| General information |
| Database: | DB00977 |
| Objective: | Nivolumab, a programmed death 1 (PD1) checkpoint inhibitor, was associated with encouraging overall survival in uncontrolled studies involving previously treated patients with advanced renalcell carcinoma. This randomized, openlabel, phase 3 study compared nivolumab with everolimus in patients with renalcell carcinoma who had received previous treatment |
| Authors: | Motzer RJ, et al |
| Title: | Nivolumab versus Everolimus in Advanced RenalCell Carcinoma. |
| Journal: | N Engl J Med. |
| Year: | 2015 |
| PMID: | 26406148 |
| Trial Design |
| Clinical Trial Id: | NCT01668784 |
| Agent: | nivolumab
|
| Target: | programmed death1
|
| Cancer Type: | renal cell carcinoma |
| Cancer Subtype: | advanced renal cell carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | randomized, openlabel, phase III study |
| Key Patients Feature: | patients with advanced clearcell renalcell carcinoma for which they had received previous treatment with one or two regimens of antiangiogenic therapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | Everolimus |
| Treatment Info: | pts were randomly assigned (in a 1:1 ratio) to receive 3 mg of nivolumab per kilogram of body weight intravenously every 2 weeks or a 10mg everolimus tablet orally once daily. |
| Primary End Point: | overall survival. |
| Secondary End Point: | the objective response rate and safety. |
| Patients Number: | 821 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | nivolumab vs everolimus: 25% vs. 5%; odds ratio, 5.98 [95% CI, 3.68 to 9.72]; P<0.001 |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.6 months (95% CI, 3.7 to 5.4) with nivolumab and 4.4 months (95% CI, 3.7 to 5.5) with everolimus (hazard ratio, 0.88; 95% CI, 0.75 to 1.03; P=0.11). |
| Median OS A vs. C: | 25.0 months (95% confidence interval [CI], 21.8 to not estimable) with nivolumab and 19.6 months (95% CI, 17.6 to 23.1) with everolimus. |
| Adverse Event(agent arm): | The most common treatmentrelated adverse events among patients who received nivolumab were fatigue (134 patients, 33%), nausea (57 patients, 14%), and pruritus (57 patients, 14%); among patients who received everolimus, the most common events were fatigue (134 patients, 34%), stomatitis (117 patients, 29%), and anemia (94 patients, 24%). Grade 3 or 4 treatmentrelated adverse events occurred in 76 of the 406 patients (19%) treated with nivolumab and in 145 of the 397 patients (37%) treated with everolimus; the most common grade 3 or grade 4 event was fatigue (10 patients, 2%) with nivolumab and anemia (31 patients, 8%) with everolimus. |
| Conclusions: | Among patients with previously treated advanced renalcell carcinoma, overall survival was longer and fetheyr grade 3 or 4 adverse events occurred with nivolumab than with everolimus. (Funded by BristolMyers Squibb; CheckMate 025 ClinicalTrials.gov number, NCT01668784.). |