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Active, Not Recruiting

NCT Number: NCT05888831

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution - 0016, Brussels, Bruxelles-Capitale, Région de, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986449

Drug

Specified dose on specified days

Nivolumab

Drug

Specified dose on specified days

Other names: OPDIVO®, BMS-936558

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2023
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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