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Active, not recruiting

NCT Number: NCT04810078

A Study 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 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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Clear Cell Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0038, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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
  • 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

Treatment and study plan

Nivolumab and rHuPH20

Biological

Specified dose on specified days

Other names: BMS-986298

Nivolumab

Biological

Specified dose on specified days

Other names: Opdivo, BMS-936558

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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)

    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.

  2. Trough Serum Concentration of Nivolumab at Day 28 (Cmind28)

    Time frame: Pre-dose at Day 28

    Blood samples were collected to assess serum concentration.

  3. Maximum Serum Concentration of Nivolumab After the First Dose (Cmax1)

    Time frame: Post dose (Day 1)

    Blood samples were collected to assess serum concentration.

  4. Peak Serum Concentration of Nivolumab at Steady State (Cmaxss)

    Time frame: Pre-dose (Day 1 to Day 28)

    Blood samples were collected to assess serum concentration.

  5. Time-averaged Serum Concentration of Nivolumab at Steady State (Cavgss)

    Time frame: Pre-dose (Day 1 to Day 28)

    Blood samples were collected to assess serum concentration.

  6. Trough Serum Concentration of Nivolumab (Ctrough)

    Time frame: Pre-dose at Week 17

    Blood samples were collected to assess serum concentration.

  7. Time to Maximum Serum Concentration of Nivolumab at Day 1 (Tmax1)

    Time frame: Post dose (Day 1)

    Blood samples were collected to assess serum concentration.

  8. Trough Serum Concentration of Nivolumab at Steady State (Cminss)

    Time frame: Pre dose (Day 1 to Day 28)

    Blood samples were collected to assess serum concentration.

  9. 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)

    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.

  10. 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)

    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.

  11. 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)

    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.

  12. 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)

    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.

  13. 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)

    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.

  14. Overall Survival

    Time frame: From first dose to the date of death (up to approximately 26 months)

    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.

  15. 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)

  16. 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)

    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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: CheckMate-67T

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Mar 22, 2021
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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