Et studie til at evaluere sikkerheden, tolerabiliteten og effekten af Pumitamig alene eller i kombination med Ipilimumab eller Cabozantinib hos deltagere med avanceret nyrecellecancer (RCC) (ROSETTA RCC-208)
22. oktober 2026 opdateret af: Bristol-Myers Squibb
ROSETTA RCC-208: En fase 1/2 åben-label, multicentrisk, randomiseret undersøgelse af Pumitamig alene eller i kombination med Ipilimumab eller Cabozantinib hos deltagere med fremskreden nyrecellekarcinom (RCC)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of Pumitamig alone or in combination with other agents in participants with advanced Renal Cell Carcinoma (RCC)
Studieoversigt
Status
Status
Rekruttering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
474
Fase
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
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
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-
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Buenos Aires, Argentina, 1426
- Rekruttering
- Instituto Medico Especializado Alexander Fleming
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Kontakt:
- Juan Pablo Sade, Site 0154
- Telefonnummer: 5432218900
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Buenos Aires, Argentina, C1199ABB
- Ikke rekrutterer endnu
- Local Institution - 0156
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Kontakt:
- Site 0156
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1419
- Rekruttering
- Asociación de Beneficencia Hospital Sirio Libanés
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Kontakt:
- Hernan Cutuli, Site 0093
- Telefonnummer: 5491157654803
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-
-
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New South Wales
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North Ryde, New South Wales, Australien, 2109
- Rekruttering
- Macquarie University
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Kontakt:
- Howard Gurney, Site 0076
- Telefonnummer: +61298123526
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St Leonards, New South Wales, Australien, 2065
- Rekruttering
- GenesisCare St Leonards
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Kontakt:
- Laurence Krieger, Site 0111
- Telefonnummer: 61294631172
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Queensland
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Brisbane, Queensland, Australien, 4101
- Rekruttering
- Mater Misericordiae Limited
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Kontakt:
- Niara Oliveira, Site 0074
- Telefonnummer: +61731636166
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Herston, Queensland, Australien, 4029
- Ikke rekrutterer endnu
- Local Institution - 0011
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Kontakt:
- Site 0011
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Victoria
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Heidelberg, Victoria, Australien, 3084
- Ikke rekrutterer endnu
- Local Institution - 0004
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Kontakt:
- Site 0004
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Malvern, Victoria, Australien, 3144
- Rekruttering
- Cabrini Hospital - Malvern
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Kontakt:
- David Pook, Site 0003
- Telefonnummer: 61412191080
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Alberta
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Calgary, Alberta, Canada, T2N 5G2
- Ikke rekrutterer endnu
- Local Institution - 0007
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Kontakt:
- Site 0007
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Edmonton, Alberta, Canada, T5M 0V9
- Ikke rekrutterer endnu
- Local Institution - 0189
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Kontakt:
- Site 0189
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- Ikke rekrutterer endnu
- Local Institution - 0009
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Kontakt:
- Site 0009
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Montreal, Quebec, Canada, H2X 3E4
- Trukket tilbage
- Local Institution - 0109
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Québec, Quebec, Canada, G1R 2J6
- Ikke rekrutterer endnu
- Local Institution - 0006
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Kontakt:
- Site 0006
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-
-
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Santiago, Chile, 8330023
- Rekruttering
- Pontificia Universidad Catolica de Chile (PUC)
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Kontakt:
- Carolina Ibanez, Site 0163
- Telefonnummer: 56223547919
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile, 8420383
- Rekruttering
- Bradfordhill
-
Kontakt:
- Carlos Rojas, Site 0005
- Telefonnummer: +56998744662
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Santiago, Santiago Metropolitan, Chile, 7510032
- Ikke rekrutterer endnu
- Local Institution - 0105
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Kontakt:
- Site 0105
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Cali, Colombia, 760032
- Ikke rekrutterer endnu
- Local Institution - 0052
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Kontakt:
- Site 0052
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-
-
-
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Cambridge, Det Forenede Kongerige, CB2 2QQ
- Rekruttering
- Addenbrooke's Hospital
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Kontakt:
- Will Ince, Site 0022
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Cardiff, Det Forenede Kongerige, CF14 2TL
- Rekruttering
- Velindre Cancer Centre
-
Kontakt:
- Satish Kumar, Site 0057
- Telefonnummer: 442920615888
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Edinburgh, Det Forenede Kongerige, EH4 2XU
- Ikke rekrutterer endnu
- Local Institution - 0061
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Kontakt:
- Site 0061
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Manchester, Det Forenede Kongerige, M20 4BX
- Rekruttering
- The Christie NHS Foundation Trust
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Kontakt:
- Tom Waddell, Site 0020
- Telefonnummer: +441619187217
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Sulton, Surrey, Det Forenede Kongerige, SM25PT
- Rekruttering
- Royal Marsden Hospital Sutton
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Kontakt:
- James Larkin, Site 0171
- Telefonnummer: 442078082132
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Kensington and Chelsea
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London, Kensington and Chelsea, Det Forenede Kongerige, SW3 6JJ
- Rekruttering
- Royal Marsden Hospital (Chelsea)
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Kontakt:
- James Larkin, Site 0063
- Telefonnummer: 442078082132
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London, City of
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London, London, City of, Det Forenede Kongerige, EC1A 7BE
- Rekruttering
- St Bartholomew's Hospital
-
Kontakt:
- Thomas Powles, Site 0019
- Telefonnummer: 02078228498
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-
North West
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Preston, North West, Det Forenede Kongerige, PR29HT
- Ikke rekrutterer endnu
- Local Institution - 0186
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Kontakt:
- Site 0186
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-
-
-
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Turku, Finland, 20521
- Ikke rekrutterer endnu
- Local Institution - 0029
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Kontakt:
- Site 0029
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Vantaa, Finland, 01640
- Ikke rekrutterer endnu
- Local Institution - 0060
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Kontakt:
- Site 0060
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Etelä-Suomen Lääni
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Helsinki, Etelä-Suomen Lääni, Finland, 00290
- Ikke rekrutterer endnu
- Local Institution - 0044
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Kontakt:
- Site 0044
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-
-
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California
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Palo Alto, California, Forenede Stater, 94305
- Ikke rekrutterer endnu
- Local Institution - 0178
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Kontakt:
- Site 0178
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06510
- Ikke rekrutterer endnu
- Local Institution - 0117
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Kontakt:
- Site 0117
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20016
- Rekruttering
- Sibley Memorial Hospital
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Kontakt:
- Yasser Ged, Site 0134
- Telefonnummer: 410-570-9410
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Florida
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Miami, Florida, Forenede Stater, 33136
- Ikke rekrutterer endnu
- Local Institution - 0177
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Kontakt:
- Site 0177
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Orlando, Florida, Forenede Stater, 32803
- Ikke rekrutterer endnu
- Local Institution - 0126
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Kontakt:
- Site 0126
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46825
- Ikke rekrutterer endnu
- Local Institution - 0170
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Kontakt:
- Site 0170
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- Rekruttering
- University Of Iowa Hospitals And Clinics
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Kontakt:
- Fernando Maciel Barbosa, Site 0124
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Rekruttering
- Johns Hopkins Hospital
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Kontakt:
- Yasser Ged, Site 0123
- Telefonnummer: 410-570-9410
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Michigan
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Big Rapids, Michigan, Forenede Stater, 49307
- Ikke rekrutterer endnu
- Local Institution - 0176
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Kontakt:
- Site 0176
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Rekruttering
- Washington University School of Medicine
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Kontakt:
- Melissa Reimers, Site 0094
- Telefonnummer: 314-362-5740
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New York
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New York, New York, Forenede Stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center
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Kontakt:
- Sahil Doshi, Site 0096
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45219
- Ikke rekrutterer endnu
- Local Institution - 0135
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Kontakt:
- Site 0135
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Cleveland, Ohio, Forenede Stater, 44195
- Rekruttering
- Cleveland Clinic
-
Kontakt:
- Moshe Ornstein, Site 0127
- Telefonnummer: 216-445-6592
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Rekruttering
- MUSC Hollings Cancer Center
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Kontakt:
- Thai Ho, Site 0165
- Telefonnummer: 843-792-9300
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Myrtle Beach, South Carolina, Forenede Stater, 29572
- Rekruttering
- Carolina Urologic Research Center, LLC
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Kontakt:
- Neal Shore, Site 0114
- Telefonnummer: 843-449-1010
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Utah
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Salt Lake City, Utah, Forenede Stater, 84112
- Trukket tilbage
- Local Institution - 0158
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Washington
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Seattle, Washington, Forenede Stater, 98109-1023
- Ikke rekrutterer endnu
- Local Institution - 0095
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Kontakt:
- Site 0095
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-
-
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Boredeaux, Frankrig, 33076
- Ikke rekrutterer endnu
- Local Institution - 0080
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Kontakt:
- Site 0080
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Nord
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Lille, Nord, Frankrig, 59020
- Ikke rekrutterer endnu
- Local Institution - 0083
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Kontakt:
- Site 0083
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Val-de-Marne
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Villejuif, Val-de-Marne, Frankrig, 94800
- Rekruttering
- Gustave Roussy
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Kontakt:
- Laurence Albiges, Site 0028
- Telefonnummer: 33142114211
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-
-
-
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Dublin, Irland, D07 R2WY
- Ikke rekrutterer endnu
- Local Institution - 0059
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Kontakt:
- Site 0059
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Dublin, Irland, D24 NR0A
- Ikke rekrutterer endnu
- Local Institution - 0062
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Kontakt:
- Site 0062
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-
-
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Milan, Italien, 20133
- Ikke rekrutterer endnu
- Local Institution - 0073
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Kontakt:
- Site 0073
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Napoli Campania, Italien, 80131
- Ikke rekrutterer endnu
- Local Institution - 0087
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Kontakt:
- Site 0087
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Veneto
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Verona, Veneto, Italien, 37126
- Ikke rekrutterer endnu
- Local Institution - 0139
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Kontakt:
- Site 0139
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-
-
-
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Fukuoka, Japan, 812-8582
- Rekruttering
- Kyushu University Hospital
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Kontakt:
- Tokiyoshi Tanegashima, Site 0172
- Telefonnummer: 0926425615
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Niigata, Japan, 951-8520
- Ikke rekrutterer endnu
- Local Institution - 0181
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Kontakt:
- Site 0181
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Hyōgo
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Kobe, Hyōgo, Japan, 650-0017
- Ikke rekrutterer endnu
- Local Institution - 0180
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Kontakt:
- Site 0180
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Iwate
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Shiwa-gun Yahaba-cho, Iwate, Japan, 028-3695
- Ikke rekrutterer endnu
- Local Institution - 0179
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Kontakt:
- Site 0179
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Tokyo
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Koto-ku, Tokyo, Japan, 135-8550
- Rekruttering
- The Cancer Institute Hospital of JFCR
-
Kontakt:
- Yuji Miura, Site 0097
- Telefonnummer: 81335200111
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-
Toyama
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Toyoma, Toyama, Japan, 930-0194
- Rekruttering
- Toyama University Hospital
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Kontakt:
- Hiroshi Kitamura, Site 0078
- Telefonnummer: 81764347372
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-
-
-
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Beijing, Kina, 100034
- Ikke rekrutterer endnu
- Local Institution - 0144
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Kontakt:
- Site 0144
-
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Ikke rekrutterer endnu
- Local Institution - 0143
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Kontakt:
- Site 0143
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Beijing, Beijing Municipality, Kina, 102200
- Ikke rekrutterer endnu
- Local Institution - 0157
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Kontakt:
- Site 0157
-
-
Guangdong
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Guangzhou, Guangdong, Kina, 510555
- Ikke rekrutterer endnu
- Local Institution - 0182
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Kontakt:
- Site 0182
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Hebei
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Tianjin, Hebei, Kina, 300060
- Ikke rekrutterer endnu
- Local Institution - 0145
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Kontakt:
- Site 0145
-
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150081
- Ikke rekrutterer endnu
- Local Institution - 0187
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Kontakt:
- Site 0187
-
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Hunan
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Changsha Shi, Hunan, Kina, 410013
- Ikke rekrutterer endnu
- Local Institution - 0183
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Kontakt:
- Site 0183
-
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Jiangsu
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Nanjing, Jiangsu, Kina, 210008
- Ikke rekrutterer endnu
- Local Institution - 0184
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Kontakt:
- Site 0184
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Shanghai Municipality
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Shanghai Shi, Shanghai Municipality, Kina, 200032
- Ikke rekrutterer endnu
- Local Institution - 0188
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Kontakt:
- Site 0188
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-
-
-
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Oaxaca City, Mexico, 68020
- Ikke rekrutterer endnu
- Local Institution - 0048
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Kontakt:
- Site 0048
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Puebla City, Mexico, 72424
- Ikke rekrutterer endnu
- Local Institution - 0122
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Kontakt:
- Site 0122
-
Tlalpan, Mexico, 14080
- Ikke rekrutterer endnu
- Local Institution - 0049
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Kontakt:
- Site 0049
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Tlalpan, Mexico, 14080
- Ikke rekrutterer endnu
- Local Institution - 0108
-
Kontakt:
- Site 0108
-
Tlalpan, Mexico, 14080
- Ikke rekrutterer endnu
- Local Institution - 0118
-
Kontakt:
- Site 0118
-
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64040
- Ikke rekrutterer endnu
- Local Institution - 0046
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Kontakt:
- Site 0046
-
-
-
-
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Cluj-Napoca, Rumænien, 400015
- Ikke rekrutterer endnu
- Local Institution - 0103
-
Kontakt:
- Site 0103
-
Craiova, Rumænien, 200347
- Rekruttering
- Centrul de Oncologie Sf. Nectarie SRL
-
Kontakt:
- Michael Schenker, Site 0161
- Telefonnummer: 40727774974
-
Iași, Rumænien, 700483
- Ikke rekrutterer endnu
- Local Institution - 0100
-
Kontakt:
- Site 0100
-
Sibiu, Rumænien, 550082
- Ikke rekrutterer endnu
- Local Institution - 0101
-
Kontakt:
- Site 0101
-
-
-
-
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Chur, Schweiz, 7000
- Rekruttering
- Kantonsspital Graubünden
-
Kontakt:
- Richard Cathomas, Site 0054
- Telefonnummer: 41812566646
-
Sankt Gallen, Schweiz, 9007
- Rekruttering
- HOCH Health Ostschweiz
-
Kontakt:
- Tobias Peres, Site 0055
- Telefonnummer: 0767931903
-
Zurich, Schweiz, 8091
- Rekruttering
- UniversitätsSpital Zürich
-
Kontakt:
- Anja Lorch, Site 0056
- Telefonnummer: 492118108776
-
-
-
-
-
Madrid, Spanien, 28041
- Ikke rekrutterer endnu
- Local Institution - 0013
-
Kontakt:
- Site 0013
-
Madrid, Spanien, 28050
- Ikke rekrutterer endnu
- Local Institution - 0091
-
Kontakt:
- Site 0091
-
Seville, Spanien, 41013
- Ikke rekrutterer endnu
- Local Institution - 0043
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Kontakt:
- Site 0043
-
-
-
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Seoul-teukbyeolsi [Seoul]
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Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
-
Kontakt:
- Se Hoon Park, Site 0112
-
Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 03722
- Rekruttering
- Severance Hospital, Yonsei University Health System
-
Kontakt:
- Sang Joon Shin, Site 0167
- Telefonnummer: 82222288138
-
Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 05505
- Rekruttering
- Asan Medical Center
-
Kontakt:
- Jae Lyun Lee, Site 0017
- Telefonnummer: 82230105977
-
-
-
-
-
Brno, Tjekkiet, 656 53
- Ikke rekrutterer endnu
- Local Institution - 0149
-
Kontakt:
- Site 0149
-
Hradec Králové, Tjekkiet, 500 05
- Ikke rekrutterer endnu
- Local Institution - 0150
-
Kontakt:
- Site 0150
-
-
Praha 5
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Prague, Praha 5, Tjekkiet, 150 06
- Ikke rekrutterer endnu
- Local Institution - 0147
-
Kontakt:
- Site 0147
-
-
-
-
-
Hamburg, Tyskland, 20251
- Ikke rekrutterer endnu
- Local Institution - 0026
-
Kontakt:
- Site 0026
-
Herne, Tyskland, 44649
- Ikke rekrutterer endnu
- Local Institution - 0014
-
Kontakt:
- Site 0014
-
München, Tyskland, 81675
- Rekruttering
- Klinikum Rechts der Isar der Technischen Universitaet Muenchen
-
Kontakt:
- Margitta Retz, Site 0027
- Telefonnummer: 498941402522
-
-
Thuringia
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Jena, Thuringia, Tyskland, 07747
- Ikke rekrutterer endnu
- Local Institution - 0025
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Kontakt:
- Site 0025
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria
-
Participants must have a histologically confirmed diagnosis of locally advanced, unresectable (not amenable to curative surgery or radiation therapy) or metastatic Renal Cell Carcinoma (RCC).
-
Participants must have clear cell RCC (ccRCC) or non-clear cell RCC (nccRCC) may be enrolled in Part 1. Note: Part 2 may only enroll participants with ccRCC.
-
Participants may have favorable, intermediate or poor risk disease categories.
-
Participants must not have received prior systemic therapy for metastatic RCC, with the following exceptions:
i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed if such therapy did not include an agent that targets vascular endothelial growth factor (VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy.
ii) For Part 1A participants: Prior systemic therapy in the metastatic setting is allowed if the participant has not received any therapy targeting cytotoxic T-lymphocyte antigen 4 (CTLA-4) (e.g., ipilimumab).
iii) For Part 1B participants: Prior systemic therapy in the metastatic setting is allowed if the participant has not received prior treatment with cabozantinib.
iv) For Parts 2D and 2E: Prior treatment with a HIF-2α inhibitor or other agent that targets the HIF-2α pathway is not allowed.
- Participants must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Exclusion Criteria
- Participants must not have any untreated known CNS metastases.
- Participants must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of Cycle 1 Day1 (C1D1).
- Participants must not have a history of interstitial lung disease or pneumonitis.
- Participants must not have an uncontrolled pleural or pericardial effusion requiring recurrent therapeutic drainage procedures.
- Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to C1D1, uncontrolled hypertension (≥ 150 systolic, ≥ 90 diastolic mm Hg) despite optimal medical management, left ventricular ejection fraction (LVEF) <50% (for Part 2D and 2E) or congenital long QT syndrome.
- Participants must not have a urine protein ≥ 2+ on dipstick or urinalysis at baseline and confirmed proteinuria ≥ 1 g/24 hours or urine protein-creatinine ratio (UPCR) > 1000 mg/g.
- Participants must not have evidence of major coagulation disorders.
- Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 6 months prior to C1D1.
- Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months.
- Participants must not have had a major surgery or trauma within 28 days prior to C1D1.
- For Part 2D and 2E: Receiving ongoing concomitant treatment with sensitive substrates of CYP3A4, CYP2C8, CYP2C9, or CYP2C19 with narrow therapeutic indices within 5 half-lives of the concomitant treatment or up to 28 days, whichever is shorter, prior to randomization.
- For Part 2D and 2E: Receiving ongoing concomitant treatment with moderate or strong CYP3A4 inducers, or moderate or strong CYP3A4 inhibitors within 5 half-lives of the concomitant treatment, or up to 28 days, whichever is shorter, prior to randomization.
- For Part 2D and 2E: Has hypoxia defined by a pulse oximeter reading < 92% at rest or requires intermittent or chronic supplemental oxygen.
- For Part 2D and 2E: Exercise-induced desaturation on a 6-minute walk test, defined as a blood oxygen saturation by pulse oximetry ≤ 88%.
- For Part 2D and 2E: Presence of significant pulmonary disease/condition (eg, chronic obstructive pulmonary disease, pleural effusion, etc) that, in the opinion of the Investigator, could put participant at increased risk from study intervention or impact interpretation of safety data.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
11
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Part 1A: 1A-1 Pumitamig + Ipilimumab
|
Specified dose on specified days
Andre navne:
Specified dose on specified days
Andre navne:
|
|
Eksperimentel: Part 1A: 1A-2 Pumitamig + Ipilimumab
|
Specified dose on specified days
Andre navne:
Specified dose on specified days
Andre navne:
|
|
Eksperimentel: Part 1B: 1B-1 Pumitamig + Cabozantinib
|
Specified dose on specified days
Andre navne:
Specified dose on specified days |
|
Eksperimentel: Part 1B: 1B-2 Pumitamig + Cabozantinib
|
Specified dose on specified days
Andre navne:
Specified dose on specified days |
|
Eksperimentel: Part 2A: 2A-1 Pumitamig + Ipilimumab
|
Specified dose on specified days
Andre navne:
Specified dose on specified days
Andre navne:
|
|
Eksperimentel: Part 2A: 2A-2 Pumitamig + Ipilimumab
|
Specified dose on specified days
Andre navne:
Specified dose on specified days
Andre navne:
|
|
Eksperimentel: Part 2B: 2B-1 Pumitamig + Cabozantinib
|
Specified dose on specified days
Andre navne:
Specified dose on specified days |
|
Eksperimentel: Part 2B: 2B-2 Pumitamig + Cabozantinib
|
Specified dose on specified days
Andre navne:
Specified dose on specified days |
|
Eksperimentel: Part 2C: 2C-1 Pumitamig
|
Specified dose on specified days
Andre navne:
|
|
Eksperimentel: Part 2D: 2D-1 Pumitamig + Casdatifan
|
Specified dose on specified days
Andre navne:
Specified dose on specified days
Andre navne:
|
|
Eksperimentel: Part 2E: 2E-1 Pumitamig + Ipilimumab + Casdatifan
|
Specified dose on specified days
Andre navne:
Specified dose on specified days
Andre navne:
Specified dose on specified days
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with adverse events (AEs)
Tidsramme: Up to approximately 2 years from end of treatment
|
Phase 1 |
Up to approximately 2 years from end of treatment
|
|
Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5))
Tidsramme: Up to approximately 2 years from end of treatment
|
Phase 1 |
Up to approximately 2 years from end of treatment
|
|
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Tidsramme: Up to day 21 from first dose
|
Phase 1 |
Up to day 21 from first dose
|
|
Number of participants with AEs leading to discontinuation
Tidsramme: Up to approximately 2 years from end of treatment
|
Phase 1 |
Up to approximately 2 years from end of treatment
|
|
Number of participants with AEs leading to death
Tidsramme: Up to approximately 2 years from end of treatment
|
Phase 1 |
Up to approximately 2 years from end of treatment
|
|
Objective response rate (ORR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Tidsramme: Up to approximately 2 years from end of treatment
|
Phase 2 |
Up to approximately 2 years from end of treatment
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with AEs
Tidsramme: Up to approximately 2 years from end of treatment
|
Phase 2 |
Up to approximately 2 years from end of treatment
|
|
Number of participants with SAEs (as per CTCAE v5)
Tidsramme: Up to approximately 2 years from end of treatment
|
Phase 2 |
Up to approximately 2 years from end of treatment
|
|
Number of participants with treatment-related adverse events (TRAEs)
Tidsramme: Up to approximately 2 years from end of treatment
|
Phase 2 |
Up to approximately 2 years from end of treatment
|
|
Number of participants with AEs leading to discontinuation
Tidsramme: Up to approximately 2 years from end of treatment
|
Phase 2 |
Up to approximately 2 years from end of treatment
|
|
Number of participants with AEs leading to death
Tidsramme: Up to approximately 2 years from end of treatment
|
Phase 2 |
Up to approximately 2 years from end of treatment
|
|
Progression-free survival (PFS) by RECIST v1.1 per investigator assessment
Tidsramme: Up to 4 years from randomization
|
Phase 2 |
Up to 4 years from randomization
|
|
Duration of response (DOR) (PR or CR) by RECIST v1.1 per investigator assessment
Tidsramme: Up to approximately 2 years from end of treatment
|
Phase 2 |
Up to approximately 2 years from end of treatment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
26. marts 2026
Primær færdiggørelse (Anslået)
Primær færdiggørelse
28. november 2029
Studieafslutning (Anslået)
Studieafslutning
26. november 2031
Datoer for studieregistrering
Først indsendt
Først indsendt
17. december 2025
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
17. december 2025
Først opslået (Faktiske)
Først opslået
19. december 2025
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
23. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. oktober 2026
Sidst verificeret
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Neoplasmer efter histologisk type
- Neoplasmer, kirtel og epitel
- Adenocarcinom
- Urologiske neoplasmer
- Karcinom
- Nyre-neoplasmer
- Karcinom, nyrecelle
- Aminosyrer, peptider og proteiner
- Proteiner
- Antistoffer, monoklonal, humaniseret
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Ipilimumab
- Cabozantinib
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- CA266-0008
- U1111-1327-6332 (Anden identifikator: WHO)
- 2026-527163-15-00 (Anden identifikator: EU CTR)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
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
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .