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History of Changes for Study: NCT03444753
An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed
Latest version (submitted May 17, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 20, 2018 None (earliest Version on record)
2 February 22, 2018 Study Status and Study Identification
3 April 2, 2018 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 April 30, 2018 Study Status
5 May 16, 2018 Study Status
6 June 19, 2018 Study Status
7 July 23, 2018 Study Status
8 October 2, 2018 References, Study Status and Contacts/Locations
9 January 30, 2019 Study Status and Contacts/Locations
10 May 30, 2019 Contacts/Locations, Arms and Interventions, Study Status, Eligibility and Study Design
11 July 10, 2019 Study Status and Contacts/Locations
12 August 7, 2019 Contacts/Locations and Study Status
13 September 4, 2019 Contacts/Locations and Study Status
14 November 12, 2019 Study Status and Contacts/Locations
15 March 23, 2020 Contacts/Locations and Study Status
16 November 19, 2021 Contacts/Locations, Study Status, References and Study Design
17 May 17, 2022 Recruitment Status, Study Status, Contacts/Locations, References, Study Design and Eligibility
Comparison Format:
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Changes (Merged) for Study: NCT03444753
November 19, 2021 (v16) -- May 17, 2022 (v17)

Changes in: Study Status, Study Design, Eligibility, Contacts/Locations and References
Open or close this module Study Identification
Unique Protocol ID: CA039-001
Brief Title: An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed
Official Title: A Phase I Study of BMS-986299 as Monotherapy and in Combination With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2021 May 2022
Overall Status: Recruiting Terminated [business objectives have changed]
Study Start: April 5, 2018
Primary Completion: October 4, 2022 [Anticipated] February 14, 2022 [Actual]
Study Completion: October 9, 2023 [Anticipated] February 14, 2022 [Actual]
First Submitted: February 20, 2018
First Submitted that
Met QC Criteria:		 February 20, 2018
First Posted: February 23, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:		 November 19, 2021 May 17, 2022
Last Update Posted: December 1 May 23, 2021 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Bristol-Myers Squibb
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The purpose of this study is to determine whether BMS-986299 both by itself and in combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced solid tumors. In addition, the ability of study drugs to stimulate an immune response against cancer will be investigated.
Detailed Description:
Open or close this module Conditions
Conditions: Advanced Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 127 [Anticipated] 82 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm A
BMS-986299
 Drug: BMS-986299
Specified dose on specified day
Experimental: Arm B
BMS-986299 in combination with nivolumab and ipilimumab
 Drug: BMS-986299
Specified dose on specified day
Biological: Nivolumab
Specified dose on specified day
Other Names:
  • Opdivo
  • BMS-936558
Biological: Ipilimumab
Specified dose on specified day
Other Names:
  • Yervoy
  • BMS-734016
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of dose-limiting toxicities (DLTs)
[ Time Frame: Up to 28 days ]
2. Incidence of adverse events (AEs)
[ Time Frame: Approximately 2 years ]
3. Incidence of clinical laboratory abnormalities
[ Time Frame: Approximately 2 years ]
4. Incidence of serious adverse events (SAEs)
[ Time Frame: Approximately 2 years ]
5. Incidence of AEs leading to discontinuation and deaths
[ Time Frame: Approximately 2 years ]
Secondary Outcome Measures:
1. Maximum observed plasma concentration (Cmax)
[ Time Frame: Approximately 2 years ]
2. Time of maximum observed plasma concentration (Tmax)
[ Time Frame: Approximately 2 years ]
3. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
[ Time Frame: Approximately 2 years ]
4. Area under the plasma concentration-time curve from time zero to 24 hours postdose [AUC(0-24)]
[ Time Frame: Approximately 2 years ]
Open or close this module 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:

  • Histologically or cytologically confirmed advanced/metastatic solid tumor and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
  • IO therapy resistant or insensitive tumors
  • Have at least 2 tumor lesions accessible for biopsy
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1

Exclusion Criteria:

  • Primary CNS malignancy
  • Participants with other active malignancy requiring concurrent intervention
  • Uncontrolled or significant cardiovascular disease

Other protocol protocol-defined inclusion/exclusion criteria could apply
Open or close this module 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
University Of California San Diego Moores Cancer Center
[Recruiting]
La Jolla, California, United States, 92093-0698
Contact:Contact: Sandip Patel, Site 0003 858-822-1962 Local Institution - 0003
La Jolla, California, United States, 92093-0698
Local Institution
[Not yet recruiting]
Orange, California, United States, 92868
Contact:Contact: Site 0008 Local Institution
Orange, California, United States, 92868
University of California Davis Medical Center
[Recruiting]
 Sacramento, California, United States, 95817
Contact:Contact: Karen Kelly, Site 0007 916-734-3604
United States, Connecticut
Local Institution
[Not yet recruiting]
 New Haven, Connecticut, United States, 06520
Contact:Contact: Site 0005
United States, Michigan
Local Institution
[Not yet recruiting]
Detroit, Michigan, United States, 48202
Contact:Contact: Site 0010 Local Institution
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University
[Completed]
 Saint Louis, Missouri, United States, 63110
United States, Oregon
Local Institution
[Not yet recruiting]
Portland, Oregon, United States, 97239
Contact:Contact: Site 0009 Local Institution
Portland, Oregon, United States, 97239
United States, Pennsylvania
Local Institution
[Not yet recruiting]
 Pittsburgh, Pennsylvania, United States, 15232-1305
Contact:Contact: Site 0006
United States, Texas
MD Anderson Cancer Center
[Active, not recruiting]
 Houston, Texas, United States, 77030
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: BMS Clinical Trial Information
Description: BMS Clinical Trial Patient Recruiting
Description: Investigator Inquiry Form
Description: FDA Safety Alerts and Recalls
Available IPD/Information:
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