Description:
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.
Title
- Brief 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
- 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 IDs
- ORG STUDY ID:
CA209-67T
- SECONDARY ID:
2020-003655-15
- SECONDARY ID:
U1111-1255-9514
- NCT ID:
NCT04810078
Conditions
- Clear Cell Renal Cell Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab and rHuPH20 | BMS-986298 | Arm A: Subcutaneous Nivolumab |
Nivolumab | Opdivo, BMS-936558 | Arm B: Intravenous Nivolumab |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A: Subcutaneous Nivolumab | Experimental | | |
Arm B: Intravenous Nivolumab | Active Comparator | | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Time-averaged serum concentration over 28 days (Cavgd28) |
Time Frame: | Up to 28 days |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | Trough serum concentration at day 28 (Cmind28) |
Time Frame: | At 28 days |
Safety Issue: | |
Description: | |
Measure: | Maximum serum concentration after the first dose (Cmax1) |
Time Frame: | Up to 7 days |
Safety Issue: | |
Description: | |
Measure: | Time to peak serum concentration after the first dose (Tmax1) |
Time Frame: | Up to 7 days |
Safety Issue: | |
Description: | |
Measure: | Peak serum concentration at steady-state (Cmaxss) |
Time Frame: | Up to 4 months |
Safety Issue: | |
Description: | |
Measure: | Steady-state average serum concentration (Cavgss) |
Time Frame: | Up to 4 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of adverse events (AEs) |
Time Frame: | Up to 2 years 3 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of serious adverse events (SAEs) |
Time Frame: | Up to 2 years 3 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of AEs leading to discontinuation |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of deaths |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of clinically significant changes in clinical laboratory results: Hematology tests |
Time Frame: | Up to 2 years 3 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests |
Time Frame: | Up to 2 years 3 months |
Safety Issue: | |
Description: | |
Measure: | Efficacy parameters: disease control rate (DCR) by BICR with a minimum of 6 months follow-up |
Time Frame: | Up to 2 years 6 months |
Safety Issue: | |
Description: | |
Measure: | Efficacy parameters: DCR by BICR with a minimum of 12 months follow-up |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Efficacy parameters: DCR by BICR at end of study |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Efficacy parameters: duration of response (DOR) by BICR with a minimum of 6 months follow-up |
Time Frame: | Up to 2 years 6 months |
Safety Issue: | |
Description: | |
Measure: | Efficacy parameters: DOR by BICR with a minimum of 12 months follow-up |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Efficacy parameters: DOR by BICR at end of study |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | Efficacy parameters: TTR by BICR with a minimum of 12 months follow-up |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Efficacy parameters: TTR by BICR at end of study |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Efficacy parameters: progression-free survival (PFS) by BICR with a minimum of 6 months follow-up |
Time Frame: | Up to 2 years 6 months |
Safety Issue: | |
Description: | |
Measure: | Efficacy parameters: PFS by BICR with a minimum of 12 months follow-up |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Efficacy parameters: PFS by BICR at end of study |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Efficacy parameters: overall survival (OS) with a minimum of 6 months follow-up |
Time Frame: | Up to 2 years 6 months |
Safety Issue: | |
Description: | |
Measure: | Efficacy parameters: OS with a minimum of 12 months follow-up |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Efficacy parameters: OS at end of study |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Efficacy parameters: ORR by BICR with a minimum of 12 months follow-up |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Efficacy parameters: ORR by BICR at end of study |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of anaphylactic, hypersensitivity, and systemic infusion reactions |
Time Frame: | Up to 2 years 3 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of local injection- or infusion-site reactions |
Time Frame: | Up to 2 years 3 months |
Safety Issue: | |
Description: | |
Measure: | Percentage of participants who develop anti-nivolumab antibodies, if applicable |
Time Frame: | Up to 2 years 3 months |
Safety Issue: | |
Description: | |
Measure: | Percentage of participants who develop neutralizing antibodies, if applicable |
Time Frame: | Up to 2 years 3 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Trial Keywords
- BMS-936558
- BMS-986298
- Clear cell renal cell carcinoma
- ccRCC
- Nivolumab
- Opdivo
- rHuPH20
- Subcutaneous
Last Updated
July 26, 2021