NCT04339738|Active Not RecruitingPhase 2ResultsFDA Drug

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

A Multicenter Phase II Trial of Paclitaxel With and Without Nivolumab in Taxane Naive, and Nivolumab and Cabozantinib in Taxane Pretreated Subjects With Angiosarcoma

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2020-02153A091902U10CA180821

Study Type

interventional

Target

Locations

2 countries

Sites

171

Timeline

RegisteredApr 2020

StartedNov 2020

CompletionJan 2027

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

9mo left

Started Nov 2020

Longer than P75 for phase_2

Geographic Reach

2 countries

171 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.2 years study duration

Study Progress89%

Nov 2020Jan 2027

First Submitted

Initial submission to the registry

April 8, 2020

Completed

1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed

7 months until next milestone

Study Start

First participant enrolled

November 4, 2020

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

May 5, 2026

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2027

Expected

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

4.4 years

First QC Date

April 8, 2020

Results QC Date

March 30, 2026

Last Update Submit

April 20, 2026

Conditions

Skin Angiosarcoma Skin Radiation-Related Angiosarcoma Visceral Angiosarcoma

Outcome Measures

Primary Outcomes (2)

Progression Free Survival (PFS) in Taxane Naive Patients With Angiosarcoma
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.
21 months
Overall Response Rate (ORR) in Angiosarcoma Patients Who Have Had Prior Taxane
ORR defined as count of participants that reported a confirmed best response of partial response (PR) or complete response (CR). Evaluation of disease response determination will be defined based on RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Each target lymph node must have reduction in short axis to \<1.0 cm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
1.5 years

Secondary Outcomes (5)

ORR in the Nivolumab + Paclitaxel
Up to 3 years
Overall Survival in Each of the 2 Combination Arms
From study enrollment until death due to any cause, assessed up to 3 years
PFS Rate
At 6 months
Incidence of Adverse Events
Up to 3 years
Patient-reported Outcomes (PRO)
Up to 3 years

Study Arms (3)

Arm I (nivolumab, paclitaxel)

EXPERIMENTAL

Patients receive nivolumab IV over 30 minutes on day 1 and paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles repeat every 4 weeks for up to 2 years (24 months) for patients who achieve CR, PR or SD on immunotherapy/nivolumab, or in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.

Procedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: FDG-Positron Emission TomographyProcedure: Magnetic Resonance ImagingBiological: NivolumabDrug: PaclitaxelOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Arm II (paclitaxel)

EXPERIMENTAL

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.

Procedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: FDG-Positron Emission TomographyProcedure: Magnetic Resonance ImagingDrug: PaclitaxelOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Arm III (nivolumab, cabozantinib S-malate)

EXPERIMENTAL

Patients receive nivolumab IV over 30 minutes on day 1 and cabozantinib S-malate PO daily. Cycles repeat every 4 weeks for up to 2 years (24 months) for patients who achieve CR, PR or SD on immunotherapy/nivolumab, or in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.

Procedure: Biospecimen CollectionDrug: Cabozantinib S-malateProcedure: Computed TomographyProcedure: FDG-Positron Emission TomographyProcedure: Magnetic Resonance ImagingBiological: NivolumabOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of blood

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (nivolumab, paclitaxel)Arm II (paclitaxel)Arm III (nivolumab, cabozantinib S-malate)

Cabozantinib S-malateDRUG

Given PO

Also known as: BMS-907351, Cabometyx, Cometriq, XL 184, XL-184, XL184

Arm III (nivolumab, cabozantinib S-malate)

Computed TomographyPROCEDURE

Undergo CT, spiral CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Arm I (nivolumab, paclitaxel)Arm II (paclitaxel)Arm III (nivolumab, cabozantinib S-malate)

FDG-Positron Emission TomographyPROCEDURE

Undergo FDG-PET

Also known as: FDG, FDG-PET, FDG-PET Imaging

Arm I (nivolumab, paclitaxel)Arm II (paclitaxel)Arm III (nivolumab, cabozantinib S-malate)

Magnetic Resonance ImagingPROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Arm I (nivolumab, paclitaxel)Arm II (paclitaxel)Arm III (nivolumab, cabozantinib S-malate)

NivolumabBIOLOGICAL

Given IV

Also known as: ABP 206, BCD-263, BMS 936558, BMS-936558, BMS936558, CMAB819, MDX 1106, MDX-1106, MDX1106, NIVO, Nivolumab Biosimilar ABP 206, Nivolumab Biosimilar BCD-263, Nivolumab Biosimilar CMAB819, ONO 4538, ONO-4538, ONO4538, Opdivo

Arm I (nivolumab, paclitaxel)Arm III (nivolumab, cabozantinib S-malate)

PaclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Arm I (nivolumab, paclitaxel)Arm II (paclitaxel)

Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (nivolumab, paclitaxel)Arm II (paclitaxel)Arm III (nivolumab, cabozantinib S-malate)

Questionnaire AdministrationOTHER

Ancillary studies

Arm I (nivolumab, paclitaxel)Arm II (paclitaxel)Arm III (nivolumab, cabozantinib S-malate)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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
+75 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (171)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, 85704, United States

Location

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

Location

University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States

Location

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, 06418, United States

Location

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, 06824, United States

Location

Smilow Cancer Hospital Care Center at Glastonbury

Glastonbury, Connecticut, 06033, United States

Location

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, 06830, United States

Location

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, 06437, United States

Location

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, 06473, United States

Location

Smilow Cancer Hospital-Orange Care Center

Orange, Connecticut, 06477, United States

Location

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, 06790, United States

Location

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611, United States

Location

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, 06708, United States

Location

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385, United States

Location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Moffitt Cancer Center-International Plaza

Tampa, Florida, 33607, United States

Location

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, 33612, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Hawaii Cancer Care Inc - Waterfront Plaza