History of Changes for Study: NCT02935634

A Study to Test Combination Treatments in Patients With Advanced Gastric Cancer (FRACTION-GC)

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Study Record Versions

Version	Submitted Date	Changes
1	October 14, 2016	None (earliest Version on record)
2	October 25, 2016	References, Contacts/Locations, Conditions, Study Status and Study Identification
3	November 30, 2016	Recruitment Status, Study Status and Contacts/Locations
4	December 6, 2016	Contacts/Locations and Study Status
5	December 23, 2016	Contacts/Locations and Study Status
6	January 19, 2017	Study Status
7	January 23, 2017	Contacts/Locations and Study Status
8	February 16, 2017	Contacts/Locations and Study Status
9	March 3, 2017	Contacts/Locations and Study Status
10	March 29, 2017	Contacts/Locations, Study Status, Oversight and References
11	April 17, 2017	Contacts/Locations, Study Status and References
12	May 15, 2017	Contacts/Locations, Study Status and References
13	May 30, 2017	Contacts/Locations, Study Design and Study Status
14	June 30, 2017	Contacts/Locations and Study Status
15	July 18, 2017	Contacts/Locations and Study Status
16	July 31, 2017	Contacts/Locations and Study Status
17	August 15, 2017	Contacts/Locations and Study Status
18	August 30, 2017	Contacts/Locations and Study Status
19	September 1, 2017	Arms and Interventions, Contacts/Locations and Study Status
20	September 15, 2017	Study Status and Contacts/Locations
21	October 4, 2017	Study Status and Contacts/Locations
22	October 17, 2017	Contacts/Locations and Study Status
23	January 31, 2018	Contacts/Locations, Arms and Interventions, Outcome Measures and Study Status
24	February 22, 2018	Contacts/Locations and Study Status
25	March 12, 2018	Study Status and Contacts/Locations
26	April 9, 2018	Contacts/Locations and Study Status
27	May 7, 2018	Contacts/Locations and Study Status
28	October 2, 2018	Contacts/Locations, References and Study Status
29	November 27, 2018	Contacts/Locations and Study Status
30	January 30, 2019	Contacts/Locations and Study Status
31	May 28, 2019	Contacts/Locations and Study Status
32	September 19, 2019	Arms and Interventions, Study Status, Contacts/Locations, Outcome Measures, Eligibility and Study Design
33	October 24, 2019	Arms and Interventions, Study Status and Sponsor/Collaborators
34	December 5, 2019	Contacts/Locations and Study Status
35	April 24, 2020	Contacts/Locations and Study Status
36	May 20, 2020	Contacts/Locations and Study Status
37	June 9, 2020	Study Status
38	June 15, 2020	Contacts/Locations and Study Status
39	August 24, 2020	Contacts/Locations and Study Status
40	July 14, 2021	Recruitment Status, Contacts/Locations, Study Status, Arms and Interventions and Study Design
41	January 20, 2022	Arms and Interventions, Study Status, Contacts/Locations, Eligibility, Outcome Measures, References, Study Design, Study Description and Study Identification
42	March 17, 2022	Study Status
43	April 13, 2022	Contacts/Locations and Study Status
44	May 5, 2022	Study Status and Contacts/Locations
45	August 18, 2022	Contacts/Locations and Study Status
46	November 30, 2022	Study Status and Contacts/Locations
47	May 9, 2023	Recruitment Status, Study Status, Outcome Measures, Document Section, Results and Contacts/Locations

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CA018-003
Brief Title:	A Study to Test Combination Treatments in Patients With Advanced Gastric Cancer (FRACTION-GC)
Official Title:	A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants With Advanced Gastric Cancer (FRACTION-Gastric Cancer)
Secondary IDs:	2016-002807-24 [EudraCT Number]

Study Status


Record Verification:	September 2017
Overall Status:	Recruiting
Study Start:	November 23, 2016
Primary Completion:	November 17, 2021 [Anticipated]
Study Completion:	November 18, 2021 [Anticipated]

First Submitted:	October 14, 2016
First Submitted that Met QC Criteria:	October 14, 2016
First Posted:	October 17, 2016 [Estimate]

Last Update Submitted that Met QC Criteria:	September 15, 2017
Last Update Posted:	September 19, 2017 [Actual]

Sponsor/Collaborators


Sponsor:	Bristol-Myers Squibb
Responsible Party:	Sponsor
Collaborators:

Oversight


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

Study Description


Brief Summary:	The purpose of this study is to determine whether Nivolumab in combination with other therapies is more effective than Nivolumab in combination with Ipilimumab in treating patients/subjects with advanced gastric cancer.
Detailed Description:

Conditions


Conditions:	Advanced Gastric Cancer
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	300 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Active Comparator: Nivolumab and Ipilimumab Combination Nivolumab and Ipilimumab Combination	Biological: Nivolumab Other Names: Opdivo BMS-936558 Biological: Ipilimumab Other Names: Yervoy BMS-734016
Experimental: Nivolumab and Relatlimab Combination Nivolumab and Relatlimab Combination	Biological: Nivolumab Other Names: Opdivo BMS-936558 Biological: Relatlimab Other Names: BMS-986016

Outcome Measures


Primary Outcome Measures:
1.	Objective Response Rate (ORR) [ Time Frame: Up to 24 weeks ]
2.	Duration of Response (DOR) [ Time Frame: Up to 24 weeks ]
3.	Progression-free Survival Rate (PFSR) [ Time Frame: Up to 24 weeks ]
Secondary Outcome Measures:
1.	Incidence of Adverse Events (AEs) [ Time Frame: Up to 38 weeks ]
2.	Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 38 weeks ]
3.	AEs leading to discontinuation [ Time Frame: Up to 38 weeks ]
4.	AEs leading to death [ Time Frame: Up to 38 weeks ]

Eligibility


Minimum Age:	18 Years
Maximum Age:	110 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Advanced Gastric Cancer Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work Must have at least 1 lesion with measurable disease Exclusion Criteria: Patients/subjects with HER2 positive tumor that have not been treated with trastuzumab prior to enrollment Must not have suspected or known central nervous system metastases unless adequately treated Patients/subjects with autoimmune disease Patients/subjects who need daily oxygen therapy Other protocol defined inclusion/exclusion criteria could apply

Contacts/Locations


Central Contact Person:	Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, Telephone: please email: Email: Clinical.Trials@bms.com
Central Contact Backup:	First line of the email MUST contain NCT# and Site #.
Study Officials:	Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Locations:	United States, Arizona
	Mayo Clinic Arizona [Recruiting] Phoenix, Arizona, United States, 85054 Contact:Contact: Daniel Ahn, Site 0037
	United States, California
	City Of Hope National Medical Center [Recruiting] Duarte, California, United States, 91010-3000 Contact:Contact: Joseph Chao, Site 0020
	United States, Colorado
	University Of Colorado [Recruiting] Aurora, Colorado, United States, 80045 Contact:Contact: Stephen Leong, Site 0011
	United States, Florida
	UF Health Medical Oncology - Davis Cancer Pavilion [Recruiting] Gainesville, Florida, United States, 32610 Contact:Contact: Thomas George, Site 0009 352-732-4938
	Mayo Clinic Jacksonville [Recruiting] Jacksonville, Florida, United States, 32224 Contact:Contact: Pashtoon Kasi, Site 0038
	Moffitt Cancer Center [Active, not recruiting] Tampa, Florida, United States, 33612
	United States, Maryland
	John Hopkins [Recruiting] Baltimore, Maryland, United States, 21287 Contact:Contact: Kelly Ronan, Site 0006 443-287-9377
	United States, Minnesota
	Mayo Clinic Rochester [Recruiting] Rochester, Minnesota, United States, 55905 Contact:Contact: Steven Alberts, Site 0017
	United States, Missouri
	Washington University School of Medicine [Recruiting] Saint Louis, Missouri, United States, 63110 Contact:Contact: Haeseong Park, Site 0003
	United States, New Jersey
	John Theurer Cancer Center at Hackensack University Medical Center [Recruiting] Hackensack, New Jersey, United States, 07601 Contact:Contact: Martin Gutierrez, Site 0001 551-996-5900
	United States, New York
	Memorial Sloan Kettering Cancer Center [Recruiting] New York, New York, United States, 10065 Contact:Contact: Geoffrey Ku, Site 0007
	United States, Oregon
	Providence Portland Medical Center [Recruiting] Portland, Oregon, United States, 97213 Contact:Contact: Rom Leidner, Site 0002
	United States, Pennsylvania
	Fox Chase Cancer Center [Recruiting] Philadelphia, Pennsylvania, United States, 19111-2412 Contact:Contact: Crystal Denlinger, Site 0005
	UPMC [Recruiting] Pittsburgh, Pennsylvania, United States, 15232 Contact:Contact: Nathan Bahary, Site 0010 412-864-7764
	United States, Washington
	Seattle Cancer Care Assoc. Univ of Washington [Recruiting] Seattle, Washington, United States, 98109 Contact:Contact: Veena Shankaran, Site 0004
	Australia
	Local Institution [Not yet recruiting] Randwick, Australia, 2031 Contact:Contact: Site 0034
	Australia, New South Wales
	Local Institution [Not yet recruiting] Westmead, New South Wales, Australia, 2145 Contact:Contact: Site 0035
	Australia, Victoria
	Local Institution [Not yet recruiting] Heidelberg, Victoria, Australia, 3084 Contact:Contact: Site 0033
	Canada, Alberta
	Local Institution [Not yet recruiting] Edmonton, Alberta, Canada, T6G 1Z2 Contact:Contact: Site 0029
	Canada, British Columbia
	Local Institution [Not yet recruiting] Vancouver, British Columbia, Canada, V5Z 4E6 Contact:Contact: Site 0022
	Canada, Nova Scotia
	Local Institution [Not yet recruiting] Halifax, Nova Scotia, Canada, B3H 2Y9 Contact:Contact: Site 0023
	Canada, Ontario
	The Ottawa Hospital Cancer Centre [Recruiting] Ottawa, Ontario, Canada, K1H 8L6 Contact:Contact: Derek Jonker, Site 0024 6137377700x70185
	Local Institution [Recruiting] Toronto, Ontario, Canada, M5G 2M9 Contact:Contact: Site 0021
	Local Institution [Not yet recruiting] Toronto,, Ontario, Canada, M4N 3M5 Contact:Contact: Site 0025
	Germany
	Local Institution [Not yet recruiting] Heidelberg, Germany, 69120 Contact:Contact: Site 0039
	Local Institution [Not yet recruiting] Leipzig, Germany, 04103 Contact:Contact: Site 0043
	Israel
	Local Institution [Recruiting] Ramat Gan, Israel, 52621 Contact:Contact: Site 0018
	Local Institution [Recruiting] Tel Aviv, Israel, Israel, 64239 Contact:Contact: Site 0019
	Italy
	Istituto Europeo Di Oncologia [Recruiting] Milan, Italy, 20141 Contact:Contact: Giuseppe Curigliano, Site 0014
	IRCCS Istituto Nazionale Tumori [Recruiting] Milano, Italy, 20133 Contact:Contact: Maria Di Bartolomeo, Site 0013
	Netherlands
	Academic Medical Center [Recruiting] Amsterdam, Netherlands, 1105 AZ Contact:Contact: Hanneke Van Laarhoven, Site 0012
	Local Institution [Not yet recruiting] Utrecht, Netherlands, 3584 CX Contact:Contact: Site 0031
	Switzerland
	Local Institution [Not yet recruiting] Chur, Switzerland, 7000 Contact:Contact: Site 0041

IPDSharing


Plan to Share IPD:

References


Citations:
Links:	URL: http://bms.com/studyconnect/Pages/home.aspx Description: BMS Clinical Trial Patient Recruiting
Available IPD/Information: