Phase 4
N=150
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)
Carcinoma, Non-Small-Cell Lung · Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT03715205 ↗Enrolled (actual)
150
Serious AEs
20.7%
Results posted
Aug 2025
Primary outcome: Primary: Number of Participants With an Adverse Event (AE) — 131 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pembrolizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Adverse Event (AE) |
131 | — |
| PRIMARY Number of Participants With a Serious Adverse Event (SAE) |
31 | — |
| PRIMARY Number of Participants With a Drug-Related AE |
61 | — |
| PRIMARY Number of Participants With a Drug-Related SAE |
10 | — |
| PRIMARY Number of Participants Who Discontinued Study Drug Due to an AE |
11 | — |
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%).
Eligibility Criteria
Inclusion Criteria
Melanoma Participant:
- Has a histologically confirmed diagnosis of unresectable Stage III or metastatic melanoma (Stage IV) not amenable to local therapy
- Has received no more than 1 line of prior systemic therapy for unresectable Stage III or Stage IV melanoma including mitogen activated protein kinase inhibitors
- Has a Lactate Dehydrogenase (LDH) ≤1.5 times ULN
NSCLC Participant-First Line Treatment:
- Has a histologically or cytologically confirmed diagnosis of Stage IV NSCLC
- Has a tumor that demonstrate PD-L1 strong expression (PD-L1 ≥50%)
- Do not have an EGFR sensitizing mutation AND are anaplastic lymphoma kinase (ALK) translocation negative
- Has received no systemic anti-cancer therapy for their metastatic NSCLC
NSCLC Participant-Second Line Treatment and Beyond:
- Has a histologically or cytologically confirmed diagnosis of stage IIIB//IIIC/IV (including any future updates to the American Joint Committee on Cancer [AJCC] guideline) or recurrent NSCLC
- Has a tumor that expresses programmed cell death ligand 1 (PD-L1) ≥1%
- Has received prior treatment with at least two cycles of a platinum-containing doublet for Stage IIIB/IV or recurrent disease
- Has received an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (either erlotinib, gefitinib, or afatinib) if they have an EGFR sensitizing mutation
- Has received crizotinib if they have an ALK translocation
NSCLC participants must also meet the following requirements:
- Have a life expectancy of at ≥3 months
- Provide a formalin fixed tumor tissue sample for PD-L1 biomarker analysis from a recent biopsy of a tumor lesion not previously irradiated; For first line, biopsies obtained PRIOR to the administration of any systemic therapy administered for the treatment of a tumor (such as neoadjuvant/adjuvant/definitive therapy) will not be permitted for analysis. For second line treatment and beyond, no systemic antineoplastic therapy may be administered between the PD-L1 biopsy and initiating study medication
- Have documented evidence of the EGFR mutation status or ALK translocation status. If unable to provide documentation of these molecular changes, formalin-fixed paraffin-embedded tumor tissue of any age should be submitted for testing
- Have measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiologist
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Women of childbearing potential (WOCP) must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of trial treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- WOCP must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of trial treatment
- Men of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
Exclusion Criteria
- For NSCLC Participant only: Has a tumor specimen that is not evaluable for PD-L1 expression by the laboratory
- Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment
- Has received prior therapy with an anti- programmed cell death 1 (PD-1), anti-PD-L1, or anti- programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another T-cell receptor (i.e., cytotoxic T-lymphocyte antigen-4 [CTLA-4], OX-40, CD137) or has previously participated in a clinical trial for pembrolizumab (MK-3475)
- Has received prior anti-cancer therapy including investigational agent or device within 4 weeks, or completed palliative radiotherapy within 7 days, prior to enrollment
- Has recovered from all AEs due to previous ther
Data sourced from ClinicalTrials.gov (NCT03715205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.