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NCT07221357PHASE2, PHASE3Recruiting

A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer

Bristol-Myers Squibb

Start Date

12/31/2025

Completion Date

3/11/2034

Summary

The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or metastatic colorectal cancer

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria * Participant must previously untreated, histologically confirmed recurrent or metastatic colorectal adenocarcinoma, not amenable to curative surgery. * Participant must have no known presence of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) per historical results (a validated test should be used). * Participant must have no known presence of the gene that encodes the protein B-Raf (BRAF) V600E mutation per local testing. * Participant must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Exclusion Criteria * Participant must not have any untreated known central nervous system (CNS) metastases including brain, leptomeningeal and/or spinal cord compression. * Participant must not have any prior malignancy active within the previous 2 years, except for locally curable cancers that have been apparently cured and considered to be of low risk of recurrence. * Participant must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, and/or ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome. * Participant must not have prior systemic treatment with an anti-PD-1, anti-programmed death (ligand)-1 (PD-L1), anti-PD-L2, CD137 agonists, or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways or chemotherapy. * Other protocol-defined Inclusion/Exclusion criteria apply.

Interventions

DRUG

Pumitamig

DRUG

FOLFOX

DRUG

FOLFIRI

DRUG

Bevacizumab

DRUG

CAPOX

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Conditions

Untreated, Unresectable, or Metastatic Colorectal Cancer

Locations

Local Institution - 0428

Tucson, Arizona 85724

United States

Highlands Oncology Group

Springdale, Arkansas 72762

United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

University of California, Irvine (UCI) Health - UC Irvine Medical Center

Orange, California 92868

United States

Local Institution - 0317

San Francisco, California 94115

United States

Local Institution - 0330

Santa Monica, California 90404

United States

Florida Cancer Specialists - East

Cape Coral, Florida 33990

United States

Florida Cancer Specialists - North

St. Petersburg, Florida 33705

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Local Institution - 0326

Atlanta, Georgia 30318

United States

Northside Hospital

Atlanta, Georgia 30342

United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Marietta, Georgia 30060

United States

Local Institution - 0433

Chicago, Illinois 60637

United States

Local Institution - 0638

Fort Wayne, Indiana 46805

United States

Local Institution - 0335

Iowa City, Iowa 52242

United States

Local Institution - 0262

Baltimore, Maryland 21287

United States

Maryland Oncology Hematology - Silver Spring

Silver Spring, Maryland 20904

United States

Local Institution - 0471

Boston, Massachusetts 02114

United States

Local Institution - 0430

Ann Arbor, Michigan 48109

United States

Local Institution - 0254

Grand Rapids, Michigan 49546

United States

Minnesota Oncology

Maple Grove, Minnesota 55369

United States

Local Institution - 0318

Kansas City, Missouri 64111

United States

Washington University School OF Medicine-Siteman Cancer Center

St Louis, Missouri 63110

United States

University Of Nebraska Medical Center

Omaha, Nebraska 68198

United States

Northwell Health/ RJ Zuckerberg Cancer Center

Lake Success, New York 11042

United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

Mineola, New York 11501

United States

New York Cancer and Blood Specialists

Shirley, New York 11967

United States

Local Institution - 0290

Charlotte, North Carolina 28207

United States

Sanford Fargo Medical Center

Fargo, North Dakota 58102

United States

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

Columbus, Ohio 43210

United States

Lehigh Valley Health Network

Allentown, Pennsylvania 18103

United States

Local Institution - 0604

Pittsburgh, Pennsylvania 15232

United States

Sanford Cancer Center

Sioux Falls, South Dakota 57104

United States

Local Institution - 0333

Nashville, Tennessee 37203

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Texas Oncology Dallas Fort Worth West (DFWW) - Arlington Cancer Center North

Arlington, Texas 76012

United States

Texas Oncology, PA

Austin, Texas 78705

United States

Baylor College of Medicine Medical Center

Houston, Texas 77030

United States

Texas Oncology - San Antonio

San Antonio, Texas 78240

United States

Local Institution - 0426

Salt Lake City, Utah 84102

United States

Local Institution - 0278

Fairfax, Virginia 22031

United States

Virginia Oncology Associates

Norfolk, Virginia 23502

United States

Local Institution - 0491

Edmonds, Washington 98026-8032

United States

Local Institution - 0253

Seattle, Washington 98109

United States

Local Institution - 0629

Spokane, Washington 99218

United States

Northwest Cancer Specialists, P.C.

Vancouver, Washington 98684

United States

Hospital Británico de Buenos Aires

CABA, Buenos Aires CP1280AEB

Argentina

Centro Médico Fleischer

Ciudad Autónoma de Buenos Aires, Buenos Aires C1414

Argentina

Instituto Alexander Fleming

Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ

Argentina

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D. C1199ABB

Argentina

Local Institution - 0632

San Miguel de Tucumán, Tucumán Province T4000IHE

Argentina

Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)

Buenos Aires, C1431FWO

Argentina

Local Institution - 0630

Córdoba, X5000JHQ

Argentina

Local Institution - 0643

Camperdown, New South Wales 2050

Australia

Liverpool Hospital

Liverpool, New South Wales 2170

Australia

GenesisCare St Leonards

St Leonards, New South Wales 2065

Australia

Westmead Hospital

Westmead, New South Wales 2145

Australia

Sunshine Coast University Hospital

Birtinya, Queensland 4575

Australia

Royal Brisbane and Women's Hospital

Brisbane, Queensland 4029

Australia

Gallipoli Medical Research Ltd

Brisbane, Queensland 4120

Australia

Flinders Medical Centre

Adelaide, South Australia 5042

Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia 5112

Australia

Grampians Health

Ballarat Central, Victoria 3350

Australia

Northern Hospital

Epping, Victoria 3076

Australia

Cabrini Hospital - Malvern

Malvern, Victoria 3144

Australia

Goulburn Valley Health

Shepparton, Victoria 3630

Australia

Western Health-Sunshine & Footscray Hospitals

St Albans, Victoria 3021

Australia

St. John of God Murdoch Hospital

Murdoch, Western Australia 6150

Australia

Local Institution - 0164

Feldkirch, 6800

Austria

Krankenhaus Der Barmherzigen Schwestern Linz

Linz, 4010

Austria

Universitaetsklinik Salzburg

Salzburg, 5020

Austria

Local Institution - 0176

Sankt Pölten, 3100

Austria

Local Institution - 0082

Vienna, 1090

Austria

Local Institution - 0622

Bonheiden, Antwerpen 2820

Belgium

Antwerp University Hospital

Edegem, Antwerpen 2650

Belgium

Cliniques universitaires Saint-Luc

Brussels, Bruxelles-Capitale, Région de 1200

Belgium

Local Institution - 0620

Charleroi, Hainaut 6060

Belgium

UZ Leuven

Leuven, Vlaams-Brabant 3000

Belgium

AZ Delta vzw

Roeselare, West-Vlaanderen 8800

Belgium

Local Institution - 0118

Brussels, 1000

Belgium

Local Institution - 0267

Curitiba, Paraná 81480-580

Brazil

Local Institution - 0331

Natal/RN, Rio Grande do Norte 59062-000

Brazil

Local Institution - 0375

Porto Alegre, Rio Grande do Sul 90035-903

Brazil

Local Institution - 0342

Porto Alegre, Rio Grande do Sul 90610000

Brazil

Local Institution - 0373

Santa Cruz do Sul, Rio Grande do Sul 96810-110

Brazil

Local Institution - 0444

Chapecó, Santa Catarina 89812-211

Brazil

Local Institution - 0266

Barretos, São Paulo 14784400

Brazil

Local Institution - 0264

São José do Rio Preto, 15090-000

Brazil

Local Institution - 0268

São Paulo, 01246-000

Brazil

Local Institution - 0341

São Paulo, 01308-060

Brazil

Local Institution - 0550

Calgary, Alberta T2N 5G2

Canada

Local Institution - 0260

Halifax, Nova Scotia B3H 3A7

Canada

Local Institution - 0255

Ottawa, Ontario K1H 8L6

Canada

Local Institution - 0424

Toronto, Ontario M4N 3M5

Canada

Local Institution - 0421

Toronto, Ontario M5G 2M9

Canada

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec H2X 3E4

Canada

Jewish General Hospital

Montreal, Quebec H3T 1E2

Canada

Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUS

Sherbrooke, Quebec J1H 5N4

Canada

Local Institution - 0171

Recoleta, Santiago Metropolitan 8420391

Chile

Local Institution - 0463

Santiago, Santiago Metropolitan 7500921

Chile

Local Institution - 0175

Santiago, Santiago Metropolitan 7620002

Chile

Local Institution - 0595

Hefei, Anhui 230601

China

Local Institution - 0499

Chongqing, Chongqing Municipality 400030

China

Local Institution - 0354

Fuzhou, Fujian 350014

China

Local Institution - 0388

Fuzhou Fujian, Fujian 350001

China

Local Institution - 0414

Guangzhou, Guangdong 510000

China

Local Institution - 0130

Guangzhou, Guangdong 510555

China

Local Institution - 0390

Tianjin, Hebei 300060

China

Local Institution - 0353

Harbin, Heilongjiang 150081

China

Local Institution - 0384

Nanyang, Henan 473009

China

Local Institution - 0412

Wuhan, Hubei 430022

China

Local Institution - 0391

Wuhan, Hubei 430079

China

Local Institution - 0376

Changsha, Hunan 410013

China

Local Institution - 0411

Changsha, Hunan 410031

China

Local Institution - 0398

Yangzhou, Jiangsu 225001

China

Local Institution - 0381

Nanchang, Jiangxi 330006

China

Local Institution - 0352

Shenyang, Liaoning 110001

China

Local Institution - 0355

Shenyang, Liaoning 110042

China

Local Institution - 0382

Jinan, Shandong 250117

China

Local Institution - 0378

Shanghai, Shanghai Municipality 200120

China

Local Institution - 0498

Chengdu, Sichuan 610041

China

Local Institution - 0360

Hangzhou, Zhejiang 310003

China

Local Institution - 0383

Hangzhou, Zhejiang 310022

China

Local Institution - 0409

Beijing, 100034

China

Local Institution - 0457

Hangzhou, 310009

China

Local Institution - 0416

Nanjing, Jiangsu, 210009

China

Local Institution - 0356

Shanghai, 200032

China

Masarykuv onkologicky ustav

Brno, Brno-město 656 53

Czechia

Local Institution - 0489

Prague, Praha 10 10034

Czechia

Fakultni nemocnice Motol a Homolka

Prague, Praha 5 150 06

Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05

Czechia

Local Institution - 0467

Olomouc, 77520

Czechia

Vseobecna fakultni nemocnice v Praze

Prague, 128 08

Czechia

CHU Bordeaux Haut-Leveque

Pessac, Aquitaine 33600

France

Local Institution - 0590

Besançon, Doubs 25000

France

CHU Rangueil

Toulouse, Haute-Garonne 31059

France

CHU Charles Nicolle

Rouen, Haute-Normandie 76031

France

Local Institution - 0182

Saint-Herblain, Loire-Atlantique 44805

France

Local Institution - 0618

Lorient, Morbihan 56100

France

Local Institution - 0613

Lille, Nord 59020

France

Local Institution - 0125

Nantes, Pays de la Loire Region 44093

France

Local Institution - 0121

Marseille, Provence-Alpes-Côte d'Azur Region 13273

France

Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand

Dijon, 21000

France

Local Institution - 0616

Limoges, 87042

France

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

Marseille, 13385

France

Hôpital Saint Antoine

Paris, 75571

France

Local Institution - 0634

Suresnes, 92151

France

Local Institution - 0098

Villejuif, 94805

France

Local Institution - 0591

Erlangen, Bavaria 91054

Germany

Local Institution - 0607

Hanover, Lower Saxony 30161

Germany

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Saxony 01307

Germany

Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin

Berlin, 10117

Germany

Local Institution - 0061

Bochum, 44791

Germany

Local Institution - 0588

Chemnitz, 09113

Germany

Marien Hospital Düsseldorf

Düsseldorf, 40479

Germany

Krankenhaus Nordwest GmbH

Frankfurt, 60488

Germany

Universitaetsmedizin Goettingen

Göttingen, 37075

Germany

Facharztzentrum Eppendorf

Hamburg, 20249

Germany

Local Institution - 0594

Hamburg, 22763

Germany

Universitatsklinikum Leipzig

Leipzig, D-04103

Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, 55131

Germany

Local Institution - 0059

Mannheim, 68167

Germany

Klinikum Neuperlach

München, 81737

Germany

Local Institution - 0037

Ulm, 89081

Germany

Local Institution - 0203

Veszprém, 8200

Hungary

Local Institution - 0010

Nashik, Dādra and Nagar Haveli and Damān and Diu 422001

India

Local Institution - 0036

Mumbai, Maharashtra 400012

India

Local Institution - 0552

Mumbai, Maharashtra 400036

India

Local Institution - 0554

Delhi, 110029

India

Local Institution - 0557

Puducherry, 605006

India

Local Institution - 0038

Pune, 411001

India

Local Institution - 0617

Castellana Grotte, Bari 70013

Italy

IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia 71013

Italy

Local Institution - 0619

Tricase, Lecce 73039

Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Milano 20162

Italy

Local Institution - 0614

Aviano, Pordenone 33081

Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany 56126

Italy

Istituto Oncologico Veneto IRCCS

Padova, Veneto 35128

Italy

Local Institution - 0609

Avellino, 83100

Italy

Local Institution - 0610

Bari, 70124

Italy

Azienda Ospedaliera Garibaldi

Catania, 95124

Italy

Local Institution - 0615

La Spezia, 19124

Italy

Local Institution - 0111

Milan, 20133

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Naples, 80131

Italy

Local Institution - 0612

Ravenna, 48121

Italy

Local Institution - 0233

Reggio Emilia, 42123

Italy

Local Institution - 0641

Toyoake, Aichi-ken 470-1192

Japan

Chiba cancer center

Chiba, Chiba 260-8717

Japan

National Cancer Center Hospital East

Kashiwa, Chiba 277-8577

Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime 791-0280

Japan

Hokkaido University Hospital

Sapporo, Hokkaido 0608648

Japan

Kobe City Medical Center General Hospital

Kobe, Hyōgo 650-0047

Japan

Local Institution - 0056

Yokohama, Kanagawa 2418515

Japan

Local Institution - 0476

Kurashiki, Okayama-ken 710-8602

Japan

The University of Osaka Hospital

Suita, Osaka 565-0871

Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka 569-8686

Japan

Saitama Medical University International Medical Center

Hidaka, Saitama 350-1298

Japan

Saitama Prefectural Cancer Center

Ina-machi, Saitama 362-0806

Japan

National Cancer Center Hospital

Chuo-ku, Tokyo 104-0045

Japan

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo 135-8550

Japan

Local Institution - 0642

Yamagata, Yamagata 990-9585

Japan

Local Institution - 0473

Chikusa-ku, 464-8681

Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395

Japan

Osaka International Cancer Institute

Osaka, 541-8567

Japan

Local Institution - 0067

Sendai, 980-8574

Japan

Local Institution - 0054

Sunto-gun, 411-8777

Japan

Local Institution - 0653

Chihuahua City, 31207

Mexico

Local Institution - 0559

Tlalpan, 14080

Mexico

Local Institution - 0173

Eindhoven, North Brabant 5623 EJ

Netherlands

Local Institution - 0112

Amsterdam, North Holland 1081 HV

Netherlands

Local Institution - 0170

Groningen, 9713 GZ

Netherlands

Local Institution - 0216

Tilburg, 5022 GC

Netherlands

Local Institution - 0167

Utrecht, 3543 AZ

Netherlands

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

Krakow, Lesser Poland Voivodeship 31-826

Poland

Luxmed Onkologia sp. z o. o.

Warsaw, Masovian Voivodeship 01-748

Poland

Państwowy Instytut Medyczny MSWiA

Warsaw, Masovian Voivodeship 02-507

Poland

Mazowiecki Szpital Onkologiczny

Wieliszew, Masovian Voivodeship 05-135

Poland

SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu

Opole, Opole Voivodeship 45-061

Poland

Local Institution - 0365

Brzozów, Podkarpackie Voivodeship 36-200

Poland

Local Institution - 0626

Gdansk, Pomeranian Voivodeship 80-219

Poland

Local Institution - 0451

Gliwice, Silesian Voivodeship 44-101

Poland

Local Institution - 0361

Koszalin, West Pomeranian Voivodeship 75-581

Poland

Wojewódzkie Centrum Szpitalne Kotliny Jeleniogórskiej

Jelenia Góra, 58-506

Poland

Fundeni Clinical Institute

Bucharest, Bucharest 022328

Romania

Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor

Cluj-Napoca, Cluj 400162

Romania

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj 200542

Romania

Institutul Oncologic Cluj

Cluj-Napoca, 400015

Romania

Local Institution - 0139

Floresti/ Cluj, 407280

Romania

S.C. Centrul de Oncologie Euroclinic S.R.L.

Iași, 700106

Romania

Institutul Regional de Oncologie

Iași, 700483

Romania

National Cancer Centre Singapore

Singapore, Central Singapore 168583

Singapore

Curie Oncology - Farrer

Singapore, Central Singapore 217562

Singapore

National University Hospital

Singapore, 119074

Singapore

Local Institution - 0285

Singapore, 308442

Singapore

Seoul National University Bundang Hospital

Seongnam, Gyeonggido 13620

South Korea

Local Institution - 0635

Goyang-si, Kyǒnggi-do 10408

South Korea

Local Institution - 0637

Seoul, Seoul-teukbyeolsi [Seoul] 02841

South Korea

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul] 03080

South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul] 03722

South Korea

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul] 05505

South Korea

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul] 06351

South Korea

The Catholic Univ. of Korea Seoul St. Mary's Hospital

Seoul, Seoul-teukbyeolsi [Seoul] 06591

South Korea

Local Institution - 0636

Deagu, Taegu-Kwangyǒkshi 41404

South Korea

Local Institution - 0593

Santiago de Compostela, A Coruña [La Coruña] 15706

Spain

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona] 08035

Spain

Local Institution - 0624

Madrid, Madrid, Comunidad de 28034

Spain

Local Institution - 0229

Madrid, Madrid, Comunidad de 28041

Spain

Complejo Hospitalario de Navarra

Pamplona, Navarre 31009

Spain

Institut Català d'Oncologia (ICO) - Badalona

Badalona, 08916

Spain

Local Institution - 0472

Elche (alicante), 03203

Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28007

Spain

H.R.U Málaga - Hospital General

Málaga, 29011

Spain

Local Institution - 0625

Salamanca, 37007

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain

Local Institution - 0301

Kaohsiung Niao Sung Dist, Kaohsiung 83301

Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333

Taiwan

Local Institution - 0020

Adana, 1370

Turkey (Türkiye)

Local Institution - 0065

Ankara, 06100

Turkey (Türkiye)

Local Institution - 0018

Erzurum, 25070

Turkey (Türkiye)

Local Institution - 0296

Istanbul, 34214

Turkey (Türkiye)

Local Institution - 0295

Kadiköy/Istanbul, 41380

Turkey (Türkiye)

Local Institution - 0640

Norwich, East NR47UY

United Kingdom

The Christie NHS Foundation Trust

Manchester, Lancashire M20 4BX

United Kingdom

Local Institution - 0600

Enfield, London EN28JL

United Kingdom

Local Institution - 0599

Metropolitan Borough of Wirral, Merseyside L63 4JY

United Kingdom

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire OX3 7LJ

United Kingdom

Local Institution - 0644

Guildford, South East GU27XX

United Kingdom

Local Institution - 0540

Birmingham, West Midlands B15 2TT

United Kingdom

Local Institution - 0601

Cardiff, CF14 2TL

United Kingdom

Local Institution - 0602

Dorchester, DT1 2JY

United Kingdom

Local Institution - 0307

Glasgow, G12 0YN

United Kingdom

Royal Marsden Hospital Sutton

London, SM2 5PT

United Kingdom

Local Institution - 0639

London, SW170QT

United Kingdom

Royal Marsden Hospital

London, SW3 6JJ

United Kingdom

Maidstone and Tunbridge Wells NHS Trust

Maidstone, ME16 9QQ

United Kingdom

Local Institution - 0310

Newcastle upon Tyne, NE7 7DN

United Kingdom