Testing the Addition of Nivolumab to Chemotherapy in Treatment of Soft Tissue Sarcoma

Running, not enrolling · Phase 2

Conditions studied: Skin Angiosarcoma, Skin Radiation-Related Angiosarcoma, Visceral Angiosarcoma

In brief

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.

Key facts

Study ID

NCT04339738

Run by

National Cancer Institute (NCI)

People needed

90

Starts

2020-11-04

Expected to finish

2027-01-21

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed cutaneous or visceral angiosarcoma, where curative treatment is either not possible or curative modality therapy is declined by the subject. Note: If a subject declines curative modality therapy, the reason must be documented (e.g. excessive morbidity to necessary surgery)
• Note: Radiation induced angiosarcomas are permitted
• All local diagnostic slides AND 5 x 4-6 micron unstained slides from diagnostic tumor tissue should be available for retrospective central pathology review
• Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Per RECIST v1.1, clinical lesions will only be considered measurable when they are superficial and >= 10 mm diameter as assessed using calipers or ruler (e.g. skin nodules). For the case of skin lesions, documentation by color photography including a ruler to estimate the size of the lesion is required. When lesions can be evaluated by both clinical exam and imagining, imaging evaluation should be undertaken since it is more objective and may also be reviewed at the end of the study. The same method of measurement should be used throughout the study, preferably performed by the same investigator. Areas previously radiated must have demonstrated disease progression at some point over the past 6 months and growth must be subsequent to the last line of anti-cancer directed therapy (e.g. chemotherapy, radiation therapy, surgery)
• Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
• Therefore, for women of childbearing potential only, a negative pregnancy test done =< 3 days prior to registration is required
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Prior Treatment
• Patient must have completed all prior cancer directed therapies (including investigational) >= 7 days prior to cycle 1 day 1
• Exception: prostate patients who are allowed to concurrently receive androgen suppression therapy
• Note: Radiation therapy must be completed >= 7 days of day 1 of study treatment, and must not be expected to significantly impact blood count recovery
• There is no limit to overall number of prior lines of therapy
• No prior PD-1 inhibitor or PD-L1 inhibitor therapy is permitted
• No prior administration of VEGF TKI therapy is permitted
• Recovery to baseline or' =< grade 1 CTCAE version 5.0 from toxicity related to any prior treatment, unless adverse events are clinically non-significant and/or stable on supportive therapy, with the exception of fatigue (which should be =< grade 2) or alopecia. Note: Patients should be expected to have experienced any nadir and have adequate blood count recovery prior to cycle 1 day 1
• Taxane Naive Patients Only: No prior exposure to taxane therapy of any duration for angiosarcoma
• Taxane Pre-treated Patients Only (Effective 10/28/2021, new patient accrual to Arm 3 was permanently closed): Prior taxane therapy is allowed at any point prior to registration as long as prior treatment eligibility criteria are met prior to cycle 1 day 1
• No major surgery (except the diagnostic biopsy) =< 28 days of study registration. Procedures such as thoracentesis, paracentesis, percutaneous biopsy, Lasik eye surgery are not considered major surgery. Subjects with clinically relevant ongoing complications from prior surgery are not eligible
• Absolute neutrophil count (ANC) >= 1,500/mm\^3
• Platelet count >= 100,000/mm\^3
• Hemoglobin >= 9.0 g/dL
• Calculated (Calc.) creatinine clearance >= 30 mL/min (per Cockcroft-Gault)
• Total bilirubin =< 1.5 x upper limit of normal (ULN)
• For patients with documented/suspected Gilbert's disease, bilirubin =< 3 x ULN

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• University of Arizona Cancer Center-Orange Grove Campus — Tucson, Arizona, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• UCHealth University of Colorado Hospital — Aurora, Colorado, United States
• Smilow Cancer Hospital-Derby Care Center — Derby, Connecticut, United States
• Smilow Cancer Hospital Care Center-Fairfield — Fairfield, Connecticut, United States
• Smilow Cancer Hospital Care Center at Glastonbury — Glastonbury, Connecticut, United States
• Smilow Cancer Hospital Care Center at Greenwich — Greenwich, Connecticut, United States
• Smilow Cancer Hospital Care Center - Guilford — Guilford, Connecticut, United States
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Yale-New Haven Hospital North Haven Medical Center — North Haven, Connecticut, United States
• Smilow Cancer Hospital-Orange Care Center — Orange, Connecticut, United States
• Smilow Cancer Hospital-Torrington Care Center — Torrington, Connecticut, United States
• Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut, United States
• Smilow Cancer Hospital-Waterbury Care Center — Waterbury, Connecticut, United States
• Smilow Cancer Hospital Care Center - Waterford — Waterford, Connecticut, United States
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
• UF Health Cancer Institute - Gainesville — Gainesville, Florida, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Moffitt Cancer Center-International Plaza — Tampa, Florida, United States
• Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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