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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Nizam's Institute of Medical Sciences ( Site 0011)
Hyderabad, Andhra Pradesh, India
Artemis Health Institute ( Site 0007)
Gurgaon, Haryana, India
Tata Memorial Hospital [M] ( Site 0005)
Mumbai, Maharashtra, India
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Kokilaben Ben Dhirubhai Ambani Hosp & Med Res Inst. ( Site 0001)
Mumbai, Maharashtra, India
Deenanath Mangeshkar Hospital and Research Center ( Site 0009)
Pune, Maharashtra, India
All India Institute of Medical Sciences ( Site 0012)
New Delhi, National Capital Territory of Delhi, India
Indraprastha Apollo Hospitals ( Site 0008)
New Delhi, National Capital Territory of Delhi, India
Rajiv Gandhi Cancer Institute and Research Centre ( Site 0003)
Delhi, India
Time frame: 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
Time frame: Up to approximately 26 months