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KEYNOTE-002 (2 mg/kg), 2015 NCT01704287

pembrolizumab (2mg/kg) (n=180) vs. Standard of Care (SoC) (n=179)

randomized controlled trial

Studied treatment

pembrolizumab
pembrolizumab 2 mg/kg given intravenously every 3 weeks

Control treatment

ICC (carboplatin plus paclitaxel, dacarbazine, paclitaxel alone or oral temozolomid)
(paclitaxel plus carboplatin (23.4%), paclitaxel (15.6%), carboplatin (7.2%) [eliminated with protocol amendment one], dacarbazine (25.1%) , or oral temozolomide (24.0%))

A designated pharmacist at each site who was unmasked prepared the pembrolizumab dose so that it could be administered to the patient in a masked fashionthey could cross over to receive pembrolizumab after a washout period

Patients

mML - L2 - all population

Randomisation was stratifi ed by ECOG performance status (0 vs 1), lactate dehydrogenaseconcentration, and BRAF status

Method

open label

73 hospitals, clinics, and academic medical centres in 12 countries

P2/ one sided test procedure with two interim analysis. 3 arms pembrolizumab 2mg/kg, 10mg/kg vs chemotherapy. repartition PFS (0.0025/arm) and OS (0.01/arm) in one-sided

Remark

Improvement in OS with pembrolizumab was not statistically significant at either dose versus chemotherapy.