Clinical trial • Phase III • Oncology

BMS-986365 for Metastatic castration-resistant prostate cancer

Phase III trial of BMS-986365 for Metastatic castration-resistant prostate cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic castration-resistant prostate cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
16-01-2025
First CTIS Authorization Date
02-05-2025

Trial design

Randomised, open-label, investigator's choice of therapy comprising either docetaxel (docetaxel; infusion; dose/schedule not specified) or a second androgen receptor pathway inhibitor (examples listed: abiraterone, enzalutamide; dose/schedule not specified). prednisone/prednisolone are included as comparator/supportive medicinal products (dose/schedule not specified).-controlled, adaptive Phase III trial in Czechia, Italy, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Investigator's choice of therapy comprising either Docetaxel (docetaxel; infusion; dose/schedule not specified) OR a second androgen receptor pathway inhibitor (examples listed: Abiraterone, Enzalutamide; dose/schedule not specified). Prednisone/Prednisolone are included as comparator/supportive medicinal products (dose/schedule not specified).
Adaptive
True, two-part adaptive design stated ("Two-part, Randomized, Open-label, Adaptive Study"); includes dose assessment to identify the BMS-986365 dose with the best benefit–risk profile (specific adaptive rules/interim analyses not provided).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
586
Trial Duration For Participant
1359

Eligibility

Recruits 586 No vulnerable population selected; participants are adult men (18 years or older). Informed consent is to be provided by the participant (no assent for minors required because minors are excluded)..

Vulnerable Population
No vulnerable population selected; participants are adult men (18 years or older). Informed consent is to be provided by the participant (no assent for minors required because minors are excluded).

Inclusion criteria

  • {"criterion_text":"- Men who are 18 years or older with a certain type of advanced prostate cancer that is getting worse."}
  • {"criterion_text":"- Men who have signs of the cancer spreading to other parts of their body, which can be seen on special scans like a bone scan or a CT/MRI scan."}
  • {"criterion_text":"- Questionnaires will be filled out by the participant to ensure they are not suffering too much from their prostate cancer symptoms."}
  • {"criterion_text":"- Participants should have also tried certain treatments before, like abiraterone, enzalutamide, apalutamide, or darolutamide, which are medicines used to treat prostate cancer."}

Exclusion criteria

  • {"criterion_text":"- There are some conditions that exclude from participation like heart problems or serious heart disease."}
  • {"criterion_text":"- Also, if the cancer has spread to the brain or liver, or if a special type of bone scan called a Tc-99m superscan shows too much cancer spread, then the man can't join the trial."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- rPFS (for radiographic progression-free survival) by BICR (Blinded Independent Central Review). The ability of BMS-986365 to work better than other treatments chosen by the doctors is tested by looking at the rPFS, which shows how long it takes for the disease to get worse by radiographic imaging techniques (like X-rays or scans)","definition_or_measurement_approach":"Radiographic progression-free survival assessed by Blinded Independent Central Review (BICR); measured as time to radiographic disease progression using radiographic imaging techniques."}

Secondary endpoints

  • {"endpoint_text":"- OS (Overall Survival) This study will assess if people live longer when they take BMS-986365 compared to other treatments chosen by the doctors. This is what is called \"Overall Survival\".","definition_or_measurement_approach":"Overall Survival measured as time from randomization to death from any cause."}

Other endpoints

  • {"endpoint_text":"- To compare BMS-986365 with the doctor's chosen treatment. It will measure success by looking at how long the patients live after starting the treatment.","definition_or_measurement_approach":"Assess survival outcomes post-treatment (text provided as objective)."}
  • {"endpoint_text":"- Assessing the dose of BMS-986365 that presents the best benefitrisk profile (= being able to control the cancer while keeping a good tolerance)","definition_or_measurement_approach":"Dose-finding assessment to identify dose with optimal benefit–risk; specific dose levels and rules not provided in available data."}
  • {"endpoint_text":"- Evaluating the level of the drug in the blood","definition_or_measurement_approach":"Pharmacokinetic sampling and measurement of drug plasma concentrations (PK)."}
  • {"endpoint_text":"- Evaluating other biological markers to see how effective is the drug","definition_or_measurement_approach":"Assessment of biomarkers (PD/biological markers) to evaluate drug effect; specifics not provided."}
  • {"endpoint_text":"- Evaluating the tolerance and impact of study drugs on symptoms, overall health and quality of life.","definition_or_measurement_approach":"Safety and patient-reported outcomes (tolerability, symptoms, overall health, quality of life) using questionnaires and clinical assessments."}

Recruitment

Planned Sample Size
586
Recruitment Window Months
44
Consent Approach
Informed consent is provided by the participant (adult men 18+). Country-specific subject information sheets and informed consent forms (L1 SIS and ICF) are available for multiple countries/languages (document versions present for English, German, Italian, French, Spanish, Polish, Czech, Slovak, Swedish, Romanian and others). No assent procedures for minors (minors excluded).

Methods

  • Country-specific recruitment arrangements documents (K1) present for multiple countries indicating local planned recruitment procedures (titles present for DE, IT, FR, CZ, IE, SK, AT, RO and others).
  • Recruitment brochures (K2) and recruitment posters — patient-facing printed materials for outreach and site-level recruitment.
  • PI-to-Patient letters (K2) — direct invitation/communication from the principal investigator to potential participants.
  • Site-based recruitment through hospitals/oncology clinics (trial sites listed for each country) — local clinician referral (site-specific contact details provided).

Geography

Total Number Of Sites
94
Total Number Of Participants
586

Czechia

Earliest CTIS Part Ii Submission Date
03-04-2025
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
361
Number Of Sites
7
Number Of Participants
28

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Onkologicka klinika
Contact Person Name
Martin Mateju
Contact Person Email
martin.mateju@vfn.cz
Site Name
Urocentrum Praha s.r.o.
Contact Person Name
Michaela Matouskova
Contact Person Email
matouskova@urocentrum.cz
Site Name
Fakultni Thomayerova nemocnice
Department Name
Onkologicka klinika
Contact Person Name
Eugen Kubala
Contact Person Email
eugen.kubala@ftn.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Onkologicka klinika
Contact Person Name
Tomas Buchler
Contact Person Email
tomas.buchler@fnmotol.cz
Site Name
University Hospital Olomouc
Department Name
Onkologicka klinika
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz
Site Name
Masarykuv Onkologicky Ustav
Department Name
Klinika komplexni onkologicke pece
Contact Person Name
Jiri Navratil
Contact Person Email
jiri.navratil@mou.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Klinika onkologie a radioterapie
Contact Person Name
Miroslav Hodek
Contact Person Email
miroslav.hodek@fnhk.cz

Italy

Earliest CTIS Part Ii Submission Date
04-03-2025
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
391
Number Of Sites
10
Number Of Participants
35

Sites

Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Oncologia Medica
Contact Person Name
Consuelo Buttigliero
Contact Person Email
consuelo.buttigliero@unito.it
Site Name
Azienda Ospedaliera S Maria Di Terni
Department Name
Oncologia Medica e Translazionale
Contact Person Name
Annalisa Guida
Contact Person Email
a.guida@aospterni.it
Site Name
San Raffaele Hospital
Department Name
Oncologia Medica
Contact Person Name
Andrea Necchi
Contact Person Email
necchi.andrea@hsr.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Oncologia Medica
Contact Person Name
Fabio Calabrò
Contact Person Email
fabio.calabro@ifo.it
Site Name
Istituto Oncologico Veneto
Department Name
Oncologia Medica 1
Contact Person Name
Umberto Basso
Contact Person Email
umberto.basso@iov.veneto.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Oncologia Clinica Sperimentale Uro-Ginecologica
Contact Person Name
Sabrina Rossetti
Site Name
Istituto Nazionale Dei Tumori
Department Name
Oncologia Medica
Contact Person Name
Giuseppe Procopio
Site Name
Azienda Provinciale Per I Servizi Sanitari
Department Name
Oncologia Medica
Contact Person Name
Orazio Caffo
Contact Person Email
orazio.caffo@apss.tn.it
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
Department Name
Oncologia Medica E Terapia Biomolecolare
Contact Person Name
Vincenza Conteduca
Contact Person Email
vincenza.conteduca@unifg.it
Site Name
Azienda Unita' Sanitaria Locale Toscana Sud Est
Department Name
Oncologia Medica
Contact Person Name
Alketa Hamzaj

France

Earliest CTIS Part Ii Submission Date
25-02-2025
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
393
Number Of Sites
11
Number Of Participants
36

Sites

Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Oncologie Médicale
Contact Person Name
Philippe Barthelemy
Contact Person Email
p.barthelemy@icans.eu
Site Name
Institut De Cancerologie De Lorraine
Department Name
Oncologie Médicale
Contact Person Name
Vincent Massard
Contact Person Email
v.massard@nancy.unicancer.fr
Site Name
Centre Jean Perrin
Department Name
Oncologie
Contact Person Name
Hakim Mahammedi
Site Name
Institut Gustave Roussy
Department Name
Oncologie Médicale
Contact Person Name
Natacha Naoun
Contact Person Email
natacha.naoun@gustaveroussy.fr
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
Oncologie Médicale
Contact Person Name
Philippe Barthelemy
Contact Person Email
p.barthelemy@icans.eu
Site Name
Centre Antoine Lacassagne
Department Name
Oncologie Médicale
Contact Person Name
Delphine Borchiellini
Site Name
Centre Hospitalier Prive Saint-Gregoire
Department Name
Oncologie Médicale
Contact Person Name
Aurélien Gobert
Contact Person Email
aurelien.gobert@icrb.fr
Site Name
Clinique Victor Hugo
Department Name
Oncologie Radiothérapie
Contact Person Name
Amandine Ruffier
Contact Person Email
essaisruffier@ilcgroupe.fr
Site Name
Oncopole Claudius Regaud
Department Name
Oncologie Médicale
Contact Person Name
Loïc Mourey
Contact Person Email
mourey.loic@iuct-oncopole.fr
Site Name
Centr Georges Francois Leclerc
Department Name
Oncologie Médicale
Contact Person Name
Sylvain Ladoire
Contact Person Email
sladoire@cgfl.fr
Site Name
Hospices Civils De Lyon
Department Name
Oncologie Médicale
Contact Person Name
Denis Maillet
Contact Person Email
denis.maillet@chu-lyon.fr

Poland

Earliest CTIS Part Ii Submission Date
07-02-2025
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
417
Number Of Sites
8
Number Of Participants
39

Sites

Site Name
Wojewodzki Szpital Specjalistyczny Nr 4 W Bytomiu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Department Name
Oddział Onkologii Klinicznej
Contact Person Name
Ewa Nowakowska-Zajdel
Contact Person Email
s.onkologia@szpital4.bytom.pl
Site Name
Pratia S.A.
Department Name
Pratia Poznan
Contact Person Name
Marek Kotlarski
Contact Person Email
marek.kotlarski@pratia.com
Site Name
Polimed Specjalistyczna Przychodnia Lekarska
Contact Person Name
Krzysztof Tupikowski
Contact Person Email
tupikowski@poczta.onet.pl
Site Name
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Department Name
Klinika Onkologii z Odcinkiem Dziennym
Contact Person Name
Barbara Radecka
Contact Person Email
brad@onkologia.opole.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Contact Person Name
Bogdan Zurawski
Contact Person Email
zurawski@co.bydgoszcz
Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
Oddział Terapii Izotopowej
Contact Person Name
Bartosz Itrych
Contact Person Email
bartosz.itrych@cskmswia.gov.pl
Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
Wojewodzkie Centrum Onkologii Oddzial Onkologii Klinicznej/ Chemioterapii
Contact Person Name
Joanna Wojcik-Tomaszewska
Site Name
Pratia Hematologia Sp. z o.o.
Department Name
Pratia Onkologia Katowice
Contact Person Name
Agata Kachel-Flis
Contact Person Email
agata.kachel-flis@pratia.com

Ireland

Earliest CTIS Part Ii Submission Date
10-04-2025
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
390
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Beaumont Hospital
Department Name
Medical Oncology
Contact Person Name
MinYuen Teo
Contact Person Email
minyuenteo@beaumont.ie
Site Name
Tallaght University Hospital
Department Name
Medical Oncology
Contact Person Name
Ray McDermott
Contact Person Email
ray.mcdermott@tuh.ie
Site Name
Cork University Hospital
Department Name
Medical Oncology
Contact Person Name
Jack Gleeson
Contact Person Email
Jack.Gleeson@hse.ie

Germany

Earliest CTIS Part Ii Submission Date
04-04-2025
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
357
Number Of Sites
14
Number Of Participants
48

Sites

Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Abt. Medizinische Onkologie
Contact Person Name
Stefanie Zschäbitz
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik und Poliklinik für Urologie
Contact Person Name
Marc-Oliver Grimm
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Klinik und Poliklinik für Urologie und Kinderurologie
Contact Person Name
Hubert Kübler
Contact Person Email
kuebler_h@ukw.de
Site Name
Urologicum Duisburg
Department Name
Studienzentrum
Contact Person Name
Eva Hellmis
Contact Person Email
hellmis@urologicum-duisburg.de
Site Name
St. Marien-Krankenhaus GmbH
Department Name
Urologie & Kinderurologie - Studienzentrum
Contact Person Name
Stefan Machtens
Contact Person Email
stefan.machtens@mkh-bgl.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Urologie
Contact Person Name
Axel Merseburger
Contact Person Email
axel.merseburger@uksh.de
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
Klinik für Urologie
Contact Person Name
Florian Roghmann
Site Name
Urologisches Zentrum Mittelhessen - Praxis Biedenkopf
Department Name
Studien
Contact Person Name
Axel Hegele
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Urologie
Contact Person Name
Claudia Kesch
Contact Person Email
claudia.kesch@uk-essen.de
Site Name
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Department Name
Studienzentrum
Contact Person Name
Tilman Todenhöfer
Contact Person Email
praxis@studienurologie.de
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Klinik und Poliklinik für Urologie
Contact Person Name
Margitta Retz
Contact Person Email
margitta.retz@tum.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Klinik und Poliklinik für Urologie und Kinderurologie
Contact Person Name
Manuel Ritter
Contact Person Email
mritter@ukbonn.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
II. Medizinische Klinik und Poliklinik
Contact Person Name
Gunhild von Amsberg
Contact Person Email
g.von-amsberg@uke.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Universitätsklinik für Urologie
Contact Person Name
Steffen Rausch

Romania

Earliest CTIS Part Ii Submission Date
07-02-2025
Latest Decision Or Authorization Date
06-04-2026
Processing Time Days
423
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
Institutul Regional De Oncologie Iasi
Department Name
Oncologie Medicala
Contact Person Name
Teodora Alexa-Stratulat
Contact Person Email
manager@iroiasi.ro
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncologie Medicala
Contact Person Name
Tudor-Eliade Ciuleanu
Contact Person Email
office@iocn.ro
Site Name
Spitalul Municipal Ploiesti
Department Name
Oncologie Medicala
Contact Person Name
Nita Amedeia
Contact Person Email
spitalschuller@yahoo.com
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Michael Schenker
Contact Person Email
office@centruldeoncologie.ro
Site Name
CF Clinical Hospital
Department Name
Oncologie Medicala
Contact Person Name
Anca Mihailov
Contact Person Email
spitalcliniccfcluj@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
17-03-2025
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
378
Number Of Sites
20
Number Of Participants
73

Sites

Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Contact Person Name
Maria Jose Mendez Vidal
Contact Person Email
xxx.xxx@xxx.es
Site Name
Complejo Hospitalario Universitario De Ourense
Department Name
Oncology
Contact Person Name
Ovidio Fernandez Calvo
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Contact Person Name
Jose Angel Arranz Arija
Contact Person Email
xxx.xxx@xxx.es
Site Name
Parc Tauli Hospital Universitari
Department Name
Oncology
Contact Person Name
Enrique Gallardo Diaz
Contact Person Email
egallardo@tauli.cat
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncology
Contact Person Name
Aranzazu Gonzalez del Alba
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital Universitario Vithas La Salud
Department Name
Oncology
Contact Person Name
Pedro Sanchez Rovira
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Contact Person Name
Teresa Alonso Gordoa
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Joaquin Mateo Valderrama
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital Universitario La Paz
Department Name
Oncology
Contact Person Name
Alvaro Pinto Marin
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital Universitario De Badajoz
Department Name
Oncology
Contact Person Name
Marta Gonzalez Cordero
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital Universitario Lucus Augusti
Department Name
Oncology
Contact Person Name
Sergio Vazquez Estevez
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Daniel Castellano Gauna
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital Universitario De Cruces
Department Name
Oncology
Contact Person Name
Ricardo Fernandez Rodriguez
Site Name
Hospital Universitario De Navarra
Department Name
Oncology
Contact Person Name
Nuria Lainez Milagro
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Contact Person Name
Alvaro Sanchez Camacho Mejias
Contact Person Email
xxx.xxx@xxx.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Begona Perez Valderrama
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Contact Person Name
Jose Pablo Maroto Rey
Contact Person Email
jmaroto@santpau.cat
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Contact Person Name
Javier Puente Vazquez
Contact Person Email
javierpuente.hcsc@gmail.com
Site Name
Hospital Universitario De Burgos
Department Name
Oncology
Contact Person Name
Guillermo Crespo Herrero
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Contact Person Name
Regina Girones Sarrio
Contact Person Email
girones_reg@gva.es

Austria

Earliest CTIS Part Ii Submission Date
24-03-2025
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
389
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
University Clinic for Urology and Andrology
Contact Person Name
Lukas Oberhammer
Contact Person Email
l.oberhammer@salk.at
Site Name
Medical University Of Vienna
Department Name
University Clinic for Urology
Contact Person Name
Gero Kramer
Contact Person Email
gero.kramer@meduniwien.ac.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Department of Urology
Contact Person Name
Ferdinand Luger
Site Name
Universitaetsklinikum Krems
Department Name
Clinical Department of Internal Medicine 2
Contact Person Name
Sonia Vallet
Contact Person Email
sonia.vallet@krems.lknoe.at

Slovakia

Earliest CTIS Part Ii Submission Date
01-08-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
276
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
F D Roosevelt University General Hospital Of Banska Bystrica
Department Name
Oncology
Contact Person Name
Matej Hrncar
Contact Person Email
mhrncar@nspbb.sk
Site Name
Urologia s.r.o.
Department Name
Urologia
Contact Person Name
Jan Kliment
Contact Person Email
jan.kliment@uniba.sk
Site Name
Milab s.r.o.
Department Name
Urology
Contact Person Name
Ivan Mincik
Contact Person Email
maria.mincikova@gmail.com
Site Name
Narodny Onkologicky Ustav
Department Name
Oncology
Contact Person Name
Michal Mego
Contact Person Email
daniela.svetlovska@nou.sk

Sweden

Earliest CTIS Part Ii Submission Date
08-04-2025
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
352
Number Of Sites
4
Number Of Participants
23

Sites

Site Name
Karolinska University Hospital
Department Name
Medicinsk enhet Bäckencancer, urologisk onkologi, A5:01 Mottagning Urologiska sjukdomar
Contact Person Name
Enrique Castellanos
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
VO Hematologi, Onkologi och Strålningsfysik
Contact Person Name
Olof Stahl
Contact Person Email
olof.stahl@skane.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Onkologkliniken
Contact Person Name
Jon Kindblom
Contact Person Email
jon.kindblom@vgregion.se
Site Name
Uppsala University Hospital
Department Name
Onkologkliniken
Contact Person Name
Ingrida Verbiene
Contact Person Email
ingrida.verbiene@akademiska.se

Denmark

Earliest CTIS Part Ii Submission Date
29-04-2025
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
330
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Region Hovedstaden
Department Name
Urology
Contact Person Name
Rasmus Bisbjerg
Contact Person Email
rasmus.bisbjerg@regionh.dk
Site Name
Aarhus University Hospital
Department Name
Oncology
Contact Person Name
simon Buus
Contact Person Email
simon.buus@auh.rm.dk
Site Name
Rigshospitalet
Department Name
Oncology
Contact Person Name
Gedske Daugaard
Site Name
Aalborg University Hospital
Department Name
Oncology
Contact Person Name
Mette Moe
Contact Person Email
mmk@rn.dk

Sponsor

Primary sponsor

Full Name
Celgene Corporation
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Third parties

  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Licensing and translation services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"Genomic Analysis, Tumor Mutational Burden analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Subject Number assignment, Treatment/Arm assignment,Drug (re)supplies assignment, PRO/COA","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"Core Technology Services","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"QPS LLC","duties_or_roles":"TS and BioA","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Nordic Bioscience A/S (Herlev Hovedgade 205)","duties_or_roles":"Speciality Biomarker Laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Nordic Bioscience A/S (Herlev Hovedgade 207)","duties_or_roles":"Speciality Biomarker Laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
BMS-986365
Active Substance
BMS-986365
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Investigational product (IMP)

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