Malignant Melanoma Clinical Trial
Official title:
Randomized, Phase II Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Patients With Advanced Melanoma (KEYNOTE 002)
This study was conducted to compare survival using pembrolizumab (SCH 900475, MK-3475) or
standard chemotherapy in participants with advanced melanoma (MEL) who had progressed after
prior therapy.
Initial Treatment Period:
Participants were initially randomized to receive either low-dose (2 mg/kg) pembrolizumab,
higher dose (10 mg/kg) pembrolizumab or Investigator-choice chemotherapy (ICC). The four
standard chemotherapy choices were: carboplatin + paclitaxel, paclitaxel alone, dacarbazine,
or temozolomide. The randomization to either pembrolizumab or ICC was conducted in an
open-label fashion.
The starting pembrolizumab dose was initially blinded to Investigators and participants until
Amendment 03. With Amendment 03, all ongoing pembrolizumab participants were to be treated
with open label, fixed dose pembrolizumab 200 mg, instead of a weight-based dosing of
pembrolizumab.
Switch-to-Pembrolizumab Treatment Period:
Participants who were initially randomized to receive ICC and experienced progressive disease
(PD) may have been eligible to switch to receiving pembrolizumab provided they met
protocol-specified requirements for switching. Qualified participants were re-randomized to
receive either pembrolizumab 2 mg/kg or pembrolizumab 10 mg/kg in a double-blind fashion.
Participants who qualified to switch to pembrolizumab must have completed a washout period of
≥28 days from last dose of chemotherapy before receiving pembrolizumab. With Amendment 03,
all switched-to-pembrolizumab participants were to be treated with open-label, fixed dose
pembrolizumab 200 mg instead of a weight-based dosing of pembrolizumab.
Two interim and one final statistical analyses were planned for and conducted during this
study:
- Interim Analysis 1 (futility analysis),
- Interim Analysis 2 (~18 months into study): database cutoff date 12-May-2014, and
- Final Analysis (~36 months into study): database cutoff date 16-Nov-2015. The End of
Trial Analysis for the study was conducted at ~75 months into the study: database cutoff
date 31-Jan-2019.
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