Phase 3 N=821 Randomized Treatment

Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)

Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma

Bottom Line

View on ClinicalTrials.gov: NCT01668784 ↗

Enrolled (actual)

821

Serious AEs

61.2%

Results posted

Apr 2016

Primary outcome: Primary: Overall Survival (OS) at Primary Endpoint — 25.00; 19.55 months — p=0.0018

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Nivolumab (Biological); Everolimus (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival (OS) at Primary Endpoint	25.00; 19.55	0.0018 sig
SECONDARY Investigator-assessed Objective Response Rate (ORR)	25.9; 6.1	—
SECONDARY Investigator-assessed Duration of Objective Response	13.11; 10.18	—
SECONDARY Investigator-assessed Time to Objective Response	3.55; 3.71	—
SECONDARY Investigator-assessed Time of Progression-free Survival (PFS)	4.21; 4.50	0.0340 sig
SECONDARY Overall Survival (OS) by Programmed Death-Ligand 1 (PD-L1) Expression Level	5.36; 4.17; 3.94; 4.67	—
SECONDARY Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events	324; 342; 211; 177; 51; 55	—
SECONDARY Percentage of Participants With Disease-related Symptom Progression (DRSP)	44.6; 54.6; 95.5; 99.4	—
SECONDARY Number of Participants Meeting Marked Laboratory Abnormality Criteria in Specific Liver and Thyroid Tests	32; 15; 20; 7; 9; 1	—
SECONDARY Number of Participants With Abnormal Hematology and Serum Chemistry Laboratory Parameters by Worse CTC Grade - SI Units	33; 61; 1; 6; 0; 1	—

Summary

The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy

Eligibility Criteria

Inclusion Criteria

Men & women ≥18 years of age
Histologic confirmation of renal cell carcinoma (RCC) with clear-cell component
Advanced/metastatic RCC
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting
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
Karnofsky Performance Score ≥70%

Exclusion Criteria

Any Central Nervous System (CNS) metastases or history of CNS metastases
Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor
Any active known or suspected autoimmune disease
Uncontrolled adrenal insufficiency
Active chronic liver disease
Prior malignancy active within past 3 years, except for locally curable cancers

Other protocol-defined inclusion/exclusion criteria apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01668784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.