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History of Changes for Study: NCT03019588
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)
Latest version (submitted June 21, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 11, 2017 None (earliest Version on record)
2 March 7, 2017 Recruitment Status, Study Status, Contacts/Locations, References and Oversight
3 March 10, 2017 Study Status and Contacts/Locations
4 March 27, 2017 Study Status
5 April 14, 2017 Contacts/Locations, Outcome Measures, Oversight, Study Status and Eligibility
6 May 11, 2017 Contacts/Locations, Oversight and Study Status
7 May 18, 2017 Contacts/Locations and Study Status
8 June 20, 2017 Study Status and Contacts/Locations
9 July 28, 2017 Study Status and Contacts/Locations
10 August 9, 2017 Study Status and Contacts/Locations
11 August 17, 2017 Contacts/Locations and Study Status
12 August 29, 2017 Contacts/Locations and Study Status
13 September 13, 2017 Study Status and Contacts/Locations
14 September 28, 2017 Contacts/Locations and Study Status
15 November 1, 2017 Study Status and Contacts/Locations
16 November 7, 2017 Contacts/Locations and Study Status
17 December 11, 2017 Study Status, Contacts/Locations, Eligibility and Study Identification
18 December 14, 2017 Contacts/Locations and Study Status
19 January 18, 2018 Study Status and Contacts/Locations
20 January 23, 2018 Contacts/Locations and Study Status
21 March 14, 2018 Study Status and Contacts/Locations
22 March 29, 2018 Contacts/Locations and Study Status
23 April 5, 2018 Recruitment Status, Study Status and Contacts/Locations
24 June 20, 2018 Study Status
25 February 28, 2020 Study Status and IPDSharing
26 July 13, 2021 Recruitment Status, Study Status, Study Design and Study Description
27 April 1, 2022 Study Status, Eligibility, Study Design and Oversight
28 June 21, 2022 Outcome Measures, Study Status, Document Section, Results, Arms and Interventions and Conditions
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Study NCT03019588
Submitted Date:  January 23, 2018 (v20)

Open or close this module Study Identification
Unique Protocol ID: 3475-063
Brief Title: 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)
Official Title: A Phase III, Randomized, Open-label Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine
Secondary IDs: MK-3475-063 [Merck Protocol Number]
Open or close this module Study Status
Record Verification: January 2018
Overall Status: Recruiting
Study Start: February 16, 2017
Primary Completion: August 17, 2019 [Anticipated]
Study Completion: June 29, 2020 [Anticipated]
First Submitted: January 11, 2017
First Submitted that
Met QC Criteria:
January 11, 2017
First Posted: January 12, 2017 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 23, 2018
Last Update Posted: January 24, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Merck Sharp & Dohme LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary:

The study will compare the efficacy and safety of treatment with pembrolizumab (MK-3475) versus paclitaxel in Asian, programmed death-ligand 1 (PD-L1) positive participants with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after failure of any combination chemotherapy containing a platinum and a fluoropyrimidine agent.

The primary study hypotheses are that pembrolizumab prolongs Overall Survival (OS) compared to paclitaxel and that pembrolizumab prolongs Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by blinded central radiologists' review compared to paclitaxel.

Detailed Description:
Open or close this module Conditions
Conditions: Gastric Neoplasms
Gastroesophageal Junction Adenocarcinoma
Keywords: PD1
PD-1
PDL1
PD-L1
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 360 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Pembrolizumab 200 mg
Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to approximately 2 years.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
Active Comparator: Paclitaxel 80 mg/m^2
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.
Drug: Paclitaxel
IV infusion
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall Survival (OS)
[ Time Frame: Up to 2 years ]

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 will be censored at the date of the last follow-up.
2. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
[ Time Frame: Up to 2 years ]

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.
Secondary Outcome Measures:
1. Objective Response Rate (ORR) per RECIST 1.1
[ Time Frame: Up to 2 years ]

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.
2. Number of Participants Who Experience an Adverse Event (AE)
[ Time Frame: Up to 27 months ]

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study treatment, whether or not considered related to the use of study treatment.
3. Number of Participants Who Discontinue Study Treatment Due to an AE
[ Time Frame: Up to 2 years ]

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study treatment, whether or not considered related to the use of study treatment.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Has histologically or cytologically-confirmed diagnosis of gastric or GEJ adenocarcinoma.
  • Has metastatic disease or locally advanced, unresectable disease.
  • Has measurable disease as defined by RECIST 1.1 as determined by investigator.
  • Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the first dose of study treatment.
  • Has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing any platinum/fluoropyrimidine doublet.
  • Is willing to provide tissue for PD-L1 biomarker analysis.
  • Has PD-L1 positive tumor (based on analysis of sample provided to core lab).
  • Female participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment for the pembrolizumab arm and through 180 days after the last dose of study treatment for the paclitaxel arm.
  • Male participants 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 treatment for the pembrolizumab arm and through 180 days after the last dose of study treatment for the paclitaxel arm.
  • Demonstrates adequate organ function.

Exclusion Criteria:

  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of trial treatment.
  • Has squamous cell or undifferentiated gastric cancer.
  • Has active autoimmune disease that has required systemic treatment in past 2 years.
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to the first dose of trial treatment or who has not recovered (i.e., ≤ Grade 1 or at Baseline) from AEs due to agents administered more than 4 weeks earlier.
  • Has had prior chemotherapy, targeted small molecule therapy, radiation therapy, or any other agents used as systemic treatment for cancer, within 2 weeks prior to the first dose of trial treatment or who has not recovered (i.e., ≤ Grade 1 or at Baseline) from AEs due to a previously administered agent.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Has an active infection requiring systemic therapy.
  • 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 study treatment for the pembrolizumab arm and through 180 days after the last dose of study treatment for the paclitaxel arm.
  • Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137).
  • Has a known history of Human Immunodeficiency Virus (HIV) infection.
  • Has known active Hepatitis B or C virus infection.
  • Has received a live vaccine within 30 days of planned start of study treatment.
  • Has known allergy or hypersensitivity to paclitaxel or any components used in the paclitaxel preparation or other contraindication for taxane therapy.
Open or close this module Contacts/Locations
Central Contact Person: Toll Free Number
Telephone: 1-888-577-8839
Email: Trialsites@merck.com
Study Officials: Medical Director
Study Director
Merck Sharp & Dohme LLC
Locations: China
301 Hospital ( Site 0008)
[Recruiting]
Beijing, China
Contact:Contact: Study Coordinator +8613601070299
307 Hospital of PLA, Dept. of Oncology ( Site 0006)
[Recruiting]
Beijing, China
Contact:Contact: Study Coordinator +8613910866712
Peking Union Medical College Hospital ( Site 0011)
[Recruiting]
Beijing, China
Contact:Contact: Study Coordinator +8613511071908
Xiangya Hospital Central -South University ( Site 0021)
[Recruiting]
Changsha, China
Contact:Contact: Study Coordinator +8613574838611
Sir Sun Sun Shaw Hosp, Zhejiang Univ,Oncology dept. ( Site 0016)
[Recruiting]
Hangzhou, China
Contact:Contact: Study Coordinator +8613605716662
The First Affiliated Hospital of Zhejiang University ( Site 0004)
[Recruiting]
Hangzhou, China
Contact:Contact: Study Coordinator +8613515715262
Harbin Medical University Cancer Hospital ( Site 0020)
[Recruiting]
Harbin, China
Contact:Contact: Study Coordinator +8613945095085
Anhui Provincial Hospital ( Site 0017)
[Recruiting]
Hefei, China
Contact:Contact: Study Coordinator +8613485691976
The First Affiliated Hospital of Anhui Medical University ( Site 0012)
[Recruiting]
Hefei, China
Contact:Contact: Study Coordinator +8613805692145
The Second Hospital of Anhui Medical University ( Site 0013)
[Recruiting]
Hefei, China
Contact:Contact: Study Coordinator +8613805519892
Jiangsu Cancer Hospital ( Site 0003)
[Recruiting]
Nanjing, China
Contact:Contact: Study Coordinator +8615380882716
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0028)
[Recruiting]
Shanghai, China
Contact:Contact: Study Coordinator +8613761254228
Ruijin Hospital, Shanghai Jiaotong University ( Site 0018)
[Recruiting]
Shanghai, China
Contact:Contact: Study Coordinator +8618917762326
Shanghai East Hospital ( Site 0033)
[Recruiting]
Shanghai, China
Contact:Contact: Study Coordinator +8613761222111
Shanghai Tenth People's Hospital ( Site 0026)
[Recruiting]
Shanghai, China
Contact:Contact: Study Coordinator +8618917683500
Zhongshan Hospital affiliated to Fudan University ( Site 0005)
[Recruiting]
Shanghai, China
Contact:Contact: Study Coordinator +8613681973996
Shanghai First People's Hospital ( Site 0027)
[Recruiting]
Songjiang, China
Contact:Contact: Study Coordinator +8613524491606
Tongji Medical College Huazhong Uinversity Of Science and Technology ( Site 0025)
[Recruiting]
Wuhan, China
Contact:Contact: Study Coordinator +8613667241722
China, Beijing
Beijing Cancer Hospital ( Site 0022)
[Recruiting]
Beijing, Beijing, China
Contact:Contact: Study Coordinator +8613911219511
China, Fujian
Fuzhou General Hospital of Nanjing Military Command ( Site 0023)
[Recruiting]
Fuzhou, Fujian, China
Contact:Contact: Study Coordinator +86137050459250000
China, Jiangsu
The First People's Hospital of Changzhou ( Site 0024)
[Recruiting]
Changzhou, Jiangsu, China
Contact:Contact: Study Coordinator +8613775227958
Nanjing 81 PLA Hospital, Dept. of Oncology ( Site 0001)
[Recruiting]
Nanjing, Jiangsu, China
Contact:Contact: Study Coordinator +862584453932
China, Jilin
Jilin Province Cancer Hospital, Department of Chemotherapy ( Site 0002)
[Recruiting]
Changchun, Jilin, China
Contact:Contact: Study Coordinator +8613943012851
China, Shanxi
Tangdu Hospital ( Site 0030)
[Recruiting]
XI An, Shanxi, China
Contact:Contact: Study Coordinator +862984777455
China, Zhejiang
2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0014)
[Recruiting]
Hangzhou, Zhejiang, China
Contact:Contact: Study Coordinator +8613858193601
Korea, Republic of
Asan Medical Center ( Site 0204)
[Active, not recruiting]
Seoul, Korea, Republic of, 4130
Kangbuk Samsung Hospital ( Site 0205)
[Recruiting]
Seoul, Korea, Republic of, 4130
Contact:Contact: Study Coordinator +82220018330
Severance Hospital Yonsei University Health System ( Site 0206)
[Active, not recruiting]
Seoul, Korea, Republic of, 4130
Korea, Republic of, Gyeonggi Do
CHA Bundang Medical Center CHA University ( Site 0203)
[Recruiting]
Seongnam si, Gyeonggi Do, Korea, Republic of, 4130
Contact:Contact: Study Coordinator +82317803928
Korea, Republic of, Gyeonggi-do
National Cancer Center ( Site 0202)
[Recruiting]
Goyang-si, Gyeonggi-do, Korea, Republic of, 4130
Contact:Contact: Study Coordinator +82319201672
The Catholic University of Korea, St. Vincent's Hospital ( Site 0201)
[Recruiting]
Suwon, Gyeonggi-do, Korea, Republic of, 4130
Contact:Contact: Study Coordinator +82312498153
Malaysia, Wilayah Persekutuan
University Malaya Medical Centre (UMMC) ( Site 0126)
[Recruiting]
Kuala Lumpur, Wilayah Persekutuan, Malaysia
Contact:Contact: Study Coordinator +60379492120
Taiwan
Chang Gung Medical Foundation - Kaohsiung ( Site 0227)
[Recruiting]
Kaohsiung, Taiwan
Contact:Contact: Study Coordinator +886773171233267
China Medical University Hospital. ( Site 0226)
[Recruiting]
Taichung, Taiwan
Contact:Contact: Study Coordinator +886 4 22052121ext5057
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0228)
[Recruiting]
Taipei, Taiwan
Contact:Contact: Study Coordinator +8862289700111661
MacKay Memorial Hospital ( Site 0229)
[Recruiting]
Taipei, Taiwan
Contact:Contact: Study Coordinator +886225433535
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: Merck Oncology Clinical Trial Information
Available IPD/Information:

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