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

Who is this study for? Adult patients with Cutaneous or Visceral Angiosarcoma
What treatments are being studied? Nivolumab
Status: Active_not_recruiting
Location: See all (171) locations...
Intervention Type: Other, Procedure, Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)

‣ For patients with significant hepatic metastases, ALT and AST =\< 5 x ULN. No clinically active or chronic liver disease resulting in moderate/severe hepatic impairment (Child-Pugh class B or C), ascites, coagulopathy or bleeding due to liver dysfunction

• Urine protein:creatinine (UPC) ratio \< 1 or urine protein =\< 1+ (Only for Arm 3 Taxane pre-treated and crossover patients)

• No uncontrolled central nervous system (CNS) metastases. Patients with history of CNS metastasis will be allowed as long as the metastatic sites were adequately treated as demonstrated by clinical and radiographic improvement, and the patient has recovered from the intervention (no residual adverse events \> CTCAE grade 1), and the patient has remained without recurrence of new or worsening CNS symptoms for a period of 28 days prior to registration. Treated CNS metastasis (mets) should have no ongoing requirement for steroids, and no evidence of hemorrhage after treatment for at least 28 days prior to registration

• No uncontrolled intercurrent illness that would put the patient at undue risk by participation in the study, in the opinion of the investigator

• No history of syncope of cardiovascular etiology, uncontrolled cardiac arrhythmia, history of Mobitz II second degree or third degree heart block without a permanent pacemaker in place, myocardial ischemia or infarction, severe or unstable angina, New York Heart Association (NYHA) class II to IV heart failure, or stroke/transient ischemic attack (TIA) within the past 3 months

• No thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 1 month before randomization. Subjects with a diagnosis of incidental, subsegmental pulmonary embolism (PE) or deep vein thrombosis (DVT) within 6 months are allowed if stable, asymptomatic, and treated with low molecular weight heparin (LMWH) for at least 2 weeks before first dose. Iatrogenic arterial embolization procedures such as tumor arterial embolization or splenic artery embolization are allowed

• Patients with a requirement for steroid treatment or other immunosuppressive treatment: Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted

• Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)

• Active autoimmune disease requiring systemic treatment (i.e. disease modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. These include but are not limited to patients with a history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), rheumatoid arthritis, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease

‣ Note: Patients are permitted to enroll if they have vitiligo; type I diabetes mellitus; hypothyroidism, pituitary or adrenal insufficiency requiring only hormone replacement; psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)

• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

• No planned palliative procedures for alleviation of pain such as radiation therapy or surgery

• No untreated or impending spinal cord compression or evidence of spinal metastases with a risk of impending fracture or spinal cord compression

• No known or suspected contraindications or hypersensitivity to paclitaxel, cabozantinib or nivolumab or to any of the excipients

• Disorders associated with a high risk of perforation or fistula formation: active inflammatory bowel disease, active diverticulitis, active cholecystitis, active symptomatic cholangitis or active appendicitis, active acute pancreatitis or active acute obstruction of the pancreatic or biliary duct, or active gastric outlet obstruction; abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before randomization. Note: Complete healing of an intra-abdominal abscess must be confirmed before randomization

• No clinically significant hematuria, hematemesis, or hemoptysis, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 3 months before randomization

• No lesions invading major pulmonary blood vessels

• No other clinically significant disorders: uncompensated/symptomatic hypothyroidism; requirements for hemodialysis or peritoneal dialysis; history of solid organ transplantation

• Serious non-healing wounds unrelated to cancer are excluded

‣ Note: Wounds that are cutaneous angiosarcoma are allowed

• Chronic concomitant treatment with strong inhibitors and inducers of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors and inducers must discontinue the drug 7 days and 14 days, respectively prior to registration on the study

• Taxane Naive Patients Only: No clinically significant neuropathy (grade \>= 2 per NCI CTCAE v5.0)

• Taxane Pre-treated only (Effective 10/28/2021, new patient accrual to Arm 3 was permanently closed):

‣ Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before first dose. Subjects with a diagnosis of DVT within 6 months are allowed if stable and treated with LMWH for at least 2 weeks before first dose

⁃ No history of clinically significant coagulopathy

⁃ No uncontrolled hypertension, defined as systolic blood pressure of \> 140 mmHg or diastolic pressure \> 90 mmHg on anti-hypertensive medications

⁃ No known or suspected gastrointestinal disorder affecting absorption of oral medications (for patients getting cabozantinib)

• No clinical, laboratory or radiographic evidence of an active bacterial, fungal, or viral infection requiring treatment at the time of registration. No concurrent use of parenteral (IV) antibiotics is permitted. Oral antibiotics administered for a defined course with expectation of resolution of infection are permitted at the discretion of the investigator

• No use of ongoing systemic steroid therapy within 7 days prior to study registration. Dose equivalence of prednisone 10mg daily or less is permitted

• Taxane Pre-treated only:

‣ No current use of aspirin (\> 81 mg/day), or any other antiplatelet agents

⁃ Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin inhibitors, and factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel) is not permitted. Low-dose (prophylactic) low molecular weight heparins (LMWH) are permitted. Anticoagulation with therapeutic doses of LMWH is allowed in subjects with no known brain metastases, no clinically significant hemorrhage, or no complications from a thromboembolic event on the anticoagulation regimen, and who have been on a stable dose of LMWH for at least 2 weeks before first dose

• Patients must be able to speak and comprehend English or Spanish in order to complete the mandatory patient-completed measures

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): 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 re-registration is required

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): Age \>= 18 years

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): ECOG performance status 0-1

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): Prior Treatment

‣ Patient must have completed all prior treatments (including investigational Arm 2 paclitaxel) \>= 28 days prior to cycle 1 day 1

• Exception: prostate patients who are allowed to concurrently receive androgen suppression therapy

∙ Note: Re-registration is only permitted after progression on Arm 2

⁃ No prior PD-1 inhibitor or PD-L1 inhibitor 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

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): No major surgery (except the diagnostic biopsy) =\< 28 days of study re-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

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): Absolute neutrophil count (ANC) \>= 1,500/mm\^3

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): Platelet count \>= 100,000/mm\^3

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): Hemoglobin \>= 9.0 g/dL

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): Calc. creatinine clearance \>= 30 mL/min (per Cockcroft-Gault)

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): Total bilirubin =\< 1.5 x upper limit of normal (ULN)

‣ For patients with documented/suspected Gilbert's disease, bilirubin =\< 3 x ULN

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): AST/ALT =\< 2.5 x upper limit of normal (ULN)

‣ For patients with significant hepatic metastases, ALT and AST =\< 5 x ULN. No clinically active or chronic liver disease resulting in moderate/severe hepatic impairment (Child-Pugh class B or C), ascites, coagulopathy or bleeding due to liver dysfunction

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): UPC ratio \< 1 or urine protein =\< 1+

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): No uncontrolled CNS metastases. Patients with history of CNS metastasis will be allowed as long as the metastatic sites were adequately treated as demonstrated by clinical and radiographic improvement, and the patient has recovered from the intervention (no residual adverse events \> CTCAE grade 1), and the patient has remained without recurrence of new or worsening CNS symptoms for a period of 28 days prior to registration. Treated CNS mets should have no ongoing requirement for steroids, and no evidence of hemorrhage after treatment for at least 28 days prior to registration

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): No uncontrolled intercurrent illness that would put the patient at undue risk by participation in the study, in the opinion of the investigator

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): No history of syncope of cardiovascular etiology, uncontrolled cardiac arrhythmia, History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place, myocardial ischemia or infarction, severe or unstable angina, New York Heart Association (NYHA) class II to IV heart failure, or stroke/transient ischemic attack (TIA) within the past 3 months

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): No thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 1 month before randomization. Subjects with a diagnosis of incidental, subsegmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with LMWH for at least 2 weeks before first dose. Iatrogenic arterial embolization procedures such as tumor arterial embolization or splenic artery embolization are allowed

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): Patients with a requirement for steroid treatment or other immunosuppressive treatment: Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): Active autoimmune disease requiring systemic treatment (i.e. disease modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. These include but are not limited to patients with a history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as SLE, rheumatoid arthritis, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease

‣ Note: Patients are permitted to enroll if they have vitiligo; type I diabetes mellitus; hypothyroidism, pituitary or adrenal insufficiency requiring only hormone replacement; psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): No planned palliative procedures for alleviation of pain such as radiation therapy or surgery

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): No untreated or impending spinal cord compression or evidence of spinal metastases with a risk of impending fracture or spinal cord compression

• Re-Registration Eligibility Criteria (upon progression on Arm 2 only): No known or suspected contraindications or hypersensitivity to cabozantinib or nivolumab or to any of the exc

Locations
United States
Arkansas
Mercy Hospital Fort Smith
Fort Smith
Arizona
Mayo Clinic Hospital in Arizona
Phoenix
Mayo Clinic in Arizona
Scottsdale
Banner University Medical Center - Tucson
Tucson
University of Arizona Cancer Center-North Campus
Tucson
University of Arizona Cancer Center-Orange Grove Campus
Tucson
California
City of Hope Comprehensive Cancer Center
Duarte
Colorado
UCHealth University of Colorado Hospital
Aurora
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
Smilow Cancer Hospital Care Center - Waterford
Waterford
Washington, D.c.
Sibley Memorial Hospital
Washington D.c.
Florida
UF Health Cancer Institute - Gainesville
Gainesville
Mayo Clinic in Florida
Jacksonville
Moffitt Cancer Center
Tampa
Moffitt Cancer Center - McKinley Campus
Tampa
Moffitt Cancer Center-International Plaza
Tampa
Georgia
Emory University Hospital Midtown
Atlanta
Hawaii
Hawaii Cancer Care - Westridge
‘aiea
Pali Momi Medical Center
‘aiea
Queen's Cancer Center - Pearlridge
‘aiea
The Cancer Center of Hawaii-Pali Momi
‘aiea
The Queen's Medical Center - West Oahu
‘ewa Beach
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu
Hawaii Cancer Care Inc-Liliha
Honolulu
Hawaii Diagnostic Radiology Services LLC
Honolulu
Island Urology
Honolulu
Kapiolani Medical Center for Women and Children
Honolulu
Kuakini Medical Center
Honolulu
Queen's Cancer Cenrer - POB I
Honolulu
Queen's Cancer Center - Kuakini
Honolulu
Queen's Medical Center
Honolulu
Straub Clinic and Hospital
Honolulu
The Cancer Center of Hawaii-Liliha
Honolulu
University of Hawaii Cancer Center
Honolulu
Straub Medical Center - Kahului Clinic
Kahului
Castle Medical Center
Kailua
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue
Iowa
Mary Greeley Medical Center
Ames
McFarland Clinic - Ames
Ames
McFarland Clinic - Boone
Boone
McFarland Clinic - Trinity Cancer Center
Fort Dodge
McFarland Clinic - Jefferson
Jefferson
McFarland Clinic - Marshalltown
Marshalltown
Illinois
OSF Saint Anthony's Health Center
Alton
Rush-Copley Medical Center
Aurora
Northwestern University
Chicago
Rush MD Anderson Cancer Center
Chicago
University of Chicago Comprehensive Cancer Center
Chicago
Carle at The Riverfront
Danville
Northwestern Medicine Cancer Center Kishwaukee
Dekalb
Carle Physician Group-Effingham
Effingham
NorthShore University HealthSystem-Evanston Hospital
Evanston
Northwestern Medicine Cancer Center Delnor
Geneva
NorthShore University HealthSystem-Glenbrook Hospital
Glenview
NorthShore University HealthSystem-Highland Park Hospital
Highland Park
Northwestern Medicine Lake Forest Hospital
Lake Forest
Carle Physician Group-Mattoon/Charleston
Mattoon
SSM Health Good Samaritan
Mount Vernon
Carle Cancer Center
Urbana
The Carle Foundation Hospital
Urbana
Northwestern Medicine Cancer Center Warrenville
Warrenville
Rush-Copley Healthcare Center
Yorkville
Indiana
Parkview Regional Medical Center
Fort Wayne
Kansas
Central Care Cancer Center - Garden City
Garden City
Central Care Cancer Center - Great Bend
Great Bend
Louisiana
LSU Health Sciences Center at Shreveport
Shreveport
Massachusetts
Dana-Farber Cancer Institute
Boston
Massachusetts General Hospital Cancer Center
Boston
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore
Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor
Minnesota
Fairview Ridges Hospital
Burnsville
Minnesota Oncology - Burnsville
Burnsville
Cambridge Medical Center
Cambridge
Mercy Hospital
Coon Rapids
Fairview Southdale Hospital
Edina
Unity Hospital
Fridley
Fairview Clinics and Surgery Center Maple Grove
Maple Grove
Minnesota Oncology Hematology PA-Maplewood
Maplewood
Saint John's Hospital - Healtheast
Maplewood
Abbott-Northwestern Hospital
Minneapolis
Health Partners Inc
Minneapolis
Hennepin County Medical Center
Minneapolis
Monticello Cancer Center
Monticello
New Ulm Medical Center
New Ulm
Fairview Northland Medical Center
Princeton
North Memorial Medical Health Center
Robbinsdale
Mayo Clinic in Rochester
Rochester
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
United Hospital
Saint Paul
Saint Francis Regional Medical Center
Shakopee
Lakeview Hospital
Stillwater
Ridgeview Medical Center
Waconia
Rice Memorial Hospital
Willmar
Minnesota Oncology Hematology PA-Woodbury
Woodbury
Fairview Lakes Medical Center
Wyoming
Missouri
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin
Central Care Cancer Center - Bolivar
Bolivar
Siteman Cancer Center at Saint Peters Hospital
City Of Saint Peters
Siteman Cancer Center at West County Hospital
Creve Coeur
Freeman Health System
Joplin
Mercy Hospital Joplin
Joplin
Mercy Clinic-Rolla-Cancer and Hematology
Rolla
Phelps Health Delbert Day Cancer Institute
Rolla
Heartland Regional Medical Center
Saint Joseph
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
Mercy Hospital Saint Louis
St Louis
Mercy Hospital South
St Louis
Mercy Infusion Center - Chippewa
St Louis
Siteman Cancer Center at Christian Hospital
St Louis
Siteman Cancer Center-South County
St Louis
Washington University School of Medicine
St Louis
Mercy Hospital Washington
Washington
North Carolina
UNC Lineberger Comprehensive Cancer Center
Chapel Hill
Atrium Health Pineville/LCI-Pineville
Charlotte
Carolinas Medical Center/Levine Cancer Institute
Charlotte
Duke University Medical Center
Durham
Nebraska
Nebraska Methodist Hospital
Omaha
New Jersey
Hackensack University Medical Center
Hackensack
New York
Roswell Park Cancer Institute
Buffalo
Northwell Health/Center for Advanced Medicine
Lake Success
Memorial Sloan Kettering Cancer Center
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York
Ohio
Ohio State University Comprehensive Cancer Center
Columbus
Oklahoma
Cancer Centers of Southwest Oklahoma Research
Lawton
Mercy Hospital Oklahoma City
Oklahoma City
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Oregon Health and Science University
Portland
Pennsylvania
UPMC Hillman Cancer Center - Monroeville
Monroeville
Fox Chase Cancer Center
Philadelphia
Thomas Jefferson University Hospital
Philadelphia
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh
UPMC-Saint Margaret
Pittsburgh
Divine Providence Hospital
Williamsport
UPMC Susquehanna
Williamsport
Rhode Island
Smilow Cancer Hospital Care Center - Westerly
Westerly
South Carolina
Gibbs Cancer Center-Gaffney
Gaffney
Gibbs Cancer Center-Pelham
Greer
North Grove Medical Park
Spartanburg
Spartanburg Medical Center
Spartanburg
Spartanburg Medical Center - Mary Black Campus
Spartanburg
SMC Center for Hematology Oncology Union
Union
Tennessee
Vanderbilt-Ingram Cancer Center Cool Springs
Franklin
Vanderbilt Breast Center at One Hundred Oaks
Nashville
Vanderbilt University/Ingram Cancer Center
Nashville
Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City
University of Utah Sugarhouse Health Center
Salt Lake City
Virginia
VCU Massey Comprehensive Cancer Center
Richmond
Washington
Fred Hutchinson Cancer Center
Seattle
University of Washington Medical Center - Montlake
Seattle
Wisconsin
Marshfield Medical Center-EC Cancer Center
Eau Claire
Marshfield Medical Center-Marshfield
Marshfield
Medical College of Wisconsin
Milwaukee
Marshfield Medical Center - Minocqua
Minocqua
Cancer Center of Western Wisconsin
New Richmond
Marshfield Medical Center-Rice Lake
Rice Lake
Marshfield Medical Center-River Region at Stevens Point
Stevens Point
Marshfield Medical Center - Weston
Weston
Other Locations
Guam
FHP Health Center-Guam
Tamuning
Time Frame
Start Date: 2020-11-04
Completion Date: 2026-09-30
Participants
Target number of participants: 90
Treatments
Experimental: Arm I (nivolumab, paclitaxel)
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.
Experimental: Arm II (paclitaxel)
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.
Experimental: Arm III (nivolumab, cabozantinib S-malate)
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.
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials