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:	April 2020
Overall Status:	Recruiting
Study Start:	November 23, 2016
Primary Completion:	June 23, 2022 [Anticipated]
Study Completion:	June 23, 2022 [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 24, 2020
Last Update Posted:	April 27, 2020 [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 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:	6
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	600 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Active Comparator: Nivolumab (nivo) and Ipilimumab (ipi) Combination	Biological: Nivolumab Other Names: Opdivo BMS-936558 Biological: Ipilimumab Other Names: Yervoy BMS-734016
Experimental: nivo and Relatlimab Combination	Biological: Nivolumab Other Names: Opdivo BMS-936558 Biological: Relatlimab Other Names: BMS-986016
Experimental: nivo and BMS-986205 Combination	Biological: Nivolumab Other Names: Opdivo BMS-936558 Biological: BMS-986205
Experimental: Nivo and rucaparib Combination	Drug: Rucaparib Other Names: Rubraca
Experimental: Ipi with rucaparib Combination	Drug: Rucaparib Other Names: Rubraca
Experimental: nivo with ipi and rucaparib	Drug: Rucaparib Other Names: Rubraca

Outcome Measures


Primary Outcome Measures:
1.	Objective Response Rate (ORR) [ Time Frame: Up to 24 months ]
2.	Duration of Response (DOR) [ 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 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 Clinical Laboratory Abnormalities in Part 1 [ Time Frame: Approximately 28 Months ]
Secondary Outcome Measures:
1.	Incidence of Adverse Events (AEs) [ Time Frame: Approximately 28 months ]
2.	Incidence of Serious Adverse Events (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 Clinical laboratory test abnormalities [ Time Frame: Approximately 28 Months ]

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 All participants must have inoperable, advanced, or metastatic EC, GC or GEJ carcinoma and have histologically confirmed predominant adenocarcinoma or squamous cell carcinoma. (sub protocol C) 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 Participants who are considered to be refractory or resistant to platinum agents (sub protocol c) Participants who have inability to swallow capsules or pills (sub protocol c) Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could interfere with absorption of orally administered systemic treatments (sub protocol c) Participants with diagnosis or history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). (sub protocol C) Prior treatment with a PARP inhibitor (such as rucaparib, olaparib, niraparib, talozaparib, etc.) or a targeted DNA damage response inhibitor (such as ATM or ataxia telangiectasia and Rad3-related protein [ATR] inhibitor). (sub protocol C) 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
	Local Institution [Not yet recruiting] Phoenix, Arizona, United States, 85054 Contact:Contact: Site 0037
	United States, California
	City Of Hope National Medical Center [Recruiting] Duarte, California, United States, 91010-3000 Contact:Contact: Joseph Chao, Site 0020 626-218-7073
	United States, Colorado
	University Of Colorado [Recruiting] Aurora, Colorado, United States, 80045 Contact:Contact: Stephen Leong, Site 0011 720-848-9352
	United States, Connecticut
	Yale University [Recruiting] New Haven, Connecticut, United States, 06520 Contact:Contact: Stacey Stein, Site 0032 203-984-0020
	United States, District of Columbia
	Georgetown University Med Ctr [Recruiting] Washington, District of Columbia, United States, 20007 Contact:Contact: Sunnie Kim, Site 0036
	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: Jason Starr, Site 0038 904-953-3570
	Moffitt Cancer Center [Withdrawn] Tampa, Florida, United States, 33612
	United States, Georgia
	Emory University [Withdrawn] Atlanta, Georgia, United States, 30322
	United States, Maryland
	John Hopkins [Recruiting] Baltimore, Maryland, United States, 21224 Contact:Contact: Vincent Lam, Site 0006
	United States, Minnesota
	Mayo Clinic Rochester [Recruiting] Rochester, Minnesota, United States, 55905 Contact:Contact: Harry Yoon, Site 0017 507-266-9161
	United States, Missouri
	Washington University School of Medicine [Recruiting] Saint Louis, Missouri, United States, 63110 Contact:Contact: Haeseong Park, Site 0003 314-362-5740
	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 Nassau [Recruiting] New York, New York, United States, 10065 Contact:Contact: Geoffrey Ku, Site 0007 646-888-4325
	United States, Oregon
	Providence Portland Medical Center [Recruiting] Portland, Oregon, United States, 97225 Contact:Contact: Gina Vaccaro, Site 0002 503-215-5696
	United States, Pennsylvania
	Fox Chase Cancer Center [Recruiting] Philadelphia, Pennsylvania, United States, 19111-2412 Contact:Contact: Crystal Denlinger, Site 0005 215-214-1676
	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 206-288-7017
	Australia
	Local Institution [Not yet recruiting] Randwick, Australia, 2031 Contact:Contact: Site 0034
	Australia, New South Wales
	Westmead Hospital [Recruiting] Westmead, New South Wales, Australia, 2145 Contact:Contact: Adnan Nagrial, Site 0035 +61287453725
	Australia, Victoria
	Austin Health [Recruiting] Heidelberg, Victoria, Australia, 3084 Contact:Contact: Niall Tebbutt, Site 0033 +61394963297
	Canada, Alberta
	Cross Cancer Institute [Recruiting] Edmonton, Alberta, Canada, T6G 1Z2 Contact:Contact: Michael Sawyer, Site 0029 7804328285
	Canada, British Columbia
	Local Institution [Active, not recruiting] Vancouver, British Columbia, Canada, V5Z 4E6
	Canada, Nova Scotia
	Local Institution [Withdrawn] Halifax, Nova Scotia, Canada, B3H 2Y9
	Canada, Ontario
	Local Institution [Completed] Ottawa, Ontario, Canada, K1H 8L6
	Local Institution [Recruiting] Toronto, Ontario, Canada, M5G 2M9 Contact:Contact: Site 0021
	Sunnybrook Research Institution [Active, not recruiting] Toronto,, Ontario, Canada, M4N 3M5
	Canada, Quebec
	Local Institution [Not yet recruiting] Montreal, Quebec, Canada, H3T 1E2 Contact:Contact: Site 0051
	France
	Local Institution [Not yet recruiting] Lyon Cedex 08, France, 69373 Contact:Contact: Site 0047
	Local Institution [Not yet recruiting] Marseille Cedex 9, France, 13273 Contact:Contact: Site 0048
	Local Institution [Not yet recruiting] Montpellier Cedex 5, France, 34298 Contact:Contact: Site 0046
	Local Institution [Not yet recruiting] Villejuif, France, 94805 Contact:Contact: Site 0049
	Germany
	Nationales Centrum Fur Tumorerkrankungen (Nct) [Recruiting] Heidelberg, Germany, 69120 Contact:Contact: Georg Martin Haag, Site 0039 +4962215638687
	Universitaetsklinikum Leipzig [Recruiting] Leipzig, Germany, 04103 Contact:Contact: Florian Lordick, Site 0043 +493419712560
	Israel
	Local Institution [Recruiting] Ramat Gan, Israel, 52621 Contact:Contact: Site 0018
	Local Institution [Recruiting] Tel Aviv, Israel, 64239 Contact:Contact: Site 0019
	Italy
	Istituto Europeo Di Oncologia [Recruiting] Milan, Italy, 20141 Contact:Contact: Giuseppe Curigliano, Site 0014 +390257489599
	IRCCS Istituto Nazionale Tumori Milano [Recruiting] Milano, Italy, 20133 Contact:Contact: Maria Di Bartolomeo, Site 0013 +390223903066
	Netherlands
	Local Institution [Recruiting] Amsterdam, Netherlands, 1105 AZ Contact:Contact: Site 0012
	Local Institution [Recruiting] Utrecht, Netherlands, 3584 CX Contact:Contact: Site 0031
	Singapore
	Local Institution [Recruiting] Singapore, Singapore, 169610 Contact:Contact: Site 0050
	Spain
	Local Institution [Not yet recruiting] Badalona-barcelona, Spain, 08916 Contact:Contact: Site 0044
	Local Institution [Not yet recruiting] Madrid, Spain, 28041 Contact:Contact: Site 0045
	Switzerland
	Kantonsspital Graubunden [Recruiting] Chur, Switzerland, 7000 Contact:Contact: Roger Von Moos, Site 0041 +41812567581
	University Hospital Zuerich [Recruiting] Zuerich, Switzerland, 8091 Contact:Contact: Ralph Fritsch, Site 0042 +41432539803

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.fda.gov/Safety/MedWatch/SafetyInformation/default.htm Description: FDA Safety Alerts and Recalls
Available IPD/Information: