Clinical trial NCT05888831: A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors
Official title: A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Keywords: BMS-986449
Nivolumab
Cancer
Solid Tumors
Non-Small Cell Lung Cancer (NSCLC)
Triple Negative Breast Cancer (TNBC)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of participants with Dose-Limiting Toxicities (DLTs)
timeFrame: Up to approximately 4 years
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to approximately 4 years
measure: Number of participants with Serious Adverse Events (SAEs)
timeFrame: Up to approximately 4 years
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to approximately 4 years
measure: Number of deaths
timeFrame: Up to approximately 4 years
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to approximately 4 years
measure: Time of maximum observed concentration within a dosing interval (Tmax)
timeFrame: Up to approximately 4 years
measure: Area under the concentration-time curve within a dosing interval (AUC[TAU])
timeFrame: Up to approximately 4 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Local Institution - 0021
state: California
city: New Haven
country: United States
facility: Local Institution - 0007
state: Connecticut
city: Hackensack
country: United States
facility: Local Institution - 0010
state: New Jersey
city: Lake Success
country: United States
facility: Local Institution - 0022
state: New York
city: Brussels
country: Belgium
facility: Local Institution - 0016
state: Bruxelles-Capitale, Région De
city: Gent
country: Belgium
facility: Local Institution - 0017
state: Oost-Vlaanderen
city: Villejuif
country: France
facility: Local Institution - 0002
state: Paris
city: Marseille
country: France
facility: Local Institution - 0004
state: Provence-Alpes-Côte-d'Azur
city: Bordeaux
country: France
facility: Local Institution - 0003
city: Rozzano
country: Italy
facility: Local Institution - 0023
state: Milano
city: Siena
country: Italy
facility: Local Institution - 0024
state: Toscana
city: Bergamo
country: Italy
facility: Local Institution - 0026
city: Roma
country: Italy
facility: Local Institution - 0025
city: Amsterdam
country: Netherlands
facility: Local Institution - 0030
state: Noord-Holland
city: Groningen
country: Netherlands
facility: Local Institution - 0018
city: Malaga
country: Spain
facility: Local Institution - 0015
state: Andalucía
city: Badalona
country: Spain
facility: Local Institution - 0013
state: Barcelona [Barcelona]
city: Pamplona
country: Spain
facility: Local Institution - 0012
state: Navarra
city: Madrid
country: Spain
facility: Local Institution - 0014
city: Madrid
country: Spain
facility: Local Institution - 0011
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: