Pembrolizumab Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants With High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)

Sponsors

Lead Sponsor: Merck Sharp & Dohme Corp.

Source Merck Sharp & Dohme Corp.
Brief Summary

This is a randomized, double-blind, study that compares pembrolizumab with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).

Overall Status Recruiting
Start Date April 1, 2019
Completion Date September 29, 2027
Primary Completion Date September 29, 2027
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy Up to approximately 60 months
Secondary Outcome
Measure Time Frame
Overall Survival (OS) Up to approximately 60 months
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score Baseline and up to approximately 60 months
Change From Baseline in Physical Functioning Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1-5 Score Baseline and up to approximately 60 months
Percentage of Participants Who Experience an Adverse Event (AE) Up to approximately 63 months
Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) Up to approximately 38 months
Enrollment 570
Condition
Intervention

Intervention Type: Biological

Intervention Name: Pembrolizumab 400 mg

Description: Administered by IV infusion on Day 1 of each 42-day cycle

Arm Group Label: Pembrolizumab

Intervention Type: Drug

Intervention Name: Placebo

Description: Administered by IV infusion on Day 1 of each 42-day cycle

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

- Has histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted)

- Has histologically confirmed LA cSCC with ≥1 high-risk feature(s) as the primary site of malignancy

- Has undergone complete macroscopic resection of all known cSCC disease with or without microscopic positive margins. For those participants with residual microscopic positive margin involvement, confirmation that additional re-excision is not possible must be provided

- Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT ≥4 weeks and ≤16 weeks from randomization

- Has completed at least 45 Gray (Gy) of adjuvant RT for LA cSCC prior to study entry

- Is disease free as assessed by the investigator with complete radiographic staging assessment ≤28 days from randomization

- Is not pregnant or breastfeeding

- Is not a woman of childbearing potential (WOCBP)

- Has a negative pregnancy test ≤72 hours before the first dose of study intervention

- Has provided an archival or newly-obtained tumor tissue sample adequate for Programmed Cell Death Ligand 1 (PD-L1) testing as determined by central laboratory testing

- Has a life expectancy of >3 months

- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ≤10 days prior to the first dose of study intervention

Exclusion Criteria:

- Has macroscopic residual cSCC after surgery and/or recurrence with active cSCC disease before randomization

- Has any other histologic type of skin cancer other than invasive cSCC (eg, basal cell carcinoma) that has not been definitively treated with surgery or radiation; Bowen's disease; Merkel cell carcinoma; or melanoma

- Has received prior therapy with an anti-programmed cell death receptor 1(PD-1), anti- PD-L1, or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another co-stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)

- Has received prior systemic anticancer therapy including investigational agents for cSCC ≤4 weeks prior to randomization

- Has not recovered from all radiation-related toxicities and has not had radiation pneumonitis

- Has received a live vaccine ≤30 days prior to the first dose of study intervention

- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device ≤4 weeks prior to the first dose of study intervention

- Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs)

- 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 [HBsAg] reactive) or known active hepatitis C virus (HCV; defined as HCV RNA [qualitative] is detected) infection

- 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 intervention

- Has had an allogeneic tissue/solid organ transplant

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Medical Director Study Director Merck Sharp & Dohme Corp.
Overall Contact

Last Name: Toll Free Number

Phone: 1-888-577-8839

Email: [email protected]

Location
Facility: Status: Contact:
City of Hope Medical Center ( Site 1505) | Duarte, California, 91010, United States Recruiting Study Coordinator 626-218-5822
University of California Davis Comprehensive Cancer Center ( Site 1560) | Sacramento, California, 95817, United States Recruiting Study Coordinator 916-734-3604
Stanford University Medical Center ( Site 1503) | Stanford, California, 94305, United States Recruiting Study Coordinator 650-498-5185
University of Colorado Cancer Center ( Site 1506) | Aurora, Colorado, 80045, United States Recruiting Study Coordinator 720-848-0676
Smilow Cancer Center at Yale-New Haven ( Site 1507) | New Haven, Connecticut, 06520, United States Recruiting Study Coordinator 203-737-7981
Boca Raton Regional Hospital ( Site 1551) | Boca Raton, Florida, 33486, United States Recruiting Study Coordinator 561-955-4539
UF Health ( Site 1511) | Gainesville, Florida, 32610, United States Recruiting Study Coordinator 352265068087617
Winship Cancer Institute of Emory University ( Site 1512) | Atlanta, Georgia, 30322-1013, United States Recruiting Study Coordinator 404-778-1900
Indiana University Melvin and Bren Simon Cancer Center ( Site 1515) | Indianapolis, Indiana, 46202, United States Recruiting Study Coordinator 317-278-5238
University of Iowa Hospital and Clinics ( Site 1514) | Iowa City, Iowa, 52242, United States Recruiting Study Coordinator 319-467-5827
University of Kentucky School of Medicine & Hospitals ( Site 1542) | Lexington, Kentucky, 40536, United States Recruiting Study Coordinator 859-323-0250
Massachusetts General Hospital ( Site 1518) | Boston, Massachusetts, 02114, United States Recruiting Study Coordinator 410-502-9746
Dana Farber Cancer Center ( Site 1519) | Boston, Massachusetts, 02215, United States Recruiting Study Coordinator 617-632-6571
John Theurer Cancer Center at Hackensack University Med Ctr ( Site 1526) | Hackensack, New Jersey, 07601, United States Recruiting Study Coordinator 551-996-5900
Cleveland Clinic ( Site 1541) | Cleveland, Ohio, 44195, United States Recruiting Study Coordinator 216-444-7552
Providence Portland Medical Center ( Site 1530) | Portland, Oregon, 97213, United States Recruiting Study Coordinator 503-215-2614
MUSC Hollings Cancer Center ( Site 1533) | Charleston, South Carolina, 29425, United States Recruiting Study Coordinator 843-792-6022
West Cancer Center - East Campus ( Site 1535) | Germantown, Tennessee, 38138, United States Recruiting Study Coordinator 901683005561236
Vanderbilt Ingram Cancer Center ( Site 1543) | Nashville, Tennessee, 37232, United States Recruiting Study Coordinator 800-811-8480
The University of Texas-MD Anderson Cancer Center ( Site 1536) | Houston, Texas, 77030, United States Recruiting Study Coordinator 713-792-2921
Huntsman Cancer Institute ( Site 1537) | Salt Lake City, Utah, 84112, United States Recruiting Study Coordinator 801-587-9834
Inova Schar Cancer Institute ( Site 1538) | Fairfax, Virginia, 22031, United States Recruiting Study Coordinator 703-970-6548
Centro Oncológico de Rosario ( Site 0003) | Rosario, Santa Fe, S2000KZE, Argentina Recruiting Study Coordinator +543414218909
Hospital Italiano- Sociedad Italiana de Beneficencia en Buenos Aires ( Site 0009) | Buenos Aires, C1181ACH, Argentina Recruiting Study Coordinator +541149590200
CEMIC ( Site 0012) | Buenos Aires, C1431FWO, Argentina Recruiting Study Coordinator +5491154939856
Fundacion CIDEA ( Site 0001) | Caba, C1121ABE, Argentina Recruiting Study Coordinator +541145802801
Centro Oncologico Riojano Integral ( Site 0002) | La Rioja, F5300COE, Argentina Recruiting Study Coordinator +543804468748
Chris OBrien Lifehouse ( Site 0051) | Camperdown, New South Wales, 2050, Australia Recruiting Study Coordinator +61285140922
Lismore Base Hospital ( Site 0050) | Lismore, New South Wales, 2480, Australia Recruiting Study Coordinator +61266294559
Orange Health Services ( Site 0053) | Orange, New South Wales, 2800, Australia Recruiting Study Coordinator +0401958122
Royal North Shore Hospital ( Site 0052) | St. Leonards, New South Wales, 2065, Australia Recruiting Study Coordinator +61294631181
Gold Coast University Hospital ( Site 0054) | Southport, Queensland, 4215, Australia Recruiting Study Coordinator +61421375349
Alfred Health ( Site 0055) | Melbourne, Victoria, 3004, Australia Recruiting Study Coordinator +61 3 9076 2000
Oncocentro Ceara ( Site 0108) | Fortaleza, Ceara, 60135-237, Brazil Recruiting Study Coordinator +5585988847459
Hospital Erasto Gaertner ( Site 0101) | Curitiba, Parana, 81520-060, Brazil Recruiting Study Coordinator +554133615195
Hospital Tacchini ( Site 0111) | Bento Goncalves, Rio Grande Do Sul, 95700-068, Brazil Recruiting Study Coordinator +5554345543331125
Hospital de Caridade de Ijui ( Site 0100) | Ijui, Rio Grande Do Sul, 98700 000, Brazil Recruiting Study Coordinator +555533319393
Hospital Bruno Born ( Site 0107) | Lajeado, Rio Grande Do Sul, 95900-000, Brazil Recruiting Study Coordinator +5551371475002476
Hospital Sao Vicente de Paulo ( Site 0105) | Passo Fundo, Rio Grande Do Sul, 99010-080, Brazil Recruiting Study Coordinator +555421034130
Cross Cancer Institute ( Site 0159) | Edmonton, Alberta, T6G 1Z2, Canada Recruiting Study Coordinator 7804328340
Juravinski Cancer Center ( Site 0151) | Hamilton, Ontario, L8V 1C3, Canada Recruiting Study Coordinator 9053879495
The Ottawa Hospital Cancer Centre ( Site 0154) | Ottawa, Ontario, K1H 8L6, Canada Recruiting Study Coordinator 613737770070185
Oncomedica S.A. ( Site 0205) | Monteria, Cordoba, 230002, Colombia Recruiting Study Coordinator +573157962122
Fundacion Universitaria de Ciencias de la Salud - Sociedad de Cirugia ( Site 0201) | Bogota, Distrito Capital De Bogota, 111411, Colombia Recruiting Study Coordinator +573002037459
Instituto Nacional de Cancerologia E.S.E ( Site 0204) | Bogota, Distrito Capital De Bogota, 111511, Colombia Recruiting Study Coordinator +573108658288
Oncologos del Occidente S.A. ( Site 0206) | Pereira, Risaralda, 660001, Colombia Recruiting Study Coordinator +573114746650
Fundacion Valle del Lili ( Site 0202) | Cali, Valle Del Cauca, 760032, Colombia Recruiting Study Coordinator +573148883972
Hopital ARCHET 2 ( Site 0356) | Nice, Alpes-Maritimes, 06200, France Recruiting Study Coordinator +33492036223
Hopital La Timone ( Site 0353) | Marseille, Bouches-du-Rhone, 13385, France Recruiting Study Coordinator +33491387991
CHU Caen Normandie ( Site 0365) | Caen, Calvados, 14033, France Recruiting Study Coordinator +33231272506
CHU Besancon - Hopital Jean Minjoz ( Site 0359) | Besancon, Doubs, 25030, France Recruiting Study Coordinator +33381218102
C.H.U. de Nimes. Hopital Caremeau ( Site 0368) | Nimes, Gard, 30029, France Recruiting Study Coordinator +33466684043
CHU de Bordeaux- Hopital Saint Andre ( Site 0370) | Bordeaux, Gironde, 33075, France Recruiting Study Coordinator +33557822521
Institut Claudius Regaud IUCT Oncopole ( Site 0354) | Toulouse, Haute-Garonne, 31059, France Recruiting Study Coordinator +33567778134
Centre Hospitalier Annecy Genevois ( Site 0361) | Pringy, Haute-Savoie, 74374, France Recruiting Study Coordinator +33450636863
CHU Montpellier. ( Site 0367) | Montpellier, Herault, 34295, France Recruiting Study Coordinator +33467336933
CHRU de Lille - Hopital Claude Huriez ( Site 0355) | Lille, Nord, 59037, France Recruiting Study Coordinator +33320444193
CHU Estaing ( Site 0360) | Clermont-Ferrand, Puy-de-Dome, 63003, France Recruiting Study Coordinator +33473755226
CH Lyon Sud Hospices Civils de Lyon ( Site 0350) | Pierre Benite, Rhone, 69495, France Recruiting Study Coordinator +33478861679
Hopital Avicenne ( Site 0358) | Bobigny, Seine-Saint-Denis, 93009, France Recruiting Study Coordinator +33148957090
Institut Gustave Roussy ( Site 0352) | Villejuif, Val-de-Marne, 94800, France Recruiting Study Coordinator +33142114210
CHU Poitiers ( Site 0375) | Poitiers, Vienne, 86021, France Recruiting Study Coordinator +33549444746
Universitaetsklinikum Tuebingen ( Site 0409) | Tuebingen, Baden-Wurttemberg, 72076, Germany Recruiting Study Coordinator +4970712985748
Universitatsklinikum Giessen und Marburg GmbH ( Site 0413) | Marburg, Hessen, 35043, Germany Recruiting Study Coordinator +4964215862321
Medizinische Hochschule Hannover ( Site 0405) | Hannover, Niedersachsen, 30625, Germany Recruiting Study Coordinator +495115320
Universitaetsklinikum Essen ( Site 0403) | Essen, Nordrhein-Westfalen, 45122, Germany Recruiting Study Coordinator +492017232431
Universitaetsklinikum Berlin - Charite - Campus Mitte ( Site 0400) | Berlin, 10117, Germany Recruiting Study Coordinator +4930450518705
Attikon University General Hospital of Athens ( Site 0454) | Chaidari, Achaḯa, 124 62, Greece Recruiting Study Coordinator +306944888568
Andreas Syggros Hospital ( Site 0450) | Athens, Attiki, 161 21, Greece Recruiting Study Coordinator +306944246247
Metropolitan Hospital ( Site 0453) | Neo Faliro, Attiki, 185 47, Greece Recruiting Study Coordinator +306944534944
Papageorgiou General Hospital ( Site 0451) | Thessaloniki, 564 03, Greece Recruiting Study Coordinator +3023133233873
Pecsi Tudomanyegyetem AOK ( Site 0501) | Pecs, Baranya, 7632, Hungary Recruiting Study Coordinator +36202520267
Szegedi Tudomanyegyetem ( Site 0504) | Szeged, Csongrad, 6720, Hungary Recruiting Study Coordinator +3662545545
Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz ( Site 0500) | Nyiregyhaza, Szabolcs-Szatmar-Bereg, 4400, Hungary Recruiting Study Coordinator +30709444840
Szent Imre Egyetemi Oktatokorhaz ( Site 0502) | Budapest, 1115, Hungary Recruiting Study Coordinator +36209434922
Debreceni Egyetem. ( Site 0506) | Debrecen, 4032, Hungary Recruiting Study Coordinator +3652255204
Soroka University Medical Center ( Site 0555) | Beer Sheva, Southern, 8410101, Israel Recruiting Study Coordinator 97286400295
Sourasky Medical Center ( Site 0554) | Tel-Aviv, Tell Abib, 6423906, Israel Recruiting Study Coordinator +97236974628
Rambam Medical Center ( Site 0552) | Haifa, 3109601, Israel Recruiting Study Coordinator +9724854311
Haddassah Medical Organization - Ein Kerem ( Site 0553) | Jerusalem, 9112001, Israel Recruiting Study Coordinator 972508946244
Rabin Medical Center ( Site 0550) | Petah Tiqwa, 4941492, Israel Recruiting Study Coordinator +97239378004
Chaim Sheba Medical Center ( Site 0551) | Ramat Gan, 5262000, Israel Recruiting Study Coordinator +97235302513
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0600) | Milano, 20133, Italy Recruiting Study Coordinator +390223903287
Istituto Europeo di Oncologia ( Site 0602) | Milano, 20141, Italy Recruiting Study Coordinator +3902574891094
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0601) | Napoli, 80131, Italy Recruiting Study Coordinator +390815903752
Azienda Ospedaliero Universitaria Pisana ( Site 0603) | Pisa, 56126, Italy Recruiting Study Coordinator +39050992466
Cimab SA de CV ( Site 0708) | Torreon, Coahuila, 27000, Mexico Completed
Hospital de Especialidades Centro Medico de Occidente ( Site 0704) | Guadalajara, Jalisco, 44349, Mexico Recruiting Study Coordinator +52333617006031310
Consultorios de Medicina Especializada del Sector Privado ( Site 0701) | Guadalajara, Jalisco, 44680, Mexico Recruiting Study Coordinator +523313141707
Centro de atencion e investigacion clinica en oncologia ( Site 0706) | Merida, Yucatan, 97134, Mexico Recruiting Study Coordinator +5219994329768
Centro Estatal de Cancerologia de Chihuahua ( Site 0703) | Chihuahua, 31000, Mexico Recruiting Study Coordinator +526144106742
FAICIC Clinical Research ( Site 0700) | Veracruz, 91900, Mexico Recruiting Study Coordinator +522299327808
Haukeland sykehus ( Site 0851) | Bergen, Hordaland, 5021, Norway Recruiting Study Coordinator +4755974200
St. Olavs Hospital HF ( Site 0852) | Trondheim, Sor-Trondelag, 7030, Norway Recruiting Study Coordinator +4772825490
Oslo Universitetssykehus Radiumhospitalet ( Site 0850) | Oslo, 0379, Norway Recruiting Study Coordinator +4722934000
Hospital Particular do Algarve ( Site 1005) | Faro, 8005-226, Portugal Recruiting Study Coordinator +351289892011
Instituto Portugues de Oncologia de Lisboa ( Site 1003) | Lisboa, 1099-023, Portugal Recruiting Study Coordinator +351217805000
Hospital CUF - Infante Santo ( Site 1004) | Lisboa, 1350-070, Portugal Recruiting Study Coordinator +351213926100
CHLN Hospital Santa Maria ( Site 1001) | Lisboa, 1649-035, Portugal Recruiting Study Coordinator +351217805096
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1000) | Porto, 4200-072, Portugal Recruiting Study Coordinator +351225084000
S C Pelican Impex SRL ( Site 1108) | Oradea, Bihor, 410450, Romania Recruiting Study Coordinator +40746103306
Hifu Terramed Conformal SRL ( Site 1111) | Bucharest, Bucuresti, 031864, Romania Recruiting Study Coordinator +40723599588
Cardiomed SRL Cluj-Napoca ( Site 1104) | Cluj-Napoca, Cluj, 400015, Romania Recruiting Study Coordinator +40724543672
Spitalul Universitar CF Cluj-Napoca ( Site 1103) | Cluj-Napoca, Cluj, 400015, Romania Recruiting Study Coordinator +40724283983
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1101) | Craiova, Dolj, 200347, Romania Recruiting Study Coordinator +40727774974
S C Oncocenter Oncologie Medicala S R L ( Site 1106) | Timisoara, Timis, 300166, Romania Recruiting Study Coordinator +40745146020
Policlinica Oncomed SRL ( Site 1105) | Timisoara, Timis, 300239, Romania Recruiting Study Coordinator +40744571617
S.C.Focus Lab Plus S.R.L ( Site 1107) | Bucuresti, 021389, Romania Recruiting Study Coordinator +40721298677
Oncological Dispensary #2 of Ministry of Health of Krasnodar region ( Site 1159) | Sochi, Krasnodarskiy Kray, 354057, Russian Federation Recruiting Study Coordinator +78622614079
N.N. Blokhin NMRCO ( Site 1153) | Moscow, Moskva, 115478, Russian Federation Recruiting Study Coordinator +79031691373
FSCC FMBA of Russia ( Site 1163) | Moscow, Moskva, 115682, Russian Federation Recruiting Study Coordinator +79265211330
Railway Hospital of OJSC ( Site 1161) | Saint Petersburg, Sankt-Peterburg, 195271, Russian Federation Recruiting Study Coordinator +79516760696
Udmurtia Republic Regional Clinical Oncology Dispensary ( Site 1158) | Izhevsk, Udmurtskaya Respublika, 426067, Russian Federation Completed
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1152) | Yaroslavl, Yaroslavskaya Oblast, 150054, Russian Federation Recruiting Study Coordinator +79036466903
Hospital Duran i Reynals ( Site 1254) | Hospitalet del Llobregat, Barcelona, 08908, Spain Recruiting Study Coordinator +34932607333
Hospital Universitario Marques de Valdecilla ( Site 1256) | Santander, Cantabria, 39008, Spain Recruiting Study Coordinator +34942202525
Hospital General Universitari Vall d Hebron ( Site 1252) | Barcelona, 08035, Spain Recruiting Study Coordinator +349327460004350
Hospital Clinic i Provincial Barcelona ( Site 1253) | Barcelona, 08036, Spain Recruiting Study Coordinator +34932275402
Hospital Universitario Ramon y Cajal ( Site 1251) | Madrid, 28034, Spain Recruiting Study Coordinator +34913368263
Hospital Universitario Carlos Haya ( Site 1255) | Malaga, 29010, Spain Recruiting Study Coordinator +34951291165
University College Hospital London ( Site 1400) | London, London, City Of, NW1 2PG, United Kingdom Recruiting Study Coordinator +4402034475085
Guy s & St Thomas NHS Foundation Trust ( Site 1407) | London, London, City Of, SE1 9RT, United Kingdom Recruiting Study Coordinator +4402071887188
The Royal Marsden Hospital-Institute of Cancer Research ( Site 1406) | London, London, City Of, SW3 6JJ, United Kingdom Recruiting Study Coordinator +442078082132
Churchill Hospital ( Site 1404) | Oxford, Oxfordshire, OX3 7LE, United Kingdom Completed
Royal Marsden NHS Foundation Trust ( Site 1408) | Sutton, Surrey, SM2 5PT, United Kingdom Recruiting Study Coordinator 0207 352 8171
Royal Cornwall Hospitals NHS Trust ( Site 1402) | Truro, TR1 3LQ, United Kingdom Recruiting Study Coordinator +441872258310
Location Countries

Argentina

Australia

Brazil

Canada

Colombia

France

Germany

Greece

Hungary

Israel

Italy

Mexico

Norway

Portugal

Romania

Russian Federation

Spain

United Kingdom

United States

Verification Date

September 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Pembrolizumab

Type: Experimental

Description: Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.

Label: Placebo

Type: Placebo Comparator

Description: Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov