Clinical Trials in Italy / 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 Italy tracker
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
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)
- Number of participants with Dose-Limiting Toxicities (DLTs) — Up to approximately 4 years
- Number of participants with Adverse Events (AEs) — Up to approximately 4 years
- Number of participants with Serious Adverse Events (SAEs) — Up to approximately 4 years
- Number of participants with AEs leading to discontinuation — Up to approximately 4 years
- Number of deaths — Up to approximately 4 years
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Italy
Other trials for the same condition
A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors
Active, not recruiting
A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors
Active, not recruiting
First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer
Active, not recruiting
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 Italy