV infusion administered Q3W
Other Names:
|
| Experimental: GEP hi TMB low: Pembrolizumab + Lenvatinib Participants receive pembrolizumab 200 mg Q3W plus lenvatinib 20 mg 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:
Drug: Lenvatinib
20 mg lenvatinib capsules administered orally once daily
Other Names:
|
| Experimental: GEP hi TMB hi: Pembrolizumab + Quavonlimab Participants receive pembrolizumab 200 mg Q3W plus quavonlimab at the RP2D (dose and schedule based on study NCT03179436) 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:
Drug: Quavonlimab
Quavonlimab solution for IV infusion administered at the RP2D (dose and schedule based on study NCT03179436)
Other Names:
|
| Experimental: GEP hi TMB hi: Pembrolizumab + Favezelimab Participants receive pembrolizumab 200 mg Q3W plus favezelimab 200 mg or 800 mg Q3W 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:
Biological: Favezelimab
200 mg or 800 mg favezelimab solution for IV infusion administered Q3W
Other Names:
|
| Experimental: GEP hi TMB hi: Pembrolizumab + Lenvatinib Participants receive pembrolizumab 200 mg Q3W plus lenvatinib 20 mg 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:
Drug: Lenvatinib
20 mg lenvatinib capsules administered orally once daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) [Up to ~2 years]
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.
Secondary Outcome Measures
- Progression Free Survival (PFS) per RECIST 1.1 [Up to ~2 years]
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by local site.
- Overall Survival (OS) [Up to ~2 years]
OS is defined as the time from randomization to death due to any cause.
- Number of Participants Experiencing Adverse Events (AEs) [Up to ~2 years]
An AE is 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 will be reported.
- Number of Participants Discontinuing Study Drug Due to AEs [Up to ~2 years]
An AE is 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 will be reported.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arizona Oncology Associates, PC- HAL ( Site 8001) | Tempe | Arizona | United States | 85284 |
| 2 | University of California Davis Comprehensive Cancer Center ( Site 0137) | Sacramento | California | United States | 95817 |
| 3 | University of California San Francisco ( Site 0111) | San Francisco | California | United States | 94143 |
| 4 | UCLA Hematology/Oncology -Santa Monica ( Site 0108) | Santa Monica | California | United States | 90404 |
| 5 | Yale University School of Medicine ( Site 0100) | New Haven | Connecticut | United States | 06520 |
| 6 | Mayo Clinic Florida ( Site 0115) | Jacksonville | Florida | United States | 32224 |
| 7 | University of Maryland ( Site 0136) | Baltimore | Maryland | United States | 21201 |
| 8 | Mayo Clinic Rochester - St. Mary's Hospital ( Site 0117) | Rochester | Minnesota | United States | 55905 |
| 9 | John Theurer Cancer Center at Hackensack University Medical Center ( Site 0112) | Hackensack | New Jersey | United States | 07601 |
| 10 | Memorial Sloan Kettering Cancer Center ( Site 0113) | New York | New York | United States | 10065 |
| 11 | Weill Cornell Medical College ( Site 0138) | New York | New York | United States | 10065 |
| 12 | Oncology Hematology Care ( Site 8005) | Cincinnati | Ohio | United States | 45242 |
| 13 | University of Pennsylvania ( Site 0132) | Philadelphia | Pennsylvania | United States | 19104 |
| 14 | UPMC Cancer Center/Hillman Cancer Center ( Site 0104) | Pittsburgh | Pennsylvania | United States | 15232 |
| 15 | Texas Oncology-Memorial City ( Site 8006) | Houston | Texas | United States | 77024 |
| 16 | Texas Oncology-Tyler ( Site 8003) | Tyler | Texas | United States | 75702 |
| 17 | Emily Couric Clinical Cancer Center ( Site 0134) | Charlottesville | Virginia | United States | 22903 |
| 18 | Northwest Cancer Specialists, P.C. ( Site 8000) | Vancouver | Washington | United States | 98684 |
| 19 | University of Wisconsin- Madison Carbone Cancer Center ( Site 0130) | Madison | Wisconsin | United States | 53792 |
| 20 | Blacktown Hospital Western Sydney Local Health District ( Site 0200) | Blacktown | New South Wales | Australia | 2148 |
| 21 | Gallipoli Medical Research Foundation ( Site 0202) | Brisbane | Queensland | Australia | 4120 |
| 22 | Fiona Stanley Hospital ( Site 0201) | Murdoch | Western Australia | Australia | 6150 |
| 23 | The Ottawa Hospital ( Site 0306) | Ottawa | Ontario | Canada | K1H 8L6 |
| 24 | Sunnybrook Health Science Centre ( Site 0304) | Toronto | Ontario | Canada | M4N 3M5 |
| 25 | Princess Margaret Cancer Centre ( Site 0309) | Toronto | Ontario | Canada | M5G 2M9 |
| 26 | CIUSSS du Saguenay-Lac-St-Jean ( Site 0305) | Chicoutimi | Quebec | Canada | G7H 5H6 |
| 27 | Jewish General Hospital ( Site 0307) | Montreal | Quebec | Canada | H3T 1E2 |
| 28 | CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0310) | Montreal | Quebec | Canada | H3T 1M5 |
| 29 | Prince of Wales Hospital ( Site 1801) | Hong Kong | Hong Kong | 000 | |
| 30 | Queen Mary Hospital ( Site 1800) | Hong Kong | Hong Kong | ||
| 31 | St James Hospital ( Site 2200) | Dublin | Ireland | D08 K0Y5 | |
| 32 | Mid Western Cancer Centre ( Site 2201) | Limerick | Ireland | V94 YVH0 | |
| 33 | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0702) | Meldola | Emilia-Romagna | Italy | 47014 |
| 34 | Istituto Clinico Humanitas Research Hospital ( Site 0700) | Rozzano | Lombardia | Italy | 20089 |
| 35 | AOU San Luigi Gonzaga di Orbassano ( Site 0707) | Orbassano | Torino | Italy | 10043 |
| 36 | AULSS21 Regione Veneto Ospedale Mater Salutis - Legnago ( Site 0701) | Legnago | Verona | Italy | 37045 |
| 37 | Azienda Ospedaliera Papardo ( Site 0706) | Messina | Italy | 98158 | |
| 38 | Seconda Universita degli Studi di Napoli ( Site 0704) | Napoli | Italy | 80131 | |
| 39 | Fondazione Policlinico Universitario A. Gemelli ( Site 0703) | Roma | Italy | 00168 | |
| 40 | Azienda Ospedaliera Universitaria Senese ( Site 0705) | Siena | Italy | 53100 | |
| 41 | National Cancer Center Hospital ( Site 2001) | Tokyo | Japan | 104-0045 | |
| 42 | The Cancer Institute Hospital of JFCR ( Site 2000) | Tokyo | Japan | 135-8550 | |
| 43 | Seoul National University Bundang Hospital ( Site 0803) | Seongnam-si | Kyonggi-do | Korea, Republic of | 13620 |
| 44 | Asan Medical Center ( Site 0801) | Songpa-gu | Seoul | Korea, Republic of | 05505 |
| 45 | Seoul National University Hospital ( Site 0800) | Seoul | Korea, Republic of | 03080 | |
| 46 | Severance Hospital Yonsei University Health System ( Site 0802) | Seoul | Korea, Republic of | 03722 | |
| 47 | Samsung Medical Center ( Site 0805) | Seoul | Korea, Republic of | 06351 | |
| 48 | Dolnoslaskie Centrum Onkologii. ( Site 0993) | Wroclaw | Dolnoslaskie | Poland | 53-413 |
| 49 | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( | Warszawa | Mazowieckie | Poland | 02-781 |
| 50 | MED-POLONIA Sp. z o.o. ( Site 0907) | Poznan | Wielkopolskie | Poland | 60-693 |
| 51 | Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1003) | Ufa | Baskortostan, Respublika | Russian Federation | 450054 |
| 52 | The Loginov Moscow Clinical Scientific Center ( Site 1008) | Moscow | Moskva | Russian Federation | 111123 |
| 53 | N.N. Blokhin NMRCO ( Site 1000) | Moscow | Moskva | Russian Federation | 115478 |
| 54 | Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site | Omsk | Omskaya Oblast | Russian Federation | 644013 |
| 55 | SBHI Leningrad Regional Clinical Hospital ( Site 1001) | Saint Petersburg | Sankt-Peterburg | Russian Federation | 194291 |
| 56 | St Petersburg City Clinical Oncology Dispensary ( Site 1002) | St. Petersburg | Sankt-Peterburg | Russian Federation | 198255 |
| 57 | Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1005) | Kazan | Tatarstan, Respublika | Russian Federation | 420029 |
| 58 | National Cancer Centre Singapore ( Site 1900) | Singapore | Central Singapore | Singapore | 169610 |
| 59 | National University Hospital ( Site 1901) | Singapore | South West | Singapore | 119074 |
| 60 | MPOC ( Site 2310) | Groenkloof Pretoria | Gauteng | South Africa | 0181 |
| 61 | Wits Clinical Research ( Site 2313) | Parktown-Johannesburg | Gauteng | South Africa | 2193 |
| 62 | Univ. Pretoria and Steve Biko Academic Hospitals ( Site 2315) | Pretoria | Gauteng | South Africa | 0002 |
| 63 | Sandton Oncology Medical Group PTY LTD ( Site 2316) | Sandton | Gauteng | South Africa | 2196 |
| 64 | Vaal Triangle Oncology Centre ( Site 2314) | Vereeniging | Gauteng | South Africa | 1939 |
| 65 | Umhlanga Oncolgy Center ( Site 2311) | Umhlanga | Kwazulu-Natal | South Africa | 4320 |
| 66 | Cape Town Oncology Trials Pty Ltd ( Site 2312) | Kraaifontein | Western Cape | South Africa | 7570 |
| 67 | Hospital General Universitari Vall d Hebron ( Site 1100) | Barcelona | Spain | 08035 | |
| 68 | Hospital Universitario Ramon y Cajal ( Site 1101) | Madrid | Spain | 28034 | |
| 69 | Hospital Universitario 12 de Octubre ( Site 1102) | Madrid | Spain | 28041 | |
| 70 | Kantonsspital St. Gallen ( Site 2102) | St. Gallen | Aargau | Switzerland | 9007 |
| 71 | Universitaetsspital Basel ( Site 2104) | Basel | Basel-Stadt | Switzerland | 4031 |
| 72 | Hopitaux Universitaires de Geneve HUG ( Site 2106) | Geneva | Geneve | Switzerland | 1211 |
| 73 | Kantonsspital Graubuenden ( Site 2103) | Chur | Grisons | Switzerland | 7000 |
| 74 | Universitaetsspital Zuerich ( Site 2100) | Zuerich | Zurich | Switzerland | 8091 |
| 75 | Kaohsiung Chang Gung Memorial Hospital ( Site 1203) | Kaohsiung | Taiwan | 83301 | |
| 76 | National Cheng Kung University Hospital ( Site 1202) | Tainan | Taiwan | 704 | |
| 77 | National Taiwan University Hospital ( Site 1200) | Taipei | Taiwan | 10048 | |
| 78 | Taipei Veterans General Hospital ( Site 1204) | Taipei | Taiwan | 11217 | |
| 79 | Cambridge University Hospitals NHS Trust ( Site 1306) | Cambridge | Cambridgeshire | United Kingdom | CB2 0QQ |
| 80 | University College London Hospital NHS Foundation Trust ( Site 1308) | London | London, City Of | United Kingdom | NW1 2PG |
| 81 | Derriford Hospital ( Site 1301) | Plymouth | United Kingdom | PL6 8DH |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3475-495
- MK-3475-495
- 194621
- KEYNOTE-495
- 2017-003134-85