Clear Cell Renal Cell CarcinomaPhase 3CheckMate-67TNCT04810078
A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread
A Phase 3 study testing Nivolumab and rHuPH20 and Nivolumab in people with Clear Cell Renal Cell Carcinoma, run by Bristol-Myers Squibb at 89 sites in 17 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma
- What is being tested?
- Nivolumab and rHuPH20 and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 681 participants
- Where
- 89 sitesin 17 countries
- Study dates
- 21 May 2021to 10 May 2027
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
- They have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization
- They continue on ART as clinically indicated while enrolled on study
Show all 12Show fewer
- CD4 counts and viral load are monitored per standard of care by a local health care provider
- 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
Trial locations and contacts
89 sites in 17 countries.
89 sites in 17 countries
Italy11 sites
Local Institution - 0033
Cremona, 26100
Local Institution - 0008
Florence, 50134
Local Institution - 0027
Meldola, 47014
Local Institution - 0018
Milan, 20141
Local Institution
Milan, 20133
Local Institution - 0014
Padova, 35128
Local Institution - 0082
Parma, 43126
Local Institution - 0092
Pavia, 27100
Local Institution - 0100
Roma, 00168
Local Institution - 0091
Rome, 00152
Local Institution - 0057
Terni, 05100
Spain10 sites
Local Institution - 0048
Barcelona, 08003
Local Institution - 0102
Barcelona, 08035
Local Institution - 0049
Barcelona, 08041
Local Institution - 0072
Madrid, 28026
Local Institution - 0067
Madrid, 28033
Local Institution - 0074
Madrid, 28046
Local Institution - 0075
Madrid, 28050
Local Institution - 0032
Sabadell, 08208
Local Institution - 0086
Santander, 39008
Local Institution - 0059
Seville, 31013
Argentina8 sites
Local Institution - 0038
Buenos Aires, Buenos Aires, C1426ANZ
Local Institution - 0095
Capital Federal, Buenos Aires, C1419AHN
Local Institution - 0058
Mar del Plata, Buenos Aires, 7600
Local Institution - 0079
Parana, Córdoba Province, 5000
Local Institution - 0037
Pergamino, Buenos Aires, B2700CPM
Local Institution - 0030
Río Cuarto, Córdoba Province, 5800
Local Institution - 0056
San Juan, San Juan Province, J5402DIL
Local Institution - 0066
Viedma, Río Negro Province, R8500ACE
Brazil8 sites
Local Institution - 0071
Barretos, São Paulo, 014784-000
Local Institution - 0064
Curitiba, Paraná, 80520-174
Local Institution - 0107
Ijuí, Rio Grande do Sul, 98700-000
Local Institution - 0039
Porto Alegre, Rio Grande do Sul, 91350-200
Local Institution - 0090
Rio de Janeiro, Rio de Janeiro, 20230-130
Local Institution - 0070
São José do Rio Preto, São Paulo, 15090-000
Local Institution - 0081
São Paulo, São Paulo, 01246-000
Local Institution - 0096
São Paulo, São Paulo, 01327-0001
Mexico7 sites
Local Institution - 0103
Monterrey, Nuevo León, 64460
Local Institution - 0031
Monterrey, Nuevo León, 64710
Local Institution - 0065
Querétaro City, Querétaro, 76000
Local Institution - 0085
Querétaro City, Querétaro, 76090
Local Institution - 0105
San Luis Potosí City, San Luis Potosí, 78200
Local Institution - 0089
Tlalpan, Mexico City, 14080
Local Institution - 0101
Torreón, Coahuila, 27010
Poland7 sites
Local Institution - 0055
Biała Podlaska, 21-500
Local Institution - 0062
Bydgoszcz, 85-796
Local Institution - 0083
Gdansk, 80-214
Local Institution - 0021
Krakow, 30-688
Local Institution - 0098
Krakow, 31-115
Local Institution - 0001
Poznan, 60-569
Local Institution - 0023
Warsaw, 02-781
Czechia6 sites
Local Institution - 0063
Brno, 656 53
Local Institution - 0036
Hradec Králové, 500 05
Local Institution - 0020
Olomouc, 77900
Local Institution - 0099
Ostrava, 708 52
Local Institution - 0010
Prague, 140 59
Local Institution - 0106
Praha 8 Liben, 18081
Russia6 sites
SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine
Chelyabinsk, 454087
Ivanovo Regional Oncology Dispensary
Ivanovo, 153040
Hertzen Moscow Oncology Research Center
Moscow, 125284
Local Institution
Nizghiy Novgorod, 603000
Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary
Omsk, 644013
LLC Eurocityclinic
Saint Petersburg, 197022
Chile5 sites
Local Institution - 0005
Santiago, Santiago Metropolitan, 0
Local Institution - 0104
Santiago, Santiago Metropolitan, 7500653
Local Institution - 0076
Santiago, Santiago Metropolitan, 7500921
Local Institution - 0084
Temuco, Araucania
Local Institution - 0077
Viña del Mar, Valparaiso, 2520598
Romania4 sites
Local Institution - 0024
Bucharest, 022238
Local Institution - 0002
Cluj-Napoca, 400132
Local Institution - 0040
Cluj-Napoca, 400641
Local Institution - 0016
Craiova, 200347
Turkey (Türkiye)4 sites
Local Institution - 0026
Ankara, 06230
Local Institution - 0097
Ankara, 06590
Local Institution - 0035
Istanbul, Bagcilar, 34284
Local Institution - 0019
Istanbul, 34098
United States3 sites
Local Institution - 0025
Buffalo, New York, 14263
Local Institution
Chicago, Illinois, 60611
Local Institution - 0088
West Reading, Pennsylvania, 19611
France3 sites
Local Institution
Nice, 6189
Local Institution - 0051
Suresnes, 92151
Local Institution - 0068
Villejuif, 94800
New Zealand3 sites
Local Institution - 0053
Auckland, 1023
Local Institution - 0041
Hamilton, 3204
Local Institution - 0078
Palmerston North, 4414
Portugal2 sites
Local Institution - 0050
Coimbra, 3030-075
Local Institution - 0052
Lisbon, 1500-650
About this study
Official title: A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy
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.
- Conditions
- Clear Cell Renal Cell Carcinoma
- Being tested
- Nivolumab and rHuPH20, Nivolumab
- Keywords
- BMS-936558, BMS-986298, Clear cell renal cell carcinoma, ccRCC, Nivolumab, Opdivo, rHuPH20, Subcutaneous
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab and rHuPH20Biological
Also called BMS-986298
Specified dose on specified days
NivolumabBiological
Also called Opdivo, BMS-936558
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Biological: Nivolumab and rHuPH20 |
| Arm B | Active comparator | Not described Receives: Biological: Nivolumab |
| Arm C | Experimental | Not described Receives: Biological: Nivolumab and rHuPH20 |
| Arm D | Experimental | Not described Receives: Biological: Nivolumab and rHuPH20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale
Plasma samples were collected to assess the serum concentration.
Measured: Pre-dose (Day 1 to Day 28)
Adjusted Geometric Mean of Nivolumab Trough Serum Concentration at Steady State (Cminss) on Original Scale
Plasma samples were collected to assess the serum concentration.
Measured: Pre-dose (Day 1 to Day 28)
Secondary outcomes (16)
Objective Response Rate (ORR) Per BICR
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.
Measured: 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)
Blood samples were collected to assess serum concentration.
Measured: Pre-dose at Day 28
Maximum Serum Concentration of Nivolumab After the First Dose (Cmax1)
Blood samples were collected to assess serum concentration.
Measured: Post dose (Day 1)
Peak Serum Concentration of Nivolumab at Steady State (Cmaxss)
Blood samples were collected to assess serum concentration.
Measured: Pre-dose (Day 1 to Day 28)
Time-averaged Serum Concentration of Nivolumab at Steady State (Cavgss)
Blood samples were collected to assess serum concentration.
Measured: Pre-dose (Day 1 to Day 28)
Trough Serum Concentration of Nivolumab (Ctrough)
Blood samples were collected to assess serum concentration.
Measured: Pre-dose at Week 17
Time to Maximum Serum Concentration of Nivolumab at Day 1 (Tmax1)
Blood samples were collected to assess serum concentration.
Measured: Post dose (Day 1)
Trough Serum Concentration of Nivolumab at Steady State (Cminss)
Blood samples were collected to assess serum concentration.
Measured: Pre dose (Day 1 to Day 28)
Number of Participants With Adverse Events, Serious Adverse Events, AEs Leading to Discontinuation and Death
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.
Measured: 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
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.
Measured: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)
Disease Control Rate (ORR) Per BICR
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Measured: 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
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.
Measured: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start21 May 2021
- Primary completion29 Jul 2025
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 681 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810078
- Sponsor's protocol ID
- CA209-67T
- Other IDs
- 2020-003655-15, U1111-1255-9514
- Acronym
- CheckMate-67T
- Status last verified
- Aug 2026
- First submitted
- 16 Mar 2021
- Last updated
- 22 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
- Expanded access
- Available
Publications
Albiges L, Bourlon MT, Chacon M, Cutuli HJ, Chuken YAL, Zurawski B, Mota JM, Magri I, Burotto M, Luz M, de Menezes J, Ruiz EPY, Fu S, Richardet M, Valderrama BP, Maruzzo M, Bracarda S, Breckenridge M, Vezina HE, Rathod D, Yu Z, Zhao Y, Dixon M, Perumal D, George S. Subcutaneous versus intravenous nivolumab for renal cell carcinoma. Ann Oncol. 2025 Jan;36(1):99-107. doi: 10.1016/j.annonc.2024.09.002. Epub 2024 Sep 15.
PubMed 39288844
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy
- ClinicalTrials.gov ID
- NCT04810078
- Acronym / sponsor ID
- CheckMate-67T / CA209-67T
- Conditions
- Clear Cell Renal Cell Carcinoma
- Keywords
- BMS-936558, BMS-986298, Clear cell renal cell carcinoma, ccRCC, Nivolumab, Opdivo, rHuPH20, Subcutaneous
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 681 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 21 May 2021 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Posted 22 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: Nivolumab and rHuPH20 |
| Arm B | Active comparator | Biological: Nivolumab |
| Arm C | Experimental | Biological: Nivolumab and rHuPH20 |
| Arm D | Experimental | Biological: Nivolumab and rHuPH20 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab and rHuPH20Also: BMS-986298Specified dose on specified days | Biological | Arm A, Arm C, Arm D |
| NivolumabAlso: Opdivo, BMS-936558Specified dose on specified days | Biological | Arm B |
Primary outcome
Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale
Time frame: Pre-dose (Day 1 to Day 28)
Plasma samples were collected to assess the serum concentration.
Adjusted Geometric Mean of Nivolumab Trough Serum Concentration at Steady State (Cminss) on Original Scale
Time frame: Pre-dose (Day 1 to Day 28)
Plasma samples were collected to assess the serum concentration.
16 secondary outcomes
Objective Response Rate (ORR) Per BICR
Time frame: 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)
Time frame: Pre-dose at Day 28
Maximum Serum Concentration of Nivolumab After the First Dose (Cmax1)
Time frame: Post dose (Day 1)
Peak Serum Concentration of Nivolumab at Steady State (Cmaxss)
Time frame: Pre-dose (Day 1 to Day 28)
Time-averaged Serum Concentration of Nivolumab at Steady State (Cavgss)
Time frame: Pre-dose (Day 1 to Day 28)
Trough Serum Concentration of Nivolumab (Ctrough)
Time frame: Pre-dose at Week 17
Time to Maximum Serum Concentration of Nivolumab at Day 1 (Tmax1)
Time frame: Post dose (Day 1)
Trough Serum Concentration of Nivolumab at Steady State (Cminss)
Time frame: Pre dose (Day 1 to Day 28)
Number of Participants With Adverse Events, Serious Adverse Events, AEs Leading to Discontinuation and Death
Time frame: 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
Time frame: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)
Disease Control Rate (ORR) Per BICR
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39288844Albiges L, Bourlon MT, Chacon M, Cutuli HJ, Chuken YAL, Zurawski B, Mota JM, Magri I, Burotto M, Luz M, de Menezes J, Ruiz EPY, Fu S, Richardet M, Valderrama BP, Maruzzo M, Bracarda S, Breckenridge M, Vezina HE, Rathod D, Yu Z, Zhao Y, Dixon M, Perumal D, George S. Subcutaneous versus intravenous nivolumab for renal cell carcinoma. Ann Oncol. 2025 Jan;36(1):99-107. doi: 10.1016/j.annonc.2024.09.002. Epub 2024 Sep 15.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
Related trials for Clear Cell Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Active, not recruitingPhase 1/2
Phase 1b/2 Trial of Ipilimumab, Nivolumab, and Ciforadenant (Adenosine A2a Receptor Antagonist) in First-line Advanced Renal Cell Carcinoma.
Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
89 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nivolumab and rHuPH20 and Nivolumab in people with Clear Cell Renal Cell Carcinoma, run by Bristol-Myers Squibb at 89 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in Italy, Spain, Argentina, Brazil, Mexico and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale (time frame: Pre-dose (Day 1 to Day 28)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04810078, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.