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NCT05694871 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma
A Phase 2 study of Metastatic Dedifferentiated Liposarcoma and Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, sponsored by Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
- 20
- Study locations
NCT05694871: Active Phase 2 study of Metastatic Dedifferentiated Liposarcoma and Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, sponsored by Alliance for Clinical Trials in Oncology.
NCT05694871 is a Phase 2 study of Metastatic Dedifferentiated Liposarcoma and Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 77 participants, below the 112-participant average among 5 other Metastatic Dedifferentiated Liposarcoma trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05694871, a Phase 2 study of Metastatic Dedifferentiated Liposarcoma and Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Efficacy analyses will be based on intention to treat principles. PFS will be compared between the two treatment arms using Kaplan-Meier methods. The hazard ratio, median PFS, and estimated PFS rates at 12, 24, 36, and 48 months will be estimated along with corresponding 95% confidence intervals. A log-rank test will be used to compare the PFS distributions between the two treatment arms in this cohort. Cox proportional hazards models will also be used to assess the impact of treatment arm on PF
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- BIOLOGICAL Cemiplimab
- PROCEDURE Biospecimen collection
- DRUG Palbociclib
Study Locations (20)
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente Dublin - Dublin
- Mercy Cancer Center - Elk Grove - Elk Grove
- Kaiser Permanente-Fremont - Fremont
- Fresno Cancer Center - Fresno
- Kaiser Permanente-Fresno - Fresno
- Mercy Cancer Center - Merced
- Kaiser Permanente-Modesto - Modesto
- Kaiser Permanente Oakland-Broadway - Oakland
- Kaiser Permanente-Oakland - Oakland
- Kaiser Permanente-Rancho Cordova Cancer Center - Rancho Cordova
- Kaiser Permanente- Marshall Medical Offices - Redwood City
Arizona
- Cancer Center at Saint Joseph's - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2023-06-07 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 2 |
What the registry record for NCT05694871 still lists
NCT05694871 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 112-participant average among 5 other Metastatic Dedifferentiated Liposarcoma trials with a reported enrollment target (31% lower).
The record links to 6 conditions, with Metastatic Dedifferentiated Liposarcoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT05694871 names 20 study sites across 3 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT05694871 about?
NCT05694871 is a clinical study titled "Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma". 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). P...
What is the current status of trial NCT05694871?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2023-06-07. Estimated completion is 2027-05-31.
What conditions does trial NCT05694871 study?
This clinical trial studies the following conditions: Metastatic Dedifferentiated Liposarcoma, Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Unresectable Dedifferentiated Liposarcoma, Advanced Dedifferentiated Liposarcoma, Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8.
What interventions are being tested in trial NCT05694871?
The interventions under investigation include: Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Cemiplimab (BIOLOGICAL), Biospecimen collection (PROCEDURE), Palbociclib (DRUG).
Who is sponsoring clinical trial NCT05694871?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05694871 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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