History of Changes for Study: NCT02935634

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

Latest version (submitted May 9, 2023) on ClinicalTrials.gov

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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

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Study NCT02935634
Submitted Date: October 25, 2016 (v2)

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:	October 2016
Overall Status:	Not yet recruiting
Study Start:	November 2016
Primary Completion:	November 2021 [Anticipated]
Study Completion:	November 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:	October 25, 2016
Last Update Posted:	October 26, 2016 [Estimate]

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:

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:	910 [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 BMS-986016 Combination Nivolumab and BMS-986016 Combination	Biological: Nivolumab Other Names: Opdivo BMS-936558 Biological: 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, 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:

References


Citations:
Links:	URL: http://www.bms.com/studyconnect/Pages/home.aspx Description: BMS clinical trial educational resource
Available IPD/Information:

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