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CTRI Number  CTRI/2018/12/016591 [Registered on: 10/12/2018] Trial Registered Prospectively
Last Modified On: 28/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Single Arm Trial 
Public Title of Study   Safety of Pembrolizumab in advanced lung cancer or melanoma 
Scientific Title of Study   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) 
Trial Acronym  KEYTRUDA® 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
MK3475-593 Version 02 dated 17-May-2018  Protocol Number 
MK3475-593 Version 03 dated 14-Dec-2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Monisha Sharma 
Designation  Therapeutic Area Head 
Affiliation  MSD Pharmaceuticals Pvt Ltd 
Address  6th Floor, Vatika Towers - B, Golf Course Road Sector 54,

Gurgaon
HARYANA
122002
India 
Phone  911244647300   
Fax  911244375561   
Email  Monisha.Sharma@merck.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Monisha Sharma 
Designation  Therapeutic Area Head 
Affiliation  MSD Pharmaceuticals Pvt Ltd 
Address  6th Floor, Vatika Towers - B, Golf Course Road Sector 54,

Gurgaon
HARYANA
122002
India 
Phone  911244647300   
Fax  911244375561   
Email  Monisha.Sharma@merck.com  
 
Details of Contact Person
Public Query
 
Name  Dr Monisha Sharma 
Designation  Therapeutic Area Head 
Affiliation  MSD Pharmaceuticals Pvt Ltd 
Address  6th Floor, Vatika Towers - B, Golf Course Road Sector 54,

Gurgaon
HARYANA
122002
India 
Phone  911244647300   
Fax  911244375561   
Email  Monisha.Sharma@merck.com  
 
Source of Monetary or Material Support  
Merck Sharp and Dohme One Merck Drive P.O. Box 100 Whitehouse Station, NJ 08889-0100 USA 
 
Primary Sponsor  
Name  Merck Sharp and Dohme Corp a subsidiary of Merck and Co Inc 
Address  One Merck Drive P.O. Box 100 Whitehouse Station, NJ 08889-0100 USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sameer Rastogi  All India Institute of Medical Sciences  Room No. 216, 2nd Floor, Dr. B.R.A Institute-Rotary Cancer Hospital; AIIMS, Ansari Nagar, New Delhi - 110029
South
DELHI 
919958975343

samdoc_mamc@yahoo.com 
Dr Hari Goyal  Artemis Hospitals  Room Number 1919; Basement; Sector 51, Gurgaon, Haryana-122001, India
Gurgaon
HARYANA 
911244511111
911246767708
drgoyalhari@hotmail.com 
Dr Chetan Deshmukh  Deenanath Mangeshkar Hospital & Research Center  Department of Oncology, Near Mhatre Bridge, Erandawne, Pune, Maharashtra 411004, India
Pune
MAHARASHTRA 
919850811449

drchetandeshmukh@gmail.com 
Dr P K Das  Indraprastha Apollo Hospitals  Hostel Complex, Basement Annexe, Sarita Vihar, Mathura Road, New Delhi- 1100076, India
New Delhi
DELHI 
911129871683
911141677024
drpratapdas@gmail.com 
Dr Sewanti Atul Limaye  Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute  2nd Floor, Medical Research Department, Rao Saheb Achutrao Patwardhan Marg, Four Bunglows, Andheri West, Mumbai-400053
Mumbai
MAHARASHTRA 
912230937275
912230972030
sewanti.limaye@relianceada.com 
Dr Sadashivudu Gundeti  Nizams Institute of Medical Sciences  Dept. of Medical Oncology, Punjagutta, Hyderabad, Telangana 500082, India
Hyderabad
TELANGANA 
914023396552

drssgundeti@yahoo.com 
Dr DCDoval  Rajiv Gandhi Cancer Institute and Research Centre  Dept. of Medical Oncology, Sector-5, Rohini Delhi-110085
New Delhi
DELHI 
91114702441
911127051037
dcdoval@gmail.com 
DrJyoti Bajpai  Tata Memorial Hospital  Room No. 1115, 11th Floor, Homi Bhabha Block, Dr. Ernest Borges Marg, Parel (E), Mumbai 400 012, Maharashtra, India
Mumbai
MAHARASHTRA 
912224177287
912224177201
drjyotibajpai25@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Institutional Ethics Committee_AIIMS  Approved 
Institutional Ethics Committee_Artemis Health Institute   Approved 
Institutional Ethics Committee_Deenanath Mangeshkar Hospital & Research Center  Approved 
Institutional Ethics Committee_Indraprastha Apollo Hospitals  Approved 
Institutional Ethics Committee_Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute  Approved 
Institutional Ethics Committee_Tata Memorial Centre  Approved 
Institutional Review Board_Rajiv Gandhi Cancer Institute and Research Centre  Approved 
NIMS Institutional Ethics Committee_Nizam Institute of medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  C439||Malignant melanoma of skin, unspecified, C349||Malignant neoplasm of unspecifiedpart of bronchus or lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Pembrolizumab   Administered as an intravenous (IV) infusion every 3 weeks (Q3W) Other Names: KEYTRUDA® MK-3475 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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/IV 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 
 
ExclusionCriteria 
Details  For NSCLC Participant only: Has a tumor specimen that is not evaluable for PD-L1 expression by the central 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 (non-infectious) pneumonitis that required steroids or current pneumonitis
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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the safety of pembrolizumab in Indian patients by measuring the incidence of Adverse Events.  From time of signing the informed consent form until the end of follow-up. 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)
Modification(s)  
31/01/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="7"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None Yet 
Brief Summary  
Pembrolizumab is approved by the Health Authorities of India for the treatment of advanced lung cancer and melanoma either as first line therapy or after prior therapy. As a condition of granting approval, the Health Authorities of India have required that a Phase 4 clinical trial with Indian participants  must be conducted so that adverse reactions related to the drug can reported to the Health Authorities in India. The present study is a Phase 4 safety study of Pembrolizumab to be conducted in India to comply with this condition. This study will provide information on the safety profile of Pembrolizumab for the treatment of NSCLC or Melanoma. This study will record the adverse events that occur during up to two years of treatment with Pembrolizumab in participants with advanced lung cancer or melanoma in India.
 
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