NCT01704287

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002)

Randomized, Phase II Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Patients With Advanced Melanoma (KEYNOTE 002)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 540 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	IV infusion
DRUG	Carboplatin	Carboplatin per institutional standard
DRUG	Paclitaxel	Paclitaxel per institutional standard
DRUG	Dacarbazine	Dacarbazine per institutional standard
DRUG	Temozolomide	Temozolomide per institutional standard

Timeline

• Start date: 2012-11-20
• Primary completion: 2015-11-16
• Completion: 2019-01-31
• First posted: 2012-10-11
• Last updated: 2020-05-18
• Results posted: 2017-03-28

Regulatory

• FDA-regulated drug study