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

Latest version (submitted April 2, 2024) on ClinicalTrials.gov

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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

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Study NCT03446040
Submitted Date: October 7, 2022 (v27)

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:	2019-000442-35 [EudraCT Number]

Study Status


Record Verification:	October 2022
Overall Status:	Active, not recruiting
Study Start:	March 8, 2018
Primary Completion:	March 20, 2023 [Anticipated]
Study Completion:	March 20, 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:	October 7, 2022
Last Update Posted:	October 10, 2022 [Actual]

Study Description


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

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:	92 [Actual]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Part A Dose Escalation: BMS-986258	Biological: BMS-986258 Specified dose on specified days
Experimental: Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)	Biological: BMS-986258 Specified dose on specified days Drug: rHuPH20 Specified dose on specified days Other Names: Enhanze
Experimental: Part B Dose Escalation: BMS-986258 + nivolumab	Biological: BMS-986258 Specified dose on specified days Biological: Nivolumab Specified dose on specified days Other Names: Opdivo BMS-936558
Experimental: Part C Cohort Expansion: BMS-986258 + nivolumab	Biological: BMS-986258 Specified dose on specified days Biological: Nivolumab Specified dose on specified days 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 [ Time Frame: Approximately 2 years ]
4.	Incidence of AEs leading to death [ Time Frame: Approximately 2 years ]
5.	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 (PFS) rate [ 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:	Inclusion Criteria: Histologic confirmation of one of the 5 tumors [renal cell carcinoma (RCC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC)] (metastatic, recurrent, and/or unresectable), with measurable disease per response evaluation criteria in solid tumors v1.1 (RECIST v1.1) 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 Women must agree to follow specific methods of contraception, if applicable Exclusion Criteria: 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 Other active malignancy requiring concurrent intervention Other protocol-defined inclusion/exclusion criteria apply

Contacts/Locations


Study Officials:	Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Locations:	United States, California
	Hoag Memorial Hospital Presbyterian Los Angeles, California, United States, 90033
	Usc/Norris Comprehensive Cancer Center Los Angeles, California, United States, 90033
	United States, Colorado
	University Of Colorado Aurora, Colorado, United States, 80045
	United States, Connecticut
	Local Institution New Haven, Connecticut, United States, 06520
	United States, Iowa
	Local Institution Iowa City, Iowa, United States, 52242
	United States, Michigan
	Local Institution Ann Arbor, Michigan, United States, 48109-5912
	Local Institution - 0010 Grand Rapids, Michigan, United States, 49546
	United States, Ohio
	Local Institution - 0016 Cincinnati, Ohio, United States, 45267
	United States, Pennsylvania
	University Of Pittsburgh Medical Center Pittsburgh, Pennsylvania, United States, 15232
	United States, Tennessee
	Local Institution - 0002 Germantown, Tennessee, United States, 38138
	Australia, New South Wales
	Local Institution - 0013 Westmead, New South Wales, Australia, 2145
	Australia, Victoria
	Local Institution - 0015 Melbourne, Victoria, Australia, 3084
	Canada
	Local Institution Edmonton, Canada, T6X 1E8
	Canada, British Columbia
	Local Institution - 0019 Vancouver, British Columbia, Canada, V5Z 4E6
	Japan, Hyogo
	Local Institution Kobe-shi, Hyogo, Japan, 6500017
	Japan, Tokyo
	Local Institution - 0008 Chuo-ku, Tokyo, Japan, 1040045

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:

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