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

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

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

Show only changed modules

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:	January 2022 February 2022
Overall Status:	Recruiting Active, not recruiting
Study Start:	March 8, 2018
Primary Completion:	March 19, 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:	January 12, 2022 February 11, 2022
Last Update Posted:	January February 14, 2022 [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 monotherapy 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:	248 [Anticipated] 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:	For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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


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
	Hoag Memorial Hospital Presbyterian [Recruiting] Los Angeles, California, United States, 90033 Contact:Contact: Anthony El-Khoueiry, Site 0006 213-740-6709
	Usc/Norris Comprehensive Cancer Center [Recruiting] Los Angeles, California, United States, 90033 Contact:Contact: Anthony El-Khoueiry, Site 0004 213-740-6709
	United States, Colorado
	University Of Colorado [Recruiting] Aurora, Colorado, United States, 80045 Contact:Contact: Elaine Lam, Site 0007 720-848-4604 University Of Colorado Aurora, Colorado, United States, 80045
	United States, Connecticut
	Local Institution [Not yet recruiting] New Haven, Connecticut, United States, 06520 Contact:Contact: Site 0011
	United States, Iowa
	Local Institution [Not yet recruiting] Iowa City, Iowa, United States, 52242 Contact:Contact: Site 0020 Local Institution Iowa City, Iowa, United States, 52242
	United States, Michigan
	Local Institution [Active, not recruiting] Ann Arbor, Michigan, United States, 48109-5912
	START Midwest [Recruiting] Grand Rapids, Michigan, United States, 49546 Contact:Contact: Manish Sharma, Site 0010 616-954-5559 START Midwest Grand Rapids, Michigan, United States, 49546
	United States, New Hampshire
	Dartmouth-Hitchcock Medical Center [Withdrawn] Lebanon, New Hampshire, United States, 03756
	United States, New York
	Roswell Park Cancer Institute [Withdrawn] Buffalo, New York, United States, 14263
	United States, Ohio
	University of Cincinnati Medical Center [Recruiting] Cincinnati, Ohio, United States, 45267 Contact:Contact: Davendra Sohal, Site 0016
	United States, Pennsylvania
	University Of Pittsburgh Medical Center [Recruiting] Pittsburgh, Pennsylvania, United States, 15232 Contact:Contact: Dan 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 [Active, not recruiting] Westmead, New South Wales, Australia, 2145
	Australia, Victoria
	Local Institution [Active, not recruiting] Heidelberg, Victoria, Australia, 3084
	Canada, Alberta
	Local Institution [Recruiting] Edmonton, Alberta, Canada, T6X 1E8 Contact:Contact: Site 0014
	Canada, British Columbia
	Local Institution [Active, not recruiting] Vancouver, British Columbia, Canada, V5Z 4E6
	Japan, Hyogo
	Local Institution [Recruiting] Kobe-shi, Hyogo, Japan, 6500017 Contact:Contact: Site 0009 Local Institution Kobe-shi, Hyogo, Japan, 6500017
	Japan, Tokyo
	Local Institution [Recruiting] Chuo-ku, Tokyo, Japan, 1040045 Contact:Contact: Site 0008 Local Institution Chuo-ku, Tokyo, Japan, 1040045

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.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: