Actively Recruiting
Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma
Led by Yana Najjar · Updated on 2025-08-01
50
Participants Needed
2
Research Sites
287 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
Nivolumab (and other agents affecting the anti-programmed death-1 \[anti-PD-1\] pathway) have demonstrated anti-tumor activity in multiple tumor types. Combinations of immune-oncology (IO) agents with complimentary mechanisms as well as radiation represent a promising strategy to improve response rates to immunotherapy and overcome resistance. In this phase I/Ib study, radiation will be used in combination with IO agents nivolumab and anti-IL-8 (BMS-986253) to assess toxicity by organ system and then assess the preliminary efficacy of the treatment regimen. In Part 1, the study will determine the safe doses of radiation by organ site in conjunction with nivolumab and BMS-986253. In Part 2, the treatment regimen will be investigated in melanoma, prioritizing acral melanoma, to describe the response rate to treatment as well as other clinical and safety outcomes. The study will also provide the opportunity to evaluate changes in the tumor microenvironment induced by the treatment.
CONDITIONS
Official 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...
- Patients with advanced, metastatic, or unresectable solid tumors that have progressed on standard therapies
- Patients with melanoma and renal cell carcinoma comprising about 30% of the safety cohort
- Patients with 1 to 4 tumor sites that can be irradiated safely
- Age 18 years or older
- ECOG performance status of 0 or 1
- Normal organ and marrow function including leukocytes 3000/mcL, absolute neutrophil count 1500/mcL, platelets 100,000/mcL
- Liver enzymes (ALT and AST) 3 times the upper limit of normal
- Total bilirubin 1.5 times the upper limit of normal (except Gilbert's Syndrome with normal direct bilirubin)
- Serum creatinine 1.5 times the upper limit of normal
- Measurable disease with at least one lesion 10 mm by CT, MRI, or clinical exam
- Ability to understand and willingness to sign informed consent
- Women of childbearing potential must have a negative pregnancy test within 24 hours before treatment, not be breastfeeding, and agree to contraception during treatment and specified follow-up periods
- Males sexually active with women of childbearing potential must agree to contraception during treatment and specified follow-up periods
- For the efficacy cohort, patients must have anti-PD1/PDL1 refractory melanoma
- Other criteria as above for safety cohort regarding tumor sites, age, performance status, organ function, measurable disease, and consent
You will not qualify if you...
- Known or suspected brain metastases unless controlled without progression for at least 4 weeks after treatment and off steroids for 2 weeks
- Symptoms of brain metastases without imaging ruling them out
- Receiving any other investigational agents
- History of allergic reactions to compounds similar to nivolumab or BMS-986253
- Active or suspected autoimmune diseases except certain controlled conditions
- Uncontrolled or significant cardiovascular disease including recent heart attack, stroke, angina, arrhythmias, prolonged QTc, or severe heart failure
- History of encephalitis, meningitis, or uncontrolled seizures in the past year
- Life-threatening toxicity from prior immune therapy unless unlikely to recur
- Chemotherapy, immunotherapy, or radiation within 4 weeks before consent unless recovered to baseline or Grade 1
- Major surgery without adequate recovery before therapy
- Additional progressing malignancies requiring treatment except certain skin cancers or in situ cervical cancer
- Medical conditions posing hazard or compliance issues as judged by investigator
- Pregnant or breastfeeding women
- Unable to tolerate venous access or venipuncture
- Active infections requiring systemic treatment within 7 days before starting study drug
- Use of immunosuppressive therapy such as systemic steroids at doses of 10 mg or more daily
- Prisoners or involuntarily incarcerated individuals
- Compulsory detention for psychiatric or infectious disease treatment
- Inability to comply with study restrictions and prohibited activities
AI-Screening
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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
CONTACT
A
Amy Rose, BSN
CONTACT
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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