Phase 3
Completed N=821
Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)
Source: ClinicalTrials.gov NCT01668784 ↗Enrolled (actual)
821
Serious AEs
61.2%
Results posted
Apr 2016
Primary outcomePrimary: Overall Survival (OS) at Primary Endpoint — 25.00; 19.55 months — p=0.0018
◆ Published Evidence
Highly cited
240citations · ~27 / year
Treatment Beyond Progression in Patients with Advanced Renal Cell Carcinoma Treated with Nivolumab in CheckMate 025.
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
Linked Publications (5)
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Treatment Beyond Progression in Patients with Advanced Renal Cell Carcinoma Treated with Nivolumab in CheckMate 025.
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Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer.
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What Did Time Tell Us? A Comparison and Retrospective Validation of Different Survival Extrapolation Methods for Immuno-Oncologic Therapy in Advanced or Metastatic Renal Cell Carcinoma.
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Clinical and economic outcomes of treatment sequences for intermediate- to poor-risk advanced renal cell carcinoma.
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A Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) Analysis of Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma (aRCC).
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT01668784) and the linked publication. 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. Informational only — not medical advice.