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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
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 20, 2026 (before its estimated October 7, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 2 years 4 months later May 17, 2024 → Oct 7, 2026
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Yana Najjar

Record History

  1. Primary completion pushed from May 17, 2024 to Oct 7, 2026 Primary endpoint(s) modified · Enrollment closed, study ongoing · Completion pushed from May 31, 2027 to Aug 5, 2027 · 2 morev18 Show 5 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment closed, study ongoing
    • Completion pushed from May 31, 2027 to Aug 5, 2027
    • Study description expanded, about 88 words
    • Site details revised at 2 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Lead sponsor: Jason J. Luke, MD to Yana Najjar Site contacts updated at 1 of 2 sites · Study description shortened, about 1 wordv17 Show 2 more changesShow less
    • Site contacts updated at 1 of 2 sites
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Eligibility criteria shortened, about 24 words Study description shortened, about 71 words · Study title expanded, about 2 wordsv16 Show 2 more changesShow less
    • Study description shortened, about 71 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Suspended to Recruiting Site details revised at 2 of 2 sitesv15 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  5. Trial status: Recruiting to Suspended Sponsor's reason: Enrollment to the safety cohort is complete. Primary completion date changed from estimate of Dec 2025 to May 17, 2024 · Completion date: Dec 2026 to May 31, 2027 · Site details revised at 2 of 2 sitesv14 Show 3 more changesShow less
    • Primary completion date changed from estimate of Dec 2025 to May 17, 2024
    • Completion date: Dec 2026 to May 31, 2027
    • Site details revised at 2 of 2 sites
Show 12 earlier versionsHide 12 earlier versions
  1. Study description expanded, about 33 wordsv13 See this version in full on ClinicalTrials.gov ↗
  2. Primary completion date: Jul 2023 to Dec 2025 Completion date: Jul 2026 to Dec 2026v12 Show 1 more changeShow less
    • Completion date: Jul 2026 to Dec 2026
  3. Primary completion date: May 2026 to Jul 2023 Start date: Oct 8, 2021 to Nov 29, 2021 · Study sites: 1 to 2 · Completion date: Aug 2027 to Jul 2026v11 Show 3 more changesShow less
    • Start date: Oct 8, 2021 to Nov 29, 2021
    • Study sites: 1 to 2
    • Completion date: Aug 2027 to Jul 2026
  4. Primary completion date: Sep 2022 to May 2026 Completion date: Feb 2023 to Aug 2027v10 Show 1 more changeShow less
    • Completion date: Feb 2023 to Aug 2027
  5. Eligibility criteria expanded, about 11 wordsv9 See this version in full on ClinicalTrials.gov ↗
  6. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 2021 to Oct 8, 2021 · Site details revisedv8 Show 2 more changesShow less
    • Start date changed from estimate of Sep 2021 to Oct 8, 2021
    • Site details revised
  7. Primary completion date: Aug 2022 to Sep 2022 Completion date: Jan 2023 to Feb 2023 · Start date: Aug 2021 to Sep 2021v7 Show 2 more changesShow less
    • Completion date: Jan 2023 to Feb 2023
    • Start date: Aug 2021 to Sep 2021
  8. Start date: Jun 2021 to Aug 2021 Primary completion date: Jun 2022 to Aug 2022 · Completion date: Nov 2022 to Jan 2023v6 Show 2 more changesShow less
    • Primary completion date: Jun 2022 to Aug 2022
    • Completion date: Nov 2022 to Jan 2023
  9. Start date: Apr 2021 to Jun 2021 Primary completion date: Apr 2022 to Jun 2022 · Completion date: Sep 2022 to Nov 2022v5 Show 2 more changesShow less
    • Primary completion date: Apr 2022 to Jun 2022
    • Completion date: Sep 2022 to Nov 2022
  10. Start date: Feb 2021 to Apr 2021 Primary completion date: Jan 2022 to Apr 2022 · Completion date: Jan 2022 to Sep 2022v4 Show 2 more changesShow less
    • Primary completion date: Jan 2022 to Apr 2022
    • Completion date: Jan 2022 to Sep 2022
  11. Start date: Jan 2021 to Feb 2021v3
  12. Start date: Oct 2020 to Jan 2021 Primary completion date: Oct 2021 to Jan 2022 · Completion date: Oct 2023 to Jan 2022v2 Show 2 more changesShow less
    • Primary completion date: Oct 2021 to Jan 2022
    • Completion date: Oct 2023 to Jan 2022
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Yana Najjar
6 trials monitored
See 1 trial at risk
Melanoma
1,026 trials monitored
See 48 trials at risk
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov