A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Medically Inoperable Stages I or IIA Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)

Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Medically Inoperable Stage I or IIA Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)

Sponsors

Lead sponsor: Merck Sharp & Dohme Corp.

Source Merck Sharp & Dohme Corp.
Brief Summary

The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with medically inoperable Stage I or IIA non-small cell lung cancer (NSCLC).

The primary study hypotheses are:

1. SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution), and

2. SBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo.

Overall Status Recruiting
Start Date June 25, 2019
Completion Date July 1, 2026
Primary Completion Date April 11, 2025
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Event-free Survival (EFS) Up to approximately 6 years
Overall Survival (OS) Up to approximately 6 years
Secondary Outcome
Measure Time Frame
Time to Death or Distant Metastases (TDDM) Up to approximately 6 years
Number of Participants Who Experience an Adverse Event (AE) Up to approximately 6 years
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) Up to approximately 6 years
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Score Baseline and up to approximately 52 weeks
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 13 (EORTC QLQ-LC13) Cough (Item 31) Score Baseline and up to approximately 52 weeks
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 13 (EORTC QLQ-LC13) Chest Pain (Item 10) Score Baseline and up to approximately 52 weeks
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score Baseline and up to approximately 52 weeks
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score Baseline and up to approximately 52 weeks
Enrollment 530
Condition
Intervention

Intervention type: Radiation

Intervention name: Stereotactic Body Radiotherapy (SBRT)

Description: SBRT

Intervention type: Biological

Intervention name: Pembrolizumab

Description: IV infusion

Arm group label: SBRT+Pembolizumab

Intervention type: Drug

Intervention name: Placebo

Description: IV infusion

Arm group label: SBRT+Placebo

Other name: Normal saline solution

Eligibility

Criteria:

Inclusion Criteria:

- Has previously untreated NSCLC diagnosed by histology or cytology and confirmed as Stage I or IIA NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan

- Cannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board

- Has a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

- Is able to receive SBRT and does not have an ultra-centrally located tumor

- Has adequate organ function within 7 days prior to the start of study treatment

- A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) not a women of childbearing potential (WOCBP) OR b) A WOCBP who agrees to use study-acceptable contraception during treatment and for at least 120 days after last dose of study treatment

Exclusion Criteria:

- Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], tumor necrosis factor receptor superfamily member 4 [OX-40], tumor necrosis factor receptor superfamily member 9 [CD137])

- Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or breast

- 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. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent

- 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. Note: Participants with 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 are not excluded.

- Has a known hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients

- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis

- Has a known history of Hepatitis B or known active Hepatitis C virus infection

- 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). However, replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency), while systemic, will be permitted for study eligibility.

- Has an active infection requiring systemic therapy

- Has a known history of human immunodeficiency virus (HIV) infection

- Has a known history of active tuberculosis (TB; Bacillus tuberculosis)

- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment

- Has had an allogenic tissue/solid organ transplant

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
USC Norris Comprehensive Cancer Center ( Site 0007) | Los Angeles, California, 90033, United States Recruiting Study Coordinator 323-865-0591
National Jewish Health ( Site 0010) | Denver, Colorado, 80206, United States Recruiting Study Coordinator 303-398-1233
Yale University ( Site 0011) | New Haven, Connecticut, 06510, United States Recruiting Study Coordinator 203-737-5801
Mid Florida Hematology and Oncology Center ( Site 0067) | Orange City, Florida, 32763, United States Recruiting Study Coordinator 386-774-1223
H. Lee Moffitt Cancer Center and Research Institute ( Site 0016) | Tampa, Florida, 33612, United States Recruiting Study Coordinator 813-745-6636
Goshen Center for Cancer Care ( Site 0022) | Goshen, Indiana, 46526, United States Recruiting Study Coordinator 574-364-2649
Franciscan Health Indianapolis ( Site 0024) | Indianapolis, Indiana, 46237, United States Recruiting Study Coordinator 317-528-7685
University of Kentucky School of Medicine & Hospitals ( Site 0026) | Lexington, Kentucky, 40536, United States Recruiting Study Coordinator 859-323-0250
Sanford Bemidji ( Site 0080) | Bemidji, Minnesota, 56601, United States Recruiting Study Coordinator 218-333-5407
University of Minnesota ( Site 0069) | Minneapolis, Minnesota, 55455, United States Recruiting Study Coordinator 612-624-6940
Rutgers Cancer Institute of New Jersey ( Site 0043) | New Brunswick, New Jersey, 08903, United States Recruiting Study Coordinator 732-235-6048
Mount Sinai Hospital ( Site 0046) | New York, New York, 10029, United States Recruiting Study Coordinator 212-241-5095
Sanford Health Roger Maris Cancer Center ( Site 0079) | Fargo, North Dakota, 58122, United States Recruiting Study Coordinator 701-234-5126
Fox Chase Cancer Center ( Site 0051) | Philadelphia, Pennsylvania, 19111, United States Recruiting Study Coordinator 215-214-4297
Sanford Cancer Center Oncology Clinic ( Site 0053) | Sioux Falls, South Dakota, 57104, United States Recruiting Study Coordinator 605-312-3320
Vanderbilt University Medical Center ( Site 0075) | Nashville, Tennessee, 37232, United States Recruiting Study Coordinator 615-875-0060
Cancer Care Northwest ( Site 0063) | Spokane Valley, Washington, 99216, United States Recruiting Study Coordinator 509-228-1689
Hospital Britanico de Buenos Aires ( Site 0204) | Caba, Ciudad Autonoma De Buenos Aires, C1280AEB, Argentina Recruiting Study Coordinator +5491121571056
Hospital Provincial del Centenario ( Site 0205) | Rosario, Santa Fe, S2002KDS, Argentina Recruiting Study Coordinator +5493413007528
CEMIC ( Site 0201) | Buenos Aires, C1431FWO, Argentina Recruiting Study Coordinator +5411529901002543
Port Macquarie Base Hospital ( Site 2500) | Port Macquarie, New South Wales, 2444, Australia Recruiting Study Coordinator +61265801807
Royal Brisbane and Women s Hospital ( Site 2502) | Herston, Queensland, 4029, Australia Recruiting Study Coordinator +61736467983
Austin Health ( Site 2501) | Melbourne, Victoria, 3084, Australia Recruiting Study Coordinator +61394963546
Keppler Universitatsklinikum ( Site 0806) | Linz, Oberosterreich, 4021, Austria Recruiting Study Coordinator +4373278066910
Landeskrankenhaus - Universitatsklinikum Graz ( Site 0804) | Graz, Steiermark, 8036, Austria Recruiting Study Coordinator +4331638512974
Universitatsklinik LKH Innsbruck ( Site 0802) | Innsbruck, Tirol, 6020, Austria Recruiting Study Coordinator +4351250481058
Social Medical Center - Otto Wagner Hospital ( Site 0801) | Vienna, Wien, 1145, Austria Recruiting Study Coordinator +4319106042003
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0318) | Porto Alegre, Rio Grande Do Sul, 90050-170, Brazil Recruiting Study Coordinator +5551999818669
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0301) | Porto Alegre, Rio Grande Do Sul, 90610-000, Brazil Recruiting Study Coordinator +555133203039
Hospital e Maternidade Celso Pierro ( Site 0313) | Campinas, Sao Paulo, 13060-904, Brazil Recruiting Study Coordinator +551933438465
Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0305) | Rio de Janeiro, 20231-050, Brazil Recruiting Study Coordinator +552132076564
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0300) | Sao Paulo, 01246-000, Brazil Recruiting Study Coordinator +551138932615
Hospital Paulistano - Amil Clinical Research ( Site 0316) | Sao Paulo, 01321-001, Brazil Recruiting Study Coordinator +552132071657
A.C. Camargo Cancer Center ( Site 0312) | Sao Paulo, 01509-900, Brazil Recruiting Study Coordinator +551121895021
Moncton Hospital - Horizon Health Network ( Site 0105) | Moncton, New Brunswick, E1C 6Z8, Canada Recruiting Study Coordinator 5068575669
Kingston Health Sciences Centre ( Site 0100) | Kingston, Ontario, K7L 2V7, Canada Recruiting Study Coordinator 6135496666
Trillium Health Partners - Credit Valley Hospital ( Site 0102) | Mississauga, Ontario, L5M 2N1, Canada Recruiting Study Coordinator 9058134299
The Ottawa Hospital ( Site 0104) | Ottawa, Ontario, K1H 8L6, Canada Recruiting Study Coordinator 613737770070175
Sault Area Hospital ( Site 0101) | Sault Ste Marie, Ontario, P6B 0A8, Canada Recruiting Study Coordinator 70575934344402
Health Sciences North Research Institute ( Site 0107) | Sudbury, Ontario, P3E 5J1, Canada Recruiting Study Coordinator 70552262372400
CHU de Brest -Site Hopital Morvan ( Site 1100) | Brest, Finistere, 29200, France Recruiting Study Coordinator +33298223578
Institut Bergonie ( Site 1102) | Bordeaux, Gironde, 33076, France Recruiting Study Coordinator +33556333229
Institut Regional du Cancer de Montpellier - ICM ( Site 1108) | Montpellier, Herault, 34298, France Recruiting Study Coordinator +33681329401
CHU de Rouen ( Site 1113) | Rouen, Seine-Maritime, 76000, France Recruiting Study Coordinator +33637886045
CHU Poitiers ( Site 1109) | Poitiers, Vienne, 86021, France Recruiting Study Coordinator +33549444538
Hopital Cochin ( Site 1107) | Paris, 75014, France Recruiting Study Coordinator +33158413091
A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 1114) | Paris, 75877, France Recruiting Study Coordinator +33140257502
Universitaetsklinikum Heidelberg. ( Site 1204) | Heidelberg, Baden-Wurttemberg, 69126, Germany Recruiting Study Coordinator +4962213968359
Pius Hospital Oldenburg ( Site 1202) | Oldenburg, Niedersachsen, 26121, Germany Recruiting Study Coordinator +494412291610
Evangelisches Krankenhaus Hamm gGmbH ( Site 1205) | Hamm, Nordrhein-Westfalen, 59063, Germany Recruiting Study Coordinator +4923819058327
Charite Universitaetsmedizin Berlin ( Site 1207) | Berlin, 13353, Germany Recruiting Study Coordinator +4930450553044
CRU Hungary KFT ( Site 2309) | Miskolc, Borsod-Abauj-Zemplen, 3529, Hungary Recruiting Study Coordinator +36304111076
Petz Aladar Megyei Oktato Korhaz ( Site 2305) | Gyor, Gyor-Moson-Sopron, 9024, Hungary Recruiting Study Coordinator +36309758356
Jasz - Nagykun Szolnok megyei Hetenyi Geza Korhaz - Rendelointezet ( Site 2310) | Szolnok, Jasz-Nagykun-Szolnok, 5000, Hungary Recruiting Study Coordinator +36209323256
Tudogyogyintezet Torokbalint ( Site 2302) | Torokbalint, Pest, 2045, Hungary Recruiting Study Coordinator +36307005601
Semmelweis Egyetem ( Site 2303) | Budapest, 1083, Hungary Recruiting Study Coordinator +36208259181
Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 2304) | Budapest, 1121, Hungary Recruiting Study Coordinator +36703288101
Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 2306) | Budapest, 1121, Hungary Recruiting Study Coordinator +36302005233
Orszagos Onkologiai Intezet ( Site 2308) | Budapest, 1122, Hungary Recruiting Study Coordinator +3612248600
Debreceni Egyetem Klinikai Kozpont ( Site 2301) | Debrecen, 4032, Hungary Recruiting Study Coordinator +36303384465
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2307) | Kaposvar, 7400, Hungary Recruiting Study Coordinator +36703685838
A.O. Universitaria Careggi ( Site 1301) | Firenze, 50134, Italy Recruiting Study Coordinator +39055794111
Policlinico di Modena ( Site 1306) | Modena, 41124, Italy Recruiting Study Coordinator +39594224385
Policlinico Agostino Gemelli ( Site 1302) | Roma, 00168, Italy Recruiting Study Coordinator +390630155440
Aichi Cancer Center Hospital ( Site 2804) | Nagoya, Aichi, 464-8681, Japan Recruiting Study Coordinator +81527626111
National Cancer Center Hospital East ( Site 2800) | Kashiwa, Chiba, 277-8577, Japan Recruiting Study Coordinator +81471331111
University of Tsukuba Hospital ( Site 2809) | Tsukuba, Ibaraki, 305-8576, Japan Recruiting Study Coordinator +81298533900
Kansai Medical University Hospital ( Site 2808) | Hirakata, Osaka, 573-1191, Japan Recruiting Study Coordinator +81728040101
University of Yamanashi Hospital ( Site 2807) | Chuo, Yamanashi, 409-3898, Japan Recruiting Study Coordinator +81552731111
Chiba University Hospital ( Site 2806) | Chiba, 260-8677, Japan Recruiting Study Coordinator +81432227171
Niigata Cancer Center Hospital ( Site 2801) | Niigata, 951-8566, Japan Recruiting Study Coordinator +81252665111
Tokyo Metropolitan Komagome Hospital ( Site 2802) | Tokyo, 113-8677, Japan Recruiting Study Coordinator +81338232101
The Cancer Institute Hospital of JFCR ( Site 2803) | Tokyo, 135-8550, Japan Recruiting Study Coordinator +81335200111
Showa University Hospital ( Site 2805) | Tokyo, 142-8666, Japan Recruiting Study Coordinator +81337848000
Chungbuk National University Hospital ( Site 2605) | Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644, Korea, Republic of Recruiting Study Coordinator +82432696015
National Cancer Center ( Site 2604) | Goyang-si, Kyonggi-do, 10408, Korea, Republic of Recruiting Study Coordinator +82319201694
The Catholic University of Korea St. Vincent s Hospital ( Site 2606) | Gyeonggi-do, Kyonggi-do, 16247, Korea, Republic of Recruiting Study Coordinator +82312498153
Seoul National University Hospital ( Site 2600) | Seoul, Seoul-teukbyeolsi [Seoul], 03080, Korea, Republic of Recruiting Study Coordinator +82220720694
Samsung Medical Center ( Site 2603) | Seoul, Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of Recruiting Study Coordinator +82234103609
Auckland City Hospital ( Site 2900) | Grafton, Auckland, 1023, New Zealand Recruiting Study Coordinator +6493074949
St Olavs Hospital ( Site 1504) | Trondheim, Sor-Trondelag, 7030, Norway Recruiting Study Coordinator +4772826170
Helse Bergen HF Haukeland Universitetssykehus ( Site 1502) | Bergen, Vestfold, 5021, Norway Recruiting Study Coordinator +4755973245
Oslo Universitetssykehus HF Ulleval Sykehus ( Site 1500) | Oslo, 0450, Norway Recruiting Study Coordinator +4722934809
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 2402) | Lodz, Lodzkie, 93-513, Poland Recruiting Study Coordinator +48426895551
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2400) | Krakow, Malopolskie, 31-826, Poland Recruiting Study Coordinator +48721295010
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2401) | Warszawa, Mazowieckie, 02-781, Poland Recruiting Study Coordinator +48225463066
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2403) | Gliwice, Slaskie, 44-101, Poland Recruiting Study Coordinator +48322788805
SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2404) | Olsztyn, Warminsko-mazurskie, 10-228, Poland Recruiting Study Coordinator +48895398527
GUZ Lipetsk Regional Oncology Dispensary ( Site 2010) | Lipetsk, Lipetskaya Oblast', 398005, Russian Federation Recruiting Study Coordinator +74742425109
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2000) | Saint-Petersburg, Sankt-Peterburg, 197758, Russian Federation Recruiting Study Coordinator +79111005005
Medical institute named after Berezin Sergey ( Site 2009) | St. Petersburg, Sankt-Peterburg, 197758, Russian Federation Recruiting Study Coordinator +78122440024
Sverdlovsk Regional Oncology Hospital ( Site 2012) | Ekaterinburg, Sverdlovskaya Oblast', 620036, Russian Federation Recruiting Study Coordinator +79222022945
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2001) | Kazan, Tatarstan, Respublika, 420029, Russian Federation Recruiting Study Coordinator +78435257346
Hospital General Universitari Vall d Hebron ( Site 1602) | Barcelona, Barcelona [Barcelona], 08035, Spain Recruiting Study Coordinator +34934894158
Hospital Universitario Quiron Madrid ( Site 1601) | Pozuelo de Alarcon, Madrid, 28223, Spain Recruiting Study Coordinator +34914521987
Hospital Universitario La Fe ( Site 1603) | Valencia, Valenciana, Comunitat, 46206, Spain Recruiting Study Coordinator +34961244000
Hopitaux Universitaires de Geneve HUG ( Site 1706) | Geneva, Geneve, 1211, Switzerland Recruiting Study Coordinator +41223729881
Universitaetsspital Zuerich ( Site 1700) | Zuerich, Zurich, 8091, Switzerland Recruiting Study Coordinator +41442558902
Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2105) | Adana, 01250, Turkey Recruiting Study Coordinator +903223444444
Hacettepe University Medical Faculty ( Site 2100) | Ankara, 06100, Turkey Recruiting Study Coordinator +9031230543304336
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 2101) | Ankara, 06200, Turkey Recruiting Study Coordinator +90 312 336 09 09
Kartal Training and Research Hospital ( Site 2102) | Istanbul, 34890, Turkey Recruiting Study Coordinator +902164583000
Medical Park Izmir Hastanesi ( Site 2115) | Izmir, 35575, Turkey Recruiting Study Coordinator +902323995050
Erciyes University Medical Faculty ( Site 2109) | Kayseri, 38030, Turkey Recruiting Study Coordinator +903522076666
Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2114) | Sakarya, 54290, Turkey Recruiting Study Coordinator +905052014666
Medical center Medikal Plaza of Ecodnipro LLC ( Site 2207) | Dnipro, Dnipropetrovska Oblast, 49055, Ukraine Recruiting Study Coordinator +380676318171
Communal non profit enterprise Regional Clinical Oncology Center ( Site 2202) | Kharkiv, Kharkivska Oblast, 61070, Ukraine Recruiting Study Coordinator +380503802915
Ukrainian Center of Tomotherapy ( Site 2206) | Kropyvnitskiy, Kirovohradska Oblast, 25011, Ukraine Recruiting Study Coordinator +380979428527
Kyiv City Clinical Oncology Centre ( Site 2200) | Kyiv, Kyivska Oblast, 03115, Ukraine Recruiting Study Coordinator +380503818536
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2203) | Kyiv, Kyivska Oblast, 03126, Ukraine Recruiting Study Coordinator +380977207250
Medical Center Cyber Clinic of Spizhenko ( Site 2205) | Kapitanovka, Kyiv, 08112, Ukraine Recruiting Study Coordinator +380992163443
University Hospitals Bristol NHS Foundation Trust ( Site 1802) | Bristol, Bristol, City Of, BS2 8ED, United Kingdom Recruiting Study Coordinator +447884216871
University College London Hospital NHS Foundation Trust ( Site 1806) | London, London, City Of, NW1 2PG, United Kingdom Recruiting Study Coordinator +447929450961
Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1808) | London, London, City Of, SE1 9RT, United Kingdom Recruiting Study Coordinator +02071882006
Norfolk and Norwich University Foundation NHS Trust ( Site 1805) | Norwich, Norfolk, NR4 7UY, United Kingdom Recruiting Study Coordinator +441603288897
Darlington Memorial Hospital NHS Trust ( Site 1810) | Darlington, DLX 6HX, United Kingdom Recruiting Study Coordinator +441642854161
Leicester Royal Infirmary ( Site 1811) | Leicester, LE1 5WW, United Kingdom Recruiting Study Coordinator +441162587632
Mount Vernon Hospital ( Site 1803) | Northwood, HA6 2RN, United Kingdom Recruiting Study Coordinator +441438284298
Location Countries

Argentina

Australia

Austria

Brazil

Canada

France

Germany

Hungary

Italy

Japan

Korea, Republic of

New Zealand

Norway

Poland

Russian Federation

Spain

Switzerland

Turkey

Ukraine

United Kingdom

United States

Verification Date

May 2020

Responsible Party

Responsible party type: Sponsor

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

Arm group label: SBRT+Pembolizumab

Arm group type: Experimental

Description: Participants receive SBRT once every 3 days for 3-5 fractions (dependent on tumor type/location; 45-54 Gray [Gy] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via intravenous (IV) infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle is 21 days.

Arm group label: SBRT+Placebo

Arm group type: Placebo Comparator

Description: Participants receive SBRT once every 3 days for 3-5 fractions (dependent on tumor type/location; 45-54 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle is 21 days.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov