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

Clear Cell Renal Cell Carcinoma Clinical Trial

— CheckMate-67T  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04810078
• Other study ID #: CA209-67T
• Secondary ID: 2020-003655-15U1
• Status: Recruiting
• Phase: Phase 3
• Start date: May 24, 2021
• Est. completion date: January 29, 2026

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 632
• Est. completion date: January 29, 2026
• Est. primary completion date: September 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Clear Cell Renal Cell Carcinoma

Intervention

Biological:
• Nivolumab and rHuPH20
Specified dose on specified days
• Nivolumab
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0038	Ciudad Autonoma de BuenosAires	Buenos Aires
Argentina	Local Institution - 0058	Mar Del Plata	Buenos Aires
Argentina	Local Institution - 0079	Parana	Cordoba
Argentina	Local Institution - 0037	Pergamino	Buenos Aires
Argentina	Cent Priv RMI Rio Cuarto SA II	Rio Cuarto	Cordoba
Argentina	Local Institution - 0056	San Juan
Argentina	Local Institution - 0066	Viedma	RIO Negro
Brazil	Local Institution - 0071	Barretos	Sao Paulo
Brazil	Local Institution - 0064	Curitiba	Parana
Brazil	Local Institution - 0011	Ijui	RIO Grande DO SUL
Brazil	Local Institution - 0107	Ijui	Rio Grande Do Sul
Brazil	Local Institution - 0039	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0090	Rio de Janeiro
Brazil	Local Institution - 0070	Sao Jose Do Rio Preto	Sao Paulo
Brazil	Local Institution - 0081	Sao Paulo
Brazil	Local Institution - 0095	Sao Paulo
Brazil	Local Institution - 0096	Sao Paulo
Chile	Local Institution - 0076	Santiago	Metropolitana
Chile	Local Institution - 0005	Santiago de Chile	Metropolitana
Chile	Local Institution - 0104	Santiago de Chile	Metropolitana
Chile	Local Institution - 0084	Temuco	Araucania
Chile	Local Institution - 0077	Vina del Mar	Valparaiso
Czechia	Local Institution - 0063	Brno
Czechia	Local Institution - 0036	Hradec Kralove
Czechia	Local Institution - 0020	Olomouc
Czechia	Local Institution - 0099	Ostrava
Czechia	Local Institution - 0010	Prague
Czechia	Local Institution - 0106	Praha 8 Liben
Finland	Local Institution	Jyvaskyla
Finland	Local Institution - 0080	Kuopio
Finland	Local Institution - 0017	Tampere
Finland	Local Institution - 0047	Turku
France	Local Institution - 0073	Lyon
France	Local Institution	Nice cedex 2
France	Local Institution - 0051	Suresnes
France	Local Institution	Toulouse
France	Local Institution - 0068	Villejuif
Ireland	Local Institution	Cork
Ireland	Local Institution	Dublin
Ireland	Local Institution - 0060	Tallaght	Dublin
Italy	Local Institution - 0033	Cremona
Italy	Local Institution - 0008	Firenze
Italy	Local Institution - 0027	Meldola
Italy	Local Institution - 0018	Milan
Italy	Local Institution	Milano
Italy	Local Institution - 0014	Padova
Italy	Local Institution - 0082	Parma
Italy	Local Institution - 0092	Pavia
Italy	Local Institution	Pisa
Italy	Local Institution - 0100	Roma
Italy	Local Institution - 0091	Rome
Italy	Local Institution - 0057	Terni
Mexico	Local Institution - 0031	Monterrey	Nuevo LEON
Mexico	Local Institution - 0103	Monterrey	Nuevo LEON
Mexico	Local Institution - 0065	Queretaro
Mexico	Local Institution - 0085	Queretaro
Mexico	Local Institution - 0105	San Luis Potosi
Mexico	Local Institution - 0089	Tlalpan	Distrito Federal
Mexico	Local Institution - 0101	Torreon	Coahuila
New Zealand	Auckland District Health Board-Auckland City Hospital	Auckland
New Zealand	Waikato Hospital	Hamilton
New Zealand	Palmerston North Hospital	Palmerston North
Poland	Local Institution - 0055	Biala Podlaska
Poland	Local Institution - 0062	Bydgoszcz
Poland	Local Institution - 0083	Gdansk
Poland	Local Institution - 0009	Gliwice
Poland	Local Institution - 0021	Krakow
Poland	Local Institution - 0098	Krakow
Poland	Local Institution - 0001	Poznan
Poland	Local Institution - 0023	Warszawa
Portugal	Local Institution - 0050	Coimbra
Portugal	Local Institution - 0052	Lisboa
Romania	Local Institution - 0024	Bucuresti
Romania	Local Institution - 0002	Cluj-Napoca
Romania	Local Institution - 0040	Cluj-Napoca
Romania	Local Institution - 0016	Craiova
Russian Federation	SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine	Chelyabinsk
Russian Federation	Ivanovo Regional Oncology Dispensary	Ivanovo
Russian Federation	Hertzen Moscow Oncology Research Center	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution - 0015	Moscow
Russian Federation	Local Institution	Nizghiy Novgorod
Russian Federation	Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary	Omsk
Russian Federation	LLC Eurocityclinic	Saint Petersburg
Spain	Local Institution - 0048	Barcelona
Spain	Local Institution - 0049	Barcelona
Spain	Local Institution - 0102	Barcelona
Spain	Local Institution - 0067	Madrid
Spain	Local Institution - 0072	Madrid
Spain	Local Institution - 0074	Madrid
Spain	Local Institution - 0075	Madrid
Spain	Local Institution - 0032	Sabadell
Spain	Local Institution - 0086	Santander
Spain	Local Institution - 0059	Sevilla
Turkey	Local Institution	Adana
Turkey	Local Institution - 0026	Ankara
Turkey	Local Institution - 0097	Ankara
Turkey	Local Institution - 0019	Istanbul
Turkey	Local Institution - 0035	Istanbul
Turkey	Local Institution	Izmir
United States	Local Institution - 0025	Buffalo	New York
United States	Local Institution	Chicago	Illinois
United States	Local Institution - 0088	West Reading	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Chile,  Czechia,  Finland,  France,  Ireland,  Italy,  Mexico,  New Zealand,  Poland,  Portugal,  Romania,  Russian Federation,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-averaged serum concentration over 28 days (Cavgd28)		Up to 28 days
Primary	Trough serum concentration at steady-state (Cminss)		Up to 4 months
Secondary	Objective response rate (ORR) by Blinded Independent Central Review (BICR) with a minimum of 6 months follow-up		Up to 2 years 6 months
Secondary	Trough serum concentration at day 28 (Cmind28)		At 28 days
Secondary	Maximum serum concentration after the first dose (Cmax1)		Up to 7 days
Secondary	Peak serum concentration at steady-state (Cmaxss)		Up to 4 months
Secondary	Steady-state average serum concentration (Cavgss)		Up to 4 months
Secondary	Trough concentration (Ctrough)		At week 17
Secondary	Incidence of adverse events (AEs)		Up to 2 years 3 months
Secondary	Incidence of serious adverse events (SAEs)		Up to 2 years 3 months
Secondary	Incidence of AEs leading to discontinuation		Up to 2 years
Secondary	Incidence of deaths		Up to 5 years
Secondary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 2 years 3 months
Secondary	Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests		Up to 2 years 3 months
Secondary	Efficacy parameters: disease control rate (DCR) by BICR with a minimum of 6 months follow-up		Up to 2 years 6 months
Secondary	Efficacy parameters: DCR by BICR with a minimum of 12 months follow-up		Up to 3 years
Secondary	Efficacy parameters: DCR by BICR at end of study		Up to 5 years
Secondary	Efficacy parameters: duration of response (DOR) by BICR with a minimum of 6 months follow-up		Up to 2 years 6 months
Secondary	Efficacy parameters: DOR by BICR with a minimum of 12 months follow-up		Up to 3 years
Secondary	Efficacy parameters: DOR by BICR at end of study		Up to 5 years
Secondary	Efficacy parameters: time to objective response (TTR) by BICR with a minimum of 6 months follow-up		Up to 2 years 6 months
Secondary	Efficacy parameters: TTR by BICR with a minimum of 12 months follow-up		Up to 3 years
Secondary	Efficacy parameters: TTR by BICR at end of study		Up to 5 years
Secondary	Efficacy parameters: progression-free survival (PFS) by BICR with a minimum of 6 months follow-up		Up to 2 years 6 months
Secondary	Efficacy parameters: PFS by BICR with a minimum of 12 months follow-up		Up to 3 years
Secondary	Efficacy parameters: PFS by BICR at end of study		Up to 5 years
Secondary	Efficacy parameters: overall survival (OS) with a minimum of 6 months follow-up		Up to 2 years 6 months
Secondary	Efficacy parameters: OS with a minimum of 12 months follow-up		Up to 3 years
Secondary	Efficacy parameters: OS at end of study		Up to 5 years
Secondary	Efficacy parameters: ORR by BICR with a minimum of 12 months follow-up		Up to 3 years
Secondary	Efficacy parameters: ORR by BICR at end of study		Up to 5 years
Secondary	Incidence of anaphylactic, hypersensitivity, and systemic infusion reactions/systemic injection reactions		Up to 2 years 3 months
Secondary	Incidence of local injection- or infusion-site reactions		Up to 2 years 3 months
Secondary	Percentage of participants who develop anti-nivolumab antibodies, if applicable		Up to 2 years 3 months
Secondary	Percentage of participants who develop neutralizing antibodies, if applicable		Up to 2 years 3 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting