A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in... | NCT07221149 | Trialant

A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in... | NCT07221149 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria

Participants must be previously untreated with systemic treatment for advanced/metastatic disease, histologically or cytologically confirmed advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC) or distal esophageal adenocarcinoma (EAC). GEJ involvement can be confirmed via biopsy, endoscopy, or imaging.

Participants must have a documented programmed cell death-(ligand)1 (PD-L1) ≥ 1 or < 1 status for Phase 2, and document PD-L1 ≥ 1 status for the Phase 3 part of the study.

Participants must have documented human epidermal growth factor receptor 2 (HER2)-negative cancer, as determined according to local guidelines.

Participants must have measurable disease as defined by RECIST v1.1.

Exclusion Criteria

Participants must not have untreated known central nervous system (CNS) metastases.

Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.

Participants must not have evidence of major coagulation disorders (eg, hemophilia).

Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 3 months prior to randomization, unless the participant has been fully treated (eg, inferior vena cava filter placed) and/or adequately anticoagulated on a stable dose.

Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months of randomization.

Participants must not have had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study intervention.

Other protocol-defined Inclusion/Exclusion criteria apply.

Local Institution - 0284Not yet recruiting

Phoenix, Arizona 85054, United States

Site 0284Contact

Local Institution - 0437Not yet recruiting

Los Angeles, California 90033, United States

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

Orange, California 92868, United States

Local Institution - 0428Not yet recruiting

San Francisco, California 94158, United States

Florida Cancer Specialists - SouthRecruiting

Fort Myers, Florida 33901, United States

Local Institution - 0433Not yet recruiting

Jacksonville, Florida 32224, United States

Florida Cancer Specialists - NorthRecruiting

St. Petersburg, Florida 33701, United States

Moffitt Cancer CenterRecruiting

Tampa, Florida 33612, United States

Emory UniversityRecruiting

Atlanta, Georgia 30308, United States

Local Institution - 0379Not yet recruiting

Chicago, Illinois 60637, United States

Local Institution - 0268Not yet recruiting

Iowa City, Iowa 52242, United States

Local Institution - 0259Not yet recruiting

Rochester, Minnesota 55905, United States

Missouri Cancer AssociatesRecruiting

Columbia, Missouri 65201, United States

Local Institution - 0286Not yet recruiting

Omaha, Nebraska 68198, United States

Northwell Health/ RJ Zuckerberg Cancer CenterRecruiting

Lake Success, New York 11042, United States

Memorial Sloan Kettering Cancer CenterRecruiting

New York, New York 10065, United States

Local Institution - 0274Not yet recruiting

Rochester, New York 14642, United States

Local Institution - 0245Not yet recruiting

Chapel Hill, North Carolina 27599, United States

Local Institution - 0443Not yet recruiting

Cleveland, Ohio 44106, United States

Local Institution - 0222Not yet recruiting

Cleveland, Ohio 44195, United States

Oncology Associates Of Oregon, PcRecruiting

Eugene, Oregon 97401, United States

Northwest Cancer Specialists, P.C.Recruiting

Portland, Oregon 97213-2982, United States

UPMC Hillman Cancer CenterRecruiting

Pittsburgh, Pennsylvania 15232, United States

SCRI Oncology PartnersRecruiting

Nashville, Tennessee 37203, United States

Tennessee OncologyRecruiting

Nashville, Tennessee 37203, United States

Texas Oncology - Amarillo Cancer CenterRecruiting

Amarillo, Texas 79124, United States

Texas Oncology-Austin CentralRecruiting

Austin, Texas 78731, United States

Texas OncologyRecruiting

Beaumont, Texas 77702, United States

Texas Oncology - Northeast TexasRecruiting

Denison, Texas 75020, United States

Texas Oncology - DFWRecruiting

Grapevine, Texas 76051, United States

University of Texas MD Anderson Cancer CenterRecruiting

Houston, Texas 77030, United States

Texas Oncology - San AntonioRecruiting

San Antonio, Texas 78240, United States

Oncology and Hematology Associates of Southwest Virginia, Inc. - SalemRecruiting

Salem, Virginia 24153, United States

University of Wisconsin Carbone Cancer Center - University HospitalRecruiting

Madison, Wisconsin 53792, United States

Centro Médico FleischerRecruiting

Ciudad Autónoma de Buenos Aires, Buenos Aires C1414, Argentina

Guillermo Mendez, Site 0069Contact

+5491162691673

Instituto Alexander FlemingRecruiting

Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ, Argentina

Federico Esteso, Site 0061Contact

01132218900

Hospital Italiano de Buenos AiresRecruiting

ABB, Buenos Aires F.D. C1199ABB, Argentina

Maria Alicia Verzura, Site 0066Contact

54111555960279

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

Buenos Aires, C1431FWO, Argentina

Local Institution - 0176Not yet recruiting

Liverpool, New South Wales 2170, Australia

Sunshine Coast University HospitalRecruiting

Birtinya, Queensland 4575, Australia

Lyell McEwin HospitalRecruiting

Elizabeth Vale, South Australia 5112, Australia

Monash HealthRecruiting

Clayton, Victoria 3168, Australia

Warringal Medical CentreRecruiting

Melbourne, Victoria 3084, Australia

St. John of God Murdoch HospitalRecruiting

Murdoch, Western Australia 6150, Australia

Núcleo de Oncologia e Hematologia do CearáRecruiting

Fortaleza, Ceará 60115-281, Brazil

Centro de Investigação Clínica Ciências MédicasRecruiting

Belo Horizonte, Minas Gerais 30140-085, Brazil

Liga Norte Riograndense Contra o CâncerRecruiting

Natal, Rio Grande do Norte 59062-000, Brazil

Hospital de Clinicas de Porto AlegreRecruiting

Porto Alegre, Rio Grande do Sul 90035-903, Brazil

Clinica ViverRecruiting

Santa Maria, Rio Grande do Sul 97015-373, Brazil

Faculdade de Medicina de Sao Jose do Rio PretoRecruiting

São José do Rio Preto, 15090-000, Brazil

Local Institution - 0088Not yet recruiting

Calgary, Alberta T2N 5G2, Canada

Local Institution - 0119Not yet recruiting

Halifax, Nova Scotia B3H 3A7, Canada

Princess Margaret Cancer CentreRecruiting

Toronto, Ontario M5G 2M9, Canada

Local Institution - 0175Not yet recruiting

Sherbrooke, Quebec J1H 5N4, Canada

Local Institution - 0068Not yet recruiting

Santiago, Santiago Metropolitan 7500921, Chile

Local Institution - 0056Not yet recruiting

Santiago, Santiago Metropolitan 7710007, Chile

Local Institution - 0055Not yet recruiting

Santiago, Santiago Metropolitan 8420383, Chile

Beijing Cancer hospitalRecruiting

Beijing, Beijing Municipality 100142, China

Fujian Cancer HospitalRecruiting

Fuzhou, Fujian 350014, China

Local Institution - 0232Not yet recruiting

Guangzhou, Guangdong 510000, China

The Sixth Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Guangzhou, Guangdong 510655, China

Guangxi Medical University Affiliated Tumor HospitalRecruiting

Nanning, Guangxi 530200, China

Local Institution - 0237Not yet recruiting

Harbin, Heilongjiang 150081, China

Local Institution - 0282Not yet recruiting

Weihui, Henan 453100, China

Local Institution - 0249Not yet recruiting

Zhengzhou, Henan 450008, China

Local Institution - 0279Not yet recruiting

Wuhan, Hubei 430079, China

Local Institution - 0292Not yet recruiting

Changsha, Hunan 410031, China

Local Institution - 0256Not yet recruiting

Nanjing, Jiangsu 210009, China

Local Institution - 0440Not yet recruiting

Yangzhou, Jiangsu 225001, China

Local Institution - 0409Not yet recruiting

Nanchang, Jiangxi 330006, China

Local Institution - 0244Not yet recruiting

Shenyang, Liaoning 110042, China

Local Institution - 0273Not yet recruiting

Jinan, Shandong 250117, China

Shanghai East HospitalRecruiting

Shanghai, Shanghai Municipality 200120, China

Local Institution - 0243Not yet recruiting

Taiyuan, Shanxi 030001, China

Local Institution - 0260Not yet recruiting

Chengdu, Sichuan 610041, China

Local Institution - 0248Not yet recruiting

Tianjin, Tianjin Municipality 300060, China

Local Institution - 0408Not yet recruiting

Hangzhou, Zhejiang 310003, China

Local Institution - 0252Not yet recruiting

Hangzhou, Zhejiang 310052, China

Local Institution - 0269Not yet recruiting

Shanghai, 200032, China

Local Institution - 0399Not yet recruiting

Pasto, Departamento de Nariño 520001, Colombia

Local Institution - 0398Not yet recruiting

Cali, Valle del Cauca Department 760032, Colombia

Centre Leon BerardRecruiting

Lyon Cedex08, Auvergne-Rhône-Alpes 69373, France

Clelia Coutzac, Site 0058Contact

+33478785992

CHRU de BrestRecruiting

Brest, Finistère 29609, France

Hopital Claude Huriez - CHU de LilleRecruiting

Lille, Nord 59000, France

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-DieuRecruiting

Nantes, Pays de la Loire Region 44093, France

Centre Hospitalier Universitaire de PoitiersRecruiting

Poitiers, Vienne 86021, France

Local Institution - 0060Not yet recruiting

Marseille, 13385, France

Hôpital Européen Georges PompidouRecruiting

Paris, 75015, France

Charité - Universitaetsmedizin Berlin - Campus Bejnamin FranklinRecruiting

Berlin, 10117, Germany

Krankenhaus Nordwest GmbHRecruiting

Frankfurt, 60488, Germany

Facharztzentrum EppendorfRecruiting

Hamburg, 20249, Germany

Nationales Centrum Fur Tumorerkrankungen (Nct)Recruiting

Heidelberg, 69120, Germany

Local Institution - 0112Not yet recruiting

Leipzig, 04103, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet MainzRecruiting

Mainz, 55131, Germany

Universitätsmedizin MannheimRecruiting

Mannheim, 68167, Germany

Universitaetsklinikum UlmRecruiting

Ulm, 89081, Germany

Local Institution - 0306Not yet recruiting

Nashik, Dādra and Nagar Haveli and Damān and Diu 422001, India

Local Institution - 0305Not yet recruiting

Mumbai, Maharashtra 400012, India

Local Institution - 0403Not yet recruiting

Delhi, 110029, India

Local Institution - 0302Not yet recruiting

Puducherry, 605006, India

Local Institution - 0310Not yet recruiting

Pune, 411001, India

AOU della Campania Luigi VanvitelliRecruiting

Naples, Campania 80138, Italy

Local Institution - 0166Not yet recruiting

Turin, Piedmont 10126, Italy

Istituto Oncologico Veneto IRCCSRecruiting

Padova, Veneto 35128, Italy

Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting

Milan, 20133, Italy

Ospedale San RaffaeleRecruiting

Milan, 20132, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro CuoreRecruiting

Roma, 00168, Italy

Aichi Cancer Center HospitalRecruiting

Nagoya, Aichi-ken 464-8681, Japan

Local Institution - 0014Not yet recruiting

Chiba, Chiba 260-8717, Japan

National Cancer Center Hospital EastRecruiting

Kashiwa, Chiba 277-8577, Japan

Local Institution - 0012Not yet recruiting

Matsuyama, Ehime 791-0280, Japan

Local Institution - 0015Not yet recruiting

Yokohama, Kanagawa 2418515, Japan

Local Institution - 0029Not yet recruiting

Kurashiki, Okayama-ken 710-8602, Japan

Local Institution - 0004Not yet recruiting

Osaka, Osaka 5418567, Japan

The University of Osaka HospitalRecruiting

Suita, Osaka 565-0871, Japan

Local Institution - 0376Not yet recruiting

Takatsuki, Osaka 569-8686, Japan

Local Institution - 0026Not yet recruiting

Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777, Japan

Site 0026Contact

National Cancer Center HospitalRecruiting

Chuo-ku, Tokyo 104-0045, Japan

Hirokazu Shoji, Site 0003Contact

81335422511

The Cancer Institute Hospital of JFCRRecruiting

Koto-ku, Tokyo 135-8550, Japan

Kensei Yamaguchi, Site 0008Contact

81335200111

Local Institution - 0006Not yet recruiting

Gifu, 501-1194, Japan

Local Institution - 0002Not yet recruiting

Minami-Ku, Fukuoka, 811-1347, Japan

Site 0002Contact

Local Institution - 0024Not yet recruiting

Sendai, 980-8574, Japan

Local Institution - 0396Not yet recruiting

Mexico City, DIF 03100, Mexico

Local Institution - 0395Not yet recruiting

Mexico City, Mexico City 14000, Mexico

Local Institution - 0397Not yet recruiting

Mexico City, Mexico City 14000, Mexico

Local Institution - 0394Not yet recruiting

Oaxaca City, Oaxaca 68020, Mexico

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w WarszawieRecruiting

Warsaw, Masovian Voivodeship 02-034, Poland

Mazowiecki Szpital OnkologicznyRecruiting

Warsaw, Masovian Voivodeship 03-411, Poland

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

Opole, Opole Voivodeship 45-061, Poland

Wojewódzkie Centrum Szpitalne Kotliny JeleniogórskiejRecruiting

Jelenia Góra, 58-506, Poland

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

Cluj-Napoca, Cluj 400162, Romania

SC Radiotherapy Center Cluj SRLRecruiting

Florești, Cluj 407280, Romania

Andrei Ungureanu, Site 0030Contact

40742206212

Centrul de Oncologie "Sfântul Nectarie"Recruiting

Craiova, Dolj 200542, Romania

Institutul Oncologic ClujRecruiting

Cluj-Napoca, 400015, Romania

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

Iași, 700106, Romania

Institutul Regional de OncologieRecruiting

Iași, 700483, Romania

Seoul National University Bundang HospitalRecruiting

Seongnam, Kyǒnggi-do 13620, South Korea

Seoul National University HospitalRecruiting

Seoul, Seoul-teukbyeolsi [Seoul] 03080, South Korea

Severance Hospital, Yonsei University Health SystemRecruiting

Seoul, Seoul-teukbyeolsi [Seoul] 03722, South Korea

Asan Medical CenterRecruiting

Seoul, Seoul-teukbyeolsi [Seoul] 05505, South Korea

Samsung Medical CenterRecruiting

Seoul, Seoul-teukbyeolsi [Seoul] 06351, South Korea

Local Institution - 0388Not yet recruiting

Barcelona, Barcelona [Barcelona] 08035, Spain

Hospital Universitario Marqués de ValdecillaRecruiting

Santander, Cantabria 39008, Spain

Complejo Hospitalario de NavarraRecruiting

Pamplona, Navarre 31009, Spain

Hospital Clinico de ValenciaRecruiting

Valencia, Valenciana, Comunitat 46010, Spain

Hospital General Universitario Gregorio MarañonRecruiting

Madrid, 28007, Spain

Hospital Clinico San CarlosRecruiting

Madrid, 28040, Spain

Hospital Universitario La PazRecruiting

Madrid, 28046, Spain

H.R.U Málaga - Hospital GeneralRecruiting

Málaga, 29011, Spain

Local Institution - 0111Not yet recruiting

Ankara, 06230, Turkey (Türkiye)

Local Institution - 0108Not yet recruiting

Edirne, 22030, Turkey (Türkiye)

Local Institution - 0125Not yet recruiting

Kadiköy/Istanbul, 41380, Turkey (Türkiye)

Site 0125Contact

Local Institution - 0093Not yet recruiting

Manisa, 45030, Turkey (Türkiye)

Local Institution - 0128Not yet recruiting

Sakarya, 54100, Turkey (Türkiye)

St Bartholomew's HospitalRecruiting

London, London, City of EC1A 7BE, United Kingdom

Oxford University Hospitals NHS TrustRecruiting

Oxford, Oxfordshire OX3 7LJ, United Kingdom

The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - SuttonRecruiting

Sutton, Surrey SM2 5PT, United Kingdom

Local Institution - 0354Not yet recruiting

Glasgow, G12 0YN, United Kingdom

Royal Marsden HospitalRecruiting

London, SW3 6JJ, United Kingdom

The Christie NHS Foundation TrustRecruiting

Manchester, M20 4BX, United Kingdom

Local Institution - 0300Not yet recruiting

Site 0300Contact