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NCT03635983CompletedPhase 3

A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma

Source: ClinicalTrials.gov · Last updated 1 Apr 2025

Brief summary (registry, in English)

The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
783 (actual)
First submitted
16 Aug 2018
Start date
21 Sept 2018
Primary completion date
19 Nov 2021
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT03635983
EudraCT number
2018-001423-40

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 783
  • From 21 Sept 2018 to the primary completion date, 19 Nov 2021
  • 167 sites in 27 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.

Other illness

  • Participants with an active, known or suspected autoimmune disease
    • Other protocol defined inclusion/exclusion criteria apply

Other

  • Active brain metastases or leptomeningeal metastases
  • Uveal melanoma

Who the study is looking for

  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only)
  • Histologically confirmed stage III (unresectable) or stage IV melanoma
  • Treatment-naive participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant and/or neoadjuvant treatment for melanoma with approved agents

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (167)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
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Buenos AiresArgentinaUnknown status
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Buenos AiresArgentinaUnknown status
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CABAArgentinaUnknown status
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Ciudad Autonoma de Buenos AiresArgentinaUnknown status
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CórdobaArgentinaUnknown status
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GrazAustriaUnknown status
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SalzburgAustriaUnknown status
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ViennaAustriaUnknown status
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CairnsAustraliaUnknown status
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Coffs HarbourAustraliaUnknown status
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Elizabeth ValeAustraliaUnknown status
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GreenslopesAustraliaUnknown status
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MelbourneAustraliaUnknown status
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MelbourneAustraliaUnknown status
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NedlandsAustraliaUnknown status
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NedlandsAustraliaUnknown status
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North SydneyAustraliaUnknown status
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WoolloongabbaAustraliaUnknown status
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BrusselsBelgiumUnknown status
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HasseltBelgiumUnknown status
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LeuvenBelgiumUnknown status
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BarretosBrazilUnknown status
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Belo HorizonteBrazilUnknown status
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FortalezaBrazilUnknown status
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IjuíBrazilUnknown status
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ItajaíBrazilUnknown status
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Porto AlegreBrazilUnknown status
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Rio de JaneiroBrazilUnknown status
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São PauloBrazilUnknown status
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Abbotsford British ColumbiaCanadaUnknown status
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EdmontonCanadaUnknown status
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HamiltonCanadaUnknown status
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KitchenerCanadaUnknown status
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QuébecCanadaUnknown status
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St. John'sCanadaUnknown status
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TorontoCanadaUnknown status
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BernSwitzerlandUnknown status
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LausanneSwitzerlandUnknown status
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ZurichSwitzerlandUnknown status
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RecoletaChileUnknown status
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SantiagoChileUnknown status
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BrnoCzechiaUnknown status
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Hradec KrálovéCzechiaUnknown status
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PragueCzechiaUnknown status
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PragueCzechiaUnknown status
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BuxtehudeGermanyUnknown status
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DresdenGermanyUnknown status
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ErfurtGermanyUnknown status
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EssenGermanyUnknown status
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GöttingenGermanyUnknown status
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HamburgGermanyUnknown status
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HanoverGermanyUnknown status
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HeidelbergGermanyUnknown status
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KielGermanyUnknown status
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LeipzigGermanyUnknown status
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MünchenGermanyUnknown status
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MünsterGermanyUnknown status
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RegensburgGermanyUnknown status
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TübingenGermanyUnknown status
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WürzburgGermanyUnknown status
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BarcelonaSpainUnknown status
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BarcelonaSpainUnknown status
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CórdobaSpainUnknown status
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Doniostia - San SebastianSpainUnknown status
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Donostia / San SebastianSpainUnknown status
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JaénSpainUnknown status
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MadridSpainUnknown status
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Santiago CompostelaSpainUnknown status
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ValenciaSpainUnknown status
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KYSFinlandUnknown status
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TampereFinlandUnknown status
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TurkuFinlandUnknown status
Centre Hospitalier Universitaire de Bordeaux Hospital Saint Andre
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BordeauxFranceUnknown status
Hopital Claude Huriez
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LilleFranceUnknown status
Hôpital Saint Eloi
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MontpellierFranceUnknown status
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NantesFranceUnknown status
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NiceFranceUnknown status
Hopital Saint Louis
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ParisFranceUnknown status
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceUnknown status
CHU Charles Nicolle
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RouenFranceUnknown status
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Saint-Priest-en-JarezFranceUnknown status
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ToulouseFranceUnknown status
Institute Gustave Roussy
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VillejuifFranceUnknown status
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BelfastUnited KingdomUnknown status
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CambridgeUnited KingdomUnknown status
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CottinghamUnited KingdomUnknown status
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EdinburghUnited KingdomUnknown status
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LiverpoolUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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ManchesterUnited KingdomUnknown status
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SouthamptonUnited KingdomUnknown status
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SuttonUnited KingdomUnknown status
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TautonUnited KingdomUnknown status
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AthensGreeceUnknown status
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Neo FaliroGreeceUnknown status
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ThessalonikiGreeceUnknown status
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DublinIrelandUnknown status
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DublinIrelandUnknown status
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DublinIrelandUnknown status
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WiltonIrelandUnknown status
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BeershebaIsraelUnknown status
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JerusalemIsraelUnknown status
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Ramat GanIsraelUnknown status
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BariItalyUnknown status
Asst Papa Giovanni XXIII
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BergamoItalyUnknown status
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Meldola (FC)ItalyUnknown status
IRCCS Istituto Nazionale Tumori Milano
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MilanItalyUnknown status
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MilanItalyUnknown status
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NaplesItalyUnknown status
Istituto Oncologico Veneto (IOV)
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PadovaItalyUnknown status
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SienaItalyUnknown status
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
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TorinoItalyUnknown status
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyUnknown status
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CancúnMexicoUnknown status
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Mexico CityMexicoUnknown status
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MonterreyMexicoUnknown status
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MonterreyMexicoUnknown status
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Puebla CityMexicoUnknown status
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San Luis Potosí CityMexicoUnknown status
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ZapopanMexicoUnknown status
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AmsterdamNetherlandsUnknown status
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AmsterdamNetherlandsUnknown status
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LeidenNetherlandsUnknown status
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NijmegenNetherlandsUnknown status
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UntrechtNetherlandsUnknown status
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AucklandNew ZealandUnknown status
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ChristchurchNew ZealandUnknown status
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WellingtonNew ZealandUnknown status
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BydgoszczPolandUnknown status
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WarsawPolandUnknown status
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LisbonPortugalUnknown status
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PortoPortugalUnknown status
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BucharestRomaniaUnknown status
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Cluj-NapocaRomaniaUnknown status
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CraiovaRomaniaUnknown status
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FloreştiRomaniaUnknown status
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KrasnoyarskRussiaUnknown status
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MoscowRussiaUnknown status
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MoscowRussiaUnknown status
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MoscowRussiaUnknown status
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GothenburgSwedenUnknown status
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LundSwedenUnknown status
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Ann ArborUnited StatesUnknown status
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AtlantaUnited StatesUnknown status
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AuroraUnited StatesUnknown status
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BostonUnited StatesUnknown status
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ClevelandUnited StatesUnknown status
St. Luke's Hospital & Health Network
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EastonUnited StatesUnknown status
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FairfaxUnited StatesUnknown status
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FridleyUnited StatesUnknown status
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HackensackUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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La JollaUnited StatesUnknown status
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LouisvilleUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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Miami BeachUnited StatesUnknown status
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New BrunswickUnited StatesUnknown status
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New HavenUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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PhiladelphiaUnited StatesUnknown status
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PortlandUnited StatesUnknown status
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PortlandUnited StatesUnknown status
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StanfordUnited StatesUnknown status
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St LouisUnited StatesUnknown status
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TampaUnited StatesUnknown status
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TucsonUnited StatesUnknown status

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