Actively Recruiting
Phase I Study of Stereotactic Body Radiotherapy with Nivolumab and BMS-986253 for Multiple Metastases in Advanced Solid Tumors and Melanoma
Led by Yana Najjar · Updated on 2025-08-01
50
Participants Needed
2
Research Sites
158 weeks
Total Duration
On this page
Sponsors
Y
Yana Najjar
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and preliminary effectiveness of combining stereotactic body radiotherapy (SBRT) with two immune-oncology agents, nivolumab and BMS-986253 (an anti-IL-8 monoclonal antibody), in people with advanced solid tumors and melanoma, focusing on acral melanoma. This phase I/Ib trial aims to find safe radiation doses and observe treatment responses in patients who have progressed on standard therapies, including prior anti-PD-(L)1 therapy. The study has two parts: Part 1 tests different SBRT doses with fixed doses of nivolumab (480 mg every 4 weeks) and BMS-986253 (2400 mg every 2 weeks) in patients with advanced solid tumors. SBRT targets 1 to 4 metastatic lesions with 3 or 5 radiation sessions completed within 14 days. Part 2 focuses on patients with advanced melanoma resistant to previous anti-PD-(L)1 therapy to assess response rates and other safety outcomes using the same drug and radiation combination. Participants will receive intravenous nivolumab and BMS-986253 alongside SBRT, with treatment timing coordinated closely. Researchers will monitor side effects, dose-limiting toxicities, tumor responses, progression-free survival, and overall survival over multiple years. Assessments include imaging scans and clinical exams to measure tumor size and response. The study also aims to understand changes in the tumor environment caused by the treatment, with safety and efficacy followed up for up to three years after starting treatment.
CONDITIONS
Brief Title
Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Patients with advanced, metastatic, or unresectable solid tumors or melanoma
- Patients with 1 to 4 tumor sites that can be safely treated with radiation
- ECOG performance status of 0 or 1 (able to carry out daily activities with little or no assistance)
- Normal organ and marrow function as defined by specific blood count and liver/kidney test thresholds
- Measurable disease with at least one tumor lesion 10 mm or larger by imaging or clinical exam
- Ability to understand and sign informed consent
- Women of childbearing potential must have a negative pregnancy test and agree to contraception requirements
- Men sexually active with women of childbearing potential must agree to contraception requirements and refrain from sperm donation during treatment period
You will not qualify if you...
- Known or suspected untreated or uncontrolled brain metastases
- Receiving other investigational agents
- History of allergic reactions to nivolumab or BMS-986253 or similar compounds
- Active autoimmune diseases, except some controlled conditions
- Uncontrolled or significant cardiovascular conditions including recent heart attack, stroke, arrhythmias, or heart failure
- History of encephalitis, meningitis, or uncontrolled seizures within the past year
- Life-threatening toxicity from prior immune therapies
- Recent chemotherapy, immunotherapy, or radiation within 4 weeks prior to consent unless recovered
- Additional progressing or active malignancies requiring treatment, except some skin or cervical cancers
- Medical conditions that could make study treatment unsafe or interfere with compliance
- Pregnant or breastfeeding women
- Inability to undergo blood draws or tolerate venous access
- Active infections requiring systemic treatment within 7 days prior to study drug
- Use of immunosuppressive therapy including systemic steroids 10mg or more daily
- Prisoners or involuntarily incarcerated individuals
- Compulsory detention for psychiatric or physical illness
- Inability to comply with study restrictions and prohibited treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies per participant depending on SBRT schedule and immunotherapy cycles
Participants receive stereotactic body radiotherapy (SBRT) targeting 1 to 4 metastatic lesions over 3 to 5 fractions within 14 days, combined with intravenous nivolumab every 4 weeks and BMS-986253 every 2 weeks.
SBRT delivered in 3 to 5 sessions within 14 days; nivolumab infusions every 4 weeks; BMS-986253 infusions every 2 weeks
Duration - Up to 3 years
Participants are monitored for safety, tolerability, and preliminary efficacy after treatment completion.
Periodic visits for assessments up to 3 years
Trial Site Locations
Total: 2 locations
1
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
2
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
D
Danielle L Bednarz, BSN
A
Amy Rose, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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