Trial Title:
A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors
NCT ID:
NCT05888831
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Nivolumab
Conditions: Keywords:
BMS-986449
Nivolumab
Cancer
Solid Tumors
Non-Small Cell Lung Cancer (NSCLC)
Triple Negative Breast Cancer (TNBC)
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BMS-986449
Description:
Specified dose on specified days
Arm group label:
Dose Escalation: BMS-986449 + nivolumab
Arm group label:
Dose Escalation: BMS-986449 monotherapy
Arm group label:
Dose Escalation: BMS-986449 monotherapy pharmacodynamic (PD) cohorts
Intervention type:
Drug
Intervention name:
Nivolumab
Description:
Specified dose on specified days
Arm group label:
Dose Escalation: BMS-986449 + nivolumab
Other name:
OPDIVO®
Other name:
BMS-936558
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Angeles Clinic and Research Institute - West Los Angeles Office
Address:
City:
Los Angeles
Zip:
90025
Country:
United States
Status:
Recruiting
Contact:
Last name:
Justin Moyers, Site 0021
Phone:
310-231-2127
Facility:
Name:
Yale New Haven Hospital-Smilow Cancer Center
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Contact:
Last name:
Patricia Lo Russo, Site 0007
Phone:
203584-2144
Facility:
Name:
Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Withdrawn
Facility:
Name:
John Theurer Cancer Center at Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Martin Gutierrez, Site 0010
Phone:
551-996-5863
Facility:
Name:
Northwell Health/ RJ Zuckerberg Cancer Center
Address:
City:
Lake Success
Zip:
11042
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nagashree Seetharamu, Site 0022
Phone:
917-574-8494
Facility:
Name:
Cliniques universitaires Saint-Luc
Address:
City:
Brussels
Zip:
1200
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Rachel Galot, Site 0016
Phone:
3227641037
Facility:
Name:
UZ Gent
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Sylvie Rottey, Site 0017
Phone:
3293320000
Facility:
Name:
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Recruiting
Contact:
Last name:
Antoine Italiano, Site 0003
Phone:
33556333333
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94800
Country:
France
Status:
Recruiting
Contact:
Last name:
Antoine Hollebecque, Site 0002
Phone:
33142114385
Facility:
Name:
Institut Paoli-Calmettes
Address:
City:
Marseille
Zip:
13273
Country:
France
Status:
Recruiting
Contact:
Last name:
Cecile Vicier, Site 0004
Phone:
33491223670
Facility:
Name:
Local Institution - 0009
Address:
City:
Lyon CEDEX 08
Zip:
69373
Country:
France
Status:
Withdrawn
Facility:
Name:
Humanitas
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Matteo Simonelli, Site 0023
Phone:
+390282244559
Facility:
Name:
Azienda Ospedaliero Universitaria Senese
Address:
City:
Siena
Zip:
53100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Michele Maio, Site 0024
Phone:
390577586335
Facility:
Name:
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Address:
City:
Bergamo
Zip:
24127
Country:
Italy
Status:
Recruiting
Contact:
Last name:
SALVATORE INTAGLIATA, Site 0026
Phone:
0352673687
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Gennaro Daniele, Site 0025
Phone:
+390630153446
Facility:
Name:
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)
Address:
City:
Amsterdam
Zip:
1066 CX
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Gerrina Ruiter, Site 0030
Phone:
0031205122958
Facility:
Name:
University Medical Center Groningen
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
T.Jeroen Hiltermann, Site 0018
Phone:
(3150)361-3532
Facility:
Name:
Hospital Universitario Virgen de la Victoria
Address:
City:
Málaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Javier Garcia Corbacho, Site 0015
Phone:
951032250
Facility:
Name:
Institut Català d'Oncologia (ICO) - Badalona
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Cinta Hierro Carbo, Site 0013
Phone:
34934978925
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Ignacio Melero Bermejo, Site 0012
Phone:
34948255400
Facility:
Name:
Hospital Universitario Fundación Jiménez Díaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Victor Moreno Garcia, Site 0014
Phone:
91554800ext2805
Facility:
Name:
Hospital Universitario HM Sanchinarro
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Emiliano Calvo Aller, Site 0011
Phone:
917567825
Start date:
June 6, 2023
Completion date:
July 1, 2027
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05888831
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT05888831.html
