OncoMatch/Clinical Trials/NCT04572451
Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma
Is NCT04572451 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including nivolumab and BMS-986253 for melanoma.
Treatment: nivolumab · BMS-986253 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Tumor Agnostic
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard therapies
Patients with advanced/metastatic/unresectable solid tumors progressed on standard therapies
Must have received: anti-PD-1/PD-L1 therapy
EFFICACY COHORT: Patients with anti-PD1/PDL1 refractory melanoma
Cannot have received: chemotherapy
Exception: Subjects with ≤ Grade 2 neuropathy may qualify; subjects with endocrinopathy adequately controlled with hormone replacement may qualify
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
Cannot have received: immunotherapy
Exception: Subjects with ≤ Grade 2 neuropathy may qualify; subjects with endocrinopathy adequately controlled with hormone replacement may qualify
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
Cannot have received: radiation therapy
Exception: Allowed if completed >4 weeks prior to consent
any with radiation therapy within 4 weeks prior to time of consent
Lab requirements
Blood counts
Leukocytes ≥ 3000/mcL; absolute neutrophil count ≥ 1500/mcL; Platelets ≥ 100,000/mcL; Hemoglobin not specified
Kidney function
Serum creatinine ≤ 1.5 × ULN
Liver function
ALT and AST ≤ 3 × ULN; Total bilirubin ≤ 1.5 × ULN (except Gilbert's Syndrome: normal direct bilirubin)
Patients must have normal organ and marrow function as defined below: Leukocytes ≥ 3000/mcL; absolute neutrophil count ≥ 1500/mcL; Platelets ≥ 100,000/mcL; ALT and AST ≤ 3 × ULN; Total bilirubin ≤ 1.5 × ULN (except Gilbert's Syndrome who must have normal direct bilirubin); Serum creatinine ≤ 1.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Chicago Medical Center · Chicago, Illinois
- UPMC Hillman Cancer Center · Pittsburgh, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify