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Trial record 1 of 1 for:    CA120-1001
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A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT05888831
Recruitment Status : Recruiting
First Posted : June 5, 2023
Last Update Posted : February 13, 2024
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: BMS-986449 Drug: Nivolumab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors
Actual Study Start Date : June 6, 2023
Estimated Primary Completion Date : May 21, 2025
Estimated Study Completion Date : July 1, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation: BMS-986449 monotherapy Drug: BMS-986449
Specified dose on specified days
Experimental: Dose Escalation: BMS-986449 + nivolumab Drug: BMS-986449
Specified dose on specified days

Drug: Nivolumab
Specified dose on specified days
Other Names:
  • OPDIVO®
  • BMS-936558
Experimental: Dose Escalation: BMS-986449 monotherapy pharmacodynamic (PD) cohorts Drug: BMS-986449
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to approximately 4 years ]
  2. Number of participants with Adverse Events (AEs) [ Time Frame: Up to approximately 4 years ]
  3. Number of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 4 years ]
  4. Number of participants with AEs leading to discontinuation [ Time Frame: Up to approximately 4 years ]
  5. Number of deaths [ Time Frame: Up to approximately 4 years ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05888831


Contacts
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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 #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05888831    
Other Study ID Numbers: CA120-1001
2023-503484-42 ( EudraCT Number )
U1111-1287-3575 ( Registry Identifier: WHO )
First Posted: June 5, 2023    Key Record Dates
Last Update Posted: February 13, 2024
Last Verified: February 2024
Individual Participant Data (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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
BMS-986449
Nivolumab
Cancer
 Solid Tumors
Non-Small Cell Lung Cancer (NSCLC)
Triple Negative Breast Cancer (TNBC)
Additional relevant MeSH terms:
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Neoplasms
Nivolumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action