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Keytruda Safety Study in Indian Patients with Advanced Melanoma or NSCLC
NCT03715205Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2019
- Primary completion
- Aug 2024
- Countries
- 1
- Sponsor
- Merck & Co.
- Modality
- Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes
- Drugs
- pembrolizumab
- Conditions
- melanomanon-small cell lung carcinoma (NSCLC)
01
Overview
Phase 4, open-label, single-arm trial of pembrolizumab in melanoma and non-small cell lung carcinoma (NSCLC), sponsored by Merck & Co. Primary endpoints: Number of Participants With an Adverse Event up to 66.5 months, Number of Participants With a Serious Adverse Event up to 66.5 months and 2 more. Started Jan 2019; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Pembrolizumab Monotherapy
Participants with Melanoma or NSCLC receive Pembrolizumab 200 mg IV Q3W
03
Who it enrols
Adult patients in India with unresectable/metastatic Melanoma (<=1 prior line) or Stage IV NSCLC. NSCLC patients must be either untreated with PD-L1 >=50% (and EGFR/ALK negative) or previously treated with platinum-chemo (and TKI if EGFR/ALK+) with PD-L1 >=1%.
04
Endpoints
Primary
Number of Participants With an Adverse Event
Number of Participants With a Serious Adverse Event
Number of Participants With a Drug-Related Adverse Event
Number of Participants Who Discontinued Study Drug Due to an AE
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