Avelumab With or Without Cetuximab in Treating Patients With Advanced Skin Squamous Cell Cancer

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Recruiting
CT.gov ID
NCT03944941
Collaborator
National Cancer Institute (NCI) (NIH)
59
420
2
54.5
0.1
0

Study Details

Study Description

Brief Summary

This phase II trial studies how well avelumab with or without cetuximab work in treating patients with skin squamous cell cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as avelumab and cetuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. To evaluate whether treatment with avelumab plus cetuximab prolongs progression free survival (PFS) compared to avelumab alone.
SECONDARY OBJECTIVES:
  1. To evaluate the confirmed objective response rate of each treatment arm. II. To evaluate the clinical benefit rate of each treatment arm. III. To evaluate the PFS of cetuximab plus avelumab in patients that have progressed on single agent avelumab.

  2. To evaluate the overall survival (OS) for each treatment arm. V. To evaluate toxicity across treatment arms of avelumab plus cetuximab and avelumab alone.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive avelumab intravenously (IV) over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with avelumab failure will crossover to arm II.

ARM II: Patients receive cetuximab IV over 1-2 hours on days 1, 8,15, and 22 and avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles for cetuximab and 24 cycles for avelumab in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months until disease progression, then every 6 months for up to 2 years.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
59 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma of the Skin (cSCC)
Actual Study Start Date :
May 17, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (Avelumab)

Patients receive avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with avelumab failure will crossover to Arm II.

Drug: Avelumab
Given IV

Experimental: Arm II (Avelumab, cetuximab)

Patients receive cetuximab IV over 1-2 hours on days 1, 8,15, and 22 and avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles for cetuximab and 24 cycles for avelumab in the absence of disease progression or unacceptable toxicity.

Drug: Avelumab
Given IV

Drug: Cetuximab
Given IV

Outcome Measures

Primary Outcome Measures

  1. Prolonging of progression free survival (PFS) on avelumab and cetuximab compared to avelumab alone [Time between registration and evidence of disease progression or death, assessed up to 2 years post treatment]

    The study will be declared promising if, after the 37th PFS event, the hazard ratio is less than 0.758.

Secondary Outcome Measures

  1. Confirmed objective response rate (RR) [Up to 2 years post treatment]

    A patient will be declared a success for RR if they achieve a partial response (PR) or better on two consecutive evaluations (at least 8 weeks apart). The number of successes will be divided by the number of evaluable patients to estimate the RR for each treatment arm and exact 95% confidence intervals will be calculated based on the properties of the binomial distribution.

  2. Clinical benefit rate (CBR) [Up to 2 years post treatment]

    The CBR is will be estimated as the number of successes divided by the total number of evaluable patients. An exact 95% confidence interval will be constructed around the CBR using the properties of the binomial distribution.

  3. PFS in patients who have progressed on avelumab alone [From time of enrollment to documented progression (or death), assessed up to 2 years]

    Will explore the PFS for those patients that crossover to combination therapy (avelumab + cetuximab) after progressing on avelumab alone (baseline time being the time of crossover). The Kaplan-Meier method will be used to calculate a median PFS as well as a 95% confidence interval.

  4. Overall Survival (OS) [Time between enrollment and or death, assessed up to 2 years post treatment]

    The Kaplan-Meier method will be used to calculate a median OS as well as a 95% confidence interval.

  5. Incidence of adverse events [Up to 30 days post treatment]

    Will be described and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. Maximum grade adverse events will be summarized in a tabular setting by treatment arm.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • PRE-REGISTRATION ELIGIBILITY CRITERIA

  • Provide adequate tissue for PD-L1 testing

  • Fresh tissue or archival tissue can be used. Sample must be at least core needle biopsy. Fine needle aspiration is not adequate. This specimen submission is mandatory prior to registration as results will be used for stratification
  • REGISTRATION ELIGIBILITY CRITERIA

  • • Biopsy-proven advanced cutaneous squamous cell carcinoma. Advanced disease is defined as either metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma not amenable to curative surgical resection, or the patient declines surgical resection

  • The patient must have at least one lesion that is measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  • If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy

  • 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 urine or serum pregnancy test done =< 7 days prior to registration is required

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

  • If human immunodeficiency virus (HIV) positive the HIV viral load must be < 200 copies/mL and CD4 count > 200. If an HIV positive patient is on highly active antiretroviral therapy (HAART) the patient must have been so for > 4 weeks

  • Absolute neutrophil count (ANC) >= 1,500/mm^3

  • Platelet count >= 100,000/mm^3

  • Calculated creatinine clearance >= 30 mL/min

  • Total bilirubin =< 1.5 x upper limit of normal (ULN)

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

Exclusion Criteria:
  • Patients who received prior treatment with cetuximab as palliative treatment for advanced cutaneous squamous cell carcinoma (cSCC) are excluded. Patients that received cetuximab based chemoradiation (either definitive or adjuvant) as prior treatment for locally advanced disease are eligible as long as the last dosage was given >= 6 months prior to registration

  • Patients who received prior cetuximab and had a severe infusion reaction requiring discontinuation of cetuximab are excluded

  • Patients treated with prior anti-PD-1 or anti-PD-L1 monoclonal antibodies (mAbs) are excluded

  • Patients cannot have received treatment with radiation or chemotherapy including another investigational agent within 2 weeks of registration. Other than as stated above for cetuximab there are no limits on the number of lines of other therapies given for advanced cSCC

  • Patients with a "currently active" second malignancy will be excluded with the exception of other non-melanoma skin cancers or cervical carcinoma in situ. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for 3 years

  • No history of the following:

  • Autoimmune disease (including inflammatory bowel disease) with the exception of patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment

  • Non-infectious pneumonitis that required steroids within 5 years

  • Organ transplant including prior stem cell transplant

  • Receipt of a live vaccine =< 4 weeks

  • Cerebral vascular accident/stroke within 6 months of enrollment

  • Myocardial infarction within 6 months of enrollment

  • Active unstable angina

  • Congestive heart failure (>= New York Heart Association Classification class II)

  • Serious cardiac arrhythmia requiring medication. Whether an arrhythmia is considered "serious" is at the discretion of the investigator

  • Active infection requiring systemic treatment

  • Use of immunosuppressive medication =< 7 days of registration, EXCEPT for the following:

  • Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)

  • Systemic corticosteroids at physiologic doses =< 10 mg/day of prednisone or equivalent

  • Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication)"

  • Other severe acute or chronic medical conditions including but not limited to immune colitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
2 Anchorage Associates in Radiation Medicine Anchorage Alaska United States 98508
3 Anchorage Radiation Therapy Center Anchorage Alaska United States 99504
4 Alaska Breast Care and Surgery LLC Anchorage Alaska United States 99508
5 Alaska Oncology and Hematology LLC Anchorage Alaska United States 99508
6 Alaska Women's Cancer Care Anchorage Alaska United States 99508
7 Anchorage Oncology Centre Anchorage Alaska United States 99508
8 Katmai Oncology Group Anchorage Alaska United States 99508
9 Providence Alaska Medical Center Anchorage Alaska United States 99508
10 Fairbanks Memorial Hospital Fairbanks Alaska United States 99701
11 Kingman Regional Medical Center Kingman Arizona United States 86401
12 University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona United States 85704
13 Banner University Medical Center - Tucson Tucson Arizona United States 85719
14 University of Arizona Cancer Center-North Campus Tucson Arizona United States 85719
15 Mercy Hospital Fort Smith Fort Smith Arkansas United States 72903
16 PCR Oncology Arroyo Grande California United States 93420
17 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
18 Epic Care-Dublin Dublin California United States 94568
19 Bay Area Breast Surgeons Inc Emeryville California United States 94608
20 Epic Care Partners in Cancer Care Emeryville California United States 94608
21 Los Angeles County-USC Medical Center Los Angeles California United States 90033
22 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
23 Contra Costa Regional Medical Center Martinez California United States 94553-3156
24 USC Norris Oncology/Hematology-Newport Beach Newport Beach California United States 92663
25 Alta Bates Summit Medical Center - Summit Campus Oakland California United States 94609
26 Bay Area Tumor Institute Oakland California United States 94609
27 Keck Medical Center of USC Pasadena Pasadena California United States 91105
28 Epic Care Cyberknife Center Walnut Creek California United States 94597
29 Rocky Mountain Cancer Centers-Aurora Aurora Colorado United States 80012
30 The Medical Center of Aurora Aurora Colorado United States 80012
31 Boulder Community Foothills Hospital Boulder Colorado United States 80303
32 Rocky Mountain Cancer Centers-Boulder Boulder Colorado United States 80304
33 Rocky Mountain Cancer Centers - Centennial Centennial Colorado United States 80112
34 The Women's Imaging Center Denver Colorado United States 80209
35 Colorado Blood Cancer Institute Denver Colorado United States 80218
36 Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado United States 80218
37 Rocky Mountain Cancer Centers-Midtown Denver Colorado United States 80218
38 Rocky Mountain Cancer Centers-Rose Denver Colorado United States 80220
39 Rose Medical Center Denver Colorado United States 80220
40 Western Surgical Care Denver Colorado United States 80220
41 Mountain Blue Cancer Care Center - Swedish Englewood Colorado United States 80113
42 Rocky Mountain Cancer Centers - Swedish Englewood Colorado United States 80113
43 Swedish Medical Center Englewood Colorado United States 80113
44 The Melanoma and Skin Cancer Institute Englewood Colorado United States 80113
45 North Colorado Medical Center Greeley Colorado United States 80631
46 Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado United States 80228
47 Rocky Mountain Cancer Centers-Littleton Littleton Colorado United States 80120
48 Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado United States 80124
49 Sky Ridge Medical Center Lone Tree Colorado United States 80124
50 McKee Medical Center Loveland Colorado United States 80539
51 Rocky Mountain Cancer Centers-Thornton Thornton Colorado United States 80260
52 Emory University Hospital Midtown Atlanta Georgia United States 30308
53 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
54 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia United States 31405
55 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
56 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
57 Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho United States 83605
58 Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho United States 83814
59 Walter Knox Memorial Hospital Emmett Idaho United States 83617
60 Saint Luke's Cancer Institute - Fruitland Fruitland Idaho United States 83619
61 Idaho Urologic Institute-Meridian Meridian Idaho United States 83642
62 Saint Luke's Cancer Institute - Meridian Meridian Idaho United States 83642
63 Saint Alphonsus Medical Center-Nampa Nampa Idaho United States 83686
64 Saint Luke's Cancer Institute - Nampa Nampa Idaho United States 83686
65 Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho United States 83854
66 Kootenai Cancer Clinic Sandpoint Idaho United States 83864
67 Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho United States 83301
68 Saint Anthony's Health Alton Illinois United States 62002
69 Rush - Copley Medical Center Aurora Illinois United States 60504
70 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
71 Illinois CancerCare-Canton Canton Illinois United States 61520
72 Memorial Hospital of Carbondale Carbondale Illinois United States 62902
73 SIH Cancer Institute Carterville Illinois United States 62918
74 Illinois CancerCare-Carthage Carthage Illinois United States 62321
75 Centralia Oncology Clinic Centralia Illinois United States 62801
76 Northwestern University Chicago Illinois United States 60611
77 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
78 Carle on Vermilion Danville Illinois United States 61832
79 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
80 Decatur Memorial Hospital Decatur Illinois United States 62526
81 Illinois CancerCare-Dixon Dixon Illinois United States 61021
82 Carle Physician Group-Effingham Effingham Illinois United States 62401
83 Crossroads Cancer Center Effingham Illinois United States 62401
84 Illinois CancerCare-Eureka Eureka Illinois United States 61530
85 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
86 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
87 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
88 Northwestern Medicine Lake Forest Hospital Lake Forest Illinois United States 60045
89 Illinois CancerCare-Macomb Macomb Illinois United States 61455
90 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
91 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
92 UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois United States 60451
93 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
94 University of Chicago Medicine-Orland Park Orland Park Illinois United States 60462
95 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
96 Illinois CancerCare-Pekin Pekin Illinois United States 61554
97 Illinois CancerCare-Peoria Peoria Illinois United States 61615
98 Methodist Medical Center of Illinois Peoria Illinois United States 61636
99 Illinois CancerCare-Peru Peru Illinois United States 61354
100 Valley Radiation Oncology Peru Illinois United States 61354
101 Illinois CancerCare-Princeton Princeton Illinois United States 61356
102 Southern Illinois University School of Medicine Springfield Illinois United States 62702
103 Springfield Clinic Springfield Illinois United States 62702
104 Memorial Medical Center Springfield Illinois United States 62781
105 Carle Cancer Center Urbana Illinois United States 61801
106 The Carle Foundation Hospital Urbana Illinois United States 61801
107 Illinois CancerCare - Washington Washington Illinois United States 61571
108 Rush-Copley Healthcare Center Yorkville Illinois United States 60560
109 Reid Health Richmond Indiana United States 47374
110 Mary Greeley Medical Center Ames Iowa United States 50010
111 McFarland Clinic PC - Ames Ames Iowa United States 50010
112 McFarland Clinic PC-Boone Boone Iowa United States 50036
113 Saint Anthony Regional Hospital Carroll Iowa United States 51401
114 Jennie Edmundson Memorial Hospital Council Bluffs Iowa United States 51502
115 Heartland Oncology and Hematology LLP Council Bluffs Iowa United States 51503
116 Iowa Methodist Medical Center Des Moines Iowa United States 50309
117 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
118 Broadlawns Medical Center Des Moines Iowa United States 50314
119 Iowa Lutheran Hospital Des Moines Iowa United States 50316
120 McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa United States 50501
121 Trinity Regional Medical Center Fort Dodge Iowa United States 50501
122 McFarland Clinic PC-Jefferson Jefferson Iowa United States 50129
123 McFarland Clinic PC-Marshalltown Marshalltown Iowa United States 50158
124 Methodist West Hospital West Des Moines Iowa United States 50266-7700
125 Central Care Cancer Center - Garden City Garden City Kansas United States 67846
126 Central Care Cancer Center - Great Bend Great Bend Kansas United States 67530
127 Ochsner Medical Center Kenner Kenner Louisiana United States 70065
128 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
129 University of Maryland/Greenebaum Cancer Center Baltimore Maryland United States 21201
130 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
131 Bronson Battle Creek Battle Creek Michigan United States 49017
132 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
133 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
134 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
135 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
136 West Michigan Cancer Center Kalamazoo Michigan United States 49007
137 Borgess Medical Center Kalamazoo Michigan United States 49048
138 Mercy Health Mercy Campus Muskegon Michigan United States 49444
139 Lakeland Hospital Niles Niles Michigan United States 49120
140 Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores Michigan United States 49444
141 Huron Medical Center PC Port Huron Michigan United States 48060
142 Lake Huron Medical Center Port Huron Michigan United States 48060
143 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
144 Lakeland Medical Center Saint Joseph Saint Joseph Michigan United States 49085
145 Marie Yeager Cancer Center Saint Joseph Michigan United States 49085
146 Munson Medical Center Traverse City Michigan United States 49684
147 Metro Health Hospital Wyoming Michigan United States 49519
148 Riverwood Healthcare Center Aitkin Minnesota United States 56431
149 Essentia Health Saint Joseph's Medical Center Brainerd Minnesota United States 56401
150 Fairview Ridges Hospital Burnsville Minnesota United States 55337
151 Minnesota Oncology - Burnsville Burnsville Minnesota United States 55337
152 Cambridge Medical Center Cambridge Minnesota United States 55008
153 Mercy Hospital Coon Rapids Minnesota United States 55433
154 Essentia Health - Deer River Clinic Deer River Minnesota United States 56636
155 Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes Minnesota United States 56501
156 Essentia Health Cancer Center Duluth Minnesota United States 55805
157 Essentia Health Saint Mary's Medical Center Duluth Minnesota United States 55805
158 Miller-Dwan Hospital Duluth Minnesota United States 55805
159 Fairview Southdale Hospital Edina Minnesota United States 55435
160 Lake Region Healthcare Corporation-Cancer Care Fergus Falls Minnesota United States 56537
161 Essentia Health - Fosston Fosston Minnesota United States 56542
162 Unity Hospital Fridley Minnesota United States 55432
163 Essentia Health Hibbing Clinic Hibbing Minnesota United States 55746
164 Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota United States 55369
165 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
166 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
167 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
168 Hennepin County Medical Center Minneapolis Minnesota United States 55415
169 Health Partners Inc Minneapolis Minnesota United States 55454
170 Monticello Cancer Center Monticello Minnesota United States 55362
171 New Ulm Medical Center New Ulm Minnesota United States 56073
172 Essentia Health - Park Rapids Park Rapids Minnesota United States 56470
173 Fairview Northland Medical Center Princeton Minnesota United States 55371
174 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
175 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
176 Regions Hospital Saint Paul Minnesota United States 55101
177 United Hospital Saint Paul Minnesota United States 55102
178 Essentia Health Sandstone Sandstone Minnesota United States 55072
179 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
180 Lakeview Hospital Stillwater Minnesota United States 55082
181 Essentia Health Virginia Clinic Virginia Minnesota United States 55792
182 Ridgeview Medical Center Waconia Minnesota United States 55387
183 Rice Memorial Hospital Willmar Minnesota United States 56201
184 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
185 Fairview Lakes Medical Center Wyoming Minnesota United States 55092
186 Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri United States 63011
187 Central Care Cancer Center - Bolivar Bolivar Missouri United States 65613
188 Cox Cancer Center Branson Branson Missouri United States 65616
189 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
190 Southeast Cancer Center Cape Girardeau Missouri United States 63703
191 Siteman Cancer Center at West County Hospital Creve Coeur Missouri United States 63141
192 Parkland Health Center - Farmington Farmington Missouri United States 63640
193 Capital Region Southwest Campus Jefferson City Missouri United States 65109
194 Freeman Health System Joplin Missouri United States 64804
195 Mercy Hospital Joplin Joplin Missouri United States 64804
196 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
197 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
198 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
199 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
200 Washington University School of Medicine Saint Louis Missouri United States 63110
201 Mercy Hospital South Saint Louis Missouri United States 63128
202 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
203 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
204 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
205 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
206 Mercy Hospital Springfield Springfield Missouri United States 65804
207 CoxHealth South Hospital Springfield Missouri United States 65807
208 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
209 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
210 Mercy Hospital Washington Washington Missouri United States 63090
211 Community Hospital of Anaconda Anaconda Montana United States 59711
212 Billings Clinic Cancer Center Billings Montana United States 59101
213 Bozeman Deaconess Hospital Bozeman Montana United States 59715
214 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
215 Great Falls Clinic Great Falls Montana United States 59405
216 Saint Peter's Community Hospital Helena Montana United States 59601
217 Kalispell Regional Medical Center Kalispell Montana United States 59901
218 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
219 Community Medical Hospital Missoula Montana United States 59804
220 Nebraska Methodist Hospital Omaha Nebraska United States 68114
221 Carson Tahoe Regional Medical Center Carson City Nevada United States 89703
222 Cancer and Blood Specialists-Henderson Henderson Nevada United States 89052
223 Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada United States 89052
224 Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson Nevada United States 89052
225 Las Vegas Cancer Center-Henderson Henderson Nevada United States 89052
226 OptumCare Cancer Care at Seven Hills Henderson Nevada United States 89052
227 Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada United States 89074
228 GenesisCare USA - Henderson Henderson Nevada United States 89074
229 Las Vegas Urology - Green Valley Henderson Nevada United States 89074
230 Las Vegas Urology - Pebble Henderson Nevada United States 89074
231 Urology Specialists of Nevada - Green Valley Henderson Nevada United States 89074
232 Las Vegas Urology - Pecos Las Vegas Nevada United States 89074
233 Desert West Surgery Las Vegas Nevada United States 89102
234 OptumCare Cancer Care at Charleston Las Vegas Nevada United States 89102
235 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
236 Hope Cancer Care of Nevada Las Vegas Nevada United States 89103
237 Cancer and Blood Specialists-Shadow Las Vegas Nevada United States 89106
238 Radiation Oncology Centers of Nevada Central Las Vegas Nevada United States 89106
239 Urology Specialists of Nevada - Central Las Vegas Nevada United States 89106
240 GenesisCare USA - Las Vegas Las Vegas Nevada United States 89109
241 HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas Nevada United States 89109
242 Sunrise Hospital and Medical Center Las Vegas Nevada United States 89109
243 HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas Nevada United States 89113
244 Las Vegas Prostate Cancer Center Las Vegas Nevada United States 89113
245 Las Vegas Urology - Sunset Las Vegas Nevada United States 89113
246 Urology Specialists of Nevada - Southwest Las Vegas Nevada United States 89113
247 Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada United States 89119
248 Ann M Wierman MD LTD Las Vegas Nevada United States 89128
249 Cancer and Blood Specialists-Tenaya Las Vegas Nevada United States 89128
250 Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada United States 89128
251 GenesisCare USA - Vegas Tenaya Las Vegas Nevada United States 89128
252 HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada United States 89128
253 Las Vegas Urology - Cathedral Rock Las Vegas Nevada United States 89128
254 Las Vegas Urology - Smoke Ranch Las Vegas Nevada United States 89128
255 OptumCare Cancer Care at MountainView Las Vegas Nevada United States 89128
256 Urology Specialists of Nevada - Northwest Las Vegas Nevada United States 89128
257 Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada United States 89135
258 Comprehensive Cancer Centers of Nevada - Town Center Las Vegas Nevada United States 89144
259 Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada United States 89144
260 Summerlin Hospital Medical Center Las Vegas Nevada United States 89144
261 Las Vegas Cancer Center-Medical Center Las Vegas Nevada United States 89148-2405
262 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
263 GenesisCare USA - Fort Apache Las Vegas Nevada United States 89148
264 OptumCare Cancer Care at Fort Apache Las Vegas Nevada United States 89148
265 HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas Nevada United States 89149
266 Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada United States 89169
267 University Cancer Center Las Vegas Nevada United States 89169
268 Hope Cancer Care of Nevada-Pahrump Pahrump Nevada United States 89048
269 Renown Regional Medical Center Reno Nevada United States 89502
270 Saint Mary's Regional Medical Center Reno Nevada United States 89503
271 Radiation Oncology Associates Reno Nevada United States 89509
272 Hackensack University Medical Center Hackensack New Jersey United States 07601
273 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
274 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
275 Southeastern Medical Oncology Center-Clinton Clinton North Carolina United States 28328
276 Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina United States 27534
277 Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina United States 28546
278 Essentia Health Cancer Center-South University Clinic Fargo North Dakota United States 58103
279 Essentia Health - Jamestown Clinic Jamestown North Dakota United States 58401
280 Indu and Raj Soin Medical Center Beavercreek Ohio United States 45431
281 Strecker Cancer Center-Belpre Belpre Ohio United States 45714
282 Saint Elizabeth Boardman Hospital Boardman Ohio United States 44512
283 Dayton Physicians LLC-Miami Valley South Centerville Ohio United States 45459
284 Miami Valley Hospital South Centerville Ohio United States 45459
285 Adena Regional Medical Center Chillicothe Ohio United States 45601
286 Oncology Hematology Care Inc-Kenwood Cincinnati Ohio United States 45236
287 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
288 Mount Carmel East Hospital Columbus Ohio United States 43213
289 Columbus Oncology and Hematology Associates Inc Columbus Ohio United States 43214
290 Riverside Methodist Hospital Columbus Ohio United States 43214
291 Grant Medical Center Columbus Ohio United States 43215
292 The Mark H Zangmeister Center Columbus Ohio United States 43219
293 Mount Carmel Health Center West Columbus Ohio United States 43222
294 Doctors Hospital Columbus Ohio United States 43228
295 Miami Valley Hospital Dayton Ohio United States 45409
296 Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio United States 45415
297 Miami Valley Hospital North Dayton Ohio United States 45415
298 Delaware Health Center-Grady Cancer Center Delaware Ohio United States 43015
299 Grady Memorial Hospital Delaware Ohio United States 43015
300 Dublin Methodist Hospital Dublin Ohio United States 43016
301 Armes Family Cancer Center Findlay Ohio United States 45840
302 Blanchard Valley Hospital Findlay Ohio United States 45840
303 Orion Cancer Care Findlay Ohio United States 45840
304 Atrium Medical Center-Middletown Regional Hospital Franklin Ohio United States 45005-1066
305 Dayton Physicians LLC-Atrium Franklin Ohio United States 45005
306 Central Ohio Breast and Endocrine Surgery Gahanna Ohio United States 43230
307 Dayton Physicians LLC-Wayne Greenville Ohio United States 45331
308 Wayne Hospital Greenville Ohio United States 45331
309 Mount Carmel Grove City Hospital Grove City Ohio United States 43123
310 Greater Dayton Cancer Center Kettering Ohio United States 45409
311 First Dayton Cancer Care Kettering Ohio United States 45420
312 Kettering Medical Center Kettering Ohio United States 45429
313 Fairfield Medical Center Lancaster Ohio United States 43130
314 Saint Rita's Medical Center Lima Ohio United States 45801
315 OhioHealth Mansfield Hospital Mansfield Ohio United States 44903
316 Marietta Memorial Hospital Marietta Ohio United States 45750
317 OhioHealth Marion General Hospital Marion Ohio United States 43302
318 Knox Community Hospital Mount Vernon Ohio United States 43050
319 Licking Memorial Hospital Newark Ohio United States 43055
320 Newark Radiation Oncology Newark Ohio United States 43055
321 Mercy Health Perrysburg Cancer Center Perrysburg Ohio United States 43551
322 Southern Ohio Medical Center Portsmouth Ohio United States 45662
323 Springfield Regional Cancer Center Springfield Ohio United States 45504
324 Springfield Regional Medical Center Springfield Ohio United States 45505
325 Saint Vincent Mercy Medical Center Toledo Ohio United States 43608
326 Mercy Health - Saint Anne Hospital Toledo Ohio United States 43623
327 Dayton Physicians LLC-Upper Valley Troy Ohio United States 45373
328 Upper Valley Medical Center Troy Ohio United States 45373
329 Saint Joseph Warren Hospital Warren Ohio United States 44484
330 Saint Ann's Hospital Westerville Ohio United States 43081
331 Saint Elizabeth Youngstown Hospital Youngstown Ohio United States 44501
332 Genesis Healthcare System Cancer Care Center Zanesville Ohio United States 43701
333 Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma United States 73505
334 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
335 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
336 Saint Alphonsus Medical Center-Baker City Baker City Oregon United States 97814
337 Saint Charles Health System Bend Oregon United States 97701
338 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
339 Providence Cancer Institute Clackamas Clinic Clackamas Oregon United States 97015
340 Bay Area Hospital Coos Bay Oregon United States 97420
341 Providence Newberg Medical Center Newberg Oregon United States 97132
342 Saint Alphonsus Medical Center-Ontario Ontario Oregon United States 97914
343 Providence Portland Medical Center Portland Oregon United States 97213
344 Providence Saint Vincent Medical Center Portland Oregon United States 97225
345 Saint Charles Health System-Redmond Redmond Oregon United States 97756
346 UPMC Altoona Altoona Pennsylvania United States 16601
347 UPMC-Heritage Valley Health System Beaver Beaver Pennsylvania United States 15009
348 UPMC Cancer Center-Bethel Park Bethel Park Pennsylvania United States 15102
349 Geisinger Medical Center Danville Pennsylvania United States 17822
350 UPMC Hamot Erie Pennsylvania United States 16550
351 UPMC Cancer Center at UPMC Horizon Farrell Pennsylvania United States 16121
352 UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania United States 15601
353 Oncology Hematology Associates Greenville Pennsylvania United States 16125
354 UPMC Pinnacle Harrisburg Harrisburg Pennsylvania United States 17101
355 UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania United States 17109
356 Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania United States 18201
357 IRMC Cancer Center Indiana Pennsylvania United States 15701
358 UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown Pennsylvania United States 15901
359 Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania United States 17837
360 Lewistown Hospital Lewistown Pennsylvania United States 17044
361 UPMC Cancer Center at UPMC McKeesport McKeesport Pennsylvania United States 15132
362 UPMC Cancer Center - Monroeville Monroeville Pennsylvania United States 15146
363 UPMC Hillman Cancer Center - Part of Frick Hospital Mount Pleasant Pennsylvania United States 15666
364 Arnold Palmer Cancer Center Medical Oncology Norwin N. Huntingdon Pennsylvania United States 15642
365 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
366 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
367 Oncology Hematology Association Pittsburgh Pennsylvania United States 15215
368 UPMC-Saint Margaret Pittsburgh Pennsylvania United States 15215
369 University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania United States 15232
370 UPMC-Shadyside Hospital Pittsburgh Pennsylvania United States 15232
371 UPMC-Passavant Hospital Pittsburgh Pennsylvania United States 15237
372 UPMC-Saint Clair Hospital Cancer Center Pittsburgh Pennsylvania United States 15243
373 Geisinger Cancer Services-Pottsville Pottsville Pennsylvania United States 17901
374 Community Medical Center Scranton Pennsylvania United States 18510
375 Geisinger Medical Oncology-Selinsgrove Selinsgrove Pennsylvania United States 17870
376 UPMC Cancer Center at UPMC Northwest Seneca Pennsylvania United States 16346
377 Geisinger Medical Group State College Pennsylvania United States 16801
378 UPMC Cancer Center-Uniontown Uniontown Pennsylvania United States 15401
379 UPMC Cancer Center-Washington Washington Pennsylvania United States 15301
380 UPMC West Mifflin-Cancer Center Jefferson West Mifflin Pennsylvania United States 15122
381 Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania United States 18711
382 UPMC Susquehanna Williamsport Pennsylvania United States 17701
383 Medical University of South Carolina Charleston South Carolina United States 29425
384 University of Tennessee - Knoxville Knoxville Tennessee United States 37920
385 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
386 Providence Regional Cancer System-Aberdeen Aberdeen Washington United States 98520
387 Overlake Medical Center Bellevue Washington United States 98004
388 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
389 Providence Regional Cancer System-Centralia Centralia Washington United States 98531
390 Swedish Cancer Institute-Edmonds Edmonds Washington United States 98026
391 Providence Regional Cancer Partnership Everett Washington United States 98201
392 Swedish Cancer Institute-Issaquah Issaquah Washington United States 98029
393 Kadlec Clinic Hematology and Oncology Kennewick Washington United States 99336
394 Providence Regional Cancer System-Lacey Lacey Washington United States 98503
395 PeaceHealth Saint John Medical Center Longview Washington United States 98632
396 Jefferson Healthcare Port Townsend Washington United States 98368
397 Valley Medical Center Renton Washington United States 98055
398 Pacific Gynecology Specialists Seattle Washington United States 98104
399 Swedish Medical Center-Ballard Campus Seattle Washington United States 98107
400 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
401 Swedish Medical Center-Cherry Hill Seattle Washington United States 98122-5711
402 PeaceHealth United General Medical Center Sedro-Woolley Washington United States 98284
403 Providence Regional Cancer System-Shelton Shelton Washington United States 98584
404 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
405 Providence Saint Mary Regional Cancer Center Walla Walla Washington United States 99362
406 North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington United States 98902
407 Providence Regional Cancer System-Yelm Yelm Washington United States 98597
408 Duluth Clinic Ashland Ashland Wisconsin United States 54806
409 Northwest Wisconsin Cancer Center Ashland Wisconsin United States 54806
410 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
411 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
412 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
413 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
414 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
415 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
416 Marshfield Clinic Stevens Point Center Stevens Point Wisconsin United States 54482
417 Marshfield Medical Center - Weston Weston Wisconsin United States 54476
418 Cheyenne Regional Medical Center-West Cheyenne Wyoming United States 82001
419 Billings Clinic-Cody Cody Wyoming United States 82414
420 Welch Cancer Center Sheridan Wyoming United States 82801

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Dan P. Zandberg, MD, University of Pittsburgh Medical Center Hillman Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT03944941
Other Study ID Numbers:
  • A091802
  • NCI-2018-02652
  • U10CA180821
First Posted:
May 10, 2019
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2022