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Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
NCT06422806 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 365 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06422806 reports 20 study locations spanning 2 distinct geographic areas — top geographies include California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06422806?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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