Clinical trial NCT03553836: Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)
Official title: Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Melanoma
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-06-12
Enrollment: 976
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design every 3 weeks (Q3W) for up to 17 cycles/\~1 year (each cycle = 21 days). Participants who complete the initial treatment of 17 cycles of pembrolizumab in Part 1 and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2 in an open label design. Participants who complete the initial treatment of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2 in an open label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo.

Per protocol, response/ progression or adverse events (AEs) during re-challenge/switch-over in Part 2 will not be counted towards the RFS outcome measure or safety outcome measures respectively.


Eligibility criteria: Inclusion:

* Has surgically resected and histologically/pathologically confirmed new diagnosis of Stage IIB or IIC cutaneous melanoma per American Joint Committee on Cancer (AJCC) 8th edition guidelines
* Has not been previously treated for melanoma beyond complete surgical resection
* Has ≤12 weeks between final surgical resection and randomization
* Has no evidence of metastatic disease on imaging as determined by investigator
* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or Lansky Play-Performance Scale (LPS) score ≥50 for participants ≤16 years old, or a Karnofsky Performance Scale (KPS) score ≥50 for participants \>16 and \<18 years old
* Has recovered adequately from toxicity and/or complications from surgery prior to study start
* Female participants must not be pregnant or breastfeeding, and must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment if they are women of childbearing potential (WOCBP)

Exclusion:

* Has a known additional malignancy that is progressing or has required active antineoplastic therapy (including hormonal) within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
* WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* 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 with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137)
* Has received prior systemic anti-cancer therapy for melanoma including investigational agents
* Has received a live vaccine within 30 days prior to 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 severe hypersensitivity (≥Grade 3) to any excipients of pembrolizumab
* Has an active autoimmune disease that has required systemic treatment in the past 2 years
* Has a history of (non-infectious) 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 reactive) or known active hepatitis C virus (defined as hepatitis C virus ribonucleic acid \[RNA\] \[qualitative\] is detected) infection
* Has a history of active tuberculosis (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 a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
* Has had an allogeneic tissue/solid organ transplant

Primary outcomes:
measure: Recurrence-free Survival (RFS)
timeFrame: Up to ~32.7 months
Secondary outcomes:
measure: Distant Metastasis-free Survival (DMFS)
timeFrame: Up to ~9 years
measure: Overall Survival (OS)
timeFrame: Up to ~15 years
measure: Number of Participants Who Experienced at Least One Adverse Event (AE)
timeFrame: Up to ~19.3 months
measure: Number of Participants Who Discontinued Study Treatment Due to an AE
timeFrame: Up to ~19.3 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center ( Site 0121)
state: Arizona
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center ( Site 0133)
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute ( Site 0029)
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology & Oncology ( Site 0130)
state: California
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute ( Site 0026)
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center ( Site 0027)
state: Colorado
city: New Haven
country: United States
facility: Yale University ( Site 0035)
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic Florida ( Site 0024)
state: Florida
city: Tampa
country: United States
facility: Moffitt McKinley Outpatient Center ( Site 0131)
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University ( Site 0046)
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital ( Site 0115)
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medical Group ( Site 0135)
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center ( Site 0007)
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Medical Group-Park Ridge ( Site 0025)
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics ( Site 0001)
state: Iowa
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0047)
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital ( Site 0126)
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center ( Site 0141)
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute ( Site 0124)
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute ( Site 0111)
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic [Rochester, MN] ( Site 0016)
state: Minnesota
city: Saint Louis
country: United States
facility: Siteman Cancer Center ( Site 0143)
state: Missouri
city: Harrison
country: United States
facility: Memorial Sloan Kettering ( Site 0006)
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center ( Site 0137)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center ( Site 0142)
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center ( Site 0038)
state: New York
city: Rochester
country: United States
facility: University of Rochester ( Site 0019)
state: New York
city: Cincinnati
country: United States
facility: The Lindner Center for Research and Education at The Christ Hospital ( Site 0004)
state: Ohio
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center ( Site 0042)
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University ( Site 0032)
state: Oregon
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh UPMC ( Site 0144)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Centers ( Site 0043)
state: Pennsylvania
city: Germantown
country: United States
facility: West Cancer Center - East Campus ( Site 0022)
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center Knoxville ( Site 0116)
state: Tennessee
city: Houston
country: United States
facility: University of Texas-MD Anderson Cancer Center ( Site 0134)
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute ( Site 0014)
state: Virginia
city: Richmond
country: United States
facility: VCU Massey Cancer Center ( Site 0008)
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance ( Site 0044)
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics ( Site 0030)
state: Wisconsin
city: North Sydney
country: Australia
facility: Melanoma Institute Australia ( Site 0856)
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital ( Site 0853)
state: New South Wales
city: Cairns
country: Australia
facility: Cairns Base Hospital ( Site 0859)
state: Queensland
city: Southport
country: Australia
facility: Tasman Oncology Research Pty Ltd ( Site 0858)
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital ( Site 0857)
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital ( Site 0861)
state: South Australia
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre Research ( Site 0860)
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital ( Site 0852)
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital ( Site 0851)
state: Western Australia
city: Wilrijk - Antwerpen
country: Belgium
facility: GZA Sint Augustinus ( Site 0259)
state: Antwerpen
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc ( Site 0251)
state: Bruxelles-Capitale, Region De
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet ( Site 0254)
state: Bruxelles-Capitale, Region De
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis Campus Virga Jesse ( Site 0256)
state: Limburg
city: Gent
country: Belgium
facility: UZ Gent ( Site 0255)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven ( Site 0252)
state: Vlaams-Brabant
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner ( Site 0159)
state: Parana
city: Ijui
country: Brazil
facility: Hospital de Caridade de Ijui ( Site 0156)
state: Rio Grande Do Sul
city: Passo Fundo
country: Brazil
facility: Hospital Sao Vicente de Paulo ( Site 0158)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0154)
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0155)
state: Sao Paulo
city: Sao Jose Do Rio Preto - SP
country: Brazil
facility: Hospital de Clinicas de Rio Preto ( Site 0162)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Cancer II ( Site 0160)
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0151)
city: Sao Paulo
country: Brazil
facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0161)
city: Sao Paulo
country: Brazil
facility: A.C. Camargo Cancer Center ( Site 0164)
city: Edmonton
country: Canada
facility: Cross Cancer Institute ( Site 0057)
state: Alberta
city: Winnipeg
country: Canada
facility: CancerCare Manitoba ( Site 0053)
state: Manitoba
city: Moncton
country: Canada
facility: Moncton Hospital - Horizon Health Network ( Site 0055)
state: New Brunswick
city: Ottawa
country: Canada
facility: The Ottawa Hospital ( Site 0058)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute ( Site 0060)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0059)
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve Rosemont ( Site 0056)
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital ( Site 0054)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre ( Site 0062)
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec - Hotel-Dieu de Quebec ( Site 0061)
city: Temuco
country: Chile
facility: Instituto Clinico Oncologico del Sur ( Site 0203)
state: Araucania
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez FALP ( Site 0200)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile ( Site 0201)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Sociedad Medica Aren y Bachero Limitada ( Site 0207)
state: Region M. De Santiago
city: Vina del Mar
country: Chile
facility: Oncocentro ( Site 0204)
state: Valparaiso
city: Antofagasta
country: Chile
facility: Centro Oncologico Antofagasta ( Site 0206)
city: Marseille
country: France
facility: Hopital La Timone ( Site 0302)
state: Bouches-du-Rhone
city: Dijon
country: France
facility: CHU Dijon Bourgogne ( Site 0320)
state: Cote-d Or
city: Bordeaux
country: France
facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0304)
state: Gironde
city: Toulouse
country: France
facility: Institut Claudius Regaud IUCT Oncopole ( Site 0306)
state: Haute-Garonne
city: Boulogne-Billancourt
country: France
facility: Hopital Ambroise Pare Boulogne ( Site 0316)
state: Hauts-de-Seine
city: Montpellier
country: France
facility: CHU Montpellier. ( Site 0312)
state: Herault
city: Rennes
country: France
facility: Centre Eugene Marquis ( Site 0305)
state: Ille-et-Vilaine
city: Angers
country: France
facility: CHU Angers ( Site 0321)
state: Maine-et-Loire
city: Reims
country: France
facility: CHU de Reims ( Site 0307)
state: Marne
city: Lille
country: France
facility: CHRU Lille - Hopital Claude Huriez ( Site 0301)
state: Nord
city: Pierre Benite
country: France
facility: C.H.U. Lyon Sud ( Site 0303)
state: Rhone
city: Amiens
country: France
facility: CHU Amiens Picardie Hopital Nord ( Site 0317)
state: Somme
city: Villejuif
country: France
facility: Institut Gustave Roussy ( Site 0300)
state: Val-de-Marne
city: Paris
country: France
facility: Hopital Saint Louis ( Site 0322)
city: Mannheim
country: Germany
facility: Universitaetsklinikum in Mannheim ( Site 0351)
state: Baden-Wurttemberg
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen ( Site 0353)
state: Baden-Wurttemberg
city: Muenchen
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen ( Site 0357)
state: Bayern
city: Nuernberg
country: Germany
facility: Klinikum Nuernberg Nord ( Site 0355)
state: Bayern
city: Wuerzburg
country: Germany
facility: Klinikum der Universitaet in Wuerzburg ( Site 0356)
state: Bayern
city: Buxtehude
country: Germany
facility: Elbe Klinikum Buxtehude ( Site 0354)
state: Niedersachsen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover ( Site 0358)
state: Niedersachsen
city: Essen
country: Germany
facility: Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie ( Site 0361)
state: Nordrhein-Westfalen
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0359)
state: Schleswig-Holstein
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH ( Site 0360)
state: Thuringen
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg Eppendorf (UKE) ( Site 0352)
city: Beer Sheva
country: Israel
facility: Soroka Medical Center ( Site 0653)
state: Southern
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 0656)
state: Tell Abib
city: Afula
country: Israel
facility: HaEmek Medical Center ( Site 0655)
city: Haifa
country: Israel
facility: Rambam Medical Center ( Site 0654)
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem Medical Center ( Site 0651)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center. ( Site 0652)
city: Zerifin
country: Israel
facility: Shamir Medical Center-Assaf Harofeh ( Site 0657)
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 0403)
state: Forli-Cesena
city: Bari
country: Italy
facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0406)
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII ( Site 0402)
city: Genova
country: Italy
facility: IRCCS A.O.U. San Martino - IST ( Site 0404)
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0408)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 0400)
city: Padova
country: Italy
facility: IRCCS Istituto Oncologico Veneto ( Site 0407)
city: Roma
country: Italy
facility: IDI - Istituto Dermopatico dell'Immacolata ( Site 0405)
city: Siena
country: Italy
facility: Azienda Ospedaliero Universitaria Senese ( Site 0401)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 0910)
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0769)
state: Kujawsko-pomorskie
city: Krakow
country: Poland
facility: Pratia MCM Krakow ( Site 0773)
state: Malopolskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0751)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Instytut Pomnik Centrum Zdrowia Dziecka ( Site 0759)
state: Mazowieckie
city: Rzeszow
country: Poland
facility: Kliniczny Szpital Wojewodzki Nr 1 ( Site 0758)
state: Podkarpackie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne ( Site 0770)
state: Pomorskie
city: Bielsko-Biala
country: Poland
facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0754)
state: Slaskie
city: Katowice
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego ( Site 0757)
state: Slaskie
city: Rybnik
country: Poland
facility: LIFTMED ( Site 0765)
state: Slaskie
city: Poznan
country: Poland
facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 0753)
state: Wielkopolskie
city: Port Elizabeth
country: South Africa
facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 0812)
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: Sandton Oncology Medical Group PTY LTD ( Site 0801)
state: Gauteng
city: Parktown
country: South Africa
facility: Charlotte Maxeke Johannesburg Academic Hospital ( Site 0811)
state: Gauteng
city: Pretoria
country: South Africa
facility: Wilgers Oncology Centre ( Site 0806)
state: Gauteng
city: Pretoria
country: South Africa
facility: MPOC ( Site 0803)
state: Gauteng
city: Cape Town
country: South Africa
facility: Cancercare ( Site 0810)
state: Limpopo
city: Kraaifontein
country: South Africa
facility: Cape Town Oncology Trials Pty Ltd ( Site 0807)
state: Western Cape
city: San Sebastian
country: Spain
facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 0457)
state: Gipuzkoa
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia ( Site 0451)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall d Hebron ( Site 0456)
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona ( Site 0452)
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon ( Site 0454)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena ( Site 0455)
city: Basel
country: Switzerland
facility: Universitaetsspital Basel ( Site 0554)
state: Basel-Stadt
city: Bern
country: Switzerland
facility: Universitaetsspital Bern ( Site 0552)
state: Berne
city: Geneva
country: Switzerland
facility: Hopitaux Universitaires de Geneve HUG ( Site 0556)
state: Geneve
city: Chur
country: Switzerland
facility: Kantonsspital Graubuenden ( Site 0555)
state: Grisons
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen ( Site 0559)
state: Sankt Gallen
city: Bellinzona
country: Switzerland
facility: Oncological Institute of Southern Switzerland ( Site 0557)
state: Ticino
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois ( Site 0553)
state: Vaud
city: Sion
country: Switzerland
facility: Hopital du Valais ( Site 0558)
state: Wallis
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich ( Site 0551)
state: Zurich
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital in Cambridge ( Site 0600)
state: Cambridgeshire
city: London
country: United Kingdom
facility: Guy s & St Thomas NHS Foundation Trust ( Site 0601)
state: London, City Of
city: London
country: United Kingdom
facility: Royal Marsden Hospital - Fulham Road London ( Site 0613)
state: London, City Of
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust. ( Site 0612)
state: Surrey
city: Manchester
country: United Kingdom
facility: Christie NHS Foundation Trust ( Site 0604)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Luke JJ, Ascierto PA, Khattak MA, de la Cruz Merino L, Del Vecchio M, Rutkowski P, Spagnolo F, Mackiewicz J, Chiarion-Sileni V, Kirkwood JM, Robert C, Grob JJ, de Galitiis F, Schadendorf D, Carlino MS, Wu XL, Fukunaga-Kalabis M, Krepler C, Eggermont AMM, Long GV. Pembrolizumab Versus Placebo as Adjuvant Therapy in Resected Stage IIB or IIC Melanoma: Final Analysis of Distant Metastasis-Free Survival in the Phase III KEYNOTE-716 Study. J Clin Oncol. 2024 May 10;42(14):1619-1624. doi: 10.1200/JCO.23.02355. Epub 2024 Mar 7.
citation: Long GV, Luke JJ, Khattak MA, de la Cruz Merino L, Del Vecchio M, Rutkowski P, Spagnolo F, Mackiewicz J, Chiarion-Sileni V, Kirkwood JM, Robert C, Grob JJ, de Galitiis F, Schadendorf D, Carlino MS, Mohr P, Dummer R, Gershenwald JE, Yoon CH, Wu XL, Fukunaga-Kalabis M, Krepler C, Eggermont AMM, Ascierto PA; KEYNOTE-716 Investigators. Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma (KEYNOTE-716): distant metastasis-free survival results of a multicentre, double-blind, randomised, phase 3 trial. Lancet Oncol. 2022 Nov;23(11):1378-1388. doi: 10.1016/S1470-2045(22)00559-9. Epub 2022 Oct 18.
citation: Luke JJ, Rutkowski P, Queirolo P, Del Vecchio M, Mackiewicz J, Chiarion-Sileni V, de la Cruz Merino L, Khattak MA, Schadendorf D, Long GV, Ascierto PA, Mandala M, De Galitiis F, Haydon A, Dummer R, Grob JJ, Robert C, Carlino MS, Mohr P, Poklepovic A, Sondak VK, Scolyer RA, Kirkwood JM, Chen K, Diede SJ, Ahsan S, Ibrahim N, Eggermont AMM; KEYNOTE-716 Investigators. Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma (KEYNOTE-716): a randomised, double-blind, phase 3 trial. Lancet. 2022 Apr 30;399(10336):1718-1729. doi: 10.1016/S0140-6736(22)00562-1. Epub 2022 Apr 1.
citation: Luke JJ, Ascierto PA, Carlino MS, Gershenwald JE, Grob JJ, Hauschild A, Kirkwood JM, Long GV, Mohr P, Robert C, Ross M, Scolyer RA, Yoon CH, Poklepovic A, Rutkowski P, Anderson JR, Ahsan S, Ibrahim N, M Eggermont AM. KEYNOTE-716: Phase III study of adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma. Future Oncol. 2020 Jan;16(3):4429-4438. doi: 10.2217/fon-2019-0666. Epub 2019 Dec 24.