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Clinical Trials in Belgium / NCT05888831
Active, not recruiting Phase 1/2

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

NCT05888831 · tracked via the Priya Life Science Belgium tracker
Phase
Phase 1/2
Started
2023-06-06
Last updated
2025-06-11

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

BMS-986449Nivolumab →

BMS-986449: Specified dose on specified days

Nivolumab: Specified dose on specified days

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
Local Institution - 0021 Los Angeles California
Local Institution - 0007 New Haven Connecticut
Local Institution - 0010 Hackensack New Jersey
Local Institution - 0022 Lake Success New York
Local Institution - 0016 Brussels Bruxelles-Capitale, Région de
Local Institution - 0017 Ghent Oost-Vlaanderen
Local Institution - 0002 Villejuif Paris
Local Institution - 0004 Marseille Provence-Alpes-Côte d'Azur Region
Local Institution - 0003 Bordeaux France
Local Institution - 0023 Rozzano Milano
Local Institution - 0024 Siena Tuscany
Local Institution - 0026 Bergamo Italy
Local Institution - 0025 Roma Italy
Local Institution - 0030 Amsterdam North Holland
Local Institution - 0018 Groningen Netherlands
Local Institution - 0015 Málaga Andalusia
Local Institution - 0013 Badalona Barcelona [Barcelona]
Local Institution - 0012 Pamplona Navarre
Local Institution - 0014 Madrid Spain
Local Institution - 0011 Madrid Spain

On this site

📄 Opdivo (nivolumab) drug profile →

More Bristol-Myers Squibb trials in Belgium

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05888831 on ClinicalTrials.gov ↗ ← All trials in Belgium