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)

NCT03715205 | Completed Phase 4 Results

• 3 other identifiers: 3475-593MK-3475-593KEYNOTE 593
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

programmed cell death 1 (PD-1, PD1); programmed cell death ligand 1 (PD-L1, PDL1); programmed cell death ligand 2 (PD-L2, PDL2)

Outcome Measures

Primary Outcomes (5)

• Number of Participants With an Adverse Event (AE)

  An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. The number of participants with an AE was reported.

  Up to approximately 66.5 months

• Number of Participants With a Serious Adverse Event (SAE)

  An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. An SAE was any adverse event occurring at any dose or during any use of Sponsor's product that resulted in death; was life threatening; resulted in persistent or significant disability/incapacity; resulted in or prolonged an existing inpatient hospitalization; was a congenital anomaly/birth defect; was another important medical event. The number of participants with an SAE was reported.

  Up to approximately 66.5 months

• Number of Participants With a Drug-Related AE

  An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. A drug-related AE was defined as an AE that was determined by the investigator to be possibly, probably, or definitely related to drug. The number of participants with a drug-related AE was reported.

  Up to approximately 66.5 months

• Number of Participants With a Drug-Related SAE

  An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An SAE was any AE occurring at any dose or during any use of Sponsor's product that resulted in death; was life threatening; resulted in persistent or significant disability/incapacity; resulted in or prolonged an existing inpatient hospitalization; was a congenital anomaly/birth defect; was another important medical event. A drug-related SAE was defined as an SAE that was determined by the investigator to be possibly, probably, or definitely related to drug. The number of participants with a drug-related SAE was reported.

  Up to approximately 66.5 months

• Number of Participants Who Discontinued Study Drug Due to an AE

  An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. The number of participants who discontinued study drug due to an AE was reported

  Up to approximately 26 months

Other Outcomes (1)

• Number of Participants With an Adverse Event of Special Interest (AEOSI)

  Up to approximately 66.5 months

Study Arms (1)

Pembrolizumab 200 mg IV Q3W

EXPERIMENTAL

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

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

Administered as an intravenous (IV) infusion every 3 weeks (Q3W)

Also known as: KEYTRUDA®, MK-3475

Pembrolizumab 200 mg IV Q3W

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 therapies to ≤ Grade 1 or baseline
• Has recovered adequately from the toxicity and/or complications from major surgery prior to starting trial treatment
• Is expected to require any other form of antineoplastic therapy while participating in the trial
• Is on systemic corticosteroid therapy within 7 days before the planned date for first dose of treatment or any other form of immunosuppressive medication
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (exceeding 10 mg daily dose of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment
• Has an active autoimmune disease that has required systemic treatment in the past 2 years
• Has a known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., cervical cancer in situ, breast carcinoma) that have undergone potentially curative therapy
• Has had an allogeneic tissue/solid organ transplant
• Has a history of or current radiographically detectable central nervous system metastases and/or carcinomatous meningitis
• Has a severe hypersensitivity (≥ Grade 3) to any excipients in pembrolizumab
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (8)

Nizam's Institute of Medical Sciences ( Site 0011)

Hyderabad, Andhra Pradesh, 500082, India

Location

Artemis Health Institute ( Site 0007)

Gurgaon, Haryana, 122001, India

Location

Tata Memorial Hospital [M] ( Site 0005)

Mumbai, Maharashtra, 400012, India

Location

Kokilaben Ben Dhirubhai Ambani Hosp & Med Res Inst. ( Site 0001)

Mumbai, Maharashtra, 400053, India

Location

Deenanath Mangeshkar Hospital and Research Center ( Site 0009)

Pune, Maharashtra, 411004, India

Location

All India Institute of Medical Sciences ( Site 0012)

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Indraprastha Apollo Hospitals ( Site 0008)

New Delhi, National Capital Territory of Delhi, 110076, India

Location

Rajiv Gandhi Cancer Institute and Research Centre ( Site 0003)

Delhi, 110085, India

Location

Related Links

• Merck Oncology Clinical Trials Information

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Melanoma; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 23, 2018
• Study Start: January 31, 2019
• Primary Completion: August 21, 2024
• Study Completion: August 21, 2024
• Last Updated: August 29, 2025
• Results First Posted: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

IN (8)