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NCT06422806 · ClinicalTrials.gov registry record · Phase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
A Phase 3 study of Metastatic Dedifferentiated Liposarcoma and Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 3
- Development phase
- 365
- Enrollment target
- 20
- Study locations
NCT06422806 is a Phase 3 study of Metastatic Dedifferentiated Liposarcoma and Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 365 participants, above the 54-participant average among 5 other Metastatic Dedifferentiated Liposarcoma trials with a reported enrollment target (576% higher). The trial reports 20 study locations across 2 states.
The verdict
NCT06422806, a Phase 3 study of Metastatic Dedifferentiated Liposarcoma and Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 365 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effect of immunotherapy (pembrolizumab) plus chemotherapy (doxorubicin) to chemotherapy (doxorubicin) alone in treating patients with dedifferentiated liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding immunotherapy (pembrolizumab) to the standard chemotherapy (doxorubicin) may help patients with metastatic or unresectable DDLPS, UPS or a related poorly differentiated sarcoma live longer without having disease progression.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Doxorubicin
- PROCEDURE Echocardiography Test
- PROCEDURE Diagnostic Imaging Testing
- PROCEDURE Multigated Acquisition Scan
Study Locations (20)
California
- Kaiser Permanente Dublin - Dublin
- Kaiser Permanente-Fremont - Fremont
- Kaiser Permanente Fresno Orchard Plaza - Fresno
- Kaiser Permanente-Fresno - Fresno
- UC San Diego Moores Cancer Center - La Jolla
- Keck Medicine of USC Koreatown - Los Angeles
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Kaiser Permanente- Modesto MOB II - Modesto
- Kaiser Permanente-Modesto - Modesto
- USC Norris Oncology/Hematology-Newport Beach - Newport Beach
- Kaiser Permanente-Oakland - Oakland
- Stanford Cancer Institute Palo Alto - Palo Alto
- VA Palo Alto Health Care System - Palo Alto
- Huntington Memorial Hospital - Pasadena
- Kaiser Permanente-Roseville - Roseville
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 365 participants |
| Start Date | 2024-09-11 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06422806
The ClinicalTrials.gov registry entry for NCT06422806 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 365 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 54-participant average among 5 other Metastatic Dedifferentiated Liposarcoma trials with a reported enrollment target (576% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Metastatic Dedifferentiated Liposarcoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06422806 reports 20 study locations spanning 2 distinct geographic areas - top geographies include California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06422806 about?
NCT06422806 is a clinical study titled "Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas". This phase III trial compares the effect of immunotherapy (pembrolizumab) plus chemotherapy (doxorubicin) to chemotherapy (doxorubicin) alone in treating patients with dedifferentiated liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has...
What is the current status of trial NCT06422806?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 365 participants. The study started on 2024-09-11. Estimated completion is 2026-06-30.
What conditions does trial NCT06422806 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, Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Metastatic Undifferentiated Pleomorphic Sarcoma.
What interventions are being tested in trial NCT06422806?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Doxorubicin (DRUG), Echocardiography Test (PROCEDURE), Diagnostic Imaging Testing (PROCEDURE), Multigated Acquisition Scan (PROCEDURE).
Who is sponsoring clinical trial NCT06422806?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06422806 being conducted?
This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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