Studieoverzicht

Study name: A Phase 1/2 Study of BMS-986482 as Monotherapy or Combination Therapy in Participants With Advanced Solid Tumors

Histology NSCLC, all subtypes
Tumor stage Stage III - IV
NCT Id NCT06697197
Host / recruiting site 1 Antoni van Leeuwenhoek Enrollment Recruiting
Therapy line Later line (≥2L)
PD-L1 expression Negative: <1%Low: 1 - 49%High: ≥50%
Design

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.

Intervention

DRUG: BMS-986482

Specified dose on specified days

DRUG: Nivolumab and rHuPH20

Specified dose on specified days

DRUG: Bevacizumab

Specified dose on specified days

Key inclusion criteria
  • Participants must have recurrent or progressive disease during or after platinum doublet-based chemotherapy for advanced or metastatic disease, OR must have recurrent or progressive disease within 6 months after completing platinum-based chemotherapy
    for local disease.
  • Participants must have received anti-PD-(L)1 therapy, if eligible and available.
  • Status for actionable mutations (eg, epidermal growth factor [EGFR], anaplastic lymphoma kinase [ALK], ROS oncogene 1 [ROS1], rearranged during transfection [RET], etc.) must be known (when testing is available as per country/region standard of
    care practices); participants with actionable mutations must have received and progressed on, have been intolerant to, or not be a
    candidate for standard tyrosine kinase inhibitors (as available per country/region standard-of-care practices).
Key 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.
  • Untreated or symptomatic central nervous system (CNS) metastases. Participants are eligible if CNS metastases have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment). In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg QD prednisone (or
    equivalent) for at least 2 weeks prior to treatment assignment.
  • History of medically significant thromboembolic events or bleeding diathesis within the past 6 months, eg, cerebrovascular accident (including transient ischemic attacks), pulmonary hemorrhage > 2 teaspoonfuls/24 hours or repeated pulmonary hemorrhage, or gastrointestinal hemorrhage requiring transfusion or procedural intervention.
Contact information