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NCT04008030Active, not recruitingPhase 3

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

A Phase 3 Randomized Clinical Trial of Nivolumab Alone, Nivolumab in Combination With Ipilimumab, or Investigator's Choice Chemotherapy in Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer

Source: ClinicalTrials.gov · Last updated 20 Aug 2026

Brief summary (registry, in English)

The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
839 (actual)
First submitted
2 Jul 2019
Start date
5 Aug 2019
Primary completion date
28 Aug 2024
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT04008030
EU CT number
2023-503956-29-00
EudraCT number
2018-000040-26

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 839
  • From 5 Aug 2019 to the primary completion date, 28 Aug 2024
  • 147 sites in 24 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

  • An active, known or suspected autoimmune disease
  • History of interstitial lung disease or pneumonitis
  • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
    • Other protocol-defined inclusion/exclusion criteria apply

Who the study is looking for

  • Histologically confirmed recurrent or metastatic colorectal cancer (CRC) irrespective of prior treatment history with chemotherapy and/or targeted agents not amenable to surgery (Applicable only during Part 1 enrollment of the study)
  • Histologically confirmed recurrent or metastatic CRC with no prior treatment history with chemotherapy and/or targeted agents for metastatic disease and not amenable to surgery (Applicable during Part 2 enrollment of the study)
  • Known tumor microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status per local standard of practice
  • Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1

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

Full criteria on ClinicalTrials.gov

Sites (147)

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

SiteCityCountrySite status
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Buenos AiresArgentinaUnknown status
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CABAArgentinaUnknown status
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CABAArgentinaUnknown status
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Ciudad Autonoma Beunos AiresArgentinaUnknown status
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ViedmaArgentinaUnknown status
Medical University of Graz
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GrazAustriaCompleted
Krankenhaus der Barmherzigen Schwestern
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LinzAustriaCompleted
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
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SalzburgAustriaCompleted
Medical University of Vienna
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ViennaAustriaCompleted
Landesklinikum Wiener Neustadt
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Wiener NeustadtAustriaCompleted
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ClaytonAustraliaUnknown status
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Elizabeth ValeAustraliaUnknown status
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HeidelbergAustraliaUnknown status
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WestmeadAustraliaUnknown status
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WoolloongabbaAustraliaUnknown status
Institut Jules Bordet
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AnderlechtBelgiumCompleted
Imelda
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BonheidenBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
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BarretosBrazilUnknown status
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IpatingaBrazilUnknown status
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NatalBrazilUnknown status
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Porto AlegreBrazilUnknown status
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Rio de JaneiroBrazilUnknown status
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São José do Rio PretoBrazilUnknown status
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São PauloBrazilUnknown status
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São PauloBrazilUnknown status
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EdmontonCanadaUnknown status
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MontrealCanadaUnknown status
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SherbrookeCanadaUnknown status
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TorontoCanadaUnknown status
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VancouverCanadaUnknown status
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IndependenciaChileUnknown status
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SantiagoChileUnknown status
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SantiagoChileUnknown status
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ChangchunChinaUnknown status
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ChangshaChinaUnknown status
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ChangzhouChinaUnknown status
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FoshanChinaUnknown status
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GuangzhouChinaUnknown status
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GuangzhouChinaUnknown status
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GuangzhouChinaUnknown status
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HangzhouChinaUnknown status
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HarbinChinaUnknown status
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HefeiChinaUnknown status
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JinanChinaUnknown status
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KunmingChinaUnknown status
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LanzhouChinaUnknown status
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LinyiChinaUnknown status
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NanchangChinaUnknown status
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NanningChinaUnknown status
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NanningChinaUnknown status
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NingboChinaUnknown status
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QingdaoChinaUnknown status
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ShanghaiChinaUnknown status
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ShanghaiChinaUnknown status
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ShanghaiChinaUnknown status
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ShenyangChinaUnknown status
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XiamenChinaUnknown status
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Xi'anChinaUnknown status
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YantaiChinaUnknown status
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ZhangzhouChinaUnknown status
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ZhengzhouChinaUnknown status
Masarykuv Onkologicky Ustav
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Brno-StredCzechiaCompleted
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaCompleted
University Hospital Olomouc
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OlomoucCzechiaCompleted
Technische Universität Dresden
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DresdenGermanyCompleted
Universitaetsklinikum Essen (AoR)
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EssenGermanyCompleted
Asklepios Klinik Altona
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HamburgGermanyCompleted
Haematologisch Onkologische Praxis Eppendorf
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HamburgGermanyCompleted
Medizinische Hochschule Hannover Service GmbH
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HanoverGermanyCompleted
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyCompleted
Philipps University Marburg
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MarburgGermanyCompleted
Klinikum der Universitaet Muenchen AöR
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MunichGermanyCompleted
Herlev Hospital
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HerlevDenmarkCompleted
Sygehus Lillebaelt - Vejle Sygehus
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VejleDenmarkCompleted
Complejo Universitario Juan Canalejo
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A CorunaSpainCompleted
Catalan Institute of Oncology
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BadalonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Regional de Málaga
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MálagaSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Hospital General Universitario de Valencia
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ValenciaSpainCompleted
Besancon University Hospital Center
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Besancon CedexFranceCompleted
Centre Oscar Lambret
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LilleFranceCompleted
Centre Hospitalier Et Universitaire de Limoges
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LimogesFranceCompleted
Centre Leon Berard
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LyonFranceCompleted
Centre Hospitalier Regional De Marseille
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MarseilleFranceCompleted
Institut Regional Du Cancer De Montpellier
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Montpellier Cedex 5FranceCompleted
Centre Hospitalier Universitaire de Nantes
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NantesFranceCompleted
Hopital Saint Antoine
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Paris Cedex 12FranceCompleted
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceCompleted
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceCompleted
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceCompleted
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LondonUnited KingdomUnknown status
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OxfordUnited KingdomUnknown status
Athens Medical Center S.A.
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AthensGreeceCompleted
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
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CholargosGreeceCompleted
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DublinIrelandUnknown status
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DublinIrelandUnknown status
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LimerickIrelandUnknown status
Ospedale Garibaldi
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CataniaItalyCompleted
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyCompleted
Istituto Oncologico Veneto
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PadovaItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
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ChibaJapanUnknown status
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Chuo-kuJapanUnknown status
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FukuokaJapanUnknown status
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HidakaJapanUnknown status
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KanazawaJapanUnknown status
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Kashiwa-shiJapanUnknown status
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KawasakiJapanUnknown status
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KitaadachigunJapanUnknown status
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Koto-kuJapanUnknown status
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KumamotoJapanUnknown status
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KurashikiJapanUnknown status
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MatsuyamaJapanUnknown status
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Minato-kuJapanUnknown status
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NagoyaJapanUnknown status
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OsakaJapanUnknown status
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ŌsakiJapanUnknown status
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SapporoJapanUnknown status
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Suita-shiJapanUnknown status
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Sunto-gunJapanUnknown status
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YokohamaJapanUnknown status
Netherlands Cancer Institute
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AmsterdamNetherlandsCompleted
Academisch Medisch Centrum
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AmsterdamNetherlandsCompleted
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsCompleted
Helse Bergen HF
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BergenNorwayCompleted
Akershus University Hospital
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LoerenskogNorwayCompleted
Oslo University Hospital HF
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OsloNorwayCompleted
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Rio PiedrasPuerto RicoUnknown status
Institutul Clinic Fundeni
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BucharestRomaniaCompleted
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaCompleted
Centrul De Oncologie SF Nectarie S.R.L.
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CraiovaRomaniaCompleted
Institutul Regional de Oncologie Iasi
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IașiRomaniaCompleted
Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava
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SuceavaRomaniaCompleted
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Arlington HeightsUnited StatesUnknown status
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DallasUnited StatesUnknown status
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DenverUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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PittsburghUnited StatesUnknown status
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PortlandUnited StatesUnknown status
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RoanokeUnited StatesUnknown status
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SacramentoUnited StatesUnknown status
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AdanaTurkey (Türkiye)Unknown status
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IstanbulTurkey (Türkiye)Unknown status

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