NCT03715205

Study to Evaluate the Safety of Pembrolizumab in Participants With Unresectable or Metastatic Melanoma or Non-small Cell Lung Cancer in India (MK-3475-593/KEYNOTE-593)

A Prospective, Open-label, Phase 4 Study to Evaluate the Safety of Pembrolizumab (KEYTRUDA®) in Subjects With Unresectable or Metastatic Melanoma or PD-L1 Positive Non-small Cell Lung Cancer (NSCLC) in India (Keynote-593)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study has been designed to evaluate the safety of pembrolizumab in participants in India with unresectable or metastatic melanoma and participants with non-small cell lung cancer (NSCLC) who are either untreated (programmed cell death ligand 1 \[PD-L1\] ≥50%) or have experienced disease progression after a platinum-containing systemic therapy (PD-L1 ≥1%).

Conditions

• Carcinoma, Non-Small-Cell Lung
• Melanoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Administered as an intravenous (IV) infusion every 3 weeks (Q3W)

Timeline

• Start date: 2019-01-31
• Primary completion: 2024-08-21
• Completion: 2024-08-21
• First posted: 2018-10-23
• Last updated: 2025-08-29
• Results posted: 2025-08-29

Locations

8 sites across 1 country: India