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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04810078




Registration number
NCT04810078
Ethics application status
Date submitted
16/03/2021
Date registered
22/03/2021
Date last updated
3/06/2024

Titles & IDs
Public title
A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread
Scientific 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
Secondary ID [1] 0 0
2020-003655-15
Secondary ID [2] 0 0
CA209-67T
Universal Trial Number (UTN)
Trial acronym
CheckMate-67T
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clear Cell Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Other interventions - Nivolumab and rHuPH20
Other interventions - Nivolumab

Experimental: Arm A -

Active Comparator: Arm B -

Experimental: Arm C -

Experimental: Arm D -


Other interventions: Nivolumab and rHuPH20
Specified dose on specified days

Other interventions: Nivolumab
Specified dose on specified days
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time-averaged serum concentration over 28 days (Cavgd28)
Timepoint [1] 0 0
Up to 28 days
Primary outcome [2] 0 0
Trough serum concentration at steady-state (Cminss)
Timepoint [2] 0 0
Up to 4 months
Secondary outcome [1] 0 0
Objective response rate (ORR) by Blinded Independent Central Review (BICR) with a minimum of 6 months follow-up
Timepoint [1] 0 0
Up to 2 years 6 months
Secondary outcome [2] 0 0
Trough serum concentration at day 28 (Cmind28)
Timepoint [2] 0 0
At 28 days
Secondary outcome [3] 0 0
Maximum serum concentration after the first dose (Cmax1)
Timepoint [3] 0 0
Up to 7 days
Secondary outcome [4] 0 0
Peak serum concentration at steady-state (Cmaxss)
Timepoint [4] 0 0
Up to 4 months
Secondary outcome [5] 0 0
Steady-state average serum concentration (Cavgss)
Timepoint [5] 0 0
Up to 4 months
Secondary outcome [6] 0 0
Trough concentration (Ctrough)
Timepoint [6] 0 0
At week 17
Secondary outcome [7] 0 0
Incidence of adverse events (AEs)
Timepoint [7] 0 0
Up to 2 years 3 months
Secondary outcome [8] 0 0
Incidence of serious adverse events (SAEs)
Timepoint [8] 0 0
Up to 2 years 3 months
Secondary outcome [9] 0 0
Incidence of AEs leading to discontinuation
Timepoint [9] 0 0
Up to 2 years
Secondary outcome [10] 0 0
Incidence of deaths
Timepoint [10] 0 0
Up to 5 years
Secondary outcome [11] 0 0
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Timepoint [11] 0 0
Up to 2 years 3 months
Secondary outcome [12] 0 0
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
Timepoint [12] 0 0
Up to 2 years 3 months
Secondary outcome [13] 0 0
Efficacy parameters: disease control rate (DCR) by BICR with a minimum of 6 months follow-up
Timepoint [13] 0 0
Up to 2 years 6 months
Secondary outcome [14] 0 0
Efficacy parameters: DCR by BICR with a minimum of 12 months follow-up
Timepoint [14] 0 0
Up to 3 years
Secondary outcome [15] 0 0
Efficacy parameters: DCR by BICR at end of study
Timepoint [15] 0 0
Up to 5 years
Secondary outcome [16] 0 0
Efficacy parameters: duration of response (DOR) by BICR with a minimum of 6 months follow-up
Timepoint [16] 0 0
Up to 2 years 6 months
Secondary outcome [17] 0 0
Efficacy parameters: DOR by BICR with a minimum of 12 months follow-up
Timepoint [17] 0 0
Up to 3 years
Secondary outcome [18] 0 0
Efficacy parameters: DOR by BICR at end of study
Timepoint [18] 0 0
Up to 5 years
Secondary outcome [19] 0 0
Efficacy parameters: time to objective response (TTR) by BICR with a minimum of 6 months follow-up
Timepoint [19] 0 0
Up to 2 years 6 months
Secondary outcome [20] 0 0
Efficacy parameters: TTR by BICR with a minimum of 12 months follow-up
Timepoint [20] 0 0
Up to 3 years
Secondary outcome [21] 0 0
Efficacy parameters: TTR by BICR at end of study
Timepoint [21] 0 0
Up to 5 years
Secondary outcome [22] 0 0
Efficacy parameters: progression-free survival (PFS) by BICR with a minimum of 6 months follow-up
Timepoint [22] 0 0
Up to 2 years 6 months
Secondary outcome [23] 0 0
Efficacy parameters: PFS by BICR with a minimum of 12 months follow-up
Timepoint [23] 0 0
Up to 3 years
Secondary outcome [24] 0 0
Efficacy parameters: PFS by BICR at end of study
Timepoint [24] 0 0
Up to 5 years
Secondary outcome [25] 0 0
Efficacy parameters: overall survival (OS) with a minimum of 6 months follow-up
Timepoint [25] 0 0
Up to 2 years 6 months
Secondary outcome [26] 0 0
Efficacy parameters: OS with a minimum of 12 months follow-up
Timepoint [26] 0 0
Up to 3 years
Secondary outcome [27] 0 0
Efficacy parameters: OS at end of study
Timepoint [27] 0 0
Up to 5 years
Secondary outcome [28] 0 0
Efficacy parameters: ORR by BICR with a minimum of 12 months follow-up
Timepoint [28] 0 0
Up to 3 years
Secondary outcome [29] 0 0
Efficacy parameters: ORR by BICR at end of study
Timepoint [29] 0 0
Up to 5 years
Secondary outcome [30] 0 0
Incidence of anaphylactic, hypersensitivity, and systemic infusion reactions/systemic injection reactions
Timepoint [30] 0 0
Up to 2 years 3 months
Secondary outcome [31] 0 0
Incidence of local injection- or infusion-site reactions
Timepoint [31] 0 0
Up to 2 years 3 months
Secondary outcome [32] 0 0
Percentage of participants who develop anti-nivolumab antibodies, if applicable
Timepoint [32] 0 0
Up to 2 years 3 months
Secondary outcome [33] 0 0
Percentage of participants who develop neutralizing antibodies, if applicable
Timepoint [33] 0 0
Up to 2 years 3 months

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



- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/01/2026
Actual
Sample size
Target
632
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
Argentina
State/province [4] 0 0
Buenos Aires
Country [5] 0 0
Argentina
State/province [5] 0 0
Cordoba
Country [6] 0 0
Argentina
State/province [6] 0 0
RIO Negro
Country [7] 0 0
Argentina
State/province [7] 0 0
San Juan
Country [8] 0 0
Brazil
State/province [8] 0 0
Parana
Country [9] 0 0
Brazil
State/province [9] 0 0
RIO Grande DO SUL
Country [10] 0 0
Brazil
State/province [10] 0 0
Rio Grande Do Sul
Country [11] 0 0
Brazil
State/province [11] 0 0
Sao Paulo
Country [12] 0 0
Brazil
State/province [12] 0 0
Rio de Janeiro
Country [13] 0 0
Chile
State/province [13] 0 0
Araucania
Country [14] 0 0
Chile
State/province [14] 0 0
Metropolitana
Country [15] 0 0
Chile
State/province [15] 0 0
Valparaiso
Country [16] 0 0
Czechia
State/province [16] 0 0
Brno
Country [17] 0 0
Czechia
State/province [17] 0 0
Hradec Kralove
Country [18] 0 0
Czechia
State/province [18] 0 0
Olomouc
Country [19] 0 0
Czechia
State/province [19] 0 0
Ostrava
Country [20] 0 0
Czechia
State/province [20] 0 0
Prague
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha 8 Liben
Country [22] 0 0
Finland
State/province [22] 0 0
Jyvaskyla
Country [23] 0 0
Finland
State/province [23] 0 0
Kuopio
Country [24] 0 0
Finland
State/province [24] 0 0
Tampere
Country [25] 0 0
Finland
State/province [25] 0 0
Turku
Country [26] 0 0
France
State/province [26] 0 0
Lyon
Country [27] 0 0
France
State/province [27] 0 0
Nice cedex 2
Country [28] 0 0
France
State/province [28] 0 0
Suresnes
Country [29] 0 0
France
State/province [29] 0 0
Toulouse
Country [30] 0 0
France
State/province [30] 0 0
Villejuif
Country [31] 0 0
Ireland
State/province [31] 0 0
Dublin
Country [32] 0 0
Ireland
State/province [32] 0 0
Cork
Country [33] 0 0
Italy
State/province [33] 0 0
Cremona
Country [34] 0 0
Italy
State/province [34] 0 0
Firenze
Country [35] 0 0
Italy
State/province [35] 0 0
Meldola
Country [36] 0 0
Italy
State/province [36] 0 0
Milano
Country [37] 0 0
Italy
State/province [37] 0 0
Milan
Country [38] 0 0
Italy
State/province [38] 0 0
Padova
Country [39] 0 0
Italy
State/province [39] 0 0
Parma
Country [40] 0 0
Italy
State/province [40] 0 0
Pavia
Country [41] 0 0
Italy
State/province [41] 0 0
Pisa
Country [42] 0 0
Italy
State/province [42] 0 0
Roma
Country [43] 0 0
Italy
State/province [43] 0 0
Rome
Country [44] 0 0
Italy
State/province [44] 0 0
Terni
Country [45] 0 0
Mexico
State/province [45] 0 0
Coahuila
Country [46] 0 0
Mexico
State/province [46] 0 0
Distrito Federal
Country [47] 0 0
Mexico
State/province [47] 0 0
Nuevo LEON
Country [48] 0 0
Mexico
State/province [48] 0 0
Queretaro
Country [49] 0 0
Mexico
State/province [49] 0 0
San Luis Potosi
Country [50] 0 0
New Zealand
State/province [50] 0 0
Auckland
Country [51] 0 0
New Zealand
State/province [51] 0 0
Hamilton
Country [52] 0 0
New Zealand
State/province [52] 0 0
Palmerston North
Country [53] 0 0
Poland
State/province [53] 0 0
Biala Podlaska
Country [54] 0 0
Poland
State/province [54] 0 0
Bydgoszcz
Country [55] 0 0
Poland
State/province [55] 0 0
Gdansk
Country [56] 0 0
Poland
State/province [56] 0 0
Gliwice
Country [57] 0 0
Poland
State/province [57] 0 0
Krakow
Country [58] 0 0
Poland
State/province [58] 0 0
Poznan
Country [59] 0 0
Poland
State/province [59] 0 0
Warszawa
Country [60] 0 0
Portugal
State/province [60] 0 0
Coimbra
Country [61] 0 0
Portugal
State/province [61] 0 0
Lisboa
Country [62] 0 0
Romania
State/province [62] 0 0
Bucuresti
Country [63] 0 0
Romania
State/province [63] 0 0
Cluj-Napoca
Country [64] 0 0
Romania
State/province [64] 0 0
Craiova
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Chelyabinsk
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Ivanovo
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Moscow
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Nizghiy Novgorod
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Omsk
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Saint Petersburg
Country [71] 0 0
Spain
State/province [71] 0 0
Barcelona
Country [72] 0 0
Spain
State/province [72] 0 0
Madrid
Country [73] 0 0
Spain
State/province [73] 0 0
Sabadell
Country [74] 0 0
Spain
State/province [74] 0 0
Santander
Country [75] 0 0
Spain
State/province [75] 0 0
Sevilla
Country [76] 0 0
Turkey
State/province [76] 0 0
Adana
Country [77] 0 0
Turkey
State/province [77] 0 0
Ankara
Country [78] 0 0
Turkey
State/province [78] 0 0
Istanbul
Country [79] 0 0
Turkey
State/province [79] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. The purpose of this
study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab
manufactured using two different manufacturing processes.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04810078
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04810078