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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 (CheckMate-67T)

  • Clinicaltrials.gov identifier

    NCT04810078

  • Recruitment Status

    Recruiting

  • First Posted

    March 22, 2021

  • Last update posted

    September 29, 2021

Save Trial
Clinical Trial Information for Patients Visit BMS Study Connect

Study Description

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.

  • Condition or Disease:Clear Cell Renal Cell Carcinoma
  • Intervention/Treatment: Biological: Nivolumab and rHuPH20
    Biological: Nivolumab
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 454 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: May 2021
  • Estimated Primary Completion Date: December 2023
  • Estimated Study Completion Date: January 2026

Arms and interventions

Arm Intervention/treatment
Experimental: Arm A: Subcutaneous Nivolumab
 Biological: Nivolumab and rHuPH20
Specified dose on specified days
Active Comparator: Arm B: Intravenous Nivolumab
 Biological: Nivolumab
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Time-averaged serum concentration over 28 days (Cavgd28) [ Time Frame: Up to 28 days ]
  • 2. Trough serum concentration at steady-state (Cminss) [ Time Frame: Up to 4 months ]
  • Secondary Outcome Measures: 1. Efficacy parameters: DCR by BICR with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ]
  • 2. Efficacy parameters: DCR by BICR at end of study [ Time Frame: Up to 5 years ]
  • 3. Efficacy parameters: disease control rate (DCR) by BICR with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ]
  • 4. Objective response rate (ORR) by Blinded Independent Central Review (BICR) with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ]
  • 5. Trough serum concentration at day 28 (Cmind28) [ Time Frame: At 28 days ]
  • 6. Maximum serum concentration after the first dose (Cmax1) [ Time Frame: Up to 7 days ]
  • 7. Time to peak serum concentration after the first dose (Tmax1) [ Time Frame: Up to 7 days ]
  • 8. Peak serum concentration at steady-state (Cmaxss) [ Time Frame: Up to 4 months ]
  • 9. Steady-state average serum concentration (Cavgss) [ Time Frame: Up to 4 months ]
  • 10. Incidence of adverse events (AEs) [ Time Frame: Up to 2 years 3 months ]
  • 11. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 2 years 3 months ]
  • 12. Incidence of AEs leading to discontinuation [ Time Frame: Up to 2 years ]
  • 13. Incidence of deaths [ Time Frame: Up to 5 years ]
  • 14. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 2 years 3 months ]
  • 15. Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests [ Time Frame: Up to 2 years 3 months ]
  • 16. Efficacy parameters: duration of response (DOR) by BICR with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ]
  • 17. Efficacy parameters: DOR by BICR with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ]
  • 18. Efficacy parameters: DOR by BICR at end of study [ Time Frame: Up to 5 years ]
  • 19. Efficacy parameters: time to objective response (TTR) by BICR with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ]
  • 20. Efficacy parameters: TTR by BICR with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ]
  • 21. Efficacy parameters: TTR by BICR at end of study [ Time Frame: Up to 5 years ]
  • 22. Efficacy parameters: progression-free survival (PFS) by BICR with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ]
  • 23. Efficacy parameters: PFS by BICR with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ]
  • 24. Efficacy parameters: PFS by BICR at end of study [ Time Frame: Up to 5 years ]
  • 25. Efficacy parameters: overall survival (OS) with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ]
  • 26. Efficacy parameters: OS with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ]
  • 27. Efficacy parameters: OS at end of study [ Time Frame: Up to 5 years ]
  • 28. Efficacy parameters: ORR by BICR with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ]
  • 29. Efficacy parameters: ORR by BICR at end of study [ Time Frame: Up to 5 years ]
  • 30. Incidence of anaphylactic, hypersensitivity, and systemic infusion reactions [ Time Frame: Up to 2 years 3 months ]
  • 31. Incidence of local injection- or infusion-site reactions [ Time Frame: Up to 2 years 3 months ]
  • 32. Percentage of participants who develop anti-nivolumab antibodies, if applicable [ Time Frame: Up to 2 years 3 months ]
  • 33. Percentage of participants who develop neutralizing antibodies, if applicable [ Time Frame: Up to 2 years 3 months ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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 on the study - 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

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Illinois
Local Institution
Chicago

United States, New York
Roswell Park Cancer Institute
Buffalo

United States, Pennsylvania
Local Institution
West Reading

Argentina, Buenos Aires
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma de BuenosAires

Argentina, Buenos Aires
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata

Argentina, Buenos Aires
Local Institution
Pergamino

Argentina, Cordoba
Centro Privado de RMI Rio Cuarto SA II
Rio Cuarto

Argentina, RIO Negro
Centro de Investigaciones Clinicas. Clinica Viedma S.A.
Viedma

Argentina
Fundacion Richardet Longo FRL
Cordoba

Argentina
CER San Juan
San Juan

Brazil, Parana
Local Institution
Curitiba

Brazil, RIO Grande DO SUL
Local Institution
Ijui

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, SAO Paulo
Local Institution
Barretos

Brazil, SAO Paulo
Local Institution
Sao Jose Do Rio Preto

Brazil
Local Institution
Rio de Janeiro

Brazil
Local Institution
Sao Paulo

Brazil
Local Institution
Sao Paulo

Chile, Araucania
Local Institution
Temuco

Chile, Metropolitana
Local Institution
Santiago de Chile

Chile, Metropolitana
Local Institution
Santiago

Chile, Valparaiso
Local Institution
Vina del Mar

Czechia
Local Institution
Brno

Czechia
Local Institution
Hradec Kralove

Czechia
Local Institution
Olomouc

Czechia
Local Institution
Prague

Finland
Local Institution
Jyvaskyla

Finland
Local Institution
Tampere

Finland
Local Institution
Turku

France
Local Institution
Nice cedex 2

France
Local Institution
Suresnes

France
Local Institution
Toulouse

France
Local Institution
Villejuif

Ireland
Local Institution
Dublin

Italy
ASST Istituti Ospitalieri, Oncology Department
Cremona

Italy
AOU Careggi
Firenze

Italy
Local Institution
Meldola

Italy
Local Institution
Milano

Italy
Local Institution
Milano

Italy
IOV - Istituto Oncologico Veneto - IRCCS
Padova

Italy
Local Institution
Pisa

Italy
Azienda Ospedaliera A S.Maria
Terni

Mexico, Distrito Federal
Local Institution
Queretaro

Mexico, Distrito Federal
Local Institution
Tlalpan

Mexico, Nuevo LEON
Local Institution
Monterrey

Mexico
Local Institution
Queretaro

New Zealand
Local Institution
Auckland

New Zealand
Local Institution
Hamilton

New Zealand
Local Institution
Palmerston North

Poland
Local Institution
Biala Podlaska

Poland
Centrum Onkologii im. Prof. F. Lukaszczyka
Bydgoszcz

Poland
Local Institution
Gdansk

Poland
Local Institution
Gliwice

Poland
Local Institution
Krakow

Poland
Local Institution
Poznan

Poland
Local Institution
Warszawa

Portugal
Local Institution
Coimbra

Portugal
Local Institution
Lisboa

Romania
Local Institution
Bucuresti

Romania
Local Institution
Cluj-Napoca

Romania
Local Institution
Cluj-Napoca

Romania
Local Institution
Craiova

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Nizghiy Novgorod

Russian Federation
Local Institution
Omsk

Spain
Local Institution
Barcelona

Spain
Local Institution
Barcelona

Spain
Local Institution
Barcelona

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Hospital Universitario La Paz
Madrid

Spain
HM Universitario Sanchinarro - CIOCC
Madrid

Spain
Hospital Marques de Valdecilla
Santander

Spain
Hospital Universitario Virgen del Rocio
Sevilla

Turkey
Local Institution
Adana

Turkey
Local Institution
Ankara

Turkey
Local Institution
Istanbul

Turkey
Local Institution
Istanbul

Turkey
Local Institution
Izmir

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04810078 History of Changes
  • Other Study ID Numbers: CA209-67T, 2020-003655-15, U1111-1255-9514
  • First Posted: March 22, 2021 Key Record Dates
  • Last Update Posted: September 29, 2021
  • Last Verified: September 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Subcutaneous
    rHuPH20
    Opdivo
    Nivolumab     ccRCC
    Clear cell renal cell carcinoma
    BMS-986298
    BMS-936558
  • Additional relevant MeSH terms: Carcinoma, Renal Cell Carcinoma