Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

En studie av subkutan nivolumab versus intravenøs nivolumab hos deltakere med tidligere behandlet klarcellet nyrecellekarsinom som er avansert eller har spredt seg (CheckMate-67T)

26. august 2026 oppdatert av: Bristol-Myers Squibb

En fase 3, åpen, randomisert, noninferioritetsstudie av subkutan formulering av nivolumab versus intravenøs nivolumab hos deltakere med avansert eller metastatisk klarcellet nyrecellekarsinom som har mottatt tidligere systemisk terapi

The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

681

Fase

  • Fase 3

Utvidet tilgang

Ikke lenger tilgjengelig utenfor den kliniske utprøvingen. Se utvidet tilgangspost.

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Argentina
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Local Institution - 0038
      • Capital Federal, Buenos Aires, Argentina, C1419AHN
        • Local Institution - 0095
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Local Institution - 0058
      • Pergamino, Buenos Aires, Argentina, B2700CPM
        • Local Institution - 0037
    • Córdoba Province
      • Parana, Córdoba Province, Argentina, 5000
        • Local Institution - 0079
      • Río Cuarto, Córdoba Province, Argentina, 5800
        • Local Institution - 0030
    • Río Negro Province
      • Viedma, Río Negro Province, Argentina, R8500ACE
        • Local Institution - 0066
    • San Juan Province
      • San Juan, San Juan Province, Argentina, J5402DIL
        • Local Institution - 0056
  • Brasil
    • Paraná
      • Curitiba, Paraná, Brasil, 80520-174
        • Local Institution - 0064
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brasil, 98700-000
        • Local Institution - 0107
      • Porto Alegre, Rio Grande do Sul, Brasil, 91350-200
        • Local Institution - 0039
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brasil, 20230-130
        • Local Institution - 0090
    • São Paulo
      • Barretos, São Paulo, Brasil, 014784-000
        • Local Institution - 0071
      • São José do Rio Preto, São Paulo, Brasil, 15090-000
        • Local Institution - 0070
      • São Paulo, São Paulo, Brasil, 01246-000
        • Local Institution - 0081
      • São Paulo, São Paulo, Brasil, 01327-0001
        • Local Institution - 0096
  • Chile
    • Araucania
      • Temuco, Araucania, Chile
        • Local Institution - 0084
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile
        • Local Institution - 0005
      • Santiago, Santiago Metropolitan, Chile, 7500653
        • Local Institution - 0104
      • Santiago, Santiago Metropolitan, Chile, 7500921
        • Local Institution - 0076
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Local Institution - 0077
  • Finland
      • Tampere, Finland, 33521
        • Local Institution - 0017
  • Forente stater
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Local Institution
    • New York
      • Buffalo, New York, Forente stater, 14263
        • Local Institution - 0025
    • Pennsylvania
      • West Reading, Pennsylvania, Forente stater, 19611
        • Local Institution - 0088
  • Frankrike
      • Nice, Frankrike, 6189
        • Local Institution
      • Suresnes, Frankrike, 92151
        • Local Institution - 0051
      • Villejuif, Frankrike, 94800
        • Local Institution - 0068
  • Irland
    • Dublin
      • Tallaght, Dublin, Irland
        • Local Institution - 0060
  • Italia
      • Cremona, Italia, 26100
        • Local Institution - 0033
      • Florence, Italia, 50134
        • Local Institution - 0008
      • Meldola, Italia, 47014
        • Local Institution - 0027
      • Milan, Italia, 20141
        • Local Institution - 0018
      • Milan, Italia, 20133
        • Local Institution
      • Padova, Italia, 35128
        • Local Institution - 0014
      • Parma, Italia, 43126
        • Local Institution - 0082
      • Pavia, Italia, 27100
        • Local Institution - 0092
      • Roma, Italia, 00168
        • Local Institution - 0100
      • Rome, Italia, 00152
        • Local Institution - 0091
      • Terni, Italia, 05100
        • Local Institution - 0057
  • Mexico
    • Coahuila
      • Torreón, Coahuila, Mexico, 27010
        • Local Institution - 0101
    • Mexico City
      • Tlalpan, Mexico City, Mexico, 14080
        • Local Institution - 0089
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Local Institution - 0103
      • Monterrey, Nuevo León, Mexico, 64710
        • Local Institution - 0031
    • Querétaro
      • Querétaro City, Querétaro, Mexico, 76000
        • Local Institution - 0065
      • Querétaro City, Querétaro, Mexico, 76090
        • Local Institution - 0085
    • San Luis Potosí
      • San Luis Potosí City, San Luis Potosí, Mexico, 78200
        • Local Institution - 0105
  • New Zealand
      • Auckland, New Zealand, 1023
        • Local Institution - 0053
      • Hamilton, New Zealand, 3204
        • Local Institution - 0041
      • Palmerston North, New Zealand, 4414
        • Local Institution - 0078
  • Polen
      • Biała Podlaska, Polen, 21-500
        • Local Institution - 0055
      • Bydgoszcz, Polen, 85-796
        • Local Institution - 0062
      • Gdansk, Polen, 80-214
        • Local Institution - 0083
      • Krakow, Polen, 30-688
        • Local Institution - 0021
      • Krakow, Polen, 31-115
        • Local Institution - 0098
      • Poznan, Polen, 60-569
        • Local Institution - 0001
      • Warsaw, Polen, 02-781
        • Local Institution - 0023
  • Portugal
      • Coimbra, Portugal, 3030-075
        • Local Institution - 0050
      • Lisbon, Portugal, 1500-650
        • Local Institution - 0052
  • Romania
      • Bucharest, Romania, 022238
        • Local Institution - 0024
      • Cluj-Napoca, Romania, 400132
        • Local Institution - 0002
      • Cluj-Napoca, Romania, 400641
        • Local Institution - 0040
      • Craiova, Romania, 200347
        • Local Institution - 0016
  • Russland
      • Chelyabinsk, Russland, 454087
        • SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine
      • Ivanovo, Russland, 153040
        • Ivanovo Regional Oncology Dispensary
      • Moscow, Russland, 125284
        • Hertzen Moscow Oncology Research Center
      • Nizghiy Novgorod, Russland, 603000
        • Local Institution
      • Omsk, Russland, 644013
        • Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary
      • Saint Petersburg, Russland, 197022
        • LLC Eurocityclinic
  • Spania
      • Barcelona, Spania, 08003
        • Local Institution - 0048
      • Barcelona, Spania, 08035
        • Local Institution - 0102
      • Barcelona, Spania, 08041
        • Local Institution - 0049
      • Madrid, Spania, 28026
        • Local Institution - 0072
      • Madrid, Spania, 28033
        • Local Institution - 0067
      • Madrid, Spania, 28046
        • Local Institution - 0074
      • Madrid, Spania, 28050
        • Local Institution - 0075
      • Sabadell, Spania, 08208
        • Local Institution - 0032
      • Santander, Spania, 39008
        • Local Institution - 0086
      • Seville, Spania, 31013
        • Local Institution - 0059
  • Tsjekkia
      • Brno, Tsjekkia, 656 53
        • Local Institution - 0063
      • Hradec Králové, Tsjekkia, 500 05
        • Local Institution - 0036
      • Olomouc, Tsjekkia, 77900
        • Local Institution - 0020
      • Ostrava, Tsjekkia, 708 52
        • Local Institution - 0099
      • Prague, Tsjekkia, 140 59
        • Local Institution - 0010
      • Praha 8 Liben, Tsjekkia, 18081
        • Local Institution - 0106
  • Tyrkia (Türkiye)
      • Ankara, Tyrkia (Türkiye), 06230
        • Local Institution - 0026
      • Ankara, Tyrkia (Türkiye), 06590
        • Local Institution - 0097
      • Istanbul, Tyrkia (Türkiye), 34098
        • Local Institution - 0019
    • Bagcilar
      • Istanbul, Bagcilar, Tyrkia (Türkiye), 34284
        • Local Institution - 0035

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Histological confirmation of renal cell carcinoma (RCC) with a clear cell component, including participants who may also have sarcomatoid features
  • Advanced RCC (not amenable to curative surgery or radiation therapy) or metastatic RCC (Stage IV)
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria within 28 days prior to randomization
  • Received no more than 2 prior systemic treatment regimens
  • Intolerance or progression on or after the last treatment regimen received and within 6 months prior to randomization
  • Karnofsky PS ≥ 70 at screening
  • Must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

  • Untreated, symptomatic central nervous system (CNS) metastases

  • Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization

  • Active, known, or suspected autoimmune disease

  • Known human immunodeficiency virus (HIV) positive with an acquired immunodeficiency syndrome (AIDS) defining opportunistic infection within the last year, or a current CD4 count < 350 cells/μL. Participants with HIV are eligible if:

    1. They have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization
    2. They continue on ART as clinically indicated while enrolled on study
    3. CD4 counts and viral load are monitored per standard of care by a local health care provider
    4. Inclusion of participants with HIV should be based on Investigator clinical judgment in consultation with the Medical Monitor NOTE: Testing for HIV must be performed at sites where mandated locally. HIV-positive participants must be excluded where mandated locally

  • Serious or uncontrolled medical disorders including for example, active severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) infection within approximately 4 weeks prior to screening. In the case of prior SARS-CoV-2 infection, acute symptoms must have resolved based on investigator clinical judgment and, in consultation with Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment to be eligible

  • Prior treatment with an programmed death receptor-1 (anti-PD-1), programmed death ligand-1 (anti-PD-L1), or cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways

  • Treatment with any live attenuated vaccine within 30 days of first study treatment

Other protocol-defined inclusion/exclusion criteria apply

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm A
Biologisk: Nivolumab and rHuPH20

Specified dose on specified days

Andre navn:
  • BMS-986298
Aktiv komparator: Arm B
Biologisk: Nivolumab

Specified dose on specified days

Andre navn:
  • BMS-936558
  • Opdivo
Eksperimentell: Arm C
Biologisk: Nivolumab and rHuPH20

Specified dose on specified days

Andre navn:
  • BMS-986298
Eksperimentell: Arm D
Biologisk: Nivolumab and rHuPH20

Specified dose on specified days

Andre navn:
  • BMS-986298

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale
Tidsramme: Pre-dose (Day 1 to Day 28)

Plasma samples were collected to assess the serum concentration.
Pre-dose (Day 1 to Day 28)
Adjusted Geometric Mean of Nivolumab Trough Serum Concentration at Steady State (Cminss) on Original Scale
Tidsramme: Pre-dose (Day 1 to Day 28)

Plasma samples were collected to assess the serum concentration.
Pre-dose (Day 1 to Day 28)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objective Response Rate (ORR) Per BICR
Tidsramme: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)

Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
Trough Serum Concentration of Nivolumab at Day 28 (Cmind28)
Tidsramme: Pre-dose at Day 28

Blood samples were collected to assess serum concentration.
Pre-dose at Day 28
Maximum Serum Concentration of Nivolumab After the First Dose (Cmax1)
Tidsramme: Post dose (Day 1)

Blood samples were collected to assess serum concentration.
Post dose (Day 1)
Peak Serum Concentration of Nivolumab at Steady State (Cmaxss)
Tidsramme: Pre-dose (Day 1 to Day 28)

Blood samples were collected to assess serum concentration.
Pre-dose (Day 1 to Day 28)
Time-averaged Serum Concentration of Nivolumab at Steady State (Cavgss)
Tidsramme: Pre-dose (Day 1 to Day 28)

Blood samples were collected to assess serum concentration.
Pre-dose (Day 1 to Day 28)
Trough Serum Concentration of Nivolumab (Ctrough)
Tidsramme: Pre-dose at Week 17

Blood samples were collected to assess serum concentration.
Pre-dose at Week 17
Time to Maximum Serum Concentration of Nivolumab at Day 1 (Tmax1)
Tidsramme: Post dose (Day 1)

Blood samples were collected to assess serum concentration.
Post dose (Day 1)
Trough Serum Concentration of Nivolumab at Steady State (Cminss)
Tidsramme: Pre dose (Day 1 to Day 28)

Blood samples were collected to assess serum concentration.
Pre dose (Day 1 to Day 28)
Number of Participants With Adverse Events, Serious Adverse Events, AEs Leading to Discontinuation and Death
Tidsramme: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 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.
First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)
Number of Participants With Grade 3/4 Laboratory Abnormalities
Tidsramme: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 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.
First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)
Disease Control Rate (ORR) Per BICR
Tidsramme: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)

Disease control rate (DCR) is defined as the percentage of participants who achieve a BOR of confirmed Complete Response (CR), confirmed Partial Response (PR), or stable disease (SD), based on BICR assessments (using RECIST 1.1) divided by the number of all randomized participants. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
Time to Response (TTR) Per BICR
Tidsramme: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)

Time to response (TTR) assessed by BICR is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria.

CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
Duration of Response (DoR) Per BICR
Tidsramme: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)

Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR is complete disappearance of all target lesions except nodal disease; all target nodes must decrease to normal size (short axis < 10 mm). PR is ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. Disease progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
Overall Survival
Tidsramme: From first dose to the date of death (up to approximately 26 months)

Overall survival is defined as the time from the first dosing date (or from randomization/on treatment) to the date of death from any cause.
From first dose to the date of death (up to approximately 26 months)
Number of Participants With Drug-Related Local Injection- or Infusion-Site Reactions
Tidsramme: First dose (Day 1) and 100 days after last dose of study therapy (up to approximately 27 months)
First dose (Day 1) and 100 days after last dose of study therapy (up to approximately 27 months)
Number of Participants With Incidence of Anti-nivolumab Antibodies
Tidsramme: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)

ADA Positive is a subject with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater [≥]than baseline positive titer) at any time after initiation of treatment.
First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bristol-Myers Squibb

Etterforskere

  • Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. mai 2021

Primær fullføring (Faktiske)

29. juli 2025

Studiet fullført (Antatt)

10. mai 2027

Datoer for studieregistrering

Først innsendt

16. mars 2021

Først innsendt som oppfylte QC-kriteriene

19. mars 2021

Først lagt ut (Faktiske)

22. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CA209-67T
  • 2020-003655-15 (EudraCT-nummer)
  • U1111-1255-9514 (Registeridentifikator: WHO)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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

Tilgangskriterier for IPD-deling

See Plan Description

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere