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History of Changes for Study: NCT03110107
First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Patients With Advanced Solid Tumors
Latest version (submitted May 2, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 7, 2017 None (earliest Version on record)
2 April 12, 2017 Outcome Measures and Study Status
3 April 24, 2017 Contacts/Locations, Outcome Measures, IPDSharing, Arms and Interventions, Oversight and Study Status
4 April 26, 2017 Contacts/Locations and Study Status
5 May 2, 2017 Recruitment Status, Contacts/Locations and Study Status
6 May 15, 2017 Contacts/Locations, Study Status and Study Design
7 May 30, 2017 Contacts/Locations and Study Status
8 June 30, 2017 Contacts/Locations and Study Status
9 July 18, 2017 Study Status
10 July 31, 2017 Contacts/Locations and Study Status
11 August 15, 2017 Study Status
12 September 15, 2017 Study Status
13 October 16, 2017 Study Status and Contacts/Locations
14 November 15, 2017 Study Status
15 December 15, 2017 Study Status
16 January 30, 2018 Study Status and Contacts/Locations
17 February 15, 2018 Study Status
18 March 22, 2018 Outcome Measures, Study Status and Contacts/Locations
19 April 2, 2018 Study Status
20 April 16, 2018 Study Status and Contacts/Locations
21 April 30, 2018 Contacts/Locations and Study Status
22 May 15, 2018 Study Status
23 May 30, 2018 Contacts/Locations and Study Status
24 June 15, 2018 Study Status
25 July 3, 2018 Contacts/Locations and Study Status
26 July 23, 2018 Contacts/Locations and Study Status
27 August 27, 2018 Contacts/Locations, References and Study Status
28 October 2, 2018 Study Status and Contacts/Locations
29 December 19, 2018 Contacts/Locations and Study Status
30 January 30, 2019 Study Status
31 June 3, 2019 Contacts/Locations, Arms and Interventions, Study Status, Study Design, Eligibility and Outcome Measures
32 July 10, 2019 Contacts/Locations and Study Status
33 July 29, 2019 Contacts/Locations and Study Status
34 September 27, 2019 Contacts/Locations and Study Status
35 October 10, 2019 Study Status and Contacts/Locations
36 March 9, 2020 Contacts/Locations, Outcome Measures, Study Status, Eligibility and Arms and Interventions
37 April 17, 2020 Study Status and Contacts/Locations
38 June 9, 2020 Contacts/Locations and Study Status
39 June 19, 2020 Contacts/Locations and Study Status
40 June 26, 2020 Contacts/Locations and Study Status
41 July 6, 2020 Study Status and Contacts/Locations
42 July 13, 2020 Contacts/Locations and Study Status
43 July 28, 2020 Contacts/Locations and Study Status
44 September 9, 2020 Contacts/Locations and Study Status
45 October 6, 2020 Contacts/Locations and Study Status
46 October 29, 2020 Contacts/Locations and Study Status
47 November 3, 2020 Contacts/Locations and Study Status
48 May 25, 2021 Contacts/Locations, Outcome Measures, Arms and Interventions, Study Status, Eligibility, Study Design and Study Identification
49 July 9, 2021 Contacts/Locations and Study Status
50 November 17, 2021 Outcome Measures, Contacts/Locations, Study Status, Arms and Interventions, References, Eligibility, Conditions and Study Description
51 March 7, 2022 Contacts/Locations and Study Status
52 March 14, 2023 Recruitment Status, Contacts/Locations, Study Status and References
53 April 11, 2023 Study Status
54 April 26, 2023 Contacts/Locations and Study Status
55 May 9, 2023 Study Status
56 May 15, 2023 Study Status
57 July 17, 2023 Study Status
58 September 14, 2023 Study Status and Contacts/Locations
59 October 3, 2023 Study Status
60 January 2, 2024 Study Status and References
61 May 2, 2024 Recruitment Status, Study Status, Study Design and Contacts/Locations
Comparison Format:
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Study NCT03110107
Submitted Date:  April 7, 2017 (v1)
Open or close this module Study Identification
Unique Protocol ID: CA022-001
Brief Title: First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Patients With Advanced Solid Tumors
Official Title: Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors
Secondary IDs: 2017-000597-11 [EudraCT Number]
Open or close this module Study Status
Record Verification: April 2017
Overall Status: Not yet recruiting
Study Start: April 28, 2017
Primary Completion: April 5, 2020 [Anticipated]
Study Completion: March 17, 2021 [Anticipated]
First Submitted: April 7, 2017
First Submitted that
Met QC Criteria:		 April 7, 2017
First Posted: April 12, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:		 April 7, 2017
Last Update Posted: April 12, 2017 [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 a Monoclonal Antibody both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors
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/Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 531 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Monotherapy
Ipilimumab Monotherapy and BMS-986218 Monotherapy
 Biological: Ipilimumab
Other Names:
  • Yervoy
Biological: BMS-986218
Experimental: Combination Therapy
BMS-986218 in combination with Nivolumab
 Biological: BMS-986218Biological: Nivolumab
Other Names:
  • Opdivo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of Adverse Events (AEs)
[ Time Frame: Up to 3 years ]
2. Incidence of Serious Adverse Events (SAEs)
[ Time Frame: Up to 3 years ]
3. Objective Response Rate (ORR) of BMS-986218 monotherapy relative to Ipilimumab in immuno-oncology (IO) progressed melanoma cohort
[ Time Frame: Up to 3 years ]
4. Median Duration of Response (mDOR) of BMS-986218 monotherapy relative to Ipilimumab in IO progressed melanoma cohort
[ Time Frame: Up to 3 years ]
5. Progression Free Survival (PFS) of BMS-986218 monotherapy relative to Ipilimumab in IO progressed melanoma cohort
[ Time Frame: Up to 3 years ]
Secondary Outcome Measures:
1. ORR of BMS-986218 alone or in combination with Nivolumab
[ Time Frame: Up to 3 years ]
2. mDOR of BMS-986218 alone or in combination with Nivolumab
[ Time Frame: Up to 3 years ]
3. PFS of BMS-986218 alone or in combination with Nivolumab
[ Time Frame: Up to 3 years ]
4. Incidence of anti-drug antibody to BMS-986218
[ Time Frame: Up to 3 years ]
5. Percentange of change from baseline in T-regulatory cells (Tregs)
[ Time Frame: Up to 3 years ]
6. Maximum observed serum concentration (Cmax)
[ Time Frame: Up to 3 years ]
7. Time of maximum observed concentration (Tmax)
[ Time Frame: Up to 3 years ]
8. Area under the concentration-time curve
[ Time Frame: Up to 3 years ]

Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [(AUC(0-T)]
9. Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]
[ Time Frame: Up to 3 years ]
10. Trough observed serum concentration (Ctrough)
[ Time Frame: Up to 3 years ]
11. Total body clearance (CLT)
[ Time Frame: Up to 3 years ]
12. Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg)
[ Time Frame: Up to 3 years ]
13. Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)]
[ Time Frame: Up to 3 years ]
14. Terminal serum half-life if data permit (T-HALF)
[ Time Frame: Up to 3 years ]
15. Observed concentration at the end of a dosing interval (Ctau)
[ Time Frame: Up to 3 years ]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
  • histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable)
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Participants must have received, and then progressed, relapsed, or been intolerant to, all standard treatment regimens with proven survival benefit in the advanced or metastatic setting according to tumor type, if such a therapy exists

Exclusion Criteria:

  • Participants with primary CNS malignancies, or tumors with CNS metastases as the only site of disease, will be excluded
  • Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
  • Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or immunotherapy (including anti-PD-1/PD-L1) are permitted

Other 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, 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, Colorado
Local Institution
Aurora, Colorado, United States, 80045
Contact:Contact: Site 0003
United States, Nevada
Local Institution
Las Vegas, Nevada, United States, 89128
Contact:Contact: Site 0005
United States, New Jersey
Local Institution
Hackensack, New Jersey, United States, 07601
Contact:Contact: Site 0002
United States, New York
Local Institution
New York, New York, United States, 10032
Contact:Contact: Site 0001
United States, Pennsylvania
Local Institution
Philadephia, Pennsylvania, United States, 19104
Contact:Contact: Site 0004
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links: Description: BMS Clinical Trial Patient Recruiting
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services