| General information |
| Database: | DB00955 |
| Objective: | Blockade of the programmed death1 inhibitory cellsurface molecule on immune cells using the fully human immunoglobulin G4 antibody nivolumab mediates tumor regression in a portion of patients with advanced treatmentrefractory solid tumors. they report clinical activity, survival, and longterm safety in patients with advanced renal cell carcinoma (RCC) treated with nivolumab in a phase I study with expansion cohorts. |
| Authors: | McDermott DF, et al |
| Title: | Survival, Durable Response, and LongTerm Safety in Patients With Previously Treated Advanced Renal Cell Carcinoma Receiving Nivolumab. |
| Journal: | J Clin Oncol. |
| Year: | 2015 |
| PMID: | 25800770 |
| Trial Design |
| Clinical Trial Id: | NA |
| 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: | a phase I study with expansion cohorts |
| Key Patients Feature: | patients with previously treated advanced RCC |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received intravenous nivolumab (1 or 10 mg/kg) in an outpatient setting once every two weeks for up to 96 weeks and were observed for survival and duration of response after treatment discontinuation. |
| Primary End Point: | clinical activity, survival, and longterm safety |
| Secondary End Point: | NA |
| Patients Number: | 34 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 29% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 22.4 months; 1, 2, and 3year survival rates were 71%, 48%, and 44%, respectively. |
| Adverse Event(agent arm): | NA |
| Conclusions: | Patients with advanced treatmentrefractory RCC treated with nivolumab demonstrated durable responses that in some responders persisted after drug discontinuation. Overall survival is encouraging, and toxicities were generally manageable. Ongoing randomized clinical trials will further assess the impact of nivolumab on overall survival in patients with advanced RCC. |