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En undersøgelse af Nivolumab-relatlimab fastdosis kombination versus Regorafenib eller TAS-102 hos deltagere med senere linjer af metastatisk tyktarmskræft (RELATIVITY-123)

5. august 2026 opdateret af: Bristol-Myers Squibb

Et fase 3, randomiseret, åbent studie af relatlimab-nivolumab fastdosis kombination versus regorafenib eller trifluridin + tipiracil (TAS-102) for deltagere med senere linjer af metastatisk kolorektal cancer

Formålet med denne undersøgelse er at evaluere relatlimab i kombination med nivolumab, administreret som en fastdosis kombination (nivolumab-relatlimab FDC, også omtalt som BMS-986213) til behandling af ikke-mikrosatellit ustabilitet høj (MSI-H)/ deficient mismatch repair (dMMR) metastatisk kolorektal cancer (mCRC) deltagere, som fejlede mindst 1 men ikke mere end 4 tidligere behandlingslinjer for metastatisk sygdom.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

769

Fase

  • Fase 3

Udvidet adgang

Ikke længere tilgængelig uden for det kliniske forsøg. Se udvidet adgangsregistrering.

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Ciudad Autónoma Buenos Aires, Argentina, 1834
        • Local Institution - 0024
      • Rio Grande, Argentina, 8500
        • Local Institution - 0023
    • B
      • Ciudad Autónoma Buenos Aires, B, Argentina, C1181ACH
        • Local Institution - 0026
    • Buenos Aires
      • Ciudad Autónoma Buenos Aires, Buenos Aires, Argentina, 1425
        • Local Institution - 0022
  • Australien
    • New South Wales
      • Wagga Wagga, New South Wales, Australien, 2650
        • Local Institution - 0098
      • Westmead, New South Wales, Australien, 2145
        • Local Institution - 0114
    • Queensland
      • Greenslopes, Queensland, Australien, 4120
        • Local Institution - 0001
    • Victoria
      • Clayton, Victoria, Australien, 3168
        • Local Institution - 0010
      • Melbourne, Victoria, Australien, 3084
        • Local Institution - 0021
    • Western Australia
      • Murdoch, Western Australia, Australien, 6150
        • Local Institution - 0027
  • Belgien
      • Edegem, Belgien, 2650
        • Local Institution - 0070
      • Leuven, Belgien, 3000
        • Local Institution - 0120
    • BRU
      • Woluwé-Saint-Lambert, BRU, Belgien, 1200
        • Local Institution - 0062
    • VOV
      • Ghent, VOV, Belgien, 9000
        • Local Institution - 0068
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0003
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Local Institution - 0014
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0007
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Local Institution - 0019
      • Montreal, Quebec, Canada, H4A 3J1
        • Local Institution - 0104
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Local Institution - 0004
  • Chile
    • RM
      • Santiago, RM, Chile, 7560908
        • Local Institution - 0015
      • Santiago, RM, Chile, 8380456
        • Local Institution - 0033
  • Forenede Stater
    • Arkansas
      • Springdale, Arkansas, Forenede Stater, 72762-5328
        • Local Institution - 0044
    • California
      • Los Angeles, California, Forenede Stater, 90089-0112
        • Local Institution - 0012
    • Connecticut
      • Norwich, Connecticut, Forenede Stater, 06360-2753
        • Local Institution - 0117
    • Florida
      • Miami, Florida, Forenede Stater, 33176
        • Local Institution - 0025
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • Local Institution - 0031
    • Idaho
      • Boise, Idaho, Forenede Stater, 83712-6267
        • Local Institution - 0071
    • Indiana
      • Fort Wayne, Indiana, Forenede Stater, 46805
        • Local Institution - 0081
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02214
        • Massachusetts General Hospital,
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-1382
        • Local Institution - 0042
    • New Jersey
      • East Brunswick, New Jersey, Forenede Stater, 08816-3340
        • Local Institution - 0043
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Local Institution - 0009
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45220
        • Local Institution - 0082
      • Columbus, Ohio, Forenede Stater, 43210-1240
        • Local Institution - 0095
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19111-2434
        • Local Institution - 0147
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29414
        • Local Institution - 0008
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57104
        • Local Institution - 0096
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203-2173
        • Local Institution - 0127
    • Texas
      • Fort Worth, Texas, Forenede Stater, 76104-4611
        • Local Institution - 0097
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23284
        • Local Institution - 0132
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53705-2275
        • Local Institution - 0005
  • Frankrig
      • Bordeaux, Frankrig, 33000
        • Local Institution - 0066
      • Dijon, Frankrig, 21000
        • Local Institution - 0090
      • Levallois-Perret, Frankrig, 92300
        • Local Institution - 0020
      • Lyon, Frankrig, 69008
        • Local Institution - 0036
      • Paris, Frankrig, 75012
        • Local Institution - 0089
      • Suresnes, Frankrig, 92151
        • Local Institution - 0039
    • Caen
      • Caen, Caen, Frankrig, 14000
        • Local Institution - 0017
  • Holland
      • Amsterdam, Holland, 1066 CX
        • Local Institution - 0050
  • Italien
      • Catania, Italien, 95122
        • Local Institution - 0060
      • Genova, Italien, 16132
        • Local Institution - 0091
      • Milan, Italien, 20133
        • Local Institution - 0045
      • Naples, Italien, 80131
        • Local Institution - 0115
      • Naples, Italien, 80138
        • Local Institution - 0061
    • MI
      • Milan, MI, Italien, 20162
        • Local Institution - 0046
    • PD
      • Padova, PD, Italien, 35128
        • Local Institution - 0148
    • RE
      • Reggio Emilia, RE, Italien, 42123
        • Local Institution - 0059
  • Japan
      • Chiba, Japan, 260-8717
        • Local Institution - 0107
      • Chūōku, Japan, 104-0045
        • Local Institution - 0103
      • Hidaka-shi, Japan, 350-1298
        • Local Institution - 0105
      • Kasama-Shi, Japan, 309-1793
        • Local Institution - 0154
      • Kashiwa-Shi, Japan, 277-8577
        • Local Institution - 0084
      • Kawasaki-Shi, Japan, 216-8511
        • Local Institution - 0086
      • Kitaadachi-gun, Japan, 362-0806
        • Local Institution - 0119
      • Kōtoku, Japan, 135-8550
        • Local Institution - 0108
      • Matsuyama, Japan, 791-0280
        • Local Institution - 0118
      • Sapporo, Japan, 060-8648
        • Local Institution - 0088
      • Suita-Shi, Japan, 565-0871
        • Local Institution - 0083
      • Sunto-gun, Japan, 411-8777
        • Local Institution - 0085
      • Yokohama, Japan, 241-8515
        • Local Institution - 0124
    • Osaka
      • Osaka, Osaka, Japan, 5418567
        • Local Institution - 0110
  • Kina
      • Beijing, Kina, 100142
        • Local Institution - 0122
      • Hangzhou, Kina, 310003
        • Local Institution - 0139
      • Shanghai, Kina, 200032
        • Local Institution - 0153
      • Shenyang, Kina, 110042
        • Local Institution - 0149
    • CQ
      • Chongqing, CQ, Kina, 400030
        • Local Institution - 0134
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510655
        • Local Institution - 0151
    • HB
      • Wuhan, HB, Kina, 430071
        • Local Institution - 0126
    • HN
      • Changsha, HN, Kina, 410013
        • Local Institution - 0138
    • Hubei
      • Wuhan, Hubei, Kina, 430079
        • Local Institution - 0164
    • Hunan
      • Changsha, Hunan, Kina, 410013
        • Local Institution - 0158
    • JS
      • Nanjing, JS, Kina, 210008
        • Local Institution - 0143
    • Jiangsu
      • Huaian, Jiangsu, Kina, 223300
        • Local Institution - 0146
    • SD
      • Jinan, SD, Kina, 250117
        • Local Institution - 0142
    • SHA
      • Xi'an, SHA, Kina, 710038
        • Local Institution - 0152
    • SX
      • Taiyuan, SX, Kina, 030013
        • Local Institution - 0141
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Local Institution - 0144
    • TJ
      • Tianjin, TJ, Kina, 300121
        • Local Institution - 0150
    • ZJ
      • Hangzhou, ZJ, Kina, 310022
        • Local Institution - 0160
  • Polen
      • Krakow, Polen, 30-727
        • Local Institution - 0018
      • Warsaw, Polen, 02-781
        • Local Institution - 0052
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 02-507
        • Local Institution - 0051
    • Pl-mz
      • Warsaw, Pl-mz, Polen, 05-400
        • Local Institution - 0037
  • Puerto Rico
    • PR
      • San Juan, PR, Puerto Rico, 00927
        • Local Institution - 0106
  • Schweiz
      • Bern, Schweiz, 3010
        • Local Institution - 0069
    • Canton of Aargau
      • Aarau, Canton of Aargau, Schweiz, 5000
        • Local Institution - 0057
  • Singapore
      • Singapore, Singapore, 169610
        • Local Institution - 0109
      • Singapore, Singapore, 329563
        • Local Institution - 0087
  • Spanien
      • A Coruña, Spanien, 15006
        • Local Institution - 0112
      • Barcelona, Spanien, 08035
        • Local Institution - 0080
      • Seville, Spanien, 41013
        • Local Institution - 0035
    • B
      • Badalona, B, Spanien, 08916
        • Local Institution - 0029
      • Barcelona, B, Spanien, 08036
        • Local Institution - 0093
    • M
      • Madrid, M, Spanien, 28041
        • Local Institution - 0102
    • Madrid
      • Madrid, Madrid, Spanien, 28046
        • Local Institution - 0113
    • Z
      • Zaragoza, Z, Spanien, 50009
        • Local Institution - 0116
  • Sverige
      • Gothenburg, Sverige, 413 45
        • Local Institution - 0067
      • Malmö, Sverige, 214 28
        • Local Institution - 0094
    • AB
      • Stockholm, AB, Sverige, 112 81
        • Local Institution - 0038
      • Stockholm, AB, Sverige, 171 76
        • Local Institution - 0135
    • C
      • Uppsala, C, Sverige, 751 85
        • Local Institution - 0058
  • Sydkorea
      • Goyang-si, Gyeonggi-do, Sydkorea, 10408
        • Local Institution - 0073
      • Seongnamsi Bundanggu, Sydkorea, 13620
        • Local Institution - 0129
      • Seoul, Sydkorea, 05505
        • Local Institution - 0092
      • Seoul, Sydkorea, 06351
        • Local Institution - 0075
      • Seoul, Sydkorea, 110-744
        • Local Institution - 0074
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, Sydkorea, 03722
        • Local Institution - 0072
  • Taiwan
      • Tainan, Taiwan, 70403
        • Local Institution - 0077
    • CHA
      • Changhua, CHA, Taiwan, 500
        • Local Institution - 0128
    • KHH
      • Kaohsiung City, KHH, Taiwan, 83301
        • Local Institution - 0111
    • TNN
      • Tainan, TNN, Taiwan, 704
        • Local Institution - 0076
    • TPE
      • Zhongzheng, TPE, Taiwan, 100
        • Local Institution - 0121
  • Tjekkiet
      • Hořovice, Tjekkiet, 26801
        • Local Institution - 0099
      • Hradec Králové, Tjekkiet, 500 05
        • Local Institution - 0016
      • Olomouc, Tjekkiet, 775 20
        • Local Institution - 0100
      • Ostrava, Tjekkiet, 708 52
        • Local Institution - 0123
      • Prague, Tjekkiet, 150 06
        • Local Institution - 0064
  • Tyskland
      • Hamburg, Tyskland, 20249
        • Local Institution - 0040
      • München, Tyskland, 81377
        • Local Institution - 0034
    • Baden-Wurttemberg
      • Mannheim, Baden-Wurttemberg, Tyskland, 68167
        • Local Institution - 0054
      • Reutlingen, Baden-Wurttemberg, Tyskland, 72764
        • Local Institution - 0056
    • Bavaria
      • Würzburg, Bavaria, Tyskland, 97080
        • Local Institution - 0053
    • Hesse
      • Frankfurt A. Main, Hesse, Tyskland, 60488
        • Local Institution - 0041
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Tyskland, 45147
        • Local Institution - 0101
    • State of Berlin
      • Berlin, State of Berlin, Tyskland, 13353
        • Local Institution - 0055
  • Østrig
      • Graz, Østrig, 6800
        • Local Institution - 0030
      • Klagenfurt, Østrig, 9020
        • Local Institution - 0078
      • Salzburg, Østrig, 5020
        • Local Institution - 0131

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

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Histologisk bekræftet tidligere behandlet kolorektal cancer med adenocarcinom histologi med metastatisk eller tilbagevendende ikke-operabel sygdom ved studiestart

  • Deltagerne skal have:

    1. udviklet sig under eller inden for ca. 3 måneder efter den sidste administration af godkendte standardterapier (mindst 1, men ikke mere end 4 tidligere behandlingslinjer), som skal omfatte en fluoropyrimidin, oxaliplatin, irinotecan, en anti-VEGF-terapi og anti- EGFR-terapi (hvis KRAS-vildtype), hvis tilgængelig i det respektive land, eller;
    2. været intolerant over for tidligere systemiske kemoterapiregimer, hvis der er dokumenteret tegn på klinisk signifikant intolerance trods tilstrækkelige støtteforanstaltninger
  • Skal have tilstrækkeligt tumorvæv og evaluerbar PD-L1-ekspression for at opfylde undersøgelseskravene
  • Skal have målbar sygdom pr. RECIST v1.1. Deltagere med læsioner i et tidligere bestrålet felt som det eneste sted for målbar sygdom vil få tilladelse til at tilmelde sig, forudsat at læsion(erne) har vist tydelig progression og kan måles nøjagtigt

Ekskluderingskriterier:

  • Forudgående behandling med enten immunterapi eller med regorafenib eller med TAS-102
  • Ubehandlede metastaser i centralnervesystemet (CNS), deltagere er kvalificerede, hvis CNS-metastaser er blevet behandlet, og deltagerne er neurologisk vendt tilbage til baseline (bortset fra resterende tegn eller symptomer relateret til CNS-behandlingen)
  • Anamnese med refraktær hypertension, der ikke er kontrolleret med antihypertensiv behandling, myocarditis (uanset ætiologi), ukontrollerede arytmier, akut koronarsyndrom inden for 6 måneder før dosering, kongestivt klasse II hjertesvigt (i henhold til New York Heart Association Functional Classification), interstitiel lungesygdom/pneumonitis eller en aktiv, kendt eller mistænkt autoimmun sygdom
  • Bekræftet tumormikrosatellit-ustabil høj/deficient mismatch repair (MSI-H/dMMR) status i henhold til lokal standardtestning; MSI/MMR-testresultater fra indledende diagnose er acceptable.

Andre protokoldefinerede inklusions-/eksklusionskriterier gælder

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)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm A: Nivolumab + Relatlimab fastdosiskombination (FDC)
Medicin: Nivolumab-relatlimab FDC
Specificeret dosis på specificerede dage
Andre navne:
  • BMS-986213
Aktiv komparator: Arm B: Efterforskerens valg
Behandling med Regorafenib eller TAS-102
Medicin: Regorafenib
Specificeret dosis på specificerede dage
Andre navne:
  • Stivarga
Medicin: TAS-102
Specificeret dosis på specificerede dage
Andre navne:
  • Lonsurf
  • Trifluridin/Tipiracil

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: From date of randomization to the date of death due to any cause (Up to approxaimtely 38 months)
OS is defined as the time from date of randomization to the date of death due to any cause.
From date of randomization to the date of death due to any cause (Up to approxaimtely 38 months)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
Tidsramme: From randomization until the date of objectively documented response (Up to approximately 38 months)

ORR is defined as the percent of participants with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR).

CR=Disappearance of all target lesions. PR=At least a 30% decrease in the sum of diameters of target lesions.
From randomization until the date of objectively documented response (Up to approximately 38 months)
Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
Tidsramme: From date of randomization to the date of first documented progression or death, whichever occurs first (Up to approximately 38 months)

PFS is defined as the time from randomization to first documented progression (PD) or death due to any cause, whichever is earlier.

PD=At least a 20% increase in the sum of diameters of target lesions.
From date of randomization to the date of first documented progression or death, whichever occurs first (Up to approximately 38 months)
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
Tidsramme: From date of randomization to the date of first documented progression or death, whichever occurs first (Up to approximately 38 months)

DoR is defined as the time between the date of first confirmed documented response (CR or PR) to the date of the first documented tumor progression as determined by BICR (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first.

CR=Disappearance of all target lesions. PR=At least a 30% decrease in the sum of diameters of target lesions. PD=At least a 20% increase in the sum of diameters of target lesions.
From date of randomization to the date of first documented progression or death, whichever occurs first (Up to approximately 38 months)
Number of Participants With Adverse Events (AEs)
Tidsramme: From first dose until 30 days post last dose (Up to 24 months)
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence at any dose that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions, results in a congenital abnormality or birth defect, or is an important medical event that may not result in death, be life-threatening, or require hospitalization, but may require medical or surgical intervention to prevent any of the outcomes listed above.
From first dose until 30 days post last dose (Up to 24 months)
Number of Participants With Select Adverse Events (AEs)
Tidsramme: From first dose until 30 days post last dose (Up to 24 months)
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.
From first dose until 30 days post last dose (Up to 24 months)
Number of Participants With Immune Mediated Adverse Events (IMAEs)
Tidsramme: From first dose until 30 days post last dose (Up to 24 months)
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.
From first dose until 30 days post last dose (Up to 24 months)
Number of Participants With Laboratory Test Results of Worst Toxicity Grade 3 and 4
Tidsramme: From first dose until 30 days post last dose (Up to 24 months)
Blood samples were collected for assessment of laboratory test results. All abnormalities were graded as per CTCAE v5.0 on a scale from 1 to 4, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.
From first dose until 30 days post last dose (Up to 24 months)
Time Until Definitive Deterioration - Quality of Life (TUDD-QoL)
Tidsramme: From randomization until the first date of a definititve clincial decline from baseline in QoL scale score (Up to approximately 38 months)
TUDD-QoL is defined as time from randomization until the first date of a definitive clinically meaningful decline from baseline in EORTC QLQ-C30 health status/QoL scale score. A definitive deterioration is defined as when all subsequent PRO assessments after a deterioration also reach or exceed the pre-defined meaningful change threshold. A decrease in score of at least 15 points from baseline will be considered to be the meaningful change threshold (MCT) for the global health status/quality-of-life and scale.
From randomization until the first date of a definititve clincial decline from baseline in QoL scale score (Up to approximately 38 months)
Time Until Definitive Deterioration - Physical Function (TUDD-PF)
Tidsramme: From randomization until the first date of a definititve clincial decline from baseline in PF scale score (Up to approximately 38 months)
TUDD-PF is defined as time from randomization until the first date of a definitive clinically meaningful decline from baseline in EORTC QLQ-C30 physical function scale score. A definitive deterioration is defined as when all subsequent PRO assessments after a deterioration also reach or exceed the pre-defined meaningful change threshold. A 10-point decrease from baseline will be considered the meaning change threshold (MCT) for the physical function scale.
From randomization until the first date of a definititve clincial decline from baseline in PF scale score (Up to approximately 38 months)
Progression Free Survival (PFS) Per Investigator
Tidsramme: From date of randomization to the date of first documented progression or death, whichever occurs first (Up to approximately 38 months)

PFS is defined as the time from randomization to first documented progression (PD) or death due to any cause, whichever is earlier.

PD=At least a 20% increase in the sum of diameters of target lesions.
From date of randomization to the date of first documented progression or death, whichever occurs first (Up to approximately 38 months)
Objective Response Rate (ORR) Per Investigator
Tidsramme: From randomization until the date of objectively documented response (Up to approximately 38 months)

ORR is defined as the percent of participants with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR).

CR=Disappearance of all target lesions. PR=At least a 30% decrease in the sum of diameters of target lesions.
From randomization until the date of objectively documented response (Up to approximately 38 months)
Duration of Response (DoR) Per Investigator
Tidsramme: From date of randomization to the date of first documented progression or death, whichever occurs first (Up to approximately 38 months)

DoR is defined as the time between the date of first confirmed documented response (CR or PR) to the date of the first documented tumor progression as determined by BICR (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first.

CR=Disappearance of all target lesions. PR=At least a 30% decrease in the sum of diameters of target lesions. PD=At least a 20% increase in the sum of diameters of target lesions.
From date of randomization to the date of first documented progression or death, whichever occurs first (Up to approximately 38 months)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bristol-Myers Squibb

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.

Hjælpsomme links

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)

28. april 2022

Primær færdiggørelse (Faktiske)

14. juli 2025

Studieafslutning (Faktiske)

14. juli 2025

Datoer for studieregistrering

Først indsendt

14. marts 2022

Først indsendt, der opfyldte QC-kriterier

13. april 2022

Først opslået (Faktiske)

14. april 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CA224-123
  • 2021-004285-35 (EudraCT nummer)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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