Efficacy and Safety Study of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Participants With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-line Therapy With Platinum and Fluoropyrimidine (MK-3475-063/KEYNOTE-063)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03019588

Recruitment Status : Terminated (Business Reasons)

First Posted : January 12, 2017

Results First Posted : March 30, 2023

Last Update Posted : March 30, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme LLC

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Gastric Neoplasms Gastroesophageal Junction Adenocarcinoma
Interventions	Biological: Pembrolizumab Drug: Paclitaxel
Enrollment	94

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Pembrolizumab 200 mg	Paclitaxel 80 mg/m^2
Arm/Group Description	Participants receive pembrolizumab ...	Participants receive paclitaxel 80 ...
Arm/Group Description	Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).	Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.
Period Title: Overall Study
Started	47	47
Treated	47	44
Completed	0	0
Not Completed	47	47
Reason Not Completed
Death	44	46
Study terminated by Sponsor	3	1

Baseline Characteristics

Arm/Group Title		Pembrolizumab 200 mg	Paclitaxel 80 mg/m^2	Total
Arm/Group Description		Participants receive pembrolizumab ...	Participants receive paclitaxel 80 ...	Total of all reporting groups
Arm/Group Description		Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).	Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.	Total of all reporting groups
Overall Number of Baseline Participants		47	47	94
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	47 participants	47 participants	94 participants
		58.0 (10.4)	59.0 (11.2)	58.5 (10.8)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	47 participants	47 participants	94 participants
	Female	15 31.9%	10 21.3%	25 26.6%
	Male	32 68.1%	37 78.7%	69 73.4%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	47 participants	47 participants	94 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	47 100.0%	47 100.0%	94 100.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	47 participants	47 participants	94 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	47 100.0%	47 100.0%	94 100.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	0 0.0%	0 0.0%	0 0.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Time to progression on first-line therapy Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	47 participants	47 participants	94 participants
< 6 months		30 63.8%	30 63.8%	60 63.8%
>= 6 months		17 36.2%	17 36.2%	34 36.2%
Eastern Cooperative Oncology Group Performance Status (ECOG PS) ^[1] Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	47 participants	47 participants	94 participants
ECOG = 0		14 29.8%	12 25.5%	26 27.7%
ECOG = 1		33 70.2%	35 74.5%	68 72.3%
		[1] Measure Description: ECOG PS is graded on a scale from 0 (best) to 5 (worst). 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2= ambulatory and capable of all selfcare but unable to carry out any work activities (up and about more than 50% of waking hours); 3= capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4= completely disabled, cannot carry on any selfcare, totally confined to bed or chair; 5= dead.

Outcome Measures

1.Primary Outcome


Title	Overall Survival (OS)
Description	OS is defined as the time from randomization to death due to any cause...
Description	OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
Time Frame	Up to approximately 50 months

Outcome Measure Data

Analysis Population Description

Analysis population includes all randomized participants.


Arm/Group Title	Pembrolizumab 200 mg	Paclitaxel 80 mg/m^2
Arm/Group Description:	Participants receive pembrolizumab ...	Participants receive paclitaxel 80 ...
Arm/Group Description:	Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).	Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.
Overall Number of Participants Analyzed	47	47
Median (95% Confidence Interval) Unit of Measure: Months
	8.4 (4.0 to 9.5)	7.7 (5.4 to 11.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pembrolizumab 200 mg, Paclitaxel 80 mg/m^2
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.2900
	Comments	[Not Specified]
	Method	Log Rank
	Comments	One-sided p-value based on log-rank test stratified by time to progression on first line therapy (< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95% 0.58 to 1.36
	Estimation Comments	Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by time to progression on first line therapy (< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).

2.Primary Outcome


Title	Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Description	PFS is defined as the time from randomization to the first documented ...
Description	PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. PFS as assessed by blinded independent central review will be presented.
Time Frame	Up to approximately 50 months

Outcome Measure Data

Analysis Population Description

Analysis population includes all randomized participants.


Arm/Group Title	Pembrolizumab 200 mg	Paclitaxel 80 mg/m^2
Arm/Group Description:	Participants receive pembrolizumab ...	Participants receive paclitaxel 80 ...
Arm/Group Description:	Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).	Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.
Overall Number of Participants Analyzed	47	47
Median (95% Confidence Interval) Unit of Measure: Months
	1.9 (1.4 to 2.8)	4.0 (2.7 to 6.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pembrolizumab 200 mg, Paclitaxel 80 mg/m^2
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.9954
	Comments	[Not Specified]
	Method	Log Rank
	Comments	One-sided p-value based on log-rank test stratified by time to progression on first line therapy (< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.77
	Confidence Interval	(2-Sided) 95% 1.14 to 2.74
	Estimation Comments	Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by time to progression on first line therapy (< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).

3.Secondary Outcome


Title	Objective Response Rate (ORR) Per RECIST 1.1
Description	ORR was defined as the percentage of participants in the analysis popu...
Description	ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1.
Time Frame	Up to approximately 50 months

Outcome Measure Data

Analysis Population Description

Analysis population includes all randomized participants.


Arm/Group Title	Pembrolizumab 200 mg	Paclitaxel 80 mg/m^2
Arm/Group Description:	Participants receive pembrolizumab ...	Participants receive paclitaxel 80 ...
Arm/Group Description:	Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).	Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.
Overall Number of Participants Analyzed	47	47
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of participants
	12.8 (4.8 to 25.7)	19.1 (9.1 to 33.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pembrolizumab 200 mg, Paclitaxel 80 mg/m^2
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.7884
	Comments	[Not Specified]
	Method	Z-test
	Comments	One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % > 0.

Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-6.0
	Confidence Interval	(2-Sided) 95% -21.6 to 9.3
	Estimation Comments	Based on Miettinen & Nurminen method stratified by time to progression on first line therapy (< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).

4.Secondary Outcome


Title	Number of Participants Who Experience an Adverse Event (AE)
Description	An adverse event is defined as any untoward medical occurrence in a pa...
Description	An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame	Up to approximately 50 months

Outcome Measure Data

Analysis Population Description

Analysis population includes all randomized participants who received at least one dose of study treatment.


Arm/Group Title	Pembrolizumab 200 mg	Paclitaxel 80 mg/m^2
Arm/Group Description:	Participants receive pembrolizumab ...	Participants receive paclitaxel 80 ...
Arm/Group Description:	Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).	Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.
Overall Number of Participants Analyzed	47	44
Measure Type: Count of Participants Unit of Measure: Participants
	46 97.9%	43 97.7%

5.Secondary Outcome


Title	Number of Participants Who Discontinue Study Treatment Due to an AE
Description	An adverse event is defined as any untoward medical occurrence in a pa...
Description	An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame	Up to approximately 25 months

Outcome Measure Data

Analysis Population Description

Analysis population includes all randomized participants who received at least one dose of study treatment.


Arm/Group Title	Pembrolizumab 200 mg	Paclitaxel 80 mg/m^2
Arm/Group Description:	Participants receive pembrolizumab ...	Participants receive paclitaxel 80 ...
Arm/Group Description:	Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).	Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.
Overall Number of Participants Analyzed	47	44
Measure Type: Count of Participants Unit of Measure: Participants
	2 4.3%	7 15.9%

Adverse Events

Time Frame	Up to approximately 50 months
Adverse Event Reporting Description	All-cause mortality includes all randomized participants; Adverse events tables include all participants who received at least one dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.

Arm/Group Title	Pembrolizumab 200 mg		Paclitaxel 80 mg/m^2
Arm/Group Description	Participants receive pembrolizumab ...		Participants receive paclitaxel 80 ...
Arm/Group Description	Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).		Participants receive paclitaxel 80 mg/m^2 IV infusion on Days 1, 8 and 15 of each 4-week cycle for up to approximately 2 years.
All-Cause Mortality
	Pembrolizumab 200 mg		Paclitaxel 80 mg/m^2
	Affected / at Risk (%)		Affected / at Risk (%)
Total	44/47 (93.62%)		46/47 (97.87%)
Serious Adverse Events Serious Adverse Events
	Pembrolizumab 200 mg		Paclitaxel 80 mg/m^2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/47 (27.66%)		14/44 (31.82%)
Blood and lymphatic system disorders
Anaemia ^† 1	2/47 (4.26%)	2	1/44 (2.27%)	1
Febrile neutropenia ^† 1	0/47 (0.00%)	0	1/44 (2.27%)	1
Endocrine disorders
Adrenal insufficiency ^† 1	1/47 (2.13%)	1	0/44 (0.00%)	0
Thyroiditis ^† 1	1/47 (2.13%)	1	0/44 (0.00%)	0
Gastrointestinal disorders
Ileus ^† 1	2/47 (4.26%)	2	0/44 (0.00%)	0
Abdominal pain ^† 1	1/47 (2.13%)	1	1/44 (2.27%)	1
Vomiting ^† 1	1/47 (2.13%)	1	0/44 (0.00%)	0
Intestinal obstruction ^† 1	0/47 (0.00%)	0	1/44 (2.27%)	1
Pancreatitis acute ^† 1	0/47 (0.00%)	0	1/44 (2.27%)	1
Small intestinal obstruction ^† 1	0/47 (0.00%)	0	1/44 (2.27%)	1
General disorders
Pyrexia ^† 1	2/47 (4.26%)	2	0/44 (0.00%)	0
Asthenia ^† 1	1/47 (2.13%)	1	3/44 (6.82%)	3
Fatigue ^† 1	0/47 (0.00%)	0	1/44 (2.27%)	1
Hepatobiliary disorders
Biliary obstruction ^† 1	1/47 (2.13%)	1	0/44 (0.00%)	0
Hepatic function abnormal ^† 1	1/47 (2.13%)	2	0/44 (0.00%)	0
Infections and infestations
Pneumonia ^† 1	1/47 (2.13%)	1	3/44 (6.82%)	3
Post procedural infection ^† 1	1/47 (2.13%)	1	0/44 (0.00%)	0
Rhinitis ^† 1	1/47 (2.13%)	1	0/44 (0.00%)	0
Sepsis ^† 1	1/47 (2.13%)	1	1/44 (2.27%)	1
Herpes zoster ^† 1	0/47 (0.00%)	0	1/44 (2.27%)	1
Peritonitis ^† 1	0/47 (0.00%)	0	1/44 (2.27%)	1
Urinary tract infection ^† 1	0/47 (0.00%)	0	1/44 (2.27%)	1
Injury, poisoning and procedural complications
Upper limb fracture ^† 1	1/47 (2.13%)	1	0/44 (0.00%)	0
Investigations
Neutrophil count decreased ^† 1	0/47 (0.00%)	0	2/44 (4.55%)	2
White blood cell count decreased ^† 1	0/47 (0.00%)	0	1/44 (2.27%)	1
Metabolism and nutrition disorders
Decreased appetite ^† 1	1/47 (2.13%)	1	0/44 (0.00%)	0
Musculoskeletal and connective tissue disorders
Bone pain ^† 1	1/47 (2.13%)	1	0/44 (0.00%)	0
Nervous system disorders
Ischaemic stroke ^† 1	0/47 (0.00%)	0	1/44 (2.27%)	1
Renal and urinary disorders
Acute kidney injury ^† 1	2/47 (4.26%)	2	0/44 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Asthma ^† 1	1/47 (2.13%)	1	0/44 (0.00%)	0
Haemoptysis ^† 1	1/47 (2.13%)	1	0/44 (0.00%)	0
Pulmonary oedema ^† 1	1/47 (2.13%)	1	0/44 (0.00%)	0
Dyspnoea ^† 1	0/47 (0.00%)	0	1/44 (2.27%)	1
Vascular disorders
Hypovolaemic shock ^† 1	1/47 (2.13%)	1	0/44 (0.00%)	0
1 Term from vocabulary, MedDRA 24.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Pembrolizumab 200 mg		Paclitaxel 80 mg/m^2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	46/47 (97.87%)		43/44 (97.73%)
Blood and lymphatic system disorders
Anaemia ^† 1	17/47 (36.17%)	21	20/44 (45.45%)	26
Granulocytopenia ^† 1	0/47 (0.00%)	0	3/44 (6.82%)	17
Leukopenia ^† 1	1/47 (2.13%)	1	4/44 (9.09%)	22
Neutropenia ^† 1	1/47 (2.13%)	1	6/44 (13.64%)	19
Endocrine disorders
Hyperthyroidism ^† 1	3/47 (6.38%)	3	0/44 (0.00%)	0
Hypothyroidism ^† 1	5/47 (10.64%)	5	1/44 (2.27%)	1
Gastrointestinal disorders
Abdominal distension ^† 1	4/47 (8.51%)	5	3/44 (6.82%)	3
Abdominal pain ^† 1	11/47 (23.40%)	12	6/44 (13.64%)	9
Abdominal pain upper ^† 1	6/47 (12.77%)	7	7/44 (15.91%)	8
Ascites ^† 1	3/47 (6.38%)	3	4/44 (9.09%)	4
Constipation ^† 1	7/47 (14.89%)	8	7/44 (15.91%)	8
Diarrhoea ^† 1	8/47 (17.02%)	21	8/44 (18.18%)	8
Dyspepsia ^† 1	5/47 (10.64%)	5	1/44 (2.27%)	1
Nausea ^† 1	10/47 (21.28%)	11	9/44 (20.45%)	10
Vomiting ^† 1	8/47 (17.02%)	11	4/44 (9.09%)	7
General disorders
Asthenia ^† 1	6/47 (12.77%)	7	6/44 (13.64%)	6
Fatigue ^† 1	9/47 (19.15%)	9	7/44 (15.91%)	9
Influenza like illness ^† 1	1/47 (2.13%)	1	3/44 (6.82%)	3
Oedema peripheral ^† 1	4/47 (8.51%)	4	3/44 (6.82%)	4
Pyrexia ^† 1	8/47 (17.02%)	9	7/44 (15.91%)	11
Infections and infestations
Pneumonia ^† 1	0/47 (0.00%)	0	5/44 (11.36%)	5
Upper respiratory tract infection ^† 1	2/47 (4.26%)	2	5/44 (11.36%)	6
Investigations
Alanine aminotransferase increased ^† 1	5/47 (10.64%)	5	7/44 (15.91%)	8
Aspartate aminotransferase increased ^† 1	6/47 (12.77%)	7	7/44 (15.91%)	7
Blood albumin decreased ^† 1	3/47 (6.38%)	3	1/44 (2.27%)	1
Blood alkaline phosphatase increased ^† 1	9/47 (19.15%)	10	1/44 (2.27%)	1
Blood bilirubin increased ^† 1	4/47 (8.51%)	5	1/44 (2.27%)	1
Gamma-glutamyltransferase increased ^† 1	7/47 (14.89%)	7	1/44 (2.27%)	1
Neutrophil count decreased ^† 1	1/47 (2.13%)	1	17/44 (38.64%)	55
Weight decreased ^† 1	5/47 (10.64%)	5	4/44 (9.09%)	4
White blood cell count decreased ^† 1	1/47 (2.13%)	1	13/44 (29.55%)	49
Metabolism and nutrition disorders
Decreased appetite ^† 1	5/47 (10.64%)	5	16/44 (36.36%)	19
Hyperglycaemia ^† 1	2/47 (4.26%)	2	3/44 (6.82%)	3
Hypoalbuminaemia ^† 1	14/47 (29.79%)	16	6/44 (13.64%)	7
Hypokalaemia ^† 1	2/47 (4.26%)	2	3/44 (6.82%)	6
Hyponatraemia ^† 1	2/47 (4.26%)	2	3/44 (6.82%)	3
Hypoproteinaemia ^† 1	3/47 (6.38%)	3	1/44 (2.27%)	1
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	4/47 (8.51%)	5	2/44 (4.55%)	4
Back pain ^† 1	7/47 (14.89%)	7	2/44 (4.55%)	2
Nervous system disorders
Dizziness ^† 1	2/47 (4.26%)	2	3/44 (6.82%)	3
Hypoaesthesia ^† 1	0/47 (0.00%)	0	4/44 (9.09%)	5
Neuropathy peripheral ^† 1	1/47 (2.13%)	1	6/44 (13.64%)	6
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	1/47 (2.13%)	1	5/44 (11.36%)	6
Dyspnoea ^† 1	2/47 (4.26%)	2	3/44 (6.82%)	3
Skin and subcutaneous tissue disorders
Alopecia ^† 1	3/47 (6.38%)	3	21/44 (47.73%)	21
Pruritus ^† 1	5/47 (10.64%)	6	2/44 (4.55%)	3
Rash ^† 1	1/47 (2.13%)	4	4/44 (9.09%)	4
1 Term from vocabulary, MedDRA 24.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Senior Vice President, Global Clinical Development
Organization:	Merck Sharp & Dohme LLC
Phone:	1-800-672-6372
EMail:	ClinicalTrialsDisclosure@merck.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chung HC, Kang YK, Chen Z, Bai Y, Wan Ishak WZ, Shim BY, Park YL, Koo DH, Lu J, Xu J, Chon HJ, Bai LY, Zeng S, Yuan Y, Chen YY, Gu K, Zhong WY, Kuang S, Shih CS, Qin SK. Pembrolizumab versus paclitaxel for previously treated advanced gastric or gastroesophageal junction cancer (KEYNOTE-063): A randomized, open-label, phase 3 trial in Asian patients. Cancer. 2022 Mar 1;128(5):995-1003. doi: 10.1002/cncr.34019. Epub 2021 Dec 8.

Layout table for additonal information

Responsible Party:	Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:	NCT03019588
Other Study ID Numbers:	3475-063 MK-3475-063 ( Other Identifier: Merck Protocol Number )
First Submitted:	January 11, 2017
First Posted:	January 12, 2017
Results First Submitted:	June 21, 2022
Results First Posted:	March 30, 2023
Last Update Posted:	March 30, 2023

To Top