Trial Outcomes & Findings for 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) (NCT NCT03715205)

NCT ID: NCT03715205

Last Updated: 2025-08-29

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

150 participants

Primary outcome timeframe

Up to approximately 66.5 months

Results posted on

2025-08-29

Participant Flow

Participants with unresectable or metastatic melanoma, or Non-small Cell Lung Cancer (NSCLC) who were either treatment naïve or had disease progression after prior treatment, were recruited to the study.

Of 284 participants screened, 150 were allocated to receive pembrolizumab.

Participant milestones

Participant milestones
Measure	Pembrolizumab 200 mg IV Q3W Participants with melanoma or NSCLC received 200 mg of pembrolizumab as an IV infusion Q3W for up to 35 cycles.
Overall Study STARTED	150
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	134

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab 200 mg IV Q3W Participants with melanoma or NSCLC received 200 mg of pembrolizumab as an IV infusion Q3W for up to 35 cycles.
Overall Study Death	13
Overall Study Lost to Follow-up	2
Overall Study Physician Decision	93
Overall Study Withdrawal by Subject	26

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab 200 mg IV Q3W n=150 Participants Participants with melanoma or NSCLC received 200 mg of pembrolizumab as an IV infusion Q3W for up to 35 cycles.
Age, Continuous	55.3 Years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	86 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	150 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	150 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 66.5 months

Population: All participants who received at least 1 dose of trial treatment were analyzed.

Outcome measures

Outcome measures
Measure	Pembrolizumab 200 mg IV Q3W n=150 Participants Participants with melanoma or NSCLC received 200 mg of pembrolizumab as an IV infusion Q3W for up to 35 cycles.
Number of Participants With an Adverse Event (AE)	131 Participants

PRIMARY outcome

Timeframe: Up to approximately 66.5 months

Population: All participants who received at least 1 dose of trial treatment were analyzed.

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.

Outcome measures

Outcome measures
Measure	Pembrolizumab 200 mg IV Q3W n=150 Participants Participants with melanoma or NSCLC received 200 mg of pembrolizumab as an IV infusion Q3W for up to 35 cycles.
Number of Participants With a Serious Adverse Event (SAE)	31 Participants

PRIMARY outcome

Timeframe: Up to approximately 66.5 months

Population: All participants who received at least 1 dose of trial treatment were analyzed.

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.

Outcome measures

Outcome measures
Measure	Pembrolizumab 200 mg IV Q3W n=150 Participants Participants with melanoma or NSCLC received 200 mg of pembrolizumab as an IV infusion Q3W for up to 35 cycles.
Number of Participants With a Drug-Related AE	61 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pembrolizumab 200 mg IV Q3W n=150 Participants Participants with melanoma or NSCLC received 200 mg of pembrolizumab as an IV infusion Q3W for up to 35 cycles.
Number of Participants With a Drug-Related SAE	10 Participants

PRIMARY outcome

Timeframe: Up to approximately 26 months

Population: All participants who received at least 1 dose of trial treatment were analyzed.

Outcome measures

Outcome measures
Measure	Pembrolizumab 200 mg IV Q3W n=150 Participants Participants with melanoma or NSCLC received 200 mg of pembrolizumab as an IV infusion Q3W for up to 35 cycles.
Number of Participants Who Discontinued Study Drug Due to an AE	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to approximately 66.5 months

Population: All participants who received at least 1 dose of trial treatment were analyzed.

An AEOSI was defined as an AE (serious or non-serious) of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor was appropriate. Pembrolizumab AEOSIs included immune-mediated events (pneumonitis, colitis, hepatitis, nephritis, adrenal insufficiency, hypophysitis, hyperthyroidism, hypothyroidism, thyroiditis, type 1 diabetes mellitus, severe skin reactions including Stevens-Johnson Syndrome \[SJS\] and Toxic Epidermal Necrolysis \[TEN\], uveitis, pancreatitis, myositis, Guillain-Barre Syndrome, myocarditis, encephalitis, sarcoidosis, myasthenic syndrome, myelitis, vasculitis, cholangitis sclerosing, hypoparathyroidism, arthritis, haemophagocytic lymphohistiocytosis, optic neuritis, gastritis, haemolytic anaemia, exocrine pancreatic insufficiency, pericarditis) and infusion reactions. The number of participants with an AEOSI was reported.

Outcome measures

Outcome measures
Measure	Pembrolizumab 200 mg IV Q3W n=150 Participants Participants with melanoma or NSCLC received 200 mg of pembrolizumab as an IV infusion Q3W for up to 35 cycles.
Number of Participants With an Adverse Event of Special Interest (AEOSI)	33 Participants

Adverse Events

Pembrolizumab 200 mg IV Q3W

Serious events: 31 serious events

Other events: 105 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab 200 mg IV Q3W n=150 participants at risk Participants with melanoma or NSCLC received 200 mg of pembrolizumab as an IV infusion Q3W for up to 35 cycles.
Cardiac disorders Cardiac tamponade	1.3% 2/150 • Number of events 2 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Cardiopulmonary failure	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Abdominal pain	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Diarrhoea	1.3% 2/150 • Number of events 2 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Rectal prolapse	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
General disorders Asthenia	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
General disorders Pyrexia	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Hepatobiliary disorders Cholecystitis	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Hepatobiliary disorders Hepatic failure	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Hepatobiliary disorders Hepatitis	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Hepatobiliary disorders Hypertransaminasaemia	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Hepatobiliary disorders Jaundice cholestatic	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations COVID-19	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Lower respiratory tract infection	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Pneumocystis jirovecii pneumonia	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Pneumonia	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Urinary tract infection	1.3% 2/150 • Number of events 2 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Radius fracture	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Diabetes mellitus	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Myositis	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour ulceration	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Cerebrovascular accident	1.3% 2/150 • Number of events 2 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Ischaemic stroke	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Paraplegia	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.3% 2/150 • Number of events 2 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.0% 3/150 • Number of events 3 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.67% 1/150 • Number of events 1 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.

Other adverse events

Other adverse events
Measure	Pembrolizumab 200 mg IV Q3W n=150 participants at risk Participants with melanoma or NSCLC received 200 mg of pembrolizumab as an IV infusion Q3W for up to 35 cycles.
Blood and lymphatic system disorders Anaemia	12.7% 19/150 • Number of events 21 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Endocrine disorders Hypothyroidism	17.3% 26/150 • Number of events 27 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Abdominal pain	6.7% 10/150 • Number of events 11 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Constipation	11.3% 17/150 • Number of events 18 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Vomiting	7.3% 11/150 • Number of events 11 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
General disorders Asthenia	5.3% 8/150 • Number of events 8 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
General disorders Fatigue	11.3% 17/150 • Number of events 18 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
General disorders Pyrexia	10.0% 15/150 • Number of events 26 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Urinary tract infection	10.0% 15/150 • Number of events 17 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	6.0% 9/150 • Number of events 9 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Arthralgia	7.3% 11/150 • Number of events 11 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	6.7% 10/150 • Number of events 11 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	5.3% 8/150 • Number of events 9 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 15/150 • Number of events 17 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.3% 8/150 • Number of events 10 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Pruritus	7.3% 11/150 • Number of events 15 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Rash	6.0% 9/150 • Number of events 10 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Vitiligo	11.3% 17/150 • Number of events 17 • Up to approximately 66.5 months All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER