History of Changes for Study: NCT02935634

A Study to Test Combination Treatments in Participants 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 Participants 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:	April 2022
Overall Status:	Active, not recruiting
Study Start:	November 29, 2016
Primary Completion:	May 21, 2023 [Anticipated]
Study Completion:	May 21, 2023 [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:	April 13, 2022
Last Update Posted:	April 15, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Bristol-Myers Squibb
Responsible Party:	Sponsor
Collaborators:	Clovis Oncology, Inc.

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 evaluate the preliminary efficacy, safety, and tolerability of Nivolumab in combination with Ipilimumab or other treatment therapies in participants 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:	6
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	190 [Actual]

Arms and Interventions

Arms	Assigned Interventions
Active Comparator: Nivolumab + Ipilimumab	Biological: Nivolumab Specified dose on specified days Other Names: Opdivo BMS-936558 Biological: Ipilimumab Specified dose on specified days Other Names: Yervoy BMS-734016
Experimental: Nivolumab + Relatlimab	Biological: Nivolumab Specified dose on specified days Other Names: Opdivo BMS-936558 Biological: Relatlimab Specified dose on specified days Other Names: BMS-986016
Experimental: Nivolumab + BMS-986205	Biological: Nivolumab Specified dose on specified days Other Names: Opdivo BMS-936558 Biological: BMS-986205 Specified dose on specified days
Experimental: Nivolumab + Rucaparib	Biological: Nivolumab Specified dose on specified days Other Names: Opdivo BMS-936558 Drug: Rucaparib Specified dose on specified days Other Names: Rubraca
Experimental: Ipilimumab + Rucaparib	Biological: Ipilimumab Specified dose on specified days Other Names: Yervoy BMS-734016 Drug: Rucaparib Specified dose on specified days Other Names: Rubraca
Experimental: Nivolumab + Ipilimumab + Rucaparib	Biological: Nivolumab Specified dose on specified days Other Names: Opdivo BMS-936558 Biological: Ipilimumab Specified dose on specified days Other Names: Yervoy BMS-734016 Drug: Rucaparib Specified dose on specified days Other Names: Rubraca

Outcome Measures


Primary Outcome Measures:
1.	Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator [ Time Frame: Up to 24 months ]
2.	Duration of Response (DOR) by RECIST v1.1 by Investigator [ Time Frame: Up to 24 months ]
3.	Progression-free Survival Rate (PFSR) [ Time Frame: Up to 24 months ]
4.	Incidence of Adverse Events (AEs) in Part 1 [ Time Frame: Approximately 28 Months ]
5.	Incidence of Serious Adverse Events (SAEs) in Part 1 [ Time Frame: Approximately 28 Months ]
6.	Incidence of AEs leading to discontinuation in Part 1 [ Time Frame: Approximately 28 Months ]
7.	Incidence of deaths in Part 1 [ Time Frame: Approximately 28 Months ]
8.	Incidence of participants with clinical laboratory abnormalities in Part 1 [ Time Frame: Approximately 28 Months ]
Secondary Outcome Measures:
1.	Incidence of AEs [ Time Frame: Approximately 28 months ]
2.	Incidence of SAEs [ Time Frame: Approximately 28 months ]
3.	Incidence of AEs leading to discontinuation [ Time Frame: Approximately 28 months ]
4.	Incidence of AEs leading to death [ Time Frame: Approximately 28 months ]
5.	Incidence of participants with clinical laboratory test abnormalities [ Time Frame: Approximately 28 Months ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Inoperable, advanced or metastatic esophageal cancer (EC), gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed predominant adenocarcinoma and/or squamous carcinoma Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 At least 1 lesion with measurable disease Exclusion Criteria: HER2-positive tumor and previously untreated with trastuzumab Suspected, known or progressive central nervous system metastases Other active malignancy requiring concurrent intervention Active, known or suspected autoimmune disease Other protocol-defined inclusion/exclusion criteria apply

Contacts/Locations


Study Officials:	Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Locations:	United States, Arizona
	Mayo Clinic Arizona Phoenix, Arizona, United States, 85054
	United States, California
	City Of Hope National Medical Center Duarte, California, United States, 91010-3000
	United States, Colorado
	University Of Colorado Aurora, Colorado, United States, 80045
	United States, Connecticut
	Yale University New Haven, Connecticut, United States, 06520
	United States, District of Columbia
	Local Institution - 0036 Washington, District of Columbia, United States, 20007
	United States, Florida
	UF Health Medical Oncology - Davis Cancer Pavilion Gainesville, Florida, United States, 32610
	Mayo Clinic Jacksonville Jacksonville, Florida, United States, 32224
	United States, Maryland
	John Hopkins Baltimore, Maryland, United States, 21224
	United States, Minnesota
	Mayo Clinic Rochester Rochester, Minnesota, United States, 55905
	United States, Missouri
	Washington University School of Medicine Saint Louis, Missouri, United States, 63110
	United States, New Jersey
	Local Institution - 0001 Hackensack, New Jersey, United States, 07601
	United States, New York
	Memorial Sloan Kettering Nassau New York, New York, United States, 10065
	United States, Oregon
	Local Institution - 0002 Portland, Oregon, United States, 97225
	United States, Pennsylvania
	Fox Chase Cancer Center Philadelphia, Pennsylvania, United States, 19111
	UPMC Pittsburgh, Pennsylvania, United States, 15232
	United States, Washington
	Local Institution - 0004 Seattle, Washington, United States, 98109
	Australia
	Local Institution Randwick, Australia, 2031
	Australia, New South Wales
	Westmead Hospital Westmead, New South Wales, Australia, 2145
	Australia, Victoria
	Austin Health-Cancer Clinical Trials Centre Heidelberg, Victoria, Australia, 3084
	Canada, Alberta
	Local Institution Edmonton, Alberta, Canada, T6G 1Z2
	Canada, British Columbia
	Local Institution Vancouver, British Columbia, Canada, V5Z 4E6
	Canada, Ontario
	Local Institution Ottawa, Ontario, Canada, K1H 8L6
	Local Institution Toronto, Ontario, Canada, M5G 2M9
	Sunnybrook Research Institution Toronto,, Ontario, Canada, M4N 3M5
	Germany
	Nationales Centrum Fur Tumorerkrankungen (Nct) Heidelberg, Germany, 69120
	Universitaetsklinikum Leipzig Leipzig, Germany, 04103
	Israel
	Local Institution Ramat Gan, Israel, 52621
	Local Institution Tel Aviv, Israel, 64239
	Italy
	Istituto Europeo Di Oncologia Milan, Italy, 20141
	IRCCS Istituto Nazionale Tumori Milano Milano, Italy, 20133
	Netherlands
	Local Institution Amsterdam, Netherlands, 1081 HV
	Local Institution Utrecht, Netherlands, 3584 CX
	Singapore
	Local Institution Singapore, Singapore, 169610
	Switzerland
	University Hospital Zuerich Zuerich, Switzerland, 8091
	Switzerland, Graubünden (de)
	Local Institution - 0041 Chur, Graubünden (de), Switzerland, 7000

IPDSharing


Plan to Share IPD:

References


Citations:
Links:	URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html Description: BMS Clinical Trial Information
	URL: https://www.bmsstudyconnect.com/s/US/English/USenHome Description: BMS Clinical Trial Patient Recruiting
	URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html Description: Investigator Inquiry Form
	URL: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm Description: FDA Safety Alerts and Recalls
Available IPD/Information: