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)

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Study Record Versions

Version	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

Comparison Format:

Merged
Side-by-Side

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:

Study Status


Record Verification:	January 2017
Overall Status:	Not yet recruiting
Study Start:	January 2017
Primary Completion:	January 2019 [Anticipated]
Study Completion:	February 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 11, 2017
Last Update Posted:	January 12, 2017 [Estimate]

Sponsor/Collaborators


Sponsor:	Merck Sharp & Dohme LLC
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	No

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:

Conditions


Conditions:	Gastric Neoplasms Gastroesophageal Junction Adenocarcinoma
Keywords:	PD1 PD-1 PDL1 PD-L1

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]

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

Outcome Measures


Primary Outcome Measures:
1.	OS [ Time Frame: Up to 2 years ]
2.	PFS [ Time Frame: Up to 2 years ]
Secondary Outcome Measures:
1.	Objective Response Rate (ORR) per RECIST 1.1 [ Time Frame: Up to 2 years ]
2.	Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to 27 months ]
3.	Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to 2 years ]

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. 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 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 study Day 1 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, or radiation therapy within 2 weeks prior to study Day 1 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 requires active treatment. 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 immunotherapy including anti-programmed cell death protein 1 (PD-1), anti-PD-L1, or anti-PD-L2 agent, or if the participant has previously participated in Merck pembrolizumab (MK-3475) clinical trials. 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.

Contacts/Locations


Study Officials:	Medical Director Study Director Merck Sharp & Dohme LLC
Locations:

IPDSharing


Plan to Share IPD:

References


Links:
Available IPD/Information: