Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 10 months later May 31, 2027 → Apr 7, 2028
See other at-risk trials from Alliance for Clinical Trials in Oncology

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from May 31, 2027 to Apr 7, 2028
  2. Eligibility criteria shortened, about 117 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description revised
    • Site details revised at 10 of 194 sites
  3. Eligibility criteria expanded, about 26 words
    • Secondary endpoints revised (4)
    • Study description revised
    v12
  4. Re-verified, no change to tracked fieldsv11
  5. Start date: May 30, 2023 to Jun 7, 2023v10
Show 8 earlier versionsHide 8 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 72 to confirmed 77
    • Study sites: 190 to 194
    v9
  2. Study sites: 188 to 190v8
  3. Study sites: 183 to 188v7
  4. Study sites: 143 to 183v6
  5. Trial status: Suspended to Recruiting
    • Study sites: 79 to 143
    v5
  6. Re-verified, no change to tracked fieldsv4
  7. Trial status: Recruiting to Suspended Sponsor's reason: Scheduled analysis of safety lead in.
    • Site details revised at 79 of 79 sites
    v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 20, 2023 to May 30, 2023
    • Study sites: 0 to 79
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 treatment with palbociclib alone to treatment with palbociclib plus cemiplimab for treating patients with dedifferentiated liposarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Cemiplimab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. The combination of these two drugs may be more effective in shrinking or stabilizing advanced dedifferentiated liposarcoma compared to palbociclib alone.
Trial Details
NCT Number NCT05694871
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Advanced Dedifferentiated Liposarcoma, Locally Advanced Dedifferentiated Liposarcoma, Metastatic Dedifferentiated Liposarcoma, Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Unresectable Dedifferentiated Liposarcoma
Related terms Liposarcoma
Enrollment 77 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov