Study of Pembrolizumab (MK-3475) in Participants With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, or Non-small Cell Lung Carcinoma (P07990/MK-3475-001/KEYNOTE-001)
Phase 1N = 135NCT01295827
- Population
- Advanced melanoma, with or without prior ipilimumab (135 patients treated)
- Design
- Phase 1 study of lambrolizumab (later pembrolizumab, MK-3475) given intravenously at 10 mg per kilogram every 2 or 3 weeks or 2 mg per kilogram every 3 weeks to patients with advanced melanoma, with and without prior ipilimumab; tumour responses assessed every 12 weeks. The registry record (KEYNOTE-001) covers carcinoma, melanoma and non-small-cell lung carcinoma cohorts and lists 1,260 enrolled; this Trial record holds the 135-patient melanoma cohort of the 2013 paper.
- Arms
- Lambrolizumab (anti-PD-1) (experimental): Lambrolizumab 10 mg per kilogram every 2 or 3 weeks, or 2 mg per kilogram every 3 weeks
- People
- Hamid O, senior author Ribas A
Show the numbers
| Endpoint | Analysis | Lambrolizumab (anti-PD-1) | Control | Effect |
|---|---|---|---|---|
| ORR135 patients treated; confirmed response rate by central review reported as 44 of 117 patients (full text) | primaryHamid 2013 | 38% | — | Confirmed response rate by central radiologic review (RECIST 1.1): 44 of 117 patients (full text). By prior ipilimumab: 38% with and 37% without prior ipilimumab. 81% of the patients with a response (42 of 52, confirmed and unconfirmed) were still receiving treatment at the March 2013 analysis. The abstract (also reproduced in the full text) prints a 95% CI of 25 to 44 for the overall rate; that interval is asymmetric around 38% and is not transcribed. |
| ORRCohort receiving 10 mg per kilogram every 2 weeks | primaryHamid 2013 | 52% (38–66%) | — | Highest confirmed response rate among the dose cohorts. |
| Endpoint | Analysis | Lambrolizumab (anti-PD-1) | Control | Effect |
|---|---|---|---|---|
| ORR135 patients treated; confirmed response rate by central review reported as 44 of 117 patients (full text) | primaryHamid 2013 | 38% | — | Confirmed response rate by central radiologic review (RECIST 1.1): 44 of 117 patients (full text). By prior ipilimumab: 38% with and 37% without prior ipilimumab. 81% of the patients with a response (42 of 52, confirmed and unconfirmed) were still receiving treatment at the March 2013 analysis. The abstract (also reproduced in the full text) prints a 95% CI of 25 to 44 for the overall rate; that interval is asymmetric around 38% and is not transcribed. |
| ORRCohort receiving 10 mg per kilogram every 2 weeks | primaryHamid 2013 | 52% (38–66%) | — | Highest confirmed response rate among the dose cohorts. |