Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03887702
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 444
• Locations: 193
• Arms: 3
• Anticipated Duration (Months): 96.2
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This phase III trial studies the effect of tenofovir alafenamide in preventing liver complications in patients with current or past hepatitis B virus (HBV) who are receiving anti-cancer therapy for solid tumors. People with chronic or past HBV who are undergoing therapy for cancer are at an increased risk for changes in the liver which could be minor or severe. Tenofovir alafenamide is a drug that acts against infections caused by HBV and may help reduce the chance that HBV gets worse or comes back in patients receiving anti-cancer therapy for solid tumors.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Infection; Malignant Solid Neoplasm	Other: Best Practice; Drug: Entecavir; Drug: Tenofovir Alafenamide; Drug: Tenofovir Disoproxil Fumarate	Phase 3

Detailed Description

PRIMARY OBJECTIVES:

1. To compare the effect of prophylactic anti-HBV therapy versus upon indication anti-HBV therapy on time-to-adverse liver outcomes of liver failure or liver-related death in patients with chronic HBV infection (hepatitis B surface antigen positive [HBsAg+] and antibody to hepatitis B core antigen positive [anti-HBc+]) receiving anti-cancer therapy for solid tumors.

2. To compare the effect of upon indication anti-HBV therapy versus usual care on time-to-adverse liver outcomes of liver failure or liver-related death in patients with past HBV infection (hepatitis B surface antigen negative [HBsAg-] and anti-HBc+) receiving anti-cancer therapy for solid tumors.

SECONDARY OBJECTIVES:

1. Using time-to-event analysis, to compare the effect of anti-HBV therapy versus upon indication anti-HBV therapy on HBV reactivation, on the combined endpoint of adverse liver outcomes (liver failure or liver-related death) and HBV reactivation, and on HBV flare by arm in patients with chronic HBV infection receiving anti-cancer therapy for solid tumors.

2. Using time-to-event analysis, to compare the effect of upon indication anti-HBV therapy versus usual care on HBV reactivation, on the combined endpoint of adverse liver outcomes (liver failure or liver-related death) and HBV reactivation, and on HBV flare by arm in patients with past HBV infection receiving anti-cancer therapy for solid tumors.

TRANSLATIONAL OBJECTIVES:

1. To compare baseline and changes in overall immune status and HBV-specific immune response in patients with solid tumors and chronic or past HBV infection receiving anti-cancer therapy, and to compare the differences in these immune responses by HBV reactivation status.

2. To identify demographic and clinical predictors and correlative immunologic biomarkers of HBV reactivation after receipt of anti-cancer therapy in patients with solid tumors and chronic or past HBV infection.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP A (Cohorts 1a & 2a): Patients receive tenofovir alafenamide (TAF) orally (PO) once daily (QD) or tenofovir disoproxil fumarate (TDF) PO QD or entecavir PO QD immediately or within 42 days after initial dose of chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.

GROUP B (Cohorts 1b & 2b): Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.

GROUP C (Cohort 3): Patients receive TAF PO QD or TDF PO QD or entecavir PO QD at the discretion of the physician during usual care. Treatment continues for up to 6 months after discontinuation of usual care or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 4 weeks for up to 24 months.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 444 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors
• Actual Study Start Date: Feb 21, 2019
• Anticipated Primary Completion Date: Feb 1, 2026
• Anticipated Study Completion Date: Feb 28, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A (TAF, TDF, entecavir) Patients receive TAF PO QD or TDF PO QD or entecavir PO QD immediately or within 42 days after initial dose of chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.	Drug: Entecavir; Given PO; Other Names: Baraclude BMS-200475-01 ETV SQ-34676 SQ34676 ; Drug: Tenofovir Alafenamide; Given PO; Other Names: GS 7340 GS-7340 TFV Alafenamide ; Drug: Tenofovir Disoproxil Fumarate; Given PO; Other Names: PMPA Prodrug TDF Tenofovir DF Viread
Experimental: Group B (TAF, TDF, entecavir) Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.	Drug: Entecavir; Given PO; Other Names: Baraclude BMS-200475-01 ETV SQ-34676 SQ34676 ; Drug: Tenofovir Alafenamide; Given PO; Other Names: GS 7340 GS-7340 TFV Alafenamide ; Drug: Tenofovir Disoproxil Fumarate; Given PO; Other Names: PMPA Prodrug TDF Tenofovir DF Viread
Experimental: Group C (TAF, TDF, entecavir, usual care) Patients receive TAF PO QD or TDF PO QD or entecavir PO QD at the discretion of the physician during usual care. Treatment continues for up to 6 months after discontinuation of usual care or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.	Other: Best Practice; Receive best practice; Other Names: standard of care standard therapy ; Drug: Entecavir; Given PO; Other Names: Baraclude BMS-200475-01 ETV SQ-34676 SQ34676 ; Drug: Tenofovir Alafenamide; Given PO; Other Names: GS 7340 GS-7340 TFV Alafenamide ; Drug: Tenofovir Disoproxil Fumarate; Given PO; Other Names: PMPA Prodrug TDF Tenofovir DF Viread

Outcome Measures

Primary Outcome Measures

1. Time until adverse liver outcome, assessed by incidence of adverse liver outcome [From the start of study treatment up to 24 months]

   Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0. Adverse liver outcome defined as liver-related death or liver failure (ascites, hepatic encephalopathy or impaired hepatic synthetic function defined as total bilirubin >= 5 mg/dL or international normalized ration [INR] >= 2.0) not due to disease progression in the liver. The study will recruit patients with multiple different cancer types, but predominantly lung, breast, colon, prostate, gynecological, and head and neck cancers. Estimates of adverse liver outcomes at 1 year will be derived using cumulative incidence to account for the competing risk of death. The final analysis will rely on Cox regression, adjusting for the stratification factors.

Secondary Outcome Measures

1. Incidence of hepatitis B Virus (HBV) reactivation among patients with solid malignancies and chronic or past HBV infection during or after completion of anti-cancer therapy [Up to 24 months]

   Estimates of HBV reactivation at one year will be derived using cumulative incidence to account for competing risks. Under this scenario, a sample size of n=222 patients for each randomized study will allow the investigators to estimate the confidence interval to within +/- 6% (based on the upper bound of the 95% confidence interval using an exact binomial in patients with complete follow-up), if the assumed incidence is at least 20%. Thus, this sample size will allow the confidence interval to be estimated to within +/- 31.1% of the assumed incidence (the "relative accuracy", defined as: (95% confidence interval [CI] upper bound - p)/p], where p is the assumed incidence).

2. HBV reactivation rate [Up to 24 months]

   The investigators will compare HBV reactivation rates by arm within each randomized trial. Based on a two-sample survival design accounting for the competing risk of death (~20% deaths at 1 year [hazard rate of 0.223]), and a one-sided alpha=0.05 test, then n=222 patients (111 per arm) will give 81% power to detect a hazard ratio for HBV reactivation for experimental to standard arms of 0.47, representing a 53% reduction in the hazard risk of HBV reactivation in the first year (from a hazard=0.223 down to hazard = 0.105), or an absolute reduction of 50% (from 20% down to 10%). Multivariable Cox regression will compare the effect of intervention assignment, adjusting for the stratification factors specified in the main clinical study.

3. Hepatitis flare [Up to 24 months]

   Defined as alanine aminotransferase (ALT) > 3 x baseline and > 100 U/L.

4. Initiation of upon indication tenofovir alafenamide (TAF) therapy [Up to 24 months]

5. Cancer therapy interruption [Up to 24 months]

   Defined as dose reduction, treatment delay, or termination of anti-cancer therapy due to hepatic-related reasons other than disease progression in the liver.

6. Death due to any cause [From date of randomization up to 24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients must be diagnosed with stage I-III solid tumor malignancy; patients with only carcinoma in situ or with stage IV disease are excluded

• Patients must not have been diagnosed with a malignancy other than the current malignancy within the past five years, with the exception of basal cell or squamous cell skin cancer, or non-invasive (in situ) malignancies of the cervix, breast, or skin

• Patients must not have lymphoma, leukemia, or myeloma

• Patients must not have primary liver cancer, known cirrhosis, or evidence of any malignancy that involves the liver

• Patients must be planning to receive systemic anti-cancer therapy (either single agent or some combination of systemic cytotoxic therapy, systemic immunotherapy or systemic targeted therapy) for this solid tumor

• Patients must not have been previously treated with the same anti-cancer therapy regimen that is now anticipated; the anti-cancer therapy does not have to be first-line therapy; prior and/or concurrent radiotherapy is allowed

• Patients must be registered =< 28 days prior to the planned start date of anti-cancer therapy; if the patient has started systemic anti-cancer therapy, patient must be registered =< 42 days after the initiation of first cycle of anti-cancer therapy

• Patients who have received prior anti-cancer therapy must have discontinued all previous therapies (excluding planned anti-cancer therapy to occur in conjunction with this study) >= 1 day prior to registration to this study

• Patients must not have had any cancer therapy regimen that includes anti-CD20

• Patients must not be receiving antiviral medications active against HBV, including: adefovir, entecavir, lamivudine, telbivudine, tenofovir disoproxil fumarate, tenofovir alafenamide (TAF), or any other Food and Drug Administration (FDA) approved agents for the treatment of hepatitis B; patients who have previously received antiviral medication must not have required any antiviral medication active against HBV >= 90 days prior to registration to this study

• Patients must not have had hematopoietic stem cell transplantation therapy

• Patients receiving any of the following medications must discontinue them (under the supervision of their treating physician) prior to registration, and must not be planning to take them during protocol therapy: acyclovir, aminoglycosides, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, valacyclovir, high-dose nonsteroidal anti-inflammatory drugs (NSAIDs), ("high-dose" based on package insert), and St. John's wort

• Patients must have results for the following HBV tests done within 28 days prior to registration: HBsAg AND anti-HBc (total immunoglobulin [Ig] or IgG, but not IgM only) AND hepatitis B surface antibody (anti-HBs); for the anti-HBs test, quantitative or qualitative (including "indeterminate") results are allowable

• Patients must have tested positive for HBsAg or anti-HBc (total Ig, IgG, but not IgM) and must have baseline HBV deoxyribonucleic acid (DNA) completed =< 42 days prior to registration

• Complete blood count (CBC) must be completed =< 28 days prior to registration; results do not need to be in the institutional limits of normal

• International normalized ratio (INR) must be completed =< 28 days prior to registration; results must < 1.2 x institutional limits of normal

• Alanine aminotransferase (ALT) must be obtained =< 28 days prior to registration; ALT must be =< 1.5 x institutional ULN

• Total bilirubin must be obtained =< 28 days prior to registration; total bilirubin must be =< 1.5 x institutional ULN

• Creatinine results must be obtained =< 28 days prior to registration; creatinine must be =< 1.5 x institutional ULN

• Patients must not have known current active hepatitis C infection (HCV); active HCV is defined by a detectable HCV ribonucleic acid (RNA) level; Note: HCV testing is not required for eligibility

• Patients must not have a history of human immunodeficiency (HIV) infection; patients with unknown HIV status must have HIV testing completed =< 365 days prior to registration

• Patients must have Zubrod performance status of 0-2

• Patients must not be pregnant or nursing, as the safety of the study drug in pregnant and nursing women has not been established; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures

• Patients must have specimens collected for submission as outlined

• Patients must be offered the opportunity to participate in optional translational medicine studies as outlined

• Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)

• Patients may have concurrent participation in other clinical trials that entail cytotoxic, immunotherapy, targeted therapy; surgical treatment; radiotherapy treatment; or any combination thereof

• Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

• As a 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mercy Hospital Fort Smith	Fort Smith	Arkansas	United States	72903
2	Kaiser Permanente-Anaheim	Anaheim	California	United States	92806
3	Kaiser Permanente-Deer Valley Medical Center	Antioch	California	United States	94531
4	Kaiser Permanente-Baldwin Park	Baldwin Park	California	United States	91706
5	Kaiser Permanente-Bellflower	Bellflower	California	United States	90706
6	Epic Care-Dublin	Dublin	California	United States	94568
7	Kaiser Permanente Dublin	Dublin	California	United States	94568
8	Bay Area Breast Surgeons Inc	Emeryville	California	United States	94608
9	Epic Care Partners in Cancer Care	Emeryville	California	United States	94608
10	Kaiser Permanente-Fontana	Fontana	California	United States	92335
11	Kaiser Permanente-Fremont	Fremont	California	United States	94538
12	Fresno Cancer Center	Fresno	California	United States	93720
13	Kaiser Permanente-Fresno	Fresno	California	United States	93720
14	Kaiser Permanente - Harbor City	Harbor City	California	United States	90710
15	Kaiser Permanente-Irvine	Irvine	California	United States	92618
16	Tibor Rubin VA Medical Center	Long Beach	California	United States	90822
17	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California	United States	90027
18	Los Angeles County-USC Medical Center	Los Angeles	California	United States	90033
19	USC / Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033
20	Kaiser Permanente West Los Angeles	Los Angeles	California	United States	90034
21	Contra Costa Regional Medical Center	Martinez	California	United States	94553-3156
22	Kaiser Permanente-Modesto	Modesto	California	United States	95356
23	USC Norris Oncology/Hematology-Newport Beach	Newport Beach	California	United States	92663
24	Alta Bates Summit Medical Center - Summit Campus	Oakland	California	United States	94609
25	Bay Area Tumor Institute	Oakland	California	United States	94609
26	Kaiser Permanente Oakland-Broadway	Oakland	California	United States	94611
27	Kaiser Permanente-Oakland	Oakland	California	United States	94611
28	Kaiser Permanente-Ontario	Ontario	California	United States	91761
29	Kaiser Permanente - Panorama City	Panorama City	California	United States	91402
30	Keck Medical Center of USC Pasadena	Pasadena	California	United States	91105
31	Kaiser Permanente-Rancho Cordova Cancer Center	Rancho Cordova	California	United States	95670
32	Kaiser Permanente-Redwood City	Redwood City	California	United States	94063
33	Kaiser Permanente-Richmond	Richmond	California	United States	94801
34	Kaiser Permanente-Riverside	Riverside	California	United States	92505
35	Rohnert Park Cancer Center	Rohnert Park	California	United States	94928
36	Kaiser Permanente-Roseville	Roseville	California	United States	95661
37	The Permanente Medical Group-Roseville Radiation Oncology	Roseville	California	United States	95678
38	Kaiser Permanente Downtown Commons	Sacramento	California	United States	95814
39	Kaiser Permanente-South Sacramento	Sacramento	California	United States	95823
40	South Sacramento Cancer Center	Sacramento	California	United States	95823
41	Kaiser Permanente - Sacramento	Sacramento	California	United States	95825
42	Kaiser Permanente-San Diego Zion	San Diego	California	United States	92120
43	Kaiser Permanente-San Francisco	San Francisco	California	United States	94115
44	Kaiser Permanente-Santa Teresa-San Jose	San Jose	California	United States	95119
45	Kaiser Permanente San Leandro	San Leandro	California	United States	94577
46	Kaiser Permanente-San Marcos	San Marcos	California	United States	92078
47	Kaiser Permanente-San Rafael	San Rafael	California	United States	94903
48	Kaiser San Rafael-Gallinas	San Rafael	California	United States	94903
49	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California	United States	95051
50	Kaiser Permanente-Santa Rosa	Santa Rosa	California	United States	95403
51	Kaiser Permanente Cancer Treatment Center	South San Francisco	California	United States	94080
52	Kaiser Permanente-South San Francisco	South San Francisco	California	United States	94080
53	Kaiser Permanente-Stockton	Stockton	California	United States	95210
54	Kaiser Permanente Medical Center-Vacaville	Vacaville	California	United States	95688
55	Kaiser Permanente-Vallejo	Vallejo	California	United States	94589
56	Kaiser Permanente-Walnut Creek	Walnut Creek	California	United States	94596
57	Epic Care Cyberknife Center	Walnut Creek	California	United States	94597
58	Kaiser Permanente-Woodland Hills	Woodland Hills	California	United States	91367
59	Broward Health North	Deerfield Beach	Florida	United States	33064
60	Broward Health Medical Center	Fort Lauderdale	Florida	United States	33316
61	Lewis Cancer and Research Pavilion at Saint Joseph's/Candler	Savannah	Georgia	United States	31405
62	Hawaii Cancer Care - Savio	'Aiea	Hawaii	United States	96701
63	Pali Momi Medical Center	'Aiea	Hawaii	United States	96701
64	Queen's Cancer Center - Pearlridge	'Aiea	Hawaii	United States	96701
65	The Cancer Center of Hawaii-Pali Momi	'Aiea	Hawaii	United States	96701
66	The Queen's Medical Center - West Oahu	'Ewa Beach	Hawaii	United States	96706
67	Hawaii Cancer Care Inc - Waterfront Plaza	Honolulu	Hawaii	United States	96813
68	Island Urology	Honolulu	Hawaii	United States	96813
69	Queen's Cancer Cenrer - POB I	Honolulu	Hawaii	United States	96813
70	Queen's Medical Center	Honolulu	Hawaii	United States	96813
71	Straub Clinic and Hospital	Honolulu	Hawaii	United States	96813
72	University of Hawaii Cancer Center	Honolulu	Hawaii	United States	96813
73	Hawaii Cancer Care Inc-Liliha	Honolulu	Hawaii	United States	96817
74	Hawaii Diagnostic Radiology Services LLC	Honolulu	Hawaii	United States	96817
75	Kuakini Medical Center	Honolulu	Hawaii	United States	96817
76	Queen's Cancer Center - Kuakini	Honolulu	Hawaii	United States	96817
77	The Cancer Center of Hawaii-Liliha	Honolulu	Hawaii	United States	96817
78	Kaiser Permanente Moanalua Medical Center	Honolulu	Hawaii	United States	96819
79	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
80	Castle Medical Center	Kailua	Hawaii	United States	96734
81	Wilcox Memorial Hospital and Kauai Medical Clinic	Lihue	Hawaii	United States	96766
82	Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho	United States	83706
83	Saint Alphonsus Cancer Care Center-Caldwell	Caldwell	Idaho	United States	83605
84	Kootenai Health - Coeur d'Alene	Coeur d'Alene	Idaho	United States	83814
85	Walter Knox Memorial Hospital	Emmett	Idaho	United States	83617
86	Idaho Urologic Institute-Meridian	Meridian	Idaho	United States	83642
87	Saint Alphonsus Medical Center-Nampa	Nampa	Idaho	United States	83686
88	Kootenai Clinic Cancer Services - Post Falls	Post Falls	Idaho	United States	83854
89	Kootenai Cancer Clinic	Sandpoint	Idaho	United States	83864
90	Saint Anthony's Health	Alton	Illinois	United States	62002
91	Rush - Copley Medical Center	Aurora	Illinois	United States	60504
92	Northwestern University	Chicago	Illinois	United States	60611
93	Carle on Vermilion	Danville	Illinois	United States	61832
94	Carle Physician Group-Effingham	Effingham	Illinois	United States	62401
95	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois	United States	61938
96	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
97	Carle Cancer Center	Urbana	Illinois	United States	61801
98	The Carle Foundation Hospital	Urbana	Illinois	United States	61801
99	Rush-Copley Healthcare Center	Yorkville	Illinois	United States	60560
100	Cancer Center of Kansas - Chanute	Chanute	Kansas	United States	66720
101	Cancer Center of Kansas - Dodge City	Dodge City	Kansas	United States	67801
102	Cancer Center of Kansas - El Dorado	El Dorado	Kansas	United States	67042
103	Central Care Cancer Center - Garden City	Garden City	Kansas	United States	67846
104	Central Care Cancer Center - Great Bend	Great Bend	Kansas	United States	67530
105	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
106	Cancer Center of Kansas-Kingman	Kingman	Kansas	United States	67068
107	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
108	Kansas Institute of Medicine Cancer and Blood Center	Lenexa	Kansas	United States	66219
109	Minimally Invasive Surgery Hospital	Lenexa	Kansas	United States	66219
110	Cancer Center of Kansas-Liberal	Liberal	Kansas	United States	67905
111	Cancer Center of Kansas-Manhattan	Manhattan	Kansas	United States	66502
112	Cancer Center of Kansas - McPherson	McPherson	Kansas	United States	67460
113	Cancer Center of Kansas - Newton	Newton	Kansas	United States	67114
114	Menorah Medical Center	Overland Park	Kansas	United States	66209
115	Cancer Center of Kansas - Parsons	Parsons	Kansas	United States	67357
116	Cancer Center of Kansas - Pratt	Pratt	Kansas	United States	67124
117	Cancer Center of Kansas - Salina	Salina	Kansas	United States	67401
118	Cancer Center of Kansas - Wellington	Wellington	Kansas	United States	67152
119	Associates In Womens Health	Wichita	Kansas	United States	67208
120	Cancer Center of Kansas-Wichita Medical Arts Tower	Wichita	Kansas	United States	67208
121	Cancer Center of Kansas - Wichita	Wichita	Kansas	United States	67214
122	Cancer Center of Kansas - Winfield	Winfield	Kansas	United States	67156
123	Ochsner LSU Health Monroe Medical Center	Monroe	Louisiana	United States	71202
124	LSU Health Sciences Center at Shreveport	Shreveport	Louisiana	United States	71103
125	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
126	Minnesota Oncology - Burnsville	Burnsville	Minnesota	United States	55337
127	Cambridge Medical Center	Cambridge	Minnesota	United States	55008
128	Mercy Hospital	Coon Rapids	Minnesota	United States	55433
129	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
130	Unity Hospital	Fridley	Minnesota	United States	55432
131	Fairview Clinics and Surgery Center Maple Grove	Maple Grove	Minnesota	United States	55369
132	Minnesota Oncology Hematology PA-Maplewood	Maplewood	Minnesota	United States	55109
133	Saint John's Hospital - Healtheast	Maplewood	Minnesota	United States	55109
134	Abbott-Northwestern Hospital	Minneapolis	Minnesota	United States	55407
135	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
136	Health Partners Inc	Minneapolis	Minnesota	United States	55454
137	Monticello Cancer Center	Monticello	Minnesota	United States	55362
138	New Ulm Medical Center	New Ulm	Minnesota	United States	56073
139	Fairview Northland Medical Center	Princeton	Minnesota	United States	55371
140	North Memorial Medical Health Center	Robbinsdale	Minnesota	United States	55422
141	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota	United States	55416
142	Regions Hospital	Saint Paul	Minnesota	United States	55101
143	United Hospital	Saint Paul	Minnesota	United States	55102
144	Saint Francis Regional Medical Center	Shakopee	Minnesota	United States	55379
145	Lakeview Hospital	Stillwater	Minnesota	United States	55082
146	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
147	Rice Memorial Hospital	Willmar	Minnesota	United States	56201
148	Minnesota Oncology Hematology PA-Woodbury	Woodbury	Minnesota	United States	55125
149	Fairview Lakes Medical Center	Wyoming	Minnesota	United States	55092
150	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
151	Saint Louis Cancer and Breast Institute-Ballwin	Ballwin	Missouri	United States	63011
152	Central Care Cancer Center - Bolivar	Bolivar	Missouri	United States	65613
153	Cox Cancer Center Branson	Branson	Missouri	United States	65616
154	Centerpoint Medical Center LLC	Independence	Missouri	United States	64057
155	Freeman Health System	Joplin	Missouri	United States	64804
156	Mercy Hospital Joplin	Joplin	Missouri	United States	64804
157	Research Medical Center	Kansas City	Missouri	United States	64132
158	Delbert Day Cancer Institute at PCRMC	Rolla	Missouri	United States	65401
159	Mercy Clinic-Rolla-Cancer and Hematology	Rolla	Missouri	United States	65401
160	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64506
161	Saint Louis Cancer and Breast Institute-South City	Saint Louis	Missouri	United States	63109
162	Mercy Hospital South	Saint Louis	Missouri	United States	63128
163	Mercy Hospital Saint Louis	Saint Louis	Missouri	United States	63141
164	Mercy Hospital Springfield	Springfield	Missouri	United States	65804
165	CoxHealth South Hospital	Springfield	Missouri	United States	65807
166	Mercy Hospital Washington	Washington	Missouri	United States	63090
167	Community Hospital of Anaconda	Anaconda	Montana	United States	59711
168	Billings Clinic Cancer Center	Billings	Montana	United States	59101
169	Bozeman Deaconess Hospital	Bozeman	Montana	United States	59715
170	Benefis Healthcare- Sletten Cancer Institute	Great Falls	Montana	United States	59405
171	Great Falls Clinic	Great Falls	Montana	United States	59405
172	Saint Peter's Community Hospital	Helena	Montana	United States	59601
173	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
174	Community Medical Hospital	Missoula	Montana	United States	59804
175	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York	United States	10032
176	Mercy Hospital Oklahoma City	Oklahoma City	Oklahoma	United States	73120
177	Saint Alphonsus Medical Center-Baker City	Baker City	Oregon	United States	97814
178	Saint Alphonsus Medical Center-Ontario	Ontario	Oregon	United States	97914
179	Kaiser Permanente Northwest	Portland	Oregon	United States	97227
180	Prisma Health Cancer Institute - Spartanburg	Boiling Springs	South Carolina	United States	29316
181	Prisma Health Cancer Institute - Easley	Easley	South Carolina	United States	29640
182	Prisma Health Cancer Institute - Butternut	Greenville	South Carolina	United States	29605
183	Prisma Health Cancer Institute - Faris	Greenville	South Carolina	United States	29605
184	Prisma Health Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
185	Prisma Health Cancer Institute - Eastside	Greenville	South Carolina	United States	29615
186	Prisma Health Cancer Institute - Greer	Greer	South Carolina	United States	29650
187	Prisma Health Cancer Institute - Seneca	Seneca	South Carolina	United States	29672
188	M D Anderson Cancer Center	Houston	Texas	United States	77030
189	Kaiser Permanente Washington	Seattle	Washington	United States	98112
190	Cancer Center of Western Wisconsin	New Richmond	Wisconsin	United States	54017
191	Billings Clinic-Cody	Cody	Wyoming	United States	82414
192	Welch Cancer Center	Sheridan	Wyoming	United States	82801
193	FHP Health Center-Guam	Tamuning		Guam	96913

Sponsors and Collaborators

• Southwest Oncology Group
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jessica P Hwang, Southwest Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Southwest Oncology Group
• ClinicalTrials.gov Identifier: NCT03887702
• Other Study ID Numbers: S1614; NCI-2018-00592; S1614; SWOG-S1614; S1614; UG1CA189974
• First Posted: Mar 25, 2019
• Last Update Posted: Apr 6, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis B; Hepatitis; Tenofovir; Entecavir

Study Results

No Results Posted as of Apr 6, 2022