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Une étude du nivolumab sous-cutané par rapport au nivolumab intraveineux chez des participants atteints d'un carcinome rénal à cellules claires déjà traité qui est avancé ou s'est propagé (CheckMate-67T)

26 août 2026 mis à jour par: Bristol-Myers Squibb

Un essai de phase 3, ouvert, randomisé, de non-infériorité de la formulation sous-cutanée de nivolumab par rapport au nivolumab intraveineux chez des participants atteints d'un carcinome rénal à cellules claires avancé ou métastatique ayant déjà reçu un traitement systémique

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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

681

Phase

  • Phase 3

Accès étendu

Plus disponible en dehors de l'essai clinique. Voir enregistrement d'accès étendu.

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Bras A
Biologique: Nivolumab and rHuPH20

Specified dose on specified days

Autres noms:
  • BMS-986298
Comparateur actif: Bras B
Biologique: Nivolumab

Specified dose on specified days

Autres noms:
  • BMS-936558
  • Opdivo
Expérimental: Bras C
Biologique: Nivolumab and rHuPH20

Specified dose on specified days

Autres noms:
  • BMS-986298
Expérimental: Bras D
Biologique: Nivolumab and rHuPH20

Specified dose on specified days

Autres noms:
  • BMS-986298

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale
Délai: 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
Délai: Pre-dose (Day 1 to Day 28)

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Objective Response Rate (ORR) Per BICR
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Bristol-Myers Squibb

Les enquêteurs

  • Directeur d'études: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

21 mai 2021

Achèvement primaire (Réel)

29 juillet 2025

Achèvement de l'étude (Estimé)

10 mai 2027

Dates d'inscription aux études

Première soumission

16 mars 2021

Première soumission répondant aux critères de contrôle qualité

19 mars 2021

Première publication (Réel)

22 mars 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CA209-67T
  • 2020-003655-15 (Numéro EudraCT)
  • U1111-1255-9514 (Identificateur de registre: WHO)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

See Plan Description

Critères d'accès au partage IPD

See Plan Description

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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