Carcinoma, Non-Small-Cell LungPhase 4NCT03715205
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 Phase 4 study testing Pembrolizumab in people with Carcinoma, Non-Small-Cell Lung and Melanoma, run by Merck Sharp & Dohme LLC at 8 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Melanoma
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 8 sitesIndia
- Study dates
- 31 Jan 2019to 21 Aug 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Has an active infection requiring systemic therapy including known history of active tuberculosis (Bacillus tuberculosis)
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of or is positive for hepatitis B (hepatitis B surface antigen [HbsAg] reactive) or hepatitis C (HCV) ribonucleic acid (RNA) [qualitative] is detected
- Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial
- If participant received prior radiation therapy to a symptomatic metastatic lesion, has recovered to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Grade 1 or Grade 0 AEs due to radiation therapy
- Is a regular user of any illicit drug or has a recent history (within the last 3 months) of substance abuse including alcohol
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment
- Has received a live vaccine within 30 days before the first dose of trial treatment
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
India8 sites
Rajiv Gandhi Cancer Institute and Research Centre ( Site 0003)
Delhi, 110085
Artemis Health Institute ( Site 0007)
Gurgaon, Haryana, 122001
Nizam's Institute of Medical Sciences ( Site 0011)
Hyderabad, Andhra Pradesh, 500082
Tata Memorial Hospital [M] ( Site 0005)
Mumbai, Maharashtra, 400012
Kokilaben Ben Dhirubhai Ambani Hosp & Med Res Inst. ( Site 0001)
Mumbai, Maharashtra, 400053
All India Institute of Medical Sciences ( Site 0012)
New Delhi, National Capital Territory of Delhi, 110029
Indraprastha Apollo Hospitals ( Site 0008)
New Delhi, National Capital Territory of Delhi, 110076
Deenanath Mangeshkar Hospital and Research Center ( Site 0009)
Pune, Maharashtra, 411004
About this study
Official title: 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)
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
- Being tested
- Pembrolizumab
- Keywords
- programmed cell death 1 (PD-1, PD1), programmed cell death ligand 1 (PD-L1, PDL1), programmed cell death ligand 2 (PD-L2, PDL2)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Melanoma, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called KEYTRUDA®, MK-3475
Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to approximately 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start31 Jan 2019
- Primary completion21 Aug 2024
- Study completion21 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715205
- Sponsor's protocol ID
- 3475-593
- Other IDs
- MK-3475-593, KEYNOTE 593
- Status last verified
- Aug 2025
- First submitted
- 19 Oct 2018
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03715205
- Acronym / sponsor ID
- 3475-593
- 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)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 21 Aug 2024 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Posted 29 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab 200 mg IV Q3W | Experimental | Drug: PembrolizumabParticipants with melanoma or NSCLC receive 200 mg of pembrolizumab as an intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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
- Has a histologically or cytologically confirmed diagnosis of Stage IV NSCLC
- Has a tumor that demonstrate PD-L1 strong expression (PD-L1 ≥50%)
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: KEYTRUDA®, MK-3475Administered as an intravenous (IV) infusion every 3 weeks (Q3W) | Drug | Pembrolizumab 200 mg IV Q3W |
Primary outcome
Number of Participants With an Adverse Event (AE)
Time frame: Up to approximately 66.5 months
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.
Number of Participants With a Serious Adverse Event (SAE)
Time frame: Up to approximately 66.5 months
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.
Number of Participants With a Drug-Related AE
Time frame: Up to approximately 66.5 months
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.
Number of Participants With a Drug-Related SAE
Time frame: Up to approximately 66.5 months
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.
Number of Participants Who Discontinued Study Drug Due to an AE
Time frame: Up to approximately 26 months
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Merck Oncology Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pembrolizumab in people with Carcinoma, Non-Small-Cell Lung and Melanoma, run by Merck Sharp & Dohme LLC at 8 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With an Adverse Event (AE) (time frame: Up to approximately 66.5 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.