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NCT07225270RecruitingPhase 3

Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care for Maintenance Treatment of Participants With Recurrent Platinum-sensitive Ovarian Cancer After Second-line (2L) Platinum-based Doublet Chemotherapy

A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L Platinum-Based Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)

Source: ClinicalTrials.gov · Last updated 6 Oct 2026

Brief summary (registry, in English)

This Phase 3 study will be conducted in different countries around the world with up to about 544 participants. The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with available standard of care therapy that is already approved and used for ovarian cancer. Participants will receive either Rina-S monotherapy (by itself), Rina-S plus bevacizumab, bevacizumab (standard of care) by itself, or no treatment (only monitoring, also standard of care). No participants will be given placebo. Participants will participate in 1 of 2 arms. The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open. Participants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 weeks). During visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity and imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) for each participant will be different for every participant.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
544 (estimated)
First submitted
4 Nov 2025
Start date
3 Apr 2026
Primary completion date
Oct 2028
Lead sponsor
Genmab
NCT number
NCT07225270
EU CT number
2025-522167-15-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 544
  • From 3 Apr 2026 to the primary completion date, Oct 2028
  • 119 sites in 14 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

  • More than 2 prior lines of systemic therapy.
  • Progression while on or following 2L platinum-based regimen prior to randomization.
  • Participants who receive an intervening systemic anticancer treatment (excluding bevacizumab) after the last dose of 2L platinum-based chemotherapy and prior to randomization.
    • Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Other

  • Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors

Who the study is looking for

  • Must have histologically or cytologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
  • Must have PSOC defined as progressive disease \> 6 months (ie, 183 days) from the last dose of primary (first-line \[1L\]) platinum therapy.
  • Participants with known breast cancer (BRCA)-mutated (somatic or germline) or homologous recombination deficiency (HRD)-positive ovarian cancer who achieved complete response (CR)/no clinical evidence of disease (NED) or partial response (PR) following 1L platinum-based chemotherapy regimen must have previously received PARPi maintenance therapy as part of their 1L treatment.
  • Must have completed platinum-based chemotherapy in the 2L treatment for recurrent PSOC.
  • Must be randomized no later than 8 weeks from the last dose of the 2L platinum-based therapy.
  • Participants must have achieved a CR/NED, PR; or SD permitted only if bevacizumab was given in 2L in combination with platinum-based chemotherapy, as assessed by the investigator, following completion of 2L platinum-based chemotherapy.

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

Full criteria on ClinicalTrials.gov

Sites (119)

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

SiteCityCountrySite status
Landeskranke nhaus Feldkirch
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Feldkirch VorarlbergAustriaRecruiting
Medical University of Graz
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GrazAustriaRecruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaRecruiting
Klinik Hietzing
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ViennaAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
Az Maria Middelares Gent
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GentBelgiumRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
JESSA Ziekenhuis
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HasseltBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Vivalia
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Libramont-ChevignyBelgiumRecruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumRecruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
Vitaz
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Sint-NiklaasBelgiumRecruiting
Fakultni Nemocnice Brno
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Brno-StredCzechiaNot yet recruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaNot yet recruiting
Nemocnice AGEL Nový Jičín a.s.
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Nový JičínCzechiaNot yet recruiting
University Hospital Olomouc
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OlomoucCzechiaNot yet recruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaNot yet recruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaNot yet recruiting
Fakultni nemocnice Bulovka
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PragueCzechiaNot yet recruiting
Fakultni Nemocnice Motol a Homolka
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PragueCzechiaNot yet recruiting
Technische Universitaet Dresden
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DresdenGermanyNot yet recruiting
KEM I Evang. Kliniken Essen-Mitte gGmbH
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EssenGermanyNot yet recruiting
Klinikum Gütersloh gGmbH
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GüterslohGermanyNot yet recruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyNot yet recruiting
SLK-Kliniken Heilbronn GmbH
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HeilbronnGermanyNot yet recruiting
Klinikum Kassel GmbH
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KasselGermanyNot yet recruiting
Krankenhausgesellschaft St. Vincenz mbH
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LimburgGermanyNot yet recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyNot yet recruiting
Universitaet Muenster
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MuensterGermanyNot yet recruiting
DIAK Klinikum Landkreis Schwaebisch Hall gGmbH
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Schwaebisch HallGermanyNot yet recruiting
Klinikum Der Landeshauptstadt Stuttgart gKAöR
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StuttgartGermanyNot yet recruiting
Aalborg University Hospital
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AalborgDenmarkNot yet recruiting
Rigshospitalet
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Copenhagen OeDenmarkNot yet recruiting
Region Sjaelland
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RoskildeDenmarkNot yet recruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainNot yet recruiting
Institut Catala d'Oncologia
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BadalonaSpainNot yet recruiting
MD Anderson Cancer Center
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MadridSpainNot yet recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainNot yet recruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainNot yet recruiting
University Hospital Son Espases
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PalmaSpainNot yet recruiting
Hospital Universitario Virgen De Valme
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SevillaSpainNot yet recruiting
Hospital Universitario Araba
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VitoriaSpainNot yet recruiting
Pohjois-Savon hyvinvointialue
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KuopioFinlandNot yet recruiting
Pohjois-Pohjanmaan hyvinvointialue
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OuluFinlandNot yet recruiting
Pirkanmaan hyvinvointialue
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TampereFinlandNot yet recruiting
Turku University Hospital
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TurkuFinlandNot yet recruiting
Centr Georges Francois Leclerc
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DijonFranceRecruiting
Institut Paoli-Calmettes
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MarseilleFranceRecruiting
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources
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Mont-De-Marsan CedexFranceRecruiting
L'Hopital Prive Du Confluent
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Nantes Cedex 2FranceRecruiting
Centre Antoine Lacassagne
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Nice Cedex 2FranceRecruiting
Fondation Hôpital Saint-Joseph
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ParisFranceRecruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceRecruiting
Centre De Lutte Contre Le Cancer Eugene Marquis
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Rennes CedexFranceRecruiting
Institut Curie
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Saint-CloudFranceRecruiting
Institut de cancérologie de Lorraine
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Vandoeuvre Les Nancy_ CedexFranceRecruiting
Semmelweis University
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Budapest VIIIHungaryNot yet recruiting
Orszagos Onkologiai Intezet
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Budapest XIIHungaryNot yet recruiting
University of Debrecen
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DebrecenHungaryNot yet recruiting
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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GyőrHungaryNot yet recruiting
Centro di Riferimento Oncologico di Aviano
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AvianoItalyNot yet recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyNot yet recruiting
Azienda Ospedaliera per l Emergenza Cannizzaro
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CataniaItalyNot yet recruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyNot yet recruiting
Ospedale Vito Fazzi Lecce
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LecceItalyNot yet recruiting
Alessandro Manzoni Hospital
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LeccoItalyNot yet recruiting
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
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LuccaItalyNot yet recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyNot yet recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyNot yet recruiting
Istituto Europeo di Oncologia s.r.l
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MilanItalyNot yet recruiting
Humanitas Mirasole S.p.A.
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MilanItalyNot yet recruiting
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyNot yet recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyNot yet recruiting
Azienda USL Toscana Centro
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PratoItalyNot yet recruiting
Azienda USL IRCCS di Reggio Emilia
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Reggio EmiliaItalyNot yet recruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyNot yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyNot yet recruiting
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
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TrevisoItalyNot yet recruiting
Azienda Ospedaliera Ordine Mauriziano di Torino
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TurinItalyNot yet recruiting
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
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VareseItalyNot yet recruiting
Hyogo Cancer Center
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AkashiJapanRecruiting
Saitama Medical University International Medical Center
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HidakaJapanRecruiting
The Jikei University Kashiwa Hospital
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KashiwaJapanRecruiting
St Marianna University School of Medicine
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KawasakiJapanRecruiting
Kurume University Hospital
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KurumeJapanRecruiting
Shizuoka Cancer Center
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Nagaizumi-chōJapanRecruiting
Niigata University Medical & Dental Hospital
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NiigataJapanRecruiting
Okayama University Hospital
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OkayamaJapanRecruiting
Kitasato University Hospital
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SagamiharaJapanRecruiting
Sapporo Medical University Hospital
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SapporoJapanRecruiting
National Hospital Organization Hokkaido Cancer Center
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SapporoJapanRecruiting
Tohoku University Hospital
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SendaiJapanRecruiting
Osaka Medical and Pharmaceutical University Hospital
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TakatsukiJapanRecruiting
The Cancer Institute Hospital of JFCR
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TokyoJapanRecruiting
Mie University Graduate School of Medicine
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TsuJapanRecruiting
Kanagawa Prefectural Cancer Center
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YokohamaJapanRecruiting
Helse Bergen HF
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BergenNorwayNot yet recruiting
Sorlandet Sykehus HF
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Kristiansand SNorwayNot yet recruiting
Oslo Universitetssykehus HF
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OsloNorwayNot yet recruiting
Universitetssykehuset Nord-Norge HF
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TromsoeNorwayNot yet recruiting
Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
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BialystokPolandNot yet recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandNot yet recruiting
Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
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KatowicePolandNot yet recruiting
Instytut Centrum Zdrowia Matki Polki
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LodzPolandNot yet recruiting
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
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LublinPolandNot yet recruiting
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
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PoznanPolandNot yet recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandNot yet recruiting
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
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SiedlcePolandNot yet recruiting
Miami Valley Hospital South
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CentervilleUnited StatesRecruiting
Novant Health Presbyterian Medical Center
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CharlotteUnited StatesRecruiting
Missouri Cancer Associates
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ColumbiaUnited StatesRecruiting
Zangmeister Cancer Center
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ColumbusUnited StatesRecruiting
Alliance Cancer Specialists - Abington Hematology Oncology Associates - Horsham
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HorshamUnited StatesRecruiting
Mt. Sinai Comprehensive Cancer Center
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MiamiUnited StatesRecruiting
Methodist Estabrook Cancer Center
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OmahaUnited StatesRecruiting
Sarasota Memorial Health Care System
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SarasotaUnited StatesRecruiting
Greater Baltimore Medical Center
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TowsonUnited StatesRecruiting

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