Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05836571 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later May 15, 2026 → May 15, 2028
See other at-risk trials from National Cancer Institute LAO

Record History

  1. Primary and study completion pushed from May 15, 2026 to May 15, 2028 Eligibility criteria expanded, about 14 words · Secondary endpoints: details revised at 2 of 2 entries · Study description revised · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
    • Study sites revised (27)
  2. Study description expanded, about 18 words Study sites revised (27)v38 Show 1 more changeShow less
    • Study sites revised (27)

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv37
  4. Trial status: Recruiting to Active, Not Recruiting Interventions: Biopsy (Procedure), Biospecimen Collection (Procedure), Cabozantinib (Drug), Computed Tomography (Procedure), Ipilimumab (Biological)… to Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Cabozantinib (Drug), Computed Tomography (Procedure), Ipilimumab… · Study sites revised (27)v36 Show 2 more changesShow less
    • Interventions: Biopsy (Procedure), Biospecimen Collection (Procedure), Cabozantinib (Drug), Computed Tomography (Procedure), Ipilimumab (Biological)… to Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Cabozantinib (Drug), Computed Tomography (Procedure), Ipilimumab…
    • Study sites revised (27)

    See this version in full on ClinicalTrials.gov ↗

  5. Lead sponsor: National Cancer Institute (NCI) to National Cancer Institute LAO Study sites: 24 to 27 · Eligibility criteria shortened, about 72 words · Study description expanded, about 107 wordsv35 Show 3 more changesShow less
    • Study sites: 24 to 27
    • Eligibility criteria shortened, about 72 words
    • Study description expanded, about 107 words

    See this version in full on ClinicalTrials.gov ↗

Show 33 earlier versionsHide 33 earlier versions
  1. Study sites: 23 to 24v34
  2. Study sites: 20 to 23v33
  3. Study sites: 19 to 20v32
  4. Site details revised at 1 of 19 sitesv31
  5. Trial status: Suspended to Recruiting Study sites: 17 to 19v30 Show 1 more changeShow less
    • Study sites: 17 to 19
  6. 5 versions Re-verified since Mar 20, 2024, no change to tracked fieldsv25-v29
  7. Trial status: Recruiting to Suspended Sponsor's reason: Other - Administrative and regulatory issues. Site details revised at 17 of 17 sitesv24 Show 1 more changeShow less
    • Site details revised at 17 of 17 sites
  8. Study sites: 16 to 17v23
  9. Re-verified, no change to tracked fieldsv22
  10. Study sites: 14 to 16v21
  11. Study sites: 13 to 14v20
  12. Study sites: 12 to 13v19
  13. Study sites: 11 to 12v18
  14. Study sites: 9 to 11v17
  15. Study sites: 8 to 9v16
  16. Site contacts updated at 1 of 8 sitesv15
  17. Study sites revised (8)v14 See this version in full on ClinicalTrials.gov ↗
  18. Study sites: 4 to 8v13
  19. Study sites: 3 to 4v12
  20. Study sites: 2 to 3v11
  21. Re-verified, no change to tracked fieldsv10
  22. Start date changed from estimate of Jun 25, 2024 to Oct 25, 2023v9
  23. 2 versions Re-verified since Nov 15, 2023, no change to tracked fieldsv7-v8
  24. Secondary endpoints: details revised at 1 of 2 entries Study description shortened, about 27 wordsv6 Show 1 more changeShow less
    • Study description shortened, about 27 words

    See this version in full on ClinicalTrials.gov ↗

  25. Re-verified, no change to tracked fieldsv5
  26. Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Jun 1, 2025 to May 15, 2026 · Start date: Sep 29, 2023 to Jun 25, 2024 · Study sites: 0 to 2 · 2 morev4 Show 5 more changesShow less
    • Primary and study completion dates: Jun 1, 2025 to May 15, 2026
    • Start date: Sep 29, 2023 to Jun 25, 2024
    • Study sites: 0 to 2
    • Eligibility criteria shortened, about 23 words
    • Study description expanded, about 170 words

    See this version in full on ClinicalTrials.gov ↗

  27. Start date: May 26, 2023 to Sep 29, 2023v3
  28. Re-verified, no change to tracked fieldsv2
  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.
This phase II trial compares the effect of immunotherapy with ipilimumab and nivolumab alone to their combination with cabozantinib in treating patients with soft tissue sarcoma that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply and may also prevent the growth of new blood vessels that tumors need to grow. By these actions it may help slow or stop the spread of cancer cells. Adding cabozantinib to the combination of ipilimumab and nivolumab may be better in stopping or slowing the growth of tumor compared to ipilimumab and nivolumab alone in patients with advanced soft tissue sarcoma.
Trial Details
NCT Number NCT05836571
Lead Sponsor National Cancer Institute LAO
Conditions Locally Advanced Extraskeletal Myxoid Chondrosarcoma, Locally Advanced Leiomyosarcoma, Locally Advanced Liposarcoma, Locally Advanced Undifferentiated Pleomorphic Sarcoma, Locally Advanced Unresectable Soft Tissue Sarcoma, Metastatic Soft Tissue Sarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma, Unresectable Leiomyosarcoma +2 more
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov