Advanced Solid Tumors
Conditions
Keywords
Immuno-oncology, Regulatory T cells, Tregs
Brief summary
The purpose of this study is to test the safety and efficacy of BMS-986482 alone and as combination therapy in participants with advanced solid tumors.
Interventions
DRUGBMS-986482
Specified dose on specified days
Specified dose on specified days
DRUGNivolumab/relatlimab/rHuPH20
Specified dose on specified days
DRUGBevacizumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy measurable by RECIST v1.1, and have received, be refractory to, ineligible for, intolerant of, or refused existing therapy(ies) known to provide clinical benefit for the condition of the participant. * Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, inclusive, at the time of signing the ICF.
Exclusion criteria
* History of life threatening immune mediated toxicity related to prior T-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures. * 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 Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Adverse Events (AEs) as assessed by National Cancer Institute -Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) | Up to 135 days post last treatment visit |
| Number of participants with Serious AEs (SAEs) as assessed by NCI-CTCAE v5.0 | Up to 135 days post last treatment visit |
| Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria as assessed by NCI-CTCAE v5.0 | Up to Day 28 |
| Number of participants with AEs leading to discontinuation as assessed by NCI-CTCAE v5.0 | Up to 135 days post last treatment visit |
| Number of deaths as assessed by NCI-CTCAE v5.0 | Through study completion (Up to 4 years) |
Secondary
| Measure | Time frame |
|---|---|
| Concentration at the end of infusion (Cmax) | Up to 135 days post last treatment visit |
| Time of maximum observed concentration (Tmax) | Up to 135 days post last treatment visit |
| Area under the concentration-time curve in one dosing interval (AUC(TAU)) | Up to 135 days post last treatment visit |
| Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as assessed by Investigator | Up to 135 days post last treatment visit |
Countries
Belgium, Denmark, France, Greece, Italy, Netherlands, Spain, Sweden, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed