History of Changes for Study: NCT03446040

An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread

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Study Record Versions

Version	Submitted Date	Changes
1	February 21, 2018	None (earliest Version on record)
2	March 15, 2018	Recruitment Status, Study Status, Contacts/Locations and Oversight
3	April 2, 2018	Contacts/Locations and Study Status
4	April 16, 2018	Study Status
5	August 22, 2018	Arms and Interventions, References, Study Status, Contacts/Locations and Study Design
6	October 2, 2018	Study Status
7	January 30, 2019	Contacts/Locations and Study Status
8	July 8, 2019	Study Status, Contacts/Locations and Study Design
9	July 11, 2019	Contacts/Locations and Study Status
10	August 12, 2019	Study Status and Contacts/Locations
11	August 22, 2019	Contacts/Locations and Study Status
12	October 30, 2019	Contacts/Locations and Study Status
13	November 15, 2019	Study Status and Contacts/Locations
14	December 18, 2019	Contacts/Locations and Study Status
15	January 24, 2020	Study Status and Contacts/Locations
16	February 28, 2020	Study Status and Contacts/Locations
17	March 9, 2020	Study Status and Contacts/Locations
18	July 6, 2020	Contacts/Locations and Study Status
19	July 17, 2020	Contacts/Locations and Study Status
20	November 23, 2020	Study Status, Arms and Interventions, Contacts/Locations, Eligibility, Outcome Measures, Study Design and Study Description
21	December 22, 2020	Contacts/Locations and Study Status
22	May 10, 2021	Study Status, Contacts/Locations, Outcome Measures, Eligibility, Study Design and Study Identification
23	January 7, 2022	Contacts/Locations, Study Status, References, Outcome Measures and Arms and Interventions
24	January 12, 2022	Contacts/Locations and Study Status
25	February 11, 2022	Recruitment Status, Contacts/Locations, Study Status, Study Design and Eligibility
26	September 21, 2022	Study Status, Contacts/Locations and References
27	October 7, 2022	Contacts/Locations and Study Status
28	November 1, 2022	Contacts/Locations and Study Status
29	November 11, 2022	Study Status
30	November 30, 2022	Contacts/Locations and Study Status
31	September 6, 2023	Study Status and Contacts/Locations
32	September 27, 2023	Study Status
33	April 2, 2024	Study Status, References and Contacts/Locations

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CA031-002
Brief Title:	An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread
Official Title:	A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
Secondary IDs:

Study Status


Record Verification:	November 2019
Overall Status:	Recruiting
Study Start:	March 1, 2018
Primary Completion:	July 4, 2023 [Anticipated]
Study Completion:	July 5, 2023 [Anticipated]

First Submitted:	February 21, 2018
First Submitted that Met QC Criteria:	February 21, 2018
First Posted:	February 26, 2018 [Actual]

Last Update Submitted that Met QC Criteria:	November 15, 2019
Last Update Posted:	November 19, 2019 [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:	No

Study Description


Brief Summary:	The purpose of this study is to determine whether BMS-986258 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors
Detailed Description:

Conditions


Conditions:	Advanced Cancer
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1/Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	4
Masking:	None (Open Label)
Allocation:	Non-Randomized
Enrollment:	383 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Arm A BMS-986258	Biological: BMS-986258 Specified dose on specified day
Experimental: Arm A1 BMS-986258 + rHuPH20	Biological: BMS-986258 Specified dose on specified day Drug: rHuPH20 Specified dose on specified days
Experimental: Arm B Dose Escalation: BMS-986258 + Nivo	Biological: BMS-986258 Specified dose on specified day Biological: Nivolumab Specified dose on specified day Other Names: Opdivo BMS-936558
Experimental: Arm C Dose Expansion: BMS-986258 + Nivo	Biological: BMS-986258 Specified dose on specified day Biological: Nivolumab Specified dose on specified day Other Names: Opdivo BMS-936558

Outcome Measures


Primary Outcome Measures:
1.	Incidence of adverse events (AEs) [ Time Frame: Approximately 2 years ]
2.	Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 2 years ]
3.	Incidence of AEs leading to discontinuation and deaths [ Time Frame: Approximately 2 years ]
4.	Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria [ Time Frame: Approximately 2 years ]
Secondary Outcome Measures:
1.	Objective response rate (ORR) [ Time Frame: up to 12 months ]
2.	Median duration of response (mDOR) [ Time Frame: up to 12 months ]
3.	Progression free survival rate (PFSR) [ Time Frame: up to 12 months ]
4.	Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 2 years ]
5.	Time of maximum observed concentration (Tmax) [ Time Frame: Approximately 2 years ]
6.	Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Approximately 2 years ]
7.	Observed concentration at the end of a dosing interval (Ctau) [ Time Frame: Approximately 2 years ]
8.	Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 2 years ]
9.	Trough observed serum concentration at the end of the dosing interval (Ctrough) [ Time Frame: Approximately 2 years ]
10.	Concentration at the end of infusion (Ceoi) [ Time Frame: Approximately 2 years ]
11.	Incidence of anti-drug antibody (ADA) to BMS-986258 [ Time Frame: Approximately 2 years ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
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: Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy Eastern Cooperative Oncology Group Performance Status of 0 or 1 Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies Exclusion Criteria: Participants with active, known or suspected autoimmune disease Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy Participants with other active malignancy requiring concurrent intervention Participants with active, known or suspected autoimmune disease 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, California
	Usc/Norris Comprehensive Cancer Center [Recruiting] Los Angeles, California, United States, 90033 Contact:Contact: Anthony El-Khoueiry, Site 0004 213-740-6709
	Hoag Memorial Hospital Presbyterian [Recruiting] Newport Beach, California, United States, 92663 Contact:Contact: Anthony El-Khoueiry, Site 0006 213-740-6709
	United States, Colorado
	University Of Colorado [Recruiting] Aurora, Colorado, United States, 80045 Contact:Contact: Elaine Lam, Site 0007 720-848-4604
	United States, Connecticut
	Local Institution [Not yet recruiting] New Haven, Connecticut, United States, 06520 Contact:Contact: Site 0011
	United States, Michigan
	START Midwest [Recruiting] Grand Rapids, Michigan, United States, 49546 Contact:Contact: Manish Sharma, Site 0010
	United States, New Hampshire
	Local Institution [Not yet recruiting] Lebanon, New Hampshire, United States, 03756 Contact:Contact: Site 0012
	United States, Pennsylvania
	University Of Pittsburgh Medical Center [Recruiting] Pittsburgh, Pennsylvania, United States, 15232 Contact:Contact: Dan Paul Zandberg, Site 0005 412-623-6121
	United States, Tennessee
	The West Clinic, P.C. [Recruiting] Germantown, Tennessee, United States, 38138 Contact:Contact: Daniel Vaena, Site 0002 901-683-0055
	Australia, New South Wales
	Local Institution [Not yet recruiting] Westmead, New South Wales, Australia, 2145 Contact:Contact: Site 0013
	Australia, Victoria
	Local Institution [Not yet recruiting] Heidelberg, Victoria, Australia, 3084 Contact:Contact: Site 0015
	Canada, Alberta
	Local Institution [Not yet recruiting] Edmonton, Alberta, Canada, T6X 1E8 Contact:Contact: Site 0014
	Japan, Hyogo
	Local Institution [Recruiting] Kobe-shi, Hyogo, Japan, 6500017 Contact:Contact: Site 0009
	Japan, Tokyo
	Local Institution [Recruiting] Chuo-ku, Tokyo, Japan, 1040045 Contact:Contact: Site 0008

IPDSharing


Plan to Share IPD:

References


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: