Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04572451 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial
NCT04572451 · ClinicalTrials.gov record · last posted 2026-08-20

Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma

StatusActive, Not Recruiting
PhasePhase 1
Started2021-11-29
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 4 changes detected by DataLookout

2026-08-21
notable
Enrollment closed, study ongoing
2026-08-21
critical
Primary endpoint(s) modified
WasRate of Dose Limiting Toxicities (DLT)
NowRate of Dose Limiting Toxicities (DLT), Response rate to SBRT/Nivolumab/BMS98625
2026-08-21
critical
Primary completion pushed: 2024-05-17 → 2026-10-07
2026-08-21
minor
Completion pushed: 2027-05-31 → 2027-08-05
Trial Details
NCT Number NCT04572451
Lead Sponsor Yana Najjar
Collaborators: Bristol-Myers Squibb
Conditions Melanoma, Unresectable Solid Tumors, Neoplasms, Neoplasms by Histologic Type, Neoplasms by Site, Antineoplastic Agents, Immunological, Antineoplastic Agents, Immune Checkpoint Inhibitors +2 more
Enrollment 50 participants
Start Date 2021-11-29
Primary Completion 2026-10-07 (estimated)
Study Completion 2027-08-05 (estimated)
Updated on ClinicalTrials.gov 2026-08-20