A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors

• ClinicalTrials.gov Identifier: NCT05888831
• Recruitment Status: Recruiting
• First Posted: June 5, 2023
• Last Update Posted: May 15, 2024
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: May 25, 2023
• First Posted Date: June 5, 2023
• Last Update Posted Date: May 15, 2024
• Actual Study Start Date: June 6, 2023
• Estimated Primary Completion Date: May 21, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 25, 2023)

• Number of participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to approximately 4 years ]
• Number of participants with Adverse Events (AEs) [ Time Frame: Up to approximately 4 years ]
• Number of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 4 years ]
• Number of participants with AEs leading to discontinuation [ Time Frame: Up to approximately 4 years ]
• Number of deaths [ Time Frame: Up to approximately 4 years ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 25, 2023)

• Maximum observed plasma concentration (Cmax) [ Time Frame: Up to approximately 4 years ]
• Time of maximum observed concentration within a dosing interval (Tmax) [ Time Frame: Up to approximately 4 years ]
• Area under the concentration-time curve within a dosing interval (AUC[TAU]) [ Time Frame: Up to approximately 4 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors
• Official Title: A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors
• Brief Summary: The purpose of this study is to evaluate the safety and efficacy of BMS-986449 alone and in combination with nivolumab in participants with advanced solid tumors.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Advanced Solid Tumors

Intervention

• Drug: BMS-986449
  Specified dose on specified days
• Drug: Nivolumab
  Specified dose on specified days
  Other Names:

  • OPDIVO®
  • BMS-936558

Study Arms

• Experimental: Dose Escalation: BMS-986449 monotherapy
  Intervention: Drug: BMS-986449
• Experimental: Dose Escalation: BMS-986449 + nivolumab
  Interventions:

  • Drug: BMS-986449
  • Drug: Nivolumab
• Experimental: Dose Escalation: BMS-986449 monotherapy pharmacodynamic (PD) cohorts
  Intervention: Drug: BMS-986449

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 25, 2023): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 1, 2027
• Estimated Primary Completion Date: May 21, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy (measurable by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1), and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant.

  • Part 1A may have a solid malignancy of any histology.
  • Part 1B is restricted to participants with Non-small cell lung cancer (NSCLC).
  • Part 1C is restricted to participants with Triple-negative breast cancer (TNBC).
• Tumor biopsy must be obtained for all participants (unless medically precluded).

Exclusion Criteria:

• History of Grade ≥ 3 toxicity related to prior T-cell agonist or checkpoint inhibitor therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], or anti-PD- 1/programmed death-ligand 1 [PD-L1] treatment, or any other antibody or drug specifically targeting T-cell co-stimulation or other immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures.
• Current or recent (within 3 months of study intervention administration) gastrointestinal disease or gastrointestinal surgery (eg, intestinal/gastric/colon resection) that could impact the absorption of study intervention.
• Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.

Other protocol-defined criteria may apply.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com; 855-907-3286; Clinical.Trials@bms.com

Contact: First line of the email MUST contain the NCT# and Site #.

• Listed Location Countries: Belgium, France, Italy, Netherlands, Spain, United States

Administrative Information

• NCT Number: NCT05888831
• Other Study ID Numbers: CA120-1001; 2023-503484-42 ( EudraCT Number ); U1111-1287-3575 ( Registry Identifier: WHO )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: See Plan Description
• Access Criteria: See Plan Description
• URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

• Current Responsible Party: Bristol-Myers Squibb
• Original Responsible Party: Same as current
• Current Study Sponsor: Bristol-Myers Squibb
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: May 2024