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)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT03715205
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Administered as an intravenous (IV) infusion every 3 weeks (Q3W)

Study Details

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%).

Key Dates

Start date
Jan 31, 2019
Status verified
Aug 2025
Primary completion
Aug 21, 2024
Completion
Aug 21, 2024

Study Design

Enrollment
150 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab 200 mg IV Q3W
    Participants with melanoma or NSCLC receive 200 mg of pembrolizumab as an intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 cycles.

Primary Outcome Measure

Number of Participants With an Adverse Event (AE) [ Time Frame: Up to approximately 66.5 months ]

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