Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05888831 | RECRUITING | Advanced Solid Tumors

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

Bristol-Myers Squibb

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

Advanced Solid Tumors

Intervention/treatment

BMS-986449

Nivolumab

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
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 : 2023-06-06
Estimated Primary Completion Date : 2025-05-21
Estimated Study Completion Date : 2027-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors

Location Details

NCT05888831

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

The Angeles Clinic and Research Institute - West Los Angeles Office

Los Angeles, California, United States, 90025

RECRUITING

United States, Connecticut

Yale New Haven Hospital-Smilow Cancer Center

New Haven, Connecticut, United States, 06510

WITHDRAWN

United States, New Jersey

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

RECRUITING

United States, New Jersey

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

RECRUITING

United States, New York

Northwell Health/ RJ Zuckerberg Cancer Center

Lake Success, New York, United States, 11042

RECRUITING

Belgium, Brussels-Capital, region of

Saint-Luc university clinics

Brussels, Brussels-Capital, region of, Belgium, 1200

RECRUITING

Belgium, East Flanders

To Gent

Gent, East Flanders, Belgium, 9000

RECRUITING

France, Aquitaine

Bergonié Institute - Regional Center for the Fight against Bordeaux and South West cancer

Bordeaux, Aquitaine, France, 33076

RECRUITING

France, Paris

Gustave Roussy

Villejuif, Paris, France, 94800

RECRUITING

France, Provence-Alpes-Côte-d'Azur

Institut Paoli-Calmettes

Marseille, Provence-Alpes-Côte-d'Azur, France, 13273

WITHDRAWN

France, Rhône-Alpes

Local Institution - 0009

Lyon Cedex 08, Rhône-Alpes, France, 69373

RECRUITING

Italy, Milano

Humanitas

Rozzano, Milano, Italy, 20089

RECRUITING

Italy, Tuscany

Sienese University Hospital

Siena, Tuscany, Italy, 53100

RECRUITING

Italy,

Pope John XXIII Territorial Healthcare Social Health Authority

Bergamo, Italy, 24127

RECRUITING

Italy,

Agostino Gemelli IRCCS University Polyclinic Foundation - Catholic University of the Sacred Heart

Roma, Italy, 00168

RECRUITING

Netherlands, North Holland

Dutch Cancer Institute Antoni van Leeuwenhoek (NKI AVL)

Amsterdam, North Holland, Netherlands, 1066 CX

RECRUITING

Netherlands,

University Medical Center Groningen

Groningen, Netherlands, 9713 GZ

RECRUITING

Spain, Andalusia

Virgen de la Victoria University Hospital

Málaga, Andalusia, Spain, 29010

RECRUITING

Spain, Barcelona [Barcelona]

Catalan Institute of Oncology (ICO) - Badalona

Badalona, Barcelona [Barcelona], Spain, 08916

RECRUITING

Spain, Navarra

Clinic University of Navarra

Pamplona, Navarra, Spain, 31008

RECRUITING

Spain,

Jiménez Díaz Foundation University Hospital

Madrid, Spain, 28040

RECRUITING

Spain,

HM Sanchinarro University Hospital

Madrid, Spain, 28050