Global Share

STATUS Recruiting

Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer (STAR-121)

LAST UPDATED

May 1, 2024

Clinicaltrials.gov ID

NCT05502237

EudraCT ID

2022-000578-25

OVERVIEW

A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations (STAR-121)

PROTOCOL SUMMARY

The primary objective of this study is to compare the effect of zimberelimab (ZIM) and domvanalimab (DOM) in combination with chemotherapy relative to pembrolizumab (PEMBRO) in combination with chemotherapy on progression-free survival (PFS) and overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable genomic alteration.

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Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

All

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

Non-small Cell Lung Cancer

Gender

N/A

Date

October 2022 - September 2027

Study Type

Interventional

Study Phase

Phase 3

Product

Zimberelimab, Domvanalimab, Pembrolizumab, Carboplatin, Cisplatin, Paclitaxel, Nab-paclitaxel, Pemetrexed

Eligibility Information

Inclusion

Inclusion Criteria

  • Life expectancy ≥ 3 months.
  • Pathologically documented NSCLC that meets both of the criteria below:
  • Have documented evidence of Stage IV NSCLC disease at the time of enrollment (based on American Joint Committee on Cancer (AJCC), Eighth Edition).
  • Have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations.
  • Have no actionable genomic alterations such as ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), RET mutations, or other driver oncogenes with approved frontline therapies.
  • Have not received prior systemic treatment for metastatic NSCLC.
  • Measurable disease per RECIST v1.1 criteria by investigator assessment.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
  • Have adequate organ functions.
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Exclusion

Exclusion Criteria

  • Have mixed small-cell lung cancer (SCLC) and NSCLC histology.
  • Positive serum pregnancy test or individuals who are breastfeeding or have plans to breastfeed during the study period.
  • Received prior treatment with any anti-PD-1, anti-PD-L1, or any other antibody targeting an immune checkpoint.
  • Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
  • Have an active second malignancy or have had an active second malignancy within 3 years prior to enrollment.
  • Have an active autoimmune disease that required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
  • Are receiving chronic systemic steroids.
  • Have significant third-space fluid retention.
  • Have untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has had an allogenic tissue/solid organ transplant.
  • Have received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
  • Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Locations

Locations (207)
Recruiting

Palo Verde Hematology Oncology Ltd

Glendale, Arizona, United States, 85304

Recruiting

California Cancer Associates for Research and Excellence

San Marcos, California, United States, 92069

Recruiting

Texas Oncology

Santa Barbara, California, United States, 93105

Recruiting

Innovative Clinical Research Institute

Whittier, California, United States, 90606

Recruiting

Eastern CT Hematology and Oncology Associates

Norwich, Connecticut, United States, 06360

Recruiting

Lake City Cancer Care

Lake City, Florida, United States, 32024

Recruiting

Florida Cancer Specialists

Sarasota, Florida, United States, 34232

Recruiting

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Recruiting

Peachtree Hematology Oncology Consultants

Atlanta, Georgia, United States, 30318

Recruiting

Illinois Cancer Care

Peoria, Illinois, United States, 61615

Recruiting

Messino Cancer Centers

Asheville, North Carolina, United States, 28806

Recruiting

Oncology Hematology Care, Inc.

Cincinnati, Ohio, United States, 45242

Recruiting

Hematology & Oncology Associates

Eugene, Oregon, United States, 97401

Recruiting

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, United States, 15212

Recruiting

Arlington Cancer Center

Arlington, Texas, United States, 76012

Recruiting

Texas Oncology - Austin

Austin, Texas, United States, 78745

Recruiting

Texas Oncology

Dallas, Texas, United States, 75246

Recruiting

Texas Oncology- Denison

Sherman, Texas, United States, 75090

Recruiting

US Oncology Investigational Products Center (IPC)

Arlington, Virginia, United States, 22205

Recruiting

Oncology and Hematology Associates of Southwest Virginia, Inc

Blacksburg, Virginia, United States, 24060

Recruiting

Northwest Cancer Specialists, PC

Vancouver, Washington, United States, 98684

Recruiting

Investigaciones CORI S.R.L.

Capital, Argentina, F5300COE

Recruiting

Centro Médico Privado Centro de Especialidades Médicas Ambulatorias e Investigación Clínica

Cardoba, Argentina, X5008HHW

Recruiting

Centro Medico Barrio Parque

Ciudad Autanoma Buenos Aires, Argentina, 1426

Recruiting

Sanatorio Allende

Cordoba, Argentina, 5000

Recruiting

Sanatorio Britanico de Rosario

Rosario, Argentina, 2000

Recruiting

Sanatorio Parque de Rosario

Rosario, Argentina, S2000DSV

Recruiting

Hospital Provincial del Centenario

Rosario, Argentina, S2002KDS

Recruiting

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, Argentina, S2013DTC

Recruiting

CAIPO - Centro para la Atención Integral del Paciente Oncológico

San Miguel de Tucumán, Argentina, 4000

Recruiting

Clínica Viedma

Viedma, Argentina, 8500

Recruiting

Klinikum Klagenfurt am Woerthersee

Klagenfurt Am Woerthersee, Austria

Recruiting

Ordensklinikum Linz GmbH, Elisabethinen

Linz, Austria, 4020

Recruiting

Klinikum Wels-Grieskirchen

Wels, Austria, 4600

Recruiting

Krankenhaus Nord - Klinik Floridsdorf

Wien, Austria, A-1140

Recruiting

Algemeen Ziekenhuis Sint-Lucas

Aalst, Belgium, 9300

Recruiting

Grand Hopital de Charleroi asbl (GHdC)

Charleroi, Belgium, 6000

Recruiting

AZ Sint-Maarten

Mechelen, Belgium, 2800

Recruiting

CHU UCL Namur / Site Sainte Elisabeth

Namur, Belgium, 5000

Recruiting

Cenantron Centro Avançado de Tratamento Oncologico Ltda

Belo Horizonte, Brazil, 30130-090

Recruiting

Hospital Evangelico de Cachoeiro de Itapemirim

Cachoeiro De Itapemirim, Brazil, 29308-014

Recruiting

Fundacao Universidade De Caxias Do Sul - FUCS/RS

Caxias Do Sul, Brazil, 95070-560

Recruiting

Instituto do Câncer do Ceará - ICC

Fortaleza, Brazil, 60430-230

Recruiting

Oncosite - Centro de Pesquisa Clinica em Oncologia LTDA

Ijui, Brazil, 98700-000

Recruiting

Centro Des Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho

Jau, Brazil, 17210080

Recruiting

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil, 90020-090

Recruiting

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil, 90035-903

Recruiting

Hospital São Lucas da PUCRS

Porto Alegre, Brazil, 90610-000

Recruiting

Hospital Ana Nery Santa Cruz do Sul

Santa Cruz Do Sul, Brazil, 96810-110

Recruiting

Instituto Brasiliero de Controle do Cancer IBCC

Sao Paulo, Brazil, 03102002

Recruiting

Centre Integre de sante et de services sociaux de la Monteregie Centre

Greenfield Park, Canada, J4V 2H1

Recruiting

Moncton Hospital

Moncton, Canada, E1C 6Z8

Recruiting

CISSS des Laurentides

Quebec, Canada, J7Z 2V4

Recruiting

Centre de santé et services sociaux de Rimouski-Neigette

Rimouski, Canada, G5L5T1

Withdrawn

BC Cancer - Victoria

Victoria, Canada, V8R 6V5

Recruiting

Clinica Alemana de Santiago

Las Condes, Chile, 7550000

Recruiting

Orlandioncologia

Providencia, Chile, 7500006

Recruiting

Oncovida- Santiago

Providencia, Chile, 7510035

Recruiting

Clinica Puerto Montt

Puerto Montt, Chile, 5500243

Recruiting

Biocinetic

Santiago, Chile, 8331143

Recruiting

James Lind Centro de Investigacion del Cancer

Temuco, Chile, 4800827

Recruiting

Oncocentro APYS

Vina del Mar, Chile, 2520612

Recruiting

West China Hospital Sichuan University

Chengdu, China, 610041

Recruiting

Deyang People's Hospital

Deyang, China, 618000

Recruiting

Shanghai Pulmonary Hospital

Shanghai, China, 200433

Recruiting

Cancer Hospital of Shantou University Medical College

Shantou, China, 0754-88555844

Recruiting

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China, 430022

Recruiting

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, China, 453100

Recruiting

Ambroise-Pare Hospital, Assistance Publique - Hopitaux de Paris

Boulogne-Billancourt, France, 92100

Recruiting

CHU de Caen

Caen, France, 14000

Recruiting

Clinique Victor Hugo, Centre de Cancerologie de la Sarthe

Le Mans, France, 72000

Recruiting

Hopital Nord

Marseille, France, 13005

Recruiting

Institut de Cancer de Montpellier (ICM) - Val d'Aurelle

Montpellier, France, 34928

Recruiting

Centre Antoine Lacassagne

Nice, France, 6189

Recruiting

Institut de cancerologie de l'ouest (ICO)

Saint-Herblain, France, 44805

Recruiting

Hopital d'Instruction des Armees (HIA) Begin

Saint-Mandé, France, 94160

Recruiting

Centre Hospitalier de Saint-Quentin

Saint-Quentin, France, 2100

Recruiting

Institut de Cancerologie Strasbourg Europe (ICANS)

Strasbourg, France, 67033

Recruiting

Hôpital Foch

Suresnes, France, 92150

Recruiting

CHI de Toulon la Seyne-sur-Mer Hopital Sainte Musse

Toulon cedex, France, 83056

Recruiting

Augusta-Kranken-Anstalt gGmbh Klinik für Hämatologie Onkologie und Palliativmedizin

Bochum, Germany, 44791

Recruiting

Klinikum Chemnitz gGmbH

Chemnitz, Germany, 9116

Recruiting

Universitatsklinikum Essen / Westdeutsches Tumorzentrum, Innere Klinik (Tumorforschung)

Essen, Germany, 45122

Recruiting

Universitätsklinikum Freiburg, Klinik für Innere Medizin I Hämatologie, Onkologie und Stammzelltransplantation

Freiburg, Germany, 79106

Recruiting

LungenClinic Grosshansdorf

Grosshansdorf, Germany, 22927

Recruiting

Krankenhaus Martha-Maria Halle Dölau

Halle, Germany, 06120

Recruiting

Asklepios Kliniken Hamburg

Hamburg, Germany, 21075

Recruiting

Katholisches Marienkrankenhaus gGmbH

Hamburg, Germany, 22087

Recruiting

Lungenklinik Hemer, Zentrum fur Pneumologie and Thoraxchirurgie

Hemer, Germany, 58675

Recruiting

Vincentius-Diakonissen-Kliniken gAG, St. Vincentius-Kliniken, Medizinische Klinik 2

Karlsruhe, Germany, 76137

Recruiting

Klinikum Kassel

Kassel, Germany, 34125

Recruiting

Kliniken der Stadt Köln ggmbh, Krankenhaus Koln-Merheim/Lungenklinik

Köln, Germany, 51109

Recruiting

Universitatsklinikum Schleswig-Holstein

Lubeck, Germany, 23538

Recruiting

Johannes Wesling Klinikum Minden

Minden, Germany, 32429

Recruiting

Munchen Klinik Bogenhausen, Klinik fur Pneumologie und Pneumologische Onkologie

Munchen, Germany, 81925

Recruiting

Sana Klinikum Offenbach GmbH, Medizinische Klinik IV, Hämatologie und Internistische Onkologie

Offenbach, Germany, 63069

Recruiting

Queen Elizabeth Hospital

Hong Kong, Hong Kong, 999077

Recruiting

Queen Mary Hospital

Hong Kong, Hong Kong

Recruiting

Prince of Wales Hospital

New Territories, Hong Kong

Recruiting

Soroka University Medical Center, Itzchak Rager Blvd.

Beer Seva, Israel, 84101

Recruiting

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

Recruiting

Oncology Institute, Galilee Medical Center, Route 89 Nahariya-Cabri

Nahariya, Israel

Recruiting

Rabin Medical Center

Petah Tiqva, Israel, 49100

Recruiting

Kaplan Medical Center

Rehovot, Israel, 76100

Recruiting

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Recruiting

Azienda Ospedaliera San Giuseppe Moscati

Avellino, Italy

Recruiting

IRCCS Fondazoine del Piemonte per l'Oncologia

Candiolo, Italy, 10060

Recruiting

Azienda Socio Sanitaria Territoriale di Cremona

Cremona, Italy, 26100

Recruiting

Ospedale Policlinico San Martino

Genova, Italy, 16132

Recruiting

Ospedale San Raffaele

Milano, Italy, 20132

Recruiting

Azienda Ospedaliero Universitaria di Modena

Modena, Italy, 41124

Recruiting

AORN Cardarelli

Naples, Italy, 80131

Recruiting

Azienda Ospedaliera dei Colli

Napoli, Italy, 80131

Recruiting

IRCCS Policlinico S. Matteo, Dipartimento Oncologia Ematologia-Oncologia Medica

Pavia, Italy, 27100

Recruiting

Azienda Sanitaria Territoriale Pesaro e Urbino (AST)

Pesaro, Italy, 61122

Recruiting

Ospedale Guglielmo da Saliceto AUSL di Piacenza

Piacenza, Italy, 29100

Recruiting

Centro di Riferimento Oncologico

Pordenone, Italy, 33081

Recruiting

Regina Elena Institute for Cancer Research

Rome, Italy, 00144

Recruiting

ASST Bergamo Ovest- ospedale di Treviglio

Treviglio, Italy, 24047

Recruiting

National Cancer Center Hospital East

Chiba, Japan, 277-0882

Recruiting

National Hospital Organization Shikoku Cancer Center

Ehime, Japan, 791-0280

Recruiting

Kyushu University Hospital

Fukuoka, Japan, 812-8582

Recruiting

Kurume University Hospital

Fukuoka, Japan, 830-0011

Recruiting

National Hospital Organization Himeji Medical Center

Hyogo, Japan, 670-8520

Recruiting

Hyogo Cancer Center

Hyogo, Japan, 673-8558

Recruiting

Kanazawa University Hospital

Ishikawa, Japan, 920-8641

Recruiting

Kanagawa Cancer Center

Kanagawa, Japan, 241-0815

Recruiting

Sendai Kousei Hospital

Miyagi, Japan, 980-0873

Recruiting

Niigata Cancer Center Hospital

Niigata, Japan, 951-8566

Recruiting

Osaka Metropolitan University Hospital

Osaka, Japan, 545-8586

Recruiting

Osaka Medical and Pharmaceutical University Hospital

Osaka, Japan, 569-8686

Recruiting

Kindai University Hospital

Osaka, Japan, 589-8511

Recruiting

National Hospital Organization Kinki Chuo Chest Medical Center

Osaka, Japan, 591-8555

Recruiting

Saitama Medical University

Saitama, Japan, 350-1298

Recruiting

SMG - SNU Boramae Medical Center

Dongjak-Gu, Korea, Republic of, 07061

Recruiting

Samsung Medical Center

Gangnam-Gu, Korea, Republic of, 6351

Recruiting

National Cancer Center

Goyang, Korea, Republic of, 410769

Recruiting

Chungbuk National University Hospital

Heungdeok-Gu, Korea, Republic of, 361-711

Recruiting

Inha University Hospital

Incheon, Korea, Republic of, 22332

Recruiting

Gachon University Gil Medical Center

Inchon, Korea, Republic of, 21565

Recruiting

Kosin University Gospel Hospital

Seo-gu, Korea, Republic of, 49267

Recruiting

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 03722

Recruiting

Asan Medical Center

Seoul, Korea, Republic of, 05505

Recruiting

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Korea, Republic of, 06591

Recruiting

Ajou University Hospital

Suwon-si, Korea, Republic of, 16499

Recruiting

The Catholic University of Korea, Saint Vincent's Hospital

Suwon, Korea, Republic of, 16247

Recruiting

Health Pharma Professional Research S.A. de C.V.

Mexico, Mexico, 3100

Recruiting

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Mitras Centro, Mexico, 64460

Recruiting

Oaxaca Site Management Organization

Oaxaca, Mexico, 68000

Recruiting

Centro de Investigacion Clinica de Oaxaca

Oaxaca, Mexico, 68020

Recruiting

Clinical Medical Research SC.

Orizaba Centro, Mexico, 94300

Recruiting

Clinica Integral Internacional de Oncologia S de RL de CV

Puebla, Mexico, 72530

Recruiting

FAICIC Clínical Research

Veracruz, Mexico, 91900

Recruiting

Amphia Ziekenhuis

Breda, Netherlands, 4818 CK

Recruiting

Ziekenhuis Gelderse Vallei

Ede, Netherlands, 6716 RP

Recruiting

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 GZ

Recruiting

Ziekenhuis St Jansdal

Harderwijk, Netherlands, 3844 DG

Recruiting

TweeSteden Ziekenhuis

Tilburg, Netherlands

Recruiting

Hospital Prof. Doutor Fernando Fonseca

Amadora, Portugal, 2720276

Recruiting

Instituto Português de Oncologia de Lisboa Francisco Gentil

Lisboa, Portugal, 1089

Recruiting

Fundacao Champalimaud

Lisboa, Portugal, 1400-038

Recruiting

Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente

Lisboa, Portugal

Recruiting

Hospital Beatriz Angelo. Hospital de Loures.

Lisbon, Portugal, 2674-514

Recruiting

Centro Hospitalar Universitario Sao Joao, EPE

Porto, Portugal, 4202-451

Recruiting

Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA

Senhora da Hora, Portugal, 4464-513

Recruiting

Raffles Hospital

Singapore, Singapore, 188770

Recruiting

Tang Tock Seng Hospital

Singapore, Singapore, 308433

Recruiting

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Recruiting

Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain, 08041

Recruiting

Hospital Universitari Dexeus (USP Institut Universitari Dexeus/Hospital Universitari Quiron Dexeus)

Barcelona, Spain, 8028

Recruiting

Hospital Universitari Vall D'Hebron

Barcelona, Spain, 8035

Recruiting

Hospital Parc Tauli

Barcelona, Spain, 8208

Recruiting

Hospital Universitario Reina Sofia

Cordoba, Spain, 14004

Recruiting

Hospital Doctor Josep Trueta

Girona, Spain, 17007

Recruiting

Hospital Universitario de Jaen

Jaen, Spain, 23007

Recruiting

Hospital Universitario de Canarias

Las Palmas de G.C., Spain, 35016

Recruiting

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain, 28020

Recruiting

Clinica Universidad de Navarra

Madrid, Spain, 28027

Recruiting

Hospital Universitario La Paz

Madrid, Spain, 28046

Recruiting

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Spain, 28222

Recruiting

Hospital Sant Joan de Reus

Reus, Spain, 43204

Recruiting

Hospital Regional Universitario de Malaga

Rincon de la Victoria, Spain, 29011

Recruiting

Hospital Universitario Virgen Macarena

Sevilla, Spain, 41009

Recruiting

Hospital Universitario Virgen del Rocio

Seville, Spain, 41014

Recruiting

Instituto Valenciano De Oncologia (IVO)

Valencia, Spain, 46009

Recruiting

Hospital Universitari i Politecnic La Fe

Valencia, Spain, 46015

Recruiting

Hospital Vithas Valencia 9 de Octubre

Valencia, Spain, 46015

Recruiting

Changhua Christian Hospital

Changhua City, Taiwan, 500-06

Recruiting

E-DA Hospital

Kaohsiung City, Taiwan, 824

Recruiting

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 807

Recruiting

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung, Taiwan, 83301

Recruiting

National Cheng Kung University Hospital

Tainan, Taiwan, 70403

Recruiting

Chi Mei Hospital, Liouying

Tainan, Taiwan

Recruiting

National Taiwan University Hospital

Taipei City, Taiwan, 100

Recruiting

Taipei Veterans General Hospital

Taipei, Taiwan, 10002

Recruiting

Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical Foundation

Taoyuan City, Taiwan, 33305

Recruiting

Ankara Bilkent Sehir Hastanesi

Ankara, Turkey, 06550

Recruiting

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, Turkey, 6200

Recruiting

Trakya University Faculty of Medicine

Edirne, Turkey, 22030

Recruiting

Istanbul University Cerrahpasa Medical Faculty Hospital

Fatih, Turkey, 34098

Recruiting

Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi

Istanbul, Turkey, 34093

Recruiting

Medipol Mega University Hospital

Istanbul, Turkey

Recruiting

Acibadem Mehmet Ali Aydinlar Universitesi Atakent Hastanesi

Kaakaekmece, Turkey, 34303

Recruiting

Turgut Ozal Medical Faculty

Malatya, Turkey, 44300

Recruiting

Colchester General Hospital

Colchester, United Kingdom, CO4 5JL

Recruiting

St Bartholomew's Hospital, Barts Health NHS Trust

London, United Kingdom, EC1A 7BE

Recruiting

University Hospital Southampton Nhs Foundation Trust

Southampton, United Kingdom, SO16 6YD