Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced Or Metastatic Clear-cell RCC

A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy + Pharmacogenetics Blood Sample Amendment 01- dated 18-jun-12, version 1.0 - CheckMate 025: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005132-26-DK

Enrollment

975

Registered

2012-09-17

Start date

2012-09-26

Completion date

Unknown

Last updated

2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or metastatic (medically or surgically unresectable) clear-cell Renal Cell Carcinoma MedDRA version: 20.0 Level: PT Classification code 10038414 Term: Renal cell carcinoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10050513 Term: Metastatic renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA vers

Interventions

Trade Name: Opdivo (100 mg/10 ml) Product Name: NIVOLUMAB - 10ml vial-CLINICAL Product Code: BMS-936558 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Nivolumab CAS Number:

MDX-1106 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Trade Name: Afinitor 5 mg Product Name: everolimus Pharmaceutical Form: Tablet INN or Pr

MDX-1106 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Men & women = 18 years of age 2.Histologic confirmation of RCC with clear-cell component 3.Advanced/metastatic RCC 4.Measurable disease per RECIST 1.1 criteria 5.Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting 6.No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within 6 months of enrollment 7.Karnofsky Performance Score = 70% Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 585 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 390

Exclusion criteria

Exclusion criteria: 1.Any CNS metastases or history of CNS metastases 2.Prior therapy with an mTOR inhibitor 3.Any active known or suspected autoimmune disease. 4.Uncontrolled adrenal insufficiency 5.Active chronic liver disease 6.Prior malignancy active within past 3 years, except for locally curable cancers

Design outcomes

Primary

Measure	Time frame
Primary end point(s): The primary endpoint is overall survival.;Timepoint(s) of evaluation of this end point: Overall survival will be followed at every clinic visit (every 2-4 weeks) while on treatment and then every 3 months.;Main Objective: The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of BMS-936558 vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy.;Secondary Objective: 1.Objective response rate 2.Progression-free survival 3.Duration of objective response 4.Duration of OS in PD-L1 positive vs negative subgroups 5.Overall safety & tolerability 6.Disease related symptom progression rate	—

Measure

Time frame

Primary end point(s): The primary endpoint is overall survival.;Timepoint(s) of evaluation of this end point: Overall survival will be followed at every clinic visit (every 2-4 weeks) while on treatment and then every 3 months.;Main Objective: The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of BMS-936558 vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy.;Secondary Objective: 1.Objective response rate 2.Progression-free survival 3.Duration of objective response 4.Duration of OS in PD-L1 positive vs negative subgroups 5.Overall safety & tolerability 6.Disease related symptom progression rate

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Secondary

Measure	Time frame
Secondary end point(s): 1.Objective response rate 2.Progression-free survival 3.Duration of objective response 4.Duration of OS in PD-L1 positive vs negative subgroups 5.Overall safety & tolerability 6.Disease related symptom progression rate ;Timepoint(s) of evaluation of this end point: 1.Disease assessments Q 8 wks after randomization for 12 months then Q 12 wks until progression of disease 2.See above 3.See above 4.At time of OS analysis (see #38 for timeframe of collection of OS) 5.Continuously throughout study treatment and up to 100 days from last dose 6.Baseline, Day 1 of each cycle (starting with cycle 2), then at first 2 follow-up visits	—

Measure

Time frame

Secondary end point(s): 1.Objective response rate 2.Progression-free survival 3.Duration of objective response 4.Duration of OS in PD-L1 positive vs negative subgroups 5.Overall safety & tolerability 6.Disease related symptom progression rate ;Timepoint(s) of evaluation of this end point: 1.Disease assessments Q 8 wks after randomization for 12 months then Q 12 wks until progression of disease 2.See above 3.See above 4.At time of OS analysis (see #38 for timeframe of collection of OS) 5.Continuously throughout study treatment and up to 100 days from last dose 6.Baseline, Day 1 of each cycle (starting with cycle 2), then at first 2 follow-up visits

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Countries

Argentina, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Norway, Poland, Romania, Russian Federation, Spain, Sweden, United Kingdom, United States

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026