Study of SBRT with Nivolumab and BMS-986253 for Advanced Solid Tumors and Melanoma
This study is looking at the safety and effectiveness of combining Stereotactic Body Radiotherapy (SBRT), a type of focused radiation, with two immunotherapy drugs: nivolumab and BMS-986253. Nivolumab is a drug that helps your immune system fight cancer, and BMS-986253 is another drug that targets a specific protein (IL-8) involved in cancer growth. This study is for people aged 18 or older with advanced solid tumors that have spread (metastases) or cannot be removed by surgery, and who have already tried standard treatments. It also includes people with melanoma. The main goal is to see if this combination treatment is safe and what side effects it might cause. The study plans to enroll 50 participants, but its current status is unclear.
- Study design
- This is an interventional study that plans to enroll 50 participants. It will be conducted in two parts, first focusing on safety and then on effectiveness.
- What's involved
- Participants will receive nivolumab intravenously every 4 weeks and BMS-986253 intravenously every 2 weeks, along with SBRT to 1 to 4 metastatic lesions.
- Compensation
- Not stated in the trial record.
- Follow-up
- The rate of dose-limiting toxicities will be measured for up to 8 weeks after the start of immunotherapeutic treatment.
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NCT04572451
Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma
Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatmentYana NajjarInvestigator-initiated
~50 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:nivolumabBMS-986253Stereotactic Body Radiotherapy (SBRT)
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Dose Limiting Toxicities (DLT)
Measured over Up to 8 weeks after start of immunotherapeutic treatment
+1 more outcome measured
Conditions
Where it's being run
2 sites across 2 statesIllinois1
Pennsylvania1
Study leadership
- Yana Najjar, MD, FACP · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
SAFETY COHORT
Leukocytes ≥ 3000/mcL;
absolute neutrophil count ≥ 1500/mcL;
Platelets ≥ 100,000/mcL;
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) ;
Total bilirubin ≤ 1.5 × ULN (except participants with Gilbert's Syndrome who must have normal direct bilirubin)
Serum creatinine ≤ 1.5 × ULN Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non- nodal lesions and short axis for nodal lesions) as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam 6. Ability to understand and the willingness to sign a written informed consent document. 7. Reproductive status
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study treatment.
Women must not be breastfeeding.
WOCBP must agree to follow instructions for method(s) of contraception (Appendix 5) for the duration of study treatment plus 5 half-lives of nivolumab plus 30 days (duration of ovulatory cycle), for a total of 155 days post treatment completion. Local laws and regulations may require use of alternative and/or additional contraception methods.
WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, but should still undergo pregnancy testing as described in this section.
Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (Appendix4) during combination treatment with study treatment BMS-986253 and nivolumab, plus 5 half-lives of nivolumab (∼125 days), plus 90 days (duration of sperm turnover), for a total of 215 days post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time.
EFFICACY COHORT
Exclusion
Patients who are receiving any other investigational agents.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab and BMS-986253
Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:
A confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
Subjects with history of life-threatening toxicity related to prior immune therapy (eg. anti-CTLA-4 or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hormone replacement after endocrinopathy).
Subject has been administered prior chemotherapy or immunotherapy at any time, and any with radiation therapy within 4 weeks prior to time of consent or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to previously administered agent.
If subject underwent major surgery, subject must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Subject has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
A known or underlying medical condition that, in the opinion of the investigator could make the administration of study drug hazardous to the subject or could adversely affect the ability of the subject to comply with or tolerate study therapy.
Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated with the study drugs.
Subjects who are unable to undergo venipuncture and/or tolerate venous access
Evidence of active infection that requires systemic antibacterial, antiviral, or antifungal therapy ≤ 7 days prior to initiation of study drug therapy
Subjects who are on immunosuppressive therapy (systemic steroids 10mg and more daily use)
Prisoners or subjects who are involuntarily incarcerated
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
Inability to comply with restrictions and prohibited activities and treatments
What this trial measures
- Rate of Dose Limiting Toxicities (DLT)Up to 8 weeks after start of immunotherapeutic treatment
The rate of Dose Limiting Toxicities (DLT) that are determined to be definitely, probably or possibly attributed to SBRT or one or both of the immunotherapies. Patients receiving one of more fractions of SBRT are evaluable for DLT. Toxicities include grade 3 or higher adverse events, by organ system, by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
- Response rate to SBRT/Nivolumab/BMS98625Up to 1 year from treatment initiation, assessed every 8 weeks.
Response to combination therapy and primary endpoint is ORR measured by RECIST v1.1 criteria.