Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial

Sponsor
Southwest Oncology Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT04510597
Collaborator
National Cancer Institute (NCI) (NIH)
364
224
2
151.5
1.6
0

Study Details

Study Description

Brief Summary

This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cytoreductive Nephrectomy
  • Drug: Active Comparator
Phase 3

Detailed Description

PRIMARY OBJECTIVE:
  1. To compare overall survival in participants with newly diagnosed metastatic renal cell carcinoma who are randomized to receive immune checkpoint inhibitor-based combination treatment plus cytoreductive nephrectomy versus immune checkpoint inhibitor-based combination treatment alone.
SECONDARY OBJECTIVES:
  1. To compare overall survival between arms in the subset who received their assigned protocol treatment.

  2. To assess complications of nephrectomy and post-randomization drug toxicities.

  3. To compare objective response rate in metastatic sites between the arms in participants with measurable metastatic disease.

  4. To assess change in diameter of primary tumor at week 12 disease assessment in participants who have received pre-randomization treatment.

BANKING OBJECTIVE:
  1. To bank specimens for future correlative studies.
OUTLINE:

PRE-RANDOMIZATION TREATMENT: Treatment naive patients are assigned to 1 of 3 treatment regimens per standard of care.

REGIMEN I: Patients receive nivolumab intravenously (IV) and ipilimumab IV. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV on day 1. Cycles repeat every 2-4 weeks in the absence of disease progression or unacceptable toxicity.

REGIMEN II: Patients receive pembrolizumab IV on day 1 and axitinib orally (PO) twice daily (BID) on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

REGIMEN III: Patients receive avelumab IV on day 1 and axitinib PO BID on days 1-14. Cycles repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

NOTE: Some patients may have already completed the standard of care pre-randomization treatment specified above off-trial.

RANDOMIZATION TREATMENT: Between 10-14 weeks from the start of on-trial or off-trial pre-randomization treatment, patients are randomized to 1 of 2 arms.

ARM I: Patients receive nivolumab IV, pembrolizumab IV, or avelumab IV on day 1. Patients also receive axitinib PO BID. Cycles with nivolumab repeat every 2 or 4 weeks, cycles with pembrolizumab repeat every 3 weeks, and cycles with avelumab repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Within 42 days following randomization, patients undergo radical or partial nephrectomy in addition to nivolumab, pembrolizumab, avelumab, and axitinib as in Arm I in the absence of disease progression or unacceptable toxicity. Axitinib should be stopped at least 24 hours prior to surgery.

After completion of trial treatment, patients are followed up every 3 months for the first year, every 6 months for years 2 and 3, and then annually for up to 7 years from randomization.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
364 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase III Trial of Immunotherapy-Based Combination Therapy With or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)
Actual Study Start Date :
Nov 16, 2020
Anticipated Primary Completion Date :
Jul 1, 2033
Anticipated Study Completion Date :
Jul 1, 2033

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm 1: Continued Systemic Therapy Only

Nivolumab 240 mg IV 1 q 2 weeks OR Nivolumab 480 mg IV 1 q 4 weeks OR Pembrolizumab 200 mg IV 1 q 3 weeks Axitinib 5 mg oral Daily BID OR Avelumab 10 mg/kg IV 1 q 2 weeks Axitinib 5 mg oral Daily BID

Procedure: Cytoreductive Nephrectomy
Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization

Drug: Active Comparator
Nivolumab 240 mg IV 1 q 2 weeks OR Nivolumab 480 mg IV 1 q 4 weeks OR Pembrolizumab 200 mg IV 1 q 3 weeks Axitinib 5 mg oral Daily BID OR Avelumab 10 mg/kg IV 1 q 2 weeks Axitinib 5 mg oral Daily BID

Experimental: Arm 2: Nephrectomy and Continued Systemic Therapy

Continued systemic therapy as above, plus: Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization.

Procedure: Cytoreductive Nephrectomy
Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization

Outcome Measures

Primary Outcome Measures

  1. Overall survival [From date of randomization to date of death due to any cause, assessed up to 7 years.]

    Analysis will be intent-to-treat. Evidence suggesting early termination of the trial and a conclusion that the cytoreductive nephrectomy (CN) approach is superior to treatment alone would be if the null hypothesis is rejected at the one-sided 0.005 level. For the second and third interim analyses, the null and alternative hypotheses with respect to survival will be tested, with superiority tested at the one-sided 0.005 level, and futility determined to be met if the (CN versus no CN) hazard ratio is greater than or equal to 1. A proportional hazards model will be fit to estimate the hazard ratio adjusting for the stratification factors as covariates in the model. Will evaluate whether each of the stratification factors are predictive factors of cytoreductive nephrectomy by placing an interaction term corresponding to each stratification factor and treatment arm in the proportional hazards survival model.

Secondary Outcome Measures

  1. Overall survival in subset who received assigned protocol treatment [From date of randomization to date of death due to any cause, assessed up to 7 years]

    Will be included in the proportional hazards regression model adjusting for stratification factors as covariates.

  2. Progression-free survival [From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 7 years]

    A proportional hazards model will be used to compare progression-free survival between arms, adjusting for the stratification factors as covariates.

  3. Objective response [Up to 7 years]

    Objective response includes all confirmed and unconfirmed partial and complete responses. Baseline will be disease assessment at randomization. Response Evaluation Criteria in Solid Tumors response rates will be evaluated, excluding the primary tumor in the kidney because that disease will be removed in half the participant's post-randomization. Comparison of response rates will be performed using logistic regression with stratification factors as covariates and an indicator for treatment arm.

  4. Change in maximum diameter of primary tumor [From the disease assessment just prior to the start of immunotherapy to the week 12 disease assessment]

    Descriptive statistics will be provided including stratified results by treatment regimen received. Potential additional analyses may include assessment of the interaction between change in primary tumor and randomized treatment arm. This will be modeled as an interaction term in the proportional hazards survival model.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • STEP 1 REGISTRATION: Participants must have a histologically proven diagnosis of clear cell or non-clear cell renal cell carcinoma. Participants with collecting duct carcinoma histology are not eligible. Participants with multifocal or bilateral tumors are eligible

  • STEP 1 REGISTRATION: Participants must have primary tumor in place

  • STEP 1 REGISTRATION: Participants must have the following scans performed, showing clinical evidence of measurable or non-measurable metastatic disease:

  • Computed tomography (CT) scan of the chest (can be performed without contrast if CT contrast cannot be given)

  • CT of abdomen and pelvis with contrast OR magnetic resonance imaging (MRI) of the abdomen and pelvis with or without contrast

Scans must be performed within the following timeframes:
  • Treatment naive participants must have scans documenting metastatic disease completed within 90 days prior to study registration

  • Previously treated participants must have scans documenting metastatic disease completed within 90 days prior to first dose of systemic treatment

  • STEP 1 REGISTRATION: Participants with symptomatic metastases may have received palliative radiotherapy or receive palliative radiotherapy after registration

  • STEP 1 REGISTRATION: Participants must have no clear contraindications to nephrectomy

  • STEP 1 REGISTRATION: Participants must be offered the opportunity to participate in specimen bank. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System

  • STEP 1 REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines

  • STEP 1 REGISTRATION: As part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

  • STEP 2 REGISTRATION: Participants must have at least one of the following scans performed 12 weeks (+/- 2 weeks) after starting pre-randomization treatment

  • CT scan of the chest (can be performed without contrast if CT contrast cannot be given)

  • CT of abdomen and pelvis with contrast OR MRI of the abdomen and pelvis with or without contrast Scans must be performed within 28 days prior to randomization. Response should be assessed by comparing with a CT or MRI of the chest, abdomen and pelvis obtained prior to starting pre-randomization treatment. Participants with complete response in all metastatic sites are not eligible to randomize to Step 2

• STEP 2 REGISTRATION: Participants must have one of the following objective statuses after 12 weeks of pre-randomization treatment

  • Stable disease

  • Partial response

  • The treating investigator believes the patient is deriving clinical benefit from systemic therapy AND have Zubrod performance status 0-1

  • STEP 2 REGISTRATION: Participants must plan to continue the immune-based therapy received during pre-randomization treatment

  • STEP 2 REGISTRATION: Participants must be randomized on or between the 11th and 14th week of protocol-directed pre-randomization treatment therapy

  • STEP 2 REGISTRATION: Participants must have received at least one of the minimum amounts of immunotherapy:

  • 2 infusions of nivolumab + 1 infusion of ipilimumab

  • 2 infusions of pembrolizumab

  • 2 infusions of avelumab

  • STEP 2 REGISTRATION: Participants must have a planned surgery date within 42 days of randomization

  • STEP 2 REGISTRATION: Participants must be a surgical candidate as determined by study urologist. The urology consult should be done within 42 days prior to randomization

  • STEP 2 REGISTRATION: Participants must have a complete physical examination and medical history within 28 days prior to randomization

  • STEP 2 REGISTRATION: Participants must have a Zubrod performance status of 0-1 within 28 days prior to randomization

  • STEP 2 REGISTRATION: Total bilirubin =< institutional upper limit of normal (ULN) (within 28 days prior to randomization)

  • STEP 2 REGISTRATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional upper limit of normal (ULN) (within 28 days prior to randomization)

  • STEP 2 REGISTRATION: Serum creatinine =< 1.5 x the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault Formula) (must have been drawn and processed within 28 days prior to randomization)

Exclusion Criteria:
  • STEP 1 REGISTRATION: Participants must not have known active brain metastases. Participants with previously treated brain metastases are eligible if participant has no neurologic signs or symptoms suggestive of brain metastasis. Brain imaging studies are not required. If brain imaging studies are performed, they must be negative for disease

  • STEP 1 REGISTRATION: Participants must not have received the following prior treatment of metastatic renal cell carcinoma:

  • Treatment naive participants must not have received any prior lines of systemic therapy for metastatic renal cell carcinoma beyond the line intended as part of protocol therapy

  • Previously treated participants must not have received any systemic therapy for metastatic renal cell carcinoma beyond the one regimen received off protocol as specified in Step 1 pre-randomization treatment

  • STEP 1 REGISTRATION: Participants must not have received more than the following amounts protocol-directed pre-randomization treatment:

  • Treatment naive participants must not have received any pre-randomization treatment.

  • Previously treated participants must not be planning to receive any additional treatment prior to Step 2 randomization, and must not have received more than the following amounts of pre-randomization treatment:

  • 4 infusions of nivolumab

  • 4 infusions of ipilimumab

  • 4 infusions of pembrolizumab

  • 7 infusions of avelumab

  • STEP 1 REGISTRATION: Participants must not have received immunotherapy for any cancer within the following timeframes:

  • Treatment naive participants must not have received any immunotherapy within a year of registration

  • Previously treated participants must not have received any other immunotherapy within a year of the start of off protocol specified pre-randomization treatment

  • STEP 1 REGISTRATION: Participants must not have a solitary kidney and not have a transplanted kidney

  • STEP 1 REGISTRATION: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, any in situ or T1 cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for at least two years

  • STEP 1 REGISTRATION: Participants must not have been previously diagnosed with a medical condition that makes them ineligible for immune based combination therapy or nephrectomy

  • STEP 2 REGISTRATION: Participants must not show progression in the primary tumor. Participants who are considered to have pseudo progression are allowed

  • STEP 2 REGISTRATION: Participants must not have known active brain metastases. Participants with previously treated brain metastases are eligible if participant has no neurologic signs or symptoms suggestive of brain metastasis. Brain imaging studies are not required. If brain imaging studies are performed, they must be negative for disease

  • STEP 2 REGISTRATION: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
2 Kingman Regional Medical Center Kingman Arizona United States 86401
3 Banner University Medical Center - Tucson Tucson Arizona United States 85719
4 University of Arizona Cancer Center-North Campus Tucson Arizona United States 85719
5 Mercy Hospital Fort Smith Fort Smith Arkansas United States 72903
6 PCR Oncology Arroyo Grande California United States 93420
7 City of Hope Comprehensive Cancer Center Duarte California United States 91010
8 Keck Medicine of USC Huntington Beach Huntington Beach California United States 92648
9 Los Angeles County-USC Medical Center Los Angeles California United States 90033
10 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
11 Cedars Sinai Medical Center Los Angeles California United States 90048
12 USC Norris Oncology/Hematology-Newport Beach Newport Beach California United States 92663
13 Keck Medical Center of USC Pasadena Pasadena California United States 91105
14 Orlando Health Cancer Institute Orlando Florida United States 32806
15 Saint Anthony's Health Alton Illinois United States 62002
16 Rush - Copley Medical Center Aurora Illinois United States 60504
17 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
18 Loyola Center for Health at Burr Ridge Burr Ridge Illinois United States 60527
19 Illinois CancerCare-Canton Canton Illinois United States 61520
20 Memorial Hospital of Carbondale Carbondale Illinois United States 62902
21 SIH Cancer Institute Carterville Illinois United States 62918
22 Illinois CancerCare-Carthage Carthage Illinois United States 62321
23 Centralia Oncology Clinic Centralia Illinois United States 62801
24 Northwestern University Chicago Illinois United States 60611
25 Rush University Medical Center Chicago Illinois United States 60612
26 University of Illinois Chicago Illinois United States 60612
27 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
28 Carle on Vermilion Danville Illinois United States 61832
29 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
30 Decatur Memorial Hospital Decatur Illinois United States 62526
31 Illinois CancerCare-Dixon Dixon Illinois United States 61021
32 Carle Physician Group-Effingham Effingham Illinois United States 62401
33 Crossroads Cancer Center Effingham Illinois United States 62401
34 Illinois CancerCare-Eureka Eureka Illinois United States 61530
35 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
36 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
37 Loyola Medicine Homer Glen Homer Glen Illinois United States 60491
38 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
39 Northwestern Medicine Lake Forest Hospital Lake Forest Illinois United States 60045
40 Illinois CancerCare-Macomb Macomb Illinois United States 61455
41 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
42 Loyola University Medical Center Maywood Illinois United States 60153
43 Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park Illinois United States 60160
44 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
45 UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois United States 60451
46 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
47 University of Chicago Medicine-Orland Park Orland Park Illinois United States 60462
48 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
49 Illinois CancerCare-Pekin Pekin Illinois United States 61554
50 Illinois CancerCare-Peoria Peoria Illinois United States 61615
51 Methodist Medical Center of Illinois Peoria Illinois United States 61636
52 Illinois CancerCare-Peru Peru Illinois United States 61354
53 Valley Radiation Oncology Peru Illinois United States 61354
54 Illinois CancerCare-Princeton Princeton Illinois United States 61356
55 Southern Illinois University School of Medicine Springfield Illinois United States 62702
56 Springfield Clinic Springfield Illinois United States 62702
57 Memorial Medical Center Springfield Illinois United States 62781
58 Carle Cancer Center Urbana Illinois United States 61801
59 The Carle Foundation Hospital Urbana Illinois United States 61801
60 Illinois CancerCare - Washington Washington Illinois United States 61571
61 Rush-Copley Healthcare Center Yorkville Illinois United States 60560
62 Mary Greeley Medical Center Ames Iowa United States 50010
63 McFarland Clinic PC - Ames Ames Iowa United States 50010
64 McFarland Clinic PC-Boone Boone Iowa United States 50036
65 Saint Anthony Regional Hospital Carroll Iowa United States 51401
66 Iowa Methodist Medical Center Des Moines Iowa United States 50309
67 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
68 Broadlawns Medical Center Des Moines Iowa United States 50314
69 Iowa Lutheran Hospital Des Moines Iowa United States 50316
70 McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa United States 50501
71 Trinity Regional Medical Center Fort Dodge Iowa United States 50501
72 McFarland Clinic PC-Jefferson Jefferson Iowa United States 50129
73 McFarland Clinic PC-Marshalltown Marshalltown Iowa United States 50158
74 Methodist West Hospital West Des Moines Iowa United States 50266-7700
75 Central Care Cancer Center - Garden City Garden City Kansas United States 67846
76 Central Care Cancer Center - Great Bend Great Bend Kansas United States 67530
77 Hematology/Oncology Clinic PLLC Baton Rouge Louisiana United States 70809
78 LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie Louisiana United States 70006
79 Louisiana State University Health Science Center New Orleans Louisiana United States 70112
80 Tulane University Health Sciences Center New Orleans Louisiana United States 70112
81 University Medical Center New Orleans New Orleans Louisiana United States 70112
82 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
83 Henry Ford Cancer Institute-Downriver Brownstown Michigan United States 48183
84 Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan United States 48038
85 Henry Ford Medical Center-Fairlane Dearborn Michigan United States 48126
86 Henry Ford Hospital Detroit Michigan United States 48202
87 Allegiance Health Jackson Michigan United States 49201
88 Henry Ford Medical Center-Columbus Novi Michigan United States 48377
89 Henry Ford Macomb Health Center - Shelby Township Shelby Michigan United States 48315
90 Henry Ford West Bloomfield Hospital West Bloomfield Michigan United States 48322
91 Fairview Ridges Hospital Burnsville Minnesota United States 55337
92 Minnesota Oncology - Burnsville Burnsville Minnesota United States 55337
93 Cambridge Medical Center Cambridge Minnesota United States 55008
94 Mercy Hospital Coon Rapids Minnesota United States 55433
95 Fairview Southdale Hospital Edina Minnesota United States 55435
96 Unity Hospital Fridley Minnesota United States 55432
97 Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota United States 55369
98 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
99 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
100 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
101 Hennepin County Medical Center Minneapolis Minnesota United States 55415
102 Health Partners Inc Minneapolis Minnesota United States 55454
103 Monticello Cancer Center Monticello Minnesota United States 55362
104 New Ulm Medical Center New Ulm Minnesota United States 56073
105 Fairview Northland Medical Center Princeton Minnesota United States 55371
106 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
107 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
108 Regions Hospital Saint Paul Minnesota United States 55101
109 United Hospital Saint Paul Minnesota United States 55102
110 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
111 Lakeview Hospital Stillwater Minnesota United States 55082
112 Ridgeview Medical Center Waconia Minnesota United States 55387
113 Rice Memorial Hospital Willmar Minnesota United States 56201
114 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
115 Fairview Lakes Medical Center Wyoming Minnesota United States 55092
116 Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri United States 63011
117 Central Care Cancer Center - Bolivar Bolivar Missouri United States 65613
118 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
119 Southeast Cancer Center Cape Girardeau Missouri United States 63703
120 Parkland Health Center - Farmington Farmington Missouri United States 63640
121 Capital Region Southwest Campus Jefferson City Missouri United States 65109
122 Freeman Health System Joplin Missouri United States 64804
123 Mercy Hospital Joplin Joplin Missouri United States 64804
124 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
125 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
126 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
127 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
128 Mercy Hospital South Saint Louis Missouri United States 63128
129 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
130 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
131 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
132 Mercy Hospital Springfield Springfield Missouri United States 65804
133 CoxHealth South Hospital Springfield Missouri United States 65807
134 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
135 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
136 Mercy Hospital Washington Washington Missouri United States 63090
137 Nebraska Methodist Hospital Omaha Nebraska United States 68114
138 Carson Tahoe Regional Medical Center Carson City Nevada United States 89703
139 Cancer and Blood Specialists-Henderson Henderson Nevada United States 89052
140 Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada United States 89052
141 Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson Nevada United States 89052
142 Las Vegas Cancer Center-Henderson Henderson Nevada United States 89052
143 OptumCare Cancer Care at Seven Hills Henderson Nevada United States 89052
144 21st Century Oncology-Henderson Henderson Nevada United States 89074
145 Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada United States 89074
146 Las Vegas Urology - Green Valley Henderson Nevada United States 89074
147 Las Vegas Urology - Pebble Henderson Nevada United States 89074
148 Urology Specialists of Nevada - Green Valley Henderson Nevada United States 89074
149 Las Vegas Urology - Pecos Las Vegas Nevada United States 89074
150 Desert West Surgery Las Vegas Nevada United States 89102
151 OptumCare Cancer Care at Charleston Las Vegas Nevada United States 89102
152 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
153 Hope Cancer Care of Nevada Las Vegas Nevada United States 89103
154 Radiation Oncology Centers of Nevada Central Las Vegas Nevada United States 89106
155 Urology Specialists of Nevada - Central Las Vegas Nevada United States 89106
156 21st Century Oncology Las Vegas Nevada United States 89109
157 Sunrise Hospital and Medical Center Las Vegas Nevada United States 89109
158 Las Vegas Prostate Cancer Center Las Vegas Nevada United States 89113
159 Las Vegas Urology - Sunset Las Vegas Nevada United States 89113
160 Urology Specialists of Nevada - Southwest Las Vegas Nevada United States 89113
161 Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada United States 89119
162 21st Century Oncology-Vegas Tenaya Las Vegas Nevada United States 89128
163 Ann M Wierman MD LTD Las Vegas Nevada United States 89128
164 Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada United States 89128
165 Las Vegas Urology - Cathedral Rock Las Vegas Nevada United States 89128
166 Las Vegas Urology - Smoke Ranch Las Vegas Nevada United States 89128
167 OptumCare Cancer Care at MountainView Las Vegas Nevada United States 89128
168 Urology Specialists of Nevada - Northwest Las Vegas Nevada United States 89128
169 Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada United States 89135
170 Comprehensive Cancer Centers of Nevada - Town Center Las Vegas Nevada United States 89144
171 Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada United States 89144
172 Summerlin Hospital Medical Center Las Vegas Nevada United States 89144
173 Las Vegas Cancer Center-Medical Center Las Vegas Nevada United States 89148-2405
174 21st Century Oncology-Fort Apache Las Vegas Nevada United States 89148
175 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
176 OptumCare Cancer Care at Fort Apache Las Vegas Nevada United States 89148
177 Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada United States 89169
178 University Cancer Center Las Vegas Nevada United States 89169
179 Hope Cancer Care of Nevada-Pahrump Pahrump Nevada United States 89048
180 Renown Regional Medical Center Reno Nevada United States 89502
181 Saint Mary's Regional Medical Center Reno Nevada United States 89503
182 Radiation Oncology Associates Reno Nevada United States 89509
183 Northwell Health/Center for Advanced Medicine Lake Success New York United States 11042
184 University of Rochester Rochester New York United States 14642
185 Phelps Memorial Hospital Center Sleepy Hollow New York United States 10591
186 Southeastern Medical Oncology Center-Clinton Clinton North Carolina United States 28328
187 Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina United States 27534
188 Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina United States 28546
189 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
190 University of Toledo Toledo Ohio United States 43614
191 University of Cincinnati Cancer Center-West Chester West Chester Ohio United States 45069
192 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
193 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
194 Rogue Valley Medical Center Medford Oregon United States 97504
195 Oregon Health and Science University Portland Oregon United States 97239
196 Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina United States 29316
197 Prisma Health Cancer Institute - Easley Easley South Carolina United States 29640
198 Prisma Health Cancer Institute - Butternut Greenville South Carolina United States 29605
199 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
200 Prisma Health Greenville Memorial Hospital Greenville South Carolina United States 29605
201 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
202 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
203 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
204 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
205 UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth Texas United States 76104
206 UT Southwestern Clinical Center at Richardson/Plano Richardson Texas United States 75080
207 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
208 University of Utah Sugarhouse Health Center Salt Lake City Utah United States 84106
209 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
210 George E Wahlen Department of Veterans Affairs Medical Center Salt Lake City Utah United States 84148
211 Overlake Medical Center Bellevue Washington United States 98004
212 Valley Medical Center Renton Washington United States 98055
213 North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington United States 98902
214 Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin United States 54729
215 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
216 Marshfield Clinic - Ladysmith Center Ladysmith Wisconsin United States 54848
217 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
218 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
219 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
220 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
221 Marshfield Clinic Stevens Point Center Stevens Point Wisconsin United States 54482
222 Marshfield Clinic-Wausau Center Wausau Wisconsin United States 54401
223 Marshfield Medical Center - Weston Weston Wisconsin United States 54476
224 Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin United States 54494

Sponsors and Collaborators

  • Southwest Oncology Group
  • National Cancer Institute (NCI)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT04510597
Other Study ID Numbers:
  • S1931
  • NCI-2020-04442
First Posted:
Aug 12, 2020
Last Update Posted:
Nov 10, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 10, 2021