| General information |
| Database: | DB00050 |
| Objective: | The antiprogrammeddeathreceptor1 (PD1) antibody pembrolizumab has shown potent antitumour activity at different doses and schedules in patients with melanoma. They compared the efficacy and safety of pembrolizumab at doses of 2 mg/kg and 10 mg/kg every 3 weeks in patients with ipilimumabrefractory advanced melanoma. |
| Authors: | Robert C, et al |
| Title: | Antiprogrammeddeathreceptor1 treatment with pembrolizumab in ipilimumabrefractory advanced melanoma: a randomised dosecomparison cohort of a phase 1 trial. |
| Journal: | Lancet |
| Year: | 2014 |
| PMID: | 25034862 |
| Trial Design |
| Clinical Trial Id: | NCT01295827 |
| Agent: | pembrolizumab
|
| Target: | The antiprogrammeddeathreceptor1
|
| Cancer Type: | melanoma |
| Cancer Subtype: | ipilimumabrefractory advanced melanoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | an openlabel, international, multicentre expansion cohort of a phase I trial |
| Key Patients Feature: | patients (aged more than and equal to 18 years) with advanced melanoma whose disease had progressed after at least two ipilimumab doses |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients received pembrolizumab 2 mg/kg (n=89) or 10 mg/kg (n=84). |
| Primary End Point: | overall response rate (ORR) assessed with the Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) by independent central review. |
| Secondary End Point: | NA |
| Patients Number: | 173 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | ORR was 26% at both doses21 of 81 patients in the 2 mg/kg group and 20 of 76 in the 10 mg/kg group (difference 0%, 95% CI 14 to 13; p=0.96). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | The results suggest that pembrolizumab at a dose of 2 mg/kg or 10 mg/kg every 3 weeks might be an effective treatment in patients for whom there are few effective treatment options. |