Immunotherapy Combined With Radiotherapy for Metastatic Sarcoma

StatusActive, Not Recruiting
PhaseEarly Phase 1
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 11% 9 → 8 participants
See other at-risk trials from University of California, Irvine

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 9 → 8 participants Show 4 more changesShow less
    • Study completion pushed from Aug 2026 to Nov 2026
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: details revised at 5 of 9 entries
    • Publications: details revised at 1 of 1 entry
  2. Study completion date: Aug 2025 to Aug 2026v8
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 12 to confirmed 9
    • Primary completion date changed from estimate of Aug 2025 to Jun 27, 2025
    • Site details revised
    v7
  4. Primary and study completion dates: Aug 2024 to Aug 2025v6
  5. Eligibility criteria expanded, about 3 wordsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary endpoint revisedv4 Show 4 more changesShow less
    • Primary and study completion dates: Apr 2024 to Aug 2024
    • Eligibility criteria expanded, about 19 words
    • Study title revised
    • Study arms: 1 to 2
  2. Primary endpoint revised
    • Interventions: Pembrolizumab (Drug), Stereotactic body radiation therapy (Radiation) to Pembrolizumab (Drug), Radiation therapy (Radiation)
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2022 to Aug 3, 2022
    • Site details revised
    v2
  1. Study First Submitted
  • 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.
This is a pilot study determining the feasibility of combination treatments, pembrolizumab and stereotactic ablative radiotherapy (SBRT) in subjects with soft-tissue sarcoma. These are subjects who have metastatic disease initially, or recurrent or progressive disease that is not eligible for curative surgery.
Trial Details
NCT Number NCT05488366
Lead Sponsor University of California, Irvine
Conditions
(from sponsor)		 Sarcoma, Soft Tissue
Related terms Sarcoma
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov