- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07291076
Et studie til at evaluere sikkerheden og tolerabiliteten af Pumitamig alene eller i kombination med Ipilimumab hos deltagere med første-linje behandling for avanceret eller uoperabel hepatocellulær karcinom (HCC) (ROSETTA HCC-206)
ROSETTA HCC-206: Et åbent, multicentret, randomiseret fase 1/2-studie af Pumitamig alene eller i kombination med Ipilimumab hos deltagere med førstelinje-avanceret eller ikke-resekabelt hepatocellulært karcinom (HCC)
The purpose of this study is to evaluate the safety and tolerability of Pumitamig alone or in combination with Ipilimumab in participants with first-line advanced or unresectable Hepatocellular Carcinoma (HCC)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: First line of the email MUST contain NCT # and Site #.
Undersøgelse Kontakt Backup
- Navn: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Telefonnummer: 855-907-3286
- E-mail: Clinical.Trials@bms.com
Studiesteder
-
-
New South Wales
-
Camperdown, New South Wales, Australien, 2050
- Rekruttering
- Royal Prince Alfred Hospital
-
Kontakt:
- Simone Strasser, Site 0024
- Telefonnummer: 61295150056
-
Westmead, New South Wales, Australien, 2145
- Ikke rekrutterer endnu
- Local Institution - 0033
-
Kontakt:
- Site 0033
-
-
Queensland
-
Birtinya, Queensland, Australien, 4575
- Rekruttering
- Sunshine Coast University Hospital
-
Kontakt:
- James O'Beirne, Site 0040
- Telefonnummer: +617520203155
-
-
Victoria
-
Parkville, Victoria, Australien, 3052
- Rekruttering
- The Royal Melbourne Hospital
-
Kontakt:
- Ashok Raj, Site 0096
-
-
-
-
Santiago Metropolitan
-
Santiago, Santiago Metropolitan, Chile, 8420383
- Rekruttering
- Bradfordhill
-
Kontakt:
- Carlos Rojas, Site 0064
- Telefonnummer: +56998744662
-
Santiago Region Metropolitana, Santiago Metropolitan, Chile, 8330034
- Rekruttering
- Pontifica Universidad Catolica De Chile
-
Kontakt:
- Sebastian Mondaca, Site 0106
-
-
-
-
-
Metropolitan Borough of Wirral, Det Forenede Kongerige, CH63 4JY
- Rekruttering
- The Clatterbridge Cancer Centre
-
Kontakt:
- Daniel Palmer, Site 0053
- Telefonnummer: +44 151 556 5000
-
-
London, City of
-
London, London, City of, Det Forenede Kongerige, W12 0HS
- Rekruttering
- Hammersmith Hospital
-
Kontakt:
- David Pinato, Site 0073
- Telefonnummer: +44 20 3313 1000
-
-
South Western Scotland
-
Glasgow, South Western Scotland, Det Forenede Kongerige, G611BD
- Rekruttering
- Cancer Research UK - The Beatson Institute for Cancer Research (Cancer Research UK Beatson Laboratories)
-
Kontakt:
- Jeff Evans, Site 0051
- Telefonnummer: +44 141 330 3953
-
-
-
-
California
-
Duarte, California, Forenede Stater, 91010
- Rekruttering
- City Of Hope
-
Kontakt:
- Daneng Li, Site 0137
- Telefonnummer: 626-471-9200
-
Los Angeles, California, Forenede Stater, 90064
- Ikke rekrutterer endnu
- Local Institution - 0070
-
Kontakt:
- Site 0070
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60611
- Ikke rekrutterer endnu
- Local Institution - 0107
-
Kontakt:
- Site 0107
-
-
Michigan
-
Detroit, Michigan, Forenede Stater, 48202
- Ikke rekrutterer endnu
- Local Institution - 0134
-
Kontakt:
- Site 0134
-
-
New Jersey
-
Hackensack, New Jersey, Forenede Stater, 07601-2191
- Rekruttering
- John Theurer Cancer Center at Hackensack University Medical Center
-
Kontakt:
- Martin Gutierrez, Site 0103
- Telefonnummer: 551-996-5863
-
-
New York
-
Mineola, New York, Forenede Stater, 11501
- Rekruttering
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Kontakt:
- Kristen Spencer, Site 0100
- Telefonnummer: 732-235-2465
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97213
- Rekruttering
- Providence Portland Medical Center
-
Kontakt:
- Binbin Zheng, Site 0080
- Telefonnummer: 503-215-3878
-
Portland, Oregon, Forenede Stater, 97225
- Rekruttering
- Providence St. Vincent Medical Center
-
Kontakt:
- Binbin Zheng, Site 0111
- Telefonnummer: 503-215-3878
-
-
Tennessee
-
Nashville, Tennessee, Forenede Stater, 37232
- Rekruttering
- Vanderbilt University Medical Center
-
Kontakt:
- Thatcher Heumann, Site 0102
- Telefonnummer: 615-875-6814
-
Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Tennessee Oncology
-
Kontakt:
- Jeffery Russell, Site 0022
- Telefonnummer: 615-986-0857
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98109-1024
- Ikke rekrutterer endnu
- Local Institution - 0083
-
Kontakt:
- Site 0083
-
-
-
-
-
Bobigny, Frankrig, 93000
- Rekruttering
- Hôpital Avicenne
-
Kontakt:
- Pierre Nahon, Site 0003
- Telefonnummer: +33148955555
-
-
Aquitaine
-
Pessac, Aquitaine, Frankrig, 33600
- Rekruttering
- CHU Bordeaux Haut-Leveque
-
Kontakt:
- Jean-Frederic Blanc, Site 0056
- Telefonnummer: +33556795679
-
-
Auvergne-Rhône-Alpes
-
La Tronche, Auvergne-Rhône-Alpes, Frankrig, 38700
- Rekruttering
- Centre Hospitalier Universitaire de Grenoble
-
Kontakt:
- Thomas Decaens, Site 0004
- Telefonnummer: +33476767575
-
-
Languedoc-Roussillon
-
Montpellier, Languedoc-Roussillon, Frankrig, 34295
- Rekruttering
- Chu Saint Eloi
-
Kontakt:
- Eric Assenat, Site 0001
- Telefonnummer: +33467336733
-
-
Pays de la Loire Region
-
Saint Priest En Jarez, Pays de la Loire Region, Frankrig, 42270
- Rekruttering
- Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
-
Kontakt:
- Jean Phelip, Site 0018
- Telefonnummer: +33477828000
-
-
-
-
-
Milan, Italien, 20132
- Ikke rekrutterer endnu
- Local Institution - 0089
-
Kontakt:
- Site 0089
-
Pisa, Italien, 56126
- Ikke rekrutterer endnu
- Local Institution - 0016
-
Kontakt:
- Site 0016
-
-
Emilia-Romagna
-
Meldola, Emilia-Romagna, Italien, 47014
- Rekruttering
- IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
-
Kontakt:
- Ilario Rapposelli, Site 0088
- Telefonnummer: 390543739100
-
-
Tuscany
-
Pisa, Tuscany, Italien, 56126
- Rekruttering
- Azienda Ospedaliero Universitaria Pisana
-
Kontakt:
- Caterina Vivaldi, Site 0109
- Telefonnummer: 39050993251
-
-
-
-
-
Kashiwa, Japan, 277-8577
- Ikke rekrutterer endnu
- Local Institution - 0008
-
Kontakt:
- Site 0008
-
-
Osaka
-
Osakasayama-shi, Osaka, Japan, 5898511
- Ikke rekrutterer endnu
- Local Institution - 0017
-
Kontakt:
- Site 0017
-
-
-
-
Anhui
-
Hefei, Anhui, Kina, 230001
- Ikke rekrutterer endnu
- Local Institution - 0122
-
Kontakt:
- Site 0122
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100142
- Ikke rekrutterer endnu
- Local Institution - 0114
-
Kontakt:
- Site 0114
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Kina, 400016
- Ikke rekrutterer endnu
- Local Institution - 0125
-
Kontakt:
- Site 0125
-
-
Fujian
-
Fuzhou, Fujian, Kina, 350028
- Ikke rekrutterer endnu
- Local Institution - 0116
-
Kontakt:
- Site 0116
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510515
- Ikke rekrutterer endnu
- Local Institution - 0075
-
Kontakt:
- Site 0075
-
-
Guangxi
-
Nanning, Guangxi, Kina, 530200
- Ikke rekrutterer endnu
- Local Institution - 0129
-
Kontakt:
- Site 0129
-
-
Heilongjiang
-
Harbin, Heilongjiang, Kina, 150001
- Ikke rekrutterer endnu
- Local Institution - 0130
-
Kontakt:
- Site 0130
-
-
Henan
-
Nanyang, Henan, Kina, 473000
- Ikke rekrutterer endnu
- Local Institution - 0128
-
Kontakt:
- Site 0128
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210008
- Ikke rekrutterer endnu
- Local Institution - 0119
-
Kontakt:
- Site 0119
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330006
- Ikke rekrutterer endnu
- Local Institution - 0123
-
Kontakt:
- Site 0123
-
-
Shaanxi
-
Xi'an, Shaanxi, Kina, 710126
- Ikke rekrutterer endnu
- Local Institution - 0086
-
Kontakt:
- Site 0086
-
Xi'an, Shaanxi, Kina, 710038
- Trukket tilbage
- Local Institution - 0115
-
-
Shandong
-
Jinan, Shandong, Kina, 250117
- Ikke rekrutterer endnu
- Local Institution - 0118
-
Kontakt:
- Site 0118
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200032
- Ikke rekrutterer endnu
- Local Institution - 0078
-
Kontakt:
- Site 0078
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 610072
- Ikke rekrutterer endnu
- Local Institution - 0138
-
Kontakt:
- Site 0138
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310022
- Ikke rekrutterer endnu
- Local Institution - 0126
-
Kontakt:
- Site 0126
-
-
-
-
-
Gdansk, Polen, 80-952
- Rekruttering
- Uniwersyteckie Centrum Kliniczne
-
Kontakt:
- Piotr Wysocki, Site 0020
- Telefonnummer: +48603347903
-
-
Lower Silesian Voivodeship
-
Wroclaw, Lower Silesian Voivodeship, Polen, 53-439
- Ikke rekrutterer endnu
- Local Institution - 0021
-
Kontakt:
- Site 0021
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Polen, 02-106
- Ikke rekrutterer endnu
- Local Institution - 0105
-
Kontakt:
- Site 0105
-
-
-
-
-
Singapore, Singapore, 119074
- Rekruttering
- National University Hospital
-
Kontakt:
- Wei Peng Yong, Site 0009
- Telefonnummer: 6567724670
-
Singapore, Singapore, 168583
- Rekruttering
- National Cancer Centre Singapore
-
Kontakt:
- David Wai Meng Tai, Site 0012
- Telefonnummer: 6564368197
-
-
-
-
-
Barcelona, Spanien, 08036
- Ikke rekrutterer endnu
- Local Institution - 0015
-
Kontakt:
- Site 0015
-
Madrid, Spanien, 28050
- Ikke rekrutterer endnu
- Local Institution - 0095
-
Kontakt:
- Site 0095
-
Madrid, Spanien, 28007
- Rekruttering
- Hospital General Universitario Gregorio Marañon
-
Kontakt:
- Ana Matilla Pena, Site 0060
- Telefonnummer: +34915868308
-
-
Navarre
-
Pamplona, Navarre, Spanien, 31008
- Rekruttering
- Clinica Universidad de Navarra
-
Kontakt:
- Bruno Sangro, Site 0014
- Telefonnummer: 0034630957722
-
-
-
-
Kyǒnggi-do
-
Seongnam-si, Kyǒnggi-do, Sydkorea, 13496
- Rekruttering
- Cha Bundang Medical Center, Cha University
-
Kontakt:
- Hong Jae Chon, Site 0027
- Telefonnummer: 82317803928
-
-
Seoul-teukbyeolsi [Seoul]
-
Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
-
Kontakt:
- Jung Yong Hong, Site 0013
- Telefonnummer: +82234103459
-
Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 05505
- Rekruttering
- Asan Medical Center
-
Kontakt:
- Baek-Yeol Ryoo, Site 0011
- Telefonnummer: 82230103211
-
-
-
-
-
Taichung, Taiwan, 404332
- Rekruttering
- China Medical University Hospital
-
Kontakt:
- Hung-Wei Wang, Site 0032
- Telefonnummer: 0975681904
-
Tainan, Taiwan, 704
- Rekruttering
- National Cheng Kung University Hospital
-
Kontakt:
- Ting-Tsung Chang, Site 0055
- Telefonnummer: 88662353535x5389
-
Taipei, Taiwan, 10002
- Rekruttering
- National Taiwan University Hospital
-
Kontakt:
- Ann-Lii Cheng, Site 0006
- Telefonnummer: 8862231234567251
-
Taipei, Taiwan, 11217
- Rekruttering
- Taipei Veterans General Hospital
-
Kontakt:
- Yi-Hsiang Huang, Site 0007
- Telefonnummer: +886938590872
-
-
-
-
-
Frankfurt, Tyskland, D-60590
- Rekruttering
- Universitaetsklinikum Frankfurt
-
Kontakt:
- Joerg Trojan, Site 0030
- Telefonnummer: 49(0)69 6301 7860
-
Mainz, Tyskland, 55101
- Rekruttering
- Universitaetsmedizin Mainz
-
Kontakt:
- Friedrich Foerster, Site 0026
- Telefonnummer: +496131175443
-
-
North Rhine-Westphalia
-
Cologne, North Rhine-Westphalia, Tyskland, 50937
- Rekruttering
- Uniklinik Koeln
-
Kontakt:
- Dirk Thomas Waldschmidt, Site 0031
- Telefonnummer: 492214787334
-
-
Schleswig-Holstein
-
Lübeck, Schleswig-Holstein, Tyskland, 23538
- Rekruttering
- Universitatsklinikum Schleswig-Holstein
-
Kontakt:
- Jens Marquardt, Site 0028
- Telefonnummer: +4945150044101
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria
- Participants must have a histologically confirmed diagnosis of locally advanced or unresectable Hepatocellular Carcinoma (HCC).
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participants must have no prior systemic therapy for advanced/ unresectable HCC.
- Participants must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Exclusion Criteria
- Participants must not have significant bleeding or coagulation disorders or other obvious bleeding risk evidence.
- Participants must not have an organ transplant or autoimmune disease.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Kohorte 1A
|
Specified dose on specified days
Andre navne:
Specified dose on specified days
Andre navne:
|
|
Eksperimentel: Kohorte 1B
|
Specified dose on specified days
Andre navne:
Specified dose on specified days
Andre navne:
|
|
Eksperimentel: Kohorte 2A
|
Specified dose on specified days
Andre navne:
Specified dose on specified days
Andre navne:
|
|
Eksperimentel: Kohorte 2B
|
Specified dose on specified days
Andre navne:
Specified dose on specified days
Andre navne:
|
|
Eksperimentel: Kohorte 2C
|
Specified dose on specified days
Andre navne:
|
|
Eksperimentel: Cohort 1A2
|
Specified dose on specified days
Andre navne:
Specified dose on specified days
Andre navne:
|
|
Eksperimentel: Cohort 1B2
|
Specified dose on specified days
Andre navne:
Specified dose on specified days
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with adverse events (AEs)
Tidsramme: Up to approximately 25 weeks
|
Phase 1 |
Up to approximately 25 weeks
|
|
Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5))
Tidsramme: Up to approximately 25 weeks
|
Phase 1 |
Up to approximately 25 weeks
|
|
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Tidsramme: Up to day 21
|
Phase 1 |
Up to day 21
|
|
Number of participants with AEs leading to discontinuation
Tidsramme: Up to approximately 25 weeks
|
Phase 1 |
Up to approximately 25 weeks
|
|
Number of participants with AEs leading to death
Tidsramme: Up to approximately 25 weeks
|
Phase 1 |
Up to approximately 25 weeks
|
|
Objective response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Tidsramme: Up to week 48
|
Phase 2 |
Up to week 48
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with AEs
Tidsramme: Up to approximately 25 weeks
|
Phase 2 |
Up to approximately 25 weeks
|
|
Number of participants with SAEs (as per CTCAE v5)
Tidsramme: Up to approximately 25 weeks
|
Phase 2 |
Up to approximately 25 weeks
|
|
Number of participants with treatment-related adverse events (TRAEs)
Tidsramme: Up to approximately 25 weeks
|
Phase 2 |
Up to approximately 25 weeks
|
|
Number of participants with AEs leading to discontinuation
Tidsramme: Up to approximately 25 weeks
|
Phase 2 |
Up to approximately 25 weeks
|
|
Number of participants with AEs leading to death
Tidsramme: Up to approximately 25 weeks
|
Phase 2 |
Up to approximately 25 weeks
|
|
End of infusion concentration of Pumitamig
Tidsramme: Up to day 21
|
Phase 2 |
Up to day 21
|
|
End of trough concentration of Pumitamig
Tidsramme: Up to day 21
|
Phase 2 |
Up to day 21
|
|
Trough concentration of Ipilimumab
Tidsramme: Up to day 21
|
Phase 2 |
Up to day 21
|
|
Incidence of anti-drug antibodies against Pumitamig
Tidsramme: Up to 5 years
|
Phase 2 |
Up to 5 years
|
|
Incidence of anti-drug antibodies against Ipilimumab
Tidsramme: Up to 5 years
|
Phase 2 |
Up to 5 years
|
|
Progression-free survival (PFS) by RECIST v1.1 per investigator assessment
Tidsramme: Up to 4 years
|
Phase 2 |
Up to 4 years
|
|
Duration of response (DOR) (confirmed by PR or CR) by RECIST v1.1 per investigator assessment
Tidsramme: Up to 4 years
|
Phase 2 |
Up to 4 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer efter histologisk type
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Leversygdomme
- Neoplasmer, kirtel og epitel
- Adenocarcinom
- Neoplasmer i leveren
- Karcinom
- Carcinom, hepatocellulært
- Aminosyrer, peptider og proteiner
- Proteiner
- Antistoffer, monoklonal, humaniseret
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Ipilimumab
Andre undersøgelses-id-numre
- CA266-0006
- 2025-523602-33 (Anden identifikator: EU CT Number)
- U1111-1327-4912 (Anden identifikator: UTN)
- 2025 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
IPD-delingstidsramme
See Plan Description
IPD-delingsadgangskriterier
See Plan Description
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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