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A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread

Study acronym: CheckMate-67T
StatusActive, Not Recruiting
PhasePhase 3
Started2021-05-21
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 2 of 2 changed
See other at-risk trials from Bristol-Myers Squibb

Amendment history

The 49 most recent of 53 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-23
Primary endpoint(s) modified2 entries, revised
WasTime-averaged serum concentration over 28 days (Cavgd28), Trough serum concentration at steady-state (Cminss)
NowAdjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale, Adjusted Geometric Mean of Nivolumab Trough Serum Concentration at Steady State (Cminss) on Original Scale
Results posted: 2026-09-22
2026-07-29
Study Status, Outcome Measures, IPDSharing, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v52
Secondary endpoints33 to 16 entries
Objective responseResponse rateRate (ORR) byPer BlindedBICR Trough IndependentSerum Central Review (BICR) with a minimumConcentration of 6 months follow-up Trough serum concentrationNivolumab at dayDay 28 (Cmind28) Maximum serumSerum concentrationConcentration afterof Nivolumab After the firstFirst doseDose (Cmax1) Peak serumSerum concentrationConcentration of Nivolumab at steady-stateSteady State (Cmaxss) Time-averaged Serum Concentration of Nivolumab at Steady-state average serum concentrationState (Cavgss) Trough concentrationSerum Concentration of Nivolumab (Ctrough) IncidenceTime to Maxim [...] [...]
Primary endpoints2 entries, revised
Time-averagedAdjusted serumGeometric concentrationMean overSerum Concentration of Nivolumab Over 28 daysDays (Cavgd28) on Original Scale Adjusted Geometric Mean of Nivolumab Trough serumSerum concentrationConcentration at steady-stateSteady State (Cminss) on Original Scale
2025-10-08
Study Status, Study Design v51
Enrollment targetestimated 632→confirmed 681
2025-06-10
Study Status v50
Primary completion date2025-09-08→2025-07-29
Completion date2026-01-29→2027-05-10
2025-05-01
Study Status, Contacts/Locations v49
Study sitesdetails revised at 1 of 89 sites
Show 45 earlier versions
2025-03-11
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v48
Trial statusRecruiting→Active, Not Recruiting
Study sites105→89
2025-02-25
Study Status, Contacts/Locations v47
Study sites105 entries, revised
InstitutoLocal deInstitution Investigaciones- Clinicas Mar del Plata Centro de Investigacion Pergamino S.A. Instituto Oncologico de Cordoba IONC Cent Priv RMI Rio Cuarto SA II Centro de Investigaciones Clinicas. Clinica Viedma S.A. Instituto Medico Especializado Alexander Fleming CER San Juan0058 Local Institution - 00640037 Local Institution - 01070079 Local Institution - 00710030 Local Institution - 00700066 Local Institution - 0090 Hospital Sirio Libanes0038 Local Institution - 00810056 Instituto de Oncologia do Parana (IOP) ONCOSITE Centro de Pesquisa Clinica em Oncologia Fundacao Pio Xii [...] [...]
2025-02-20
Study Status, Contacts/Locations v46
Study sitesdetails revised at 4 of 105 sites
2024-11-13
Study Status, Contacts/Locations, References v45
Study sitesdetails revised at 2 of 105 sites
2024-09-26
Study Status, Contacts/Locations, References v44
Start date2021-05-24→2021-05-21
Study sitesdetails revised at 2 of 105 sites
2024-07-24
Study Status, Contacts/Locations v43
Study sites105 entries, revised
LocalRoswell InstitutionPark -Cancer 0025Institute LocalInstituto Institutionde -Investigaciones 0038Clinicas Mar del Plata LocalCentro Institutionde -Investigacion 0058Pergamino S.A. LocalInstituto InstitutionOncologico -de 0037Cordoba IONC LocalCentro Institutionde -Investigaciones 0079Clinicas. Clinica Viedma S.A. LocalInstituto InstitutionMedico -Especializado 0066Alexander Fleming LocalCER InstitutionSan -Juan Hospital 0056Sirio Libanes LocalSIM InstitutionCentro -de 0095Investigacion Clinica LocalBradford InstitutionHill -Centro 0084de Investigacion Clinica LocalCentro Institutionde -Est [...] [...]
2024-05-31
Study Status, Contacts/Locations v42
Study sitesdetails revised at 6 of 105 sites
2024-02-29
Study Status, Contacts/Locations v41
Study sites105 entries, revised
LocalCent InstitutionPriv -RMI 0030Rio Cuarto SA II
2024-02-23
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v40
Trial statusActive, Not Recruiting→Recruiting
Study sites89→105
2024-01-17
Study Status, Contacts/Locations v39
Study sitesdetails revised at 1 of 89 sites
2024-01-02
Study Status, References v38
Re-verified, no change to tracked fields
2023-12-14
Study Status, Study Description, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v37
Enrollment target454→632
Study arms2→4
Eligibility criteria-13 characters
[...] regimen received and within 6 months prior to randomization on the study Karnofsky PS ≥ 70 at screening Must agree to follow specifi [...]
Study sitesdetails revised at 1 of 89 sites
2023-10-11
Study Status, Contacts/Locations v36
Study sites90→89
2023-09-19
Study Status, Contacts/Locations, References v35
Primary completion date2023-07-24→2025-09-08
Study sitesdetails revised at 2 of 90 sites
2023-06-29
Study Status, Outcome Measures v34
Secondary endpoints33 entries, revised
Time to peak serumTrough concentration after the first dose (Tmax1Ctrough) Incidence of anaphylactic, hypersensitivity, and systemic infusion reactions/systemic injection reactions
2023-05-30
Study Status, Contacts/Locations v33
Primary completion date2023-05-24→2023-07-24
Study sitesdetails revised at 1 of 90 sites
2023-04-13
Study Status v32
Primary completion date2023-12-14→2023-05-24
2023-02-21
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v31
Trial statusRecruiting→Active, Not Recruiting
Study sites105→90
2023-01-13
Study Status, Contacts/Locations v30
Study sites105 entries, revised
Local Institution - 0047 Local Institution - 0009 Local Institution - 0015
2022-12-12
Study Status, Contacts/Locations v29
Study sitesdetails revised at 23 of 105 sites
2022-11-15
Study Status, Contacts/Locations v28
Study sites105 entries, revised
ReadingLocal HospitalInstitution McGlinn- Cancer Institute Centro de Investigacion Pergamino S.A. Centro de Investigaciones Clinicas. Clinica Viedma S.A.0088 Local Institution - 0037 Local Institution - 0066 Local Institution - 0107 Local Institution - 0039 Local Institution - 0081 Local Institution - 0071 Local Institution Fakultni nemocnice- Ostrava Fakultna nemocnice Bulovka0070 Local Institution ASST Istituti- Ospitalieri, Oncology Department0090 Local Institution - 0096 Local Institution - 0099 Local Institution - 0106 Local Institution - 0073 Local Institution - 0033 Local Institution In [...] [...]
2022-06-28
Study Status, Contacts/Locations v27
Study sites105 entries, revised
Local Institution - 0080
2022-06-15
Study Status, Contacts/Locations v26
Primary completion date2023-12-13→2023-12-14
Study sites105 entries, revised
InstitutoLocal Oncologico de Cordoba IONC CER San Juan Instituto de Oncologia do Parana (IOP) Oncocentro Apys Thomayerova nemocnice Tampere University Hospital Tallaght University Hospital AOU Careggi IOVInstitution - Istituto Oncologico Veneto - IRCCS Azienda Ospedaliera A S.Maria Wojewadzki Szpital Specjalistyczny w Biaej Podlaskiej SMO KO-MED CENTRA KLINICZNE SP. Z O.O. Uniwersyteckie Centrum Kliniczne Hospital da Luz0079 Local Institution - 0056 Local Institution - 0064 Local Institution - 0077 Local Institution - 0010 Local Institution Hospital Del- Mar0017 Local Institution - 0051 Local [...]
2022-04-14
Study Status, Contacts/Locations, References v25
Study sites105 entries, revised
InstitutoLocal deInstitution Investigaciones- Clinicas Mar del Plata Cent Priv RMI Rio Cuarto SA II Instituto Medico Especializado Alexander Fleming Hospital Sirio Libanes0058 Local Institution Centro de- Estudios Clinicos SAGA0030 Local Institution Bradford Hill- Centro de Investigacion Clinica Masarykuv onkologicky ustav FNHK Klinika onkologie a radioterapie Fakultni nemocnice Olomouc0038 Local Institution IRCCS Istituto- Europeo di Oncologia0095 Local Institution - 0084 Local Institution I Can- Oncology Center Cancerologia0005 Local Institution - 0104 Local Institution - 0076 Local Institut [...] [...]
2022-03-15
Study Status, Contacts/Locations v24
Study sitesdetails revised at 6 of 105 sites
2022-03-07
Study Status, Contacts/Locations v23
Study sites103→105
2022-02-23
Study Status, Contacts/Locations v22
Study sites102→103
2022-02-16
Study Status, Contacts/Locations v21
Study sitesdetails revised at 2 of 102 sites
2022-02-07
Study Status, Contacts/Locations v20
Study sitesdetails revised at 1 of 102 sites
2022-02-02
Study Status, Contacts/Locations v19
Study sitesdetails revised at 2 of 102 sites
2022-01-28
Study Status, Contacts/Locations v18
Study sites102 entries, revised
LocalHertzen InstitutionMoscow Oncology Research Center
2022-01-25
Study Status, Contacts/Locations v17
Study sitesdetails revised at 3 of 102 sites
2022-01-18
Study Status, Contacts/Locations v16
Study sites99→102
2022-01-07
Study Status, Contacts/Locations v15
Study sitesdetails revised at 6 of 99 sites
2021-12-19
Study Status, Contacts/Locations v14
Study sitesdetails revised at 1 of 99 sites
2021-12-15
Study Status, Contacts/Locations v13
Study sites98→99
2021-12-13
Study Status, Contacts/Locations v12
Study sites98 entries, revised
LocalCentro Institutionde Estudios Clinicos SAGA LocalBradford InstitutionHill Centro de Investigacion Clinica
2021-12-09
Study Status, Contacts/Locations v11
Study sites98 entries, revised
LocalOncocentro InstitutionApys ASST Istituti Ospitalieri, Oncology DepartmentCremona
2021-12-07
Study Status, Contacts/Locations v10
Study sitesdetails revised at 2 of 98 sites
2021-12-06
Study Status, Contacts/Locations v9
Study sites98 entries, revised
LocalBudgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary LocalLLC InstitutionEurocityclinic
2021-11-29
Study Status, Contacts/Locations v8
Study sites97→98
2021-11-22
Study Status, Contacts/Locations v7
Study sites96→97
2021-11-05
Study Status, Contacts/Locations v6
Study sites82→96
2021-09-28
Study Status, Contacts/Locations v5
Study sites77→82
2021-07-23
Study Status, Contacts/Locations v4
Study sites77 entries, revised
LocalIOV Institution- Istituto Oncologico Veneto - IRCCS LocalHospital InstitutionUniversitario La Paz LocalHospital InstitutionUniversitario Virgen del Rocio
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.
Trial Details
NCT Number NCT04810078
Lead Sponsor Bristol-Myers Squibb
Conditions Clear Cell Renal Cell Carcinoma
Enrollment 681 participants
Start Date 2021-05-21
Primary Completion 2025-07-29 (estimated)
Study Completion 2027-05-10 (estimated)
Updated on ClinicalTrials.gov 2026-09-22