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NCT04339738 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of Nivolumab to Chemotherapy in Treatment of Soft Tissue Sarcoma
A Phase 2 study of Skin Angiosarcoma and Skin Radiation-Related Angiosarcoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 89
- Enrollment target
- 20
- Study locations
NCT04339738: Active Phase 2 study of Skin Angiosarcoma and Skin Radiation-Related Angiosarcoma, sponsored by National Cancer Institute (NCI).
NCT04339738 is a Phase 2 study of Skin Angiosarcoma and Skin Radiation-Related Angiosarcoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 89 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04339738, a Phase 2 study of Skin Angiosarcoma and Skin Radiation-Related Angiosarcoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 89 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well paclitaxel with and without nivolumab works in treating patients with soft tissue sarcoma that have not received taxane drugs, and how well nivolumab and cabozantinib work in treating taxane pretreated patients with soft tissue sarcoma. Nivolumab works through the body's immune system to help the immune system act against tumor cells. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial is being done to see if the combination of nivolumab and paclitaxel or cabozantinib can shrink soft tissue sarcoma and possibly prevent it from coming back.
Primary Outcome
Will compare the PFS in taxane naive angiosarcoma patients receiving either (1) paclitaxel + nivolumab compared to (2) paclitaxel alone. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions compared to the nadir (smallest) sum of target lesions, any new lesions, or unequivocal progression of existing non-target lesions.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- DRUG Cabozantinib S-malate
- PROCEDURE FDG-Positron Emission Tomography
Study Locations (20)
Connecticut
- Smilow Cancer Hospital-Derby Care Center - Derby
- Smilow Cancer Hospital Care Center-Fairfield - Fairfield
- Smilow Cancer Hospital Care Center at Glastonbury - Glastonbury
- Smilow Cancer Hospital Care Center at Greenwich - Greenwich
- Smilow Cancer Hospital Care Center - Guilford - Guilford
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford
- Yale University - New Haven
- Yale-New Haven Hospital North Haven Medical Center - North Haven
- Smilow Cancer Hospital-Orange Care Center - Orange
- Smilow Cancer Hospital-Torrington Care Center - Torrington
- Smilow Cancer Hospital Care Center-Trumbull - Trumbull
- Smilow Cancer Hospital-Waterbury Care Center - Waterbury
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
- University of Arizona Cancer Center-Orange Grove Campus - Tucson
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
California
- City of Hope Comprehensive Cancer Center - Duarte
Colorado
- UCHealth University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2020-11-04 |
| Est. Completion | 2027-01-21 |
| Phase | Phase 2 |
What the registry record for NCT04339738 still lists
NCT04339738 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% lower).
The record links to 3 conditions, with Skin Angiosarcoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04339738 names 20 study sites across 5 states, led by Connecticut, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04339738 about?
NCT04339738 is a clinical study titled "Testing the Addition of Nivolumab to Chemotherapy in Treatment of Soft Tissue Sarcoma". This phase II trial studies how well paclitaxel with and without nivolumab works in treating patients with soft tissue sarcoma that have not received taxane drugs, and how well nivolumab and cabozantinib work in treating taxane pretreated patients with soft tissue sarcoma. Nivolumab works through th...
What is the current status of trial NCT04339738?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 89 participants. The study started on 2020-11-04. Estimated completion is 2027-01-21.
What conditions does trial NCT04339738 study?
This clinical trial studies the following conditions: Skin Angiosarcoma, Skin Radiation-Related Angiosarcoma, Visceral Angiosarcoma.
What interventions are being tested in trial NCT04339738?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Cabozantinib S-malate (DRUG), FDG-Positron Emission Tomography (PROCEDURE).
Who is sponsoring clinical trial NCT04339738?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04339738 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04339738's enrollment target sits among peer trials
89 802nd of 2000 higher than 1,198 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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