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NCT07221149RecruitingPhase 2/3

A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204)

ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the safety and efficacy of Pumitamig in combination with chemotherapy versus Nivolumab in combination with chemotherapy in participants with previously untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
690 (estimated)
First submitted
23 Oct 2025
Start date
13 Mar 2026
Primary completion date
8 Nov 2030
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT07221149
EU CT number
2025-523263-37-00
EudraCT number
2025-523263-37

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 690
  • From 13 Mar 2026 to the primary completion date, 8 Nov 2030
  • 162 sites in 20 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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 illness

  • Participants must not have evidence of major coagulation disorders (eg, hemophilia).
  • Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months of randomization.

Lab values

  • 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.

Other

  • Participants must not have untreated known central nervous system (CNS) metastases.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (162)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Italiano de Buenos Aires
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ABBArgentinaRecruiting
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
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Buenos AiresArgentinaRecruiting
Centro Médico Fleischer
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Ciudad Autónoma de Buenos AiresArgentinaRecruiting
Instituto Alexander Fleming
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Ciudad Autónoma de Buenos AiresArgentinaRecruiting
Sunshine Coast University Hospital
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BirtinyaAustraliaRecruiting
Monash Health
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ClaytonAustraliaRecruiting
Lyell McEwin Hospital
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Elizabeth ValeAustraliaRecruiting
Liverpool Hospital
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LiverpoolAustraliaRecruiting
Warringal Medical Centre
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MelbourneAustraliaRecruiting
St John of God Murdoch Hospital
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MurdochAustraliaRecruiting
Centro de Investigação Clínica Ciências Médicas
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Belo HorizonteBrazilRecruiting
Núcleo de Oncologia e Hematologia do Ceará
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FortalezaBrazilRecruiting
Liga Norte Riograndense Contra o Cancer
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NatalBrazilRecruiting
Hospital de Clinicas de Porto Alegre
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Porto AlegreBrazilRecruiting
Clinica Viver
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Santa MariaBrazilRecruiting
Faculdade de Medicina de Sao Jose do Rio Preto
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São José do Rio PretoBrazilRecruiting
Arthur J.E. Child Comprehensive Cancer Centre
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CalgaryCanadaRecruiting
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HalifaxCanadaNot yet recruiting
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SherbrookeCanadaNot yet recruiting
Princess Margaret Cancer Centre
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TorontoCanadaRecruiting
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SantiagoChileNot yet recruiting
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SantiagoChileNot yet recruiting
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SantiagoChileNot yet recruiting
Beijing Cancer Hospital
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BeijingChinaRecruiting
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ChangshaChinaNot yet recruiting
-
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ChengduChinaNot yet recruiting
Fujian Cancer Hospital
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FuzhouChinaRecruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
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GuangzhouChinaRecruiting
-
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GuangzhouChinaNot yet recruiting
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HangzhouChinaNot yet recruiting
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HangzhouChinaNot yet recruiting
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HarbinChinaNot yet recruiting
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JinanChinaNot yet recruiting
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NanchangChinaNot yet recruiting
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NanjingChinaNot yet recruiting
Guangxi Medical University Affiliated Tumor Hospital
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NanningChinaRecruiting
-
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ShanghaiChinaNot yet recruiting
Shanghai East Hospital
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ShanghaiChinaRecruiting
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ShenyangChinaNot yet recruiting
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TaiyuanChinaNot yet recruiting
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TianjinChinaNot yet recruiting
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WeihuiChinaNot yet recruiting
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WuhanChinaNot yet recruiting
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YangzhouChinaNot yet recruiting
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ZhengzhouChinaNot yet recruiting
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CaliColombiaNot yet recruiting
-
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PastoColombiaNot yet recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Krankenhaus Nordwest GmbH
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Frankfurt am MainGermanyRecruiting
Haematologisch Onkologische Praxis Eppendorf
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HamburgGermanyRecruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyRecruiting
Universitaet Leipzig
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LeipzigGermanyRecruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyRecruiting
Heidelberg University
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MannheimGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Clínico San Carlos
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MadridSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario Regional de Málaga
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MálagaSpainRecruiting
Hospital Universitario de Navarra
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PamplonaSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainRecruiting
Centre Hospitalier Régional et Universitaire de Brest
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BrestFranceRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Centre Leon Berard
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LyonFranceRecruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceRecruiting
-
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GlasgowUnited KingdomNot yet recruiting
St. Bartholomew's Hospital
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LondonUnited KingdomRecruiting
Royal Marsden Hospital
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LondonUnited KingdomRecruiting
The Christie NHS Foundation Trust
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ManchesterUnited KingdomRecruiting
Oxford University Hospitals NHS Trust
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OxfordUnited KingdomRecruiting
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton
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SuttonUnited KingdomRecruiting
-
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DelhiIndiaNot yet recruiting
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MumbaiIndiaNot yet recruiting
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NashikIndiaNot yet recruiting
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PuducherryIndiaNot yet recruiting
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PuneIndiaNot yet recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyRecruiting
Istituto Oncologico Veneto
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PadovaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyRecruiting
-
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ChibaJapanNot yet recruiting
National Cancer Center Hospital
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Chuo KuJapanRecruiting
Gifu University Hospital
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GifuJapanRecruiting
National Cancer Center Hospital East
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KashiwaJapanRecruiting
The Cancer Institute Hospital of JFCR
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Koto-kuJapanRecruiting
-
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KurashikiJapanNot yet recruiting
-
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MatsuyamaJapanNot yet recruiting
-
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Minami-Ku, FukuokaJapanNot yet recruiting
Shizuoka Cancer Center
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Nagaizumi-cho,Sunto-gunJapanRecruiting
Aichi Cancer Center Hospital
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NagoyaJapanRecruiting
-
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OsakaJapanNot yet recruiting
-
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SendaiJapanNot yet recruiting
The University of Osaka Hospital
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SuitaJapanRecruiting
-
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TakatsukiJapanNot yet recruiting
Kanagawa Cancer Center
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YokohamaJapanRecruiting
Seoul National University Bundang Hospital
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SeongnamSouth KoreaRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
-
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Mexico CityMexicoNot yet recruiting
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Mexico CityMexicoNot yet recruiting
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Mexico CityMexicoNot yet recruiting
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Oaxaca CityMexicoNot yet recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
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GliwicePolandRecruiting
Wojewódzkie Centrum Szpitalne Kotliny Jeleniogórskiej
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Jelenia GóraPolandRecruiting
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
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OpolePolandRecruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
Mazowiecki Szpital Onkologiczny Sp. z o.o.
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WieliszewPolandRecruiting
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaRecruiting
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj
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Cluj-NapocaRomaniaRecruiting
Centrul De Oncologie SF Nectarie S.R.L.
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CraiovaRomaniaRecruiting
Radiotherapy Center Cluj S.R.L.
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FlorestiRomaniaRecruiting
Centrul De Oncologie-Euroclinic S.R.L.
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IasiRomaniaRecruiting
Institutul Regional de Oncologie Iasi
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IașiRomaniaRecruiting
Texas Oncology - Amarillo Cancer Center
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AmarilloUnited StatesRecruiting
Emory University
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AtlantaUnited StatesRecruiting
Texas Oncology - Austin Central
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AustinUnited StatesRecruiting
Texas Oncology
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BeaumontUnited StatesRecruiting
University of North Carolina Medical Center
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Chapel HillUnited StatesRecruiting
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ChicagoUnited StatesNot yet recruiting
Cleveland Clinic
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ClevelandUnited StatesRecruiting
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ClevelandUnited StatesNot yet recruiting
Missouri Cancer Associates
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ColumbiaUnited StatesRecruiting
Texas Oncology - Northeast Texas
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DenisonUnited StatesRecruiting
Oncology Associates Of Oregon, Pc
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EugeneUnited StatesRecruiting
Florida Cancer Specialists - South
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Fort MyersUnited StatesRecruiting
Texas Oncology - DFW
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GrapevineUnited StatesRecruiting
University of Texas - MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
-
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Iowa CityUnited StatesNot yet recruiting
Mayo Clinic in Florida
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JacksonvilleUnited StatesRecruiting
Northwell Health/ RJ Zuckerberg Cancer Center
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Lake SuccessUnited StatesRecruiting
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - University Hospital
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MadisonUnited StatesRecruiting
Tennessee Oncology
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NashvilleUnited StatesRecruiting
SCRI Oncology Partners
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NashvilleUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
University of Nebraska Medical Center
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OmahaUnited StatesRecruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center
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OrangeUnited StatesRecruiting
Mayo Clinic in Arizona - Phoenix
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PhoenixUnited StatesRecruiting
UPMC Hillman Cancer Center
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PittsburghUnited StatesRecruiting
Northwest Cancer Specialists, P.C.
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PortlandUnited StatesRecruiting
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RochesterUnited StatesNot yet recruiting
Mayo Clinic in Rochester, Minnesota
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RochesterUnited StatesRecruiting
Oncology and Hematology Associates of Southwest Virginia, Inc. - Salem
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SalemUnited StatesRecruiting
Texas Oncology - San Antonio
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San AntonioUnited StatesRecruiting
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San FranciscoUnited StatesNot yet recruiting
Florida Cancer Specialists - North
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St. PetersburgUnited StatesRecruiting
Moffitt Cancer Center
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TampaUnited StatesRecruiting
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AnkaraTurkey (Türkiye)Not yet recruiting
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EdirneTurkey (Türkiye)Not yet recruiting
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Kadiköy/IstanbulTurkey (Türkiye)Not yet recruiting
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ManisaTurkey (Türkiye)Not yet recruiting
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SakaryaTurkey (Türkiye)Not yet recruiting
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--Not yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.