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

Primary Purpose

Hepatitis B Infection, Malignant Solid Neoplasm

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Best Practice
Entecavir
Tenofovir Alafenamide
Tenofovir Disoproxil Fumarate
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mercy Hospital Fort Smith
  • Kaiser Permanente-Anaheim
  • Kaiser Permanente-Deer Valley Medical Center
  • Kaiser Permanente-Baldwin Park
  • Kaiser Permanente-Bellflower
  • Epic Care-Dublin
  • Kaiser Permanente Dublin
  • Bay Area Breast Surgeons Inc
  • Epic Care Partners in Cancer Care
  • Kaiser Permanente-Fontana
  • Kaiser Permanente-Fremont
  • Fresno Cancer Center
  • Kaiser Permanente-Fresno
  • Kaiser Permanente - Harbor City
  • Kaiser Permanente-Irvine
  • Tibor Rubin VA Medical Center
  • Kaiser Permanente Los Angeles Medical Center
  • Los Angeles County-USC Medical Center
  • USC / Norris Comprehensive Cancer Center
  • Kaiser Permanente West Los Angeles
  • Contra Costa Regional Medical Center
  • Kaiser Permanente-Modesto
  • USC Norris Oncology/Hematology-Newport Beach
  • Alta Bates Summit Medical Center - Summit Campus
  • Bay Area Tumor Institute
  • Kaiser Permanente Oakland-Broadway
  • Kaiser Permanente-Oakland
  • Kaiser Permanente-Ontario
  • Kaiser Permanente - Panorama City
  • Keck Medical Center of USC Pasadena
  • Kaiser Permanente-Rancho Cordova Cancer Center
  • Kaiser Permanente-Redwood City
  • Kaiser Permanente-Richmond
  • Kaiser Permanente-Riverside
  • Rohnert Park Cancer Center
  • Kaiser Permanente-Roseville
  • The Permanente Medical Group-Roseville Radiation Oncology
  • Kaiser Permanente Downtown Commons
  • Kaiser Permanente-South Sacramento
  • South Sacramento Cancer Center
  • Kaiser Permanente - Sacramento
  • Kaiser Permanente-San Diego Zion
  • Kaiser Permanente-San Francisco
  • Kaiser Permanente-Santa Teresa-San Jose
  • Kaiser Permanente San Leandro
  • Kaiser Permanente-San Marcos
  • Kaiser Permanente-San Rafael
  • Kaiser San Rafael-Gallinas
  • Kaiser Permanente Medical Center - Santa Clara
  • Kaiser Permanente-Santa Rosa
  • Kaiser Permanente Cancer Treatment Center
  • Kaiser Permanente-South San Francisco
  • Kaiser Permanente-Stockton
  • Kaiser Permanente Medical Center-Vacaville
  • Kaiser Permanente-Vallejo
  • Kaiser Permanente-Walnut Creek
  • Epic Care Cyberknife Center
  • Kaiser Permanente-Woodland Hills
  • Broward Health North
  • Broward Health Medical Center
  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  • Hawaii Cancer Care - Savio
  • Pali Momi Medical Center
  • Queen's Cancer Center - Pearlridge
  • The Cancer Center of Hawaii-Pali Momi
  • The Queen's Medical Center - West Oahu
  • Hawaii Cancer Care Inc - Waterfront Plaza
  • Island Urology
  • Queen's Cancer Cenrer - POB I
  • Queen's Medical Center
  • Straub Clinic and Hospital
  • University of Hawaii Cancer Center
  • Hawaii Cancer Care Inc-Liliha
  • Hawaii Diagnostic Radiology Services LLC
  • Kuakini Medical Center
  • Queen's Cancer Center - Kuakini
  • The Cancer Center of Hawaii-Liliha
  • Kaiser Permanente Moanalua Medical Center
  • Kapiolani Medical Center for Women and Children
  • Castle Medical Center
  • Wilcox Memorial Hospital and Kauai Medical Clinic
  • Saint Alphonsus Cancer Care Center-Boise
  • Saint Alphonsus Cancer Care Center-Caldwell
  • Kootenai Health - Coeur d'Alene
  • Walter Knox Memorial Hospital
  • Idaho Urologic Institute-Meridian
  • Saint Alphonsus Medical Center-Nampa
  • Kootenai Clinic Cancer Services - Post Falls
  • Kootenai Cancer Clinic
  • Saint Anthony's Health
  • Rush - Copley Medical Center
  • Northwestern University
  • Carle on Vermilion
  • Carle Physician Group-Effingham
  • Carle Physician Group-Mattoon/Charleston
  • Good Samaritan Regional Health Center
  • Carle Cancer Center
  • The Carle Foundation Hospital
  • Rush-Copley Healthcare Center
  • Cancer Center of Kansas - Chanute
  • Cancer Center of Kansas - Dodge City
  • Cancer Center of Kansas - El Dorado
  • Central Care Cancer Center - Garden City
  • Central Care Cancer Center - Great Bend
  • Cancer Center of Kansas-Independence
  • Cancer Center of Kansas-Kingman
  • Lawrence Memorial Hospital
  • Kansas Institute of Medicine Cancer and Blood Center
  • Minimally Invasive Surgery Hospital
  • Cancer Center of Kansas-Liberal
  • Cancer Center of Kansas-Manhattan
  • Cancer Center of Kansas - McPherson
  • Cancer Center of Kansas - Newton
  • Menorah Medical Center
  • Cancer Center of Kansas - Parsons
  • Cancer Center of Kansas - Pratt
  • Cancer Center of Kansas - Salina
  • Cancer Center of Kansas - Wellington
  • Associates In Womens Health
  • Cancer Center of Kansas-Wichita Medical Arts Tower
  • Cancer Center of Kansas - Wichita
  • Cancer Center of Kansas - Winfield
  • Ochsner LSU Health Monroe Medical Center
  • LSU Health Sciences Center at Shreveport
  • Fairview Ridges Hospital
  • Minnesota Oncology - Burnsville
  • Cambridge Medical Center
  • Mercy Hospital
  • Fairview Southdale Hospital
  • Unity Hospital
  • Fairview Clinics and Surgery Center Maple Grove
  • Minnesota Oncology Hematology PA-Maplewood
  • Saint John's Hospital - Healtheast
  • Abbott-Northwestern Hospital
  • Hennepin County Medical Center
  • Health Partners Inc
  • Monticello Cancer Center
  • New Ulm Medical Center
  • Fairview Northland Medical Center
  • North Memorial Medical Health Center
  • Park Nicollet Clinic - Saint Louis Park
  • Regions Hospital
  • United Hospital
  • Saint Francis Regional Medical Center
  • Lakeview Hospital
  • Ridgeview Medical Center
  • Rice Memorial Hospital
  • Minnesota Oncology Hematology PA-Woodbury
  • Fairview Lakes Medical Center
  • University of Mississippi Medical Center
  • Saint Louis Cancer and Breast Institute-Ballwin
  • Central Care Cancer Center - Bolivar
  • Cox Cancer Center Branson
  • Centerpoint Medical Center LLC
  • Freeman Health System
  • Mercy Hospital Joplin
  • Research Medical Center
  • Delbert Day Cancer Institute at PCRMC
  • Mercy Clinic-Rolla-Cancer and Hematology
  • Heartland Regional Medical Center
  • Saint Louis Cancer and Breast Institute-South City
  • Mercy Hospital South
  • Mercy Hospital Saint Louis
  • Mercy Hospital Springfield
  • CoxHealth South Hospital
  • Mercy Hospital Washington
  • Community Hospital of Anaconda
  • Billings Clinic Cancer Center
  • Bozeman Deaconess Hospital
  • Benefis Healthcare- Sletten Cancer Institute
  • Great Falls Clinic
  • Saint Peter's Community Hospital
  • Kalispell Regional Medical Center
  • Community Medical Hospital
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  • Mercy Hospital Oklahoma City
  • Saint Alphonsus Medical Center-Baker City
  • Saint Alphonsus Medical Center-Ontario
  • Kaiser Permanente Northwest
  • Prisma Health Cancer Institute - Spartanburg
  • Prisma Health Cancer Institute - Easley
  • Prisma Health Cancer Institute - Butternut
  • Prisma Health Cancer Institute - Faris
  • Prisma Health Greenville Memorial Hospital
  • Prisma Health Cancer Institute - Eastside
  • Prisma Health Cancer Institute - Greer
  • Prisma Health Cancer Institute - Seneca
  • M D Anderson Cancer Center
  • Kaiser Permanente Washington
  • Cancer Center of Western Wisconsin
  • Billings Clinic-Cody
  • Welch Cancer Center
  • FHP Health Center-Guam

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A (TAF, TDF, entecavir)

Group B (TAF, TDF, entecavir)

Group C (TAF, TDF, entecavir, usual care)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Time until adverse liver outcome, assessed by incidence of adverse liver outcome
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

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
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).
HBV reactivation rate
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.
Hepatitis flare
Defined as alanine aminotransferase (ALT) > 3 x baseline and > 100 U/L.
Initiation of upon indication tenofovir alafenamide (TAF) therapy
Cancer therapy interruption
Defined as dose reduction, treatment delay, or termination of anti-cancer therapy due to hepatic-related reasons other than disease progression in the liver.
Death due to any cause

Full Information

First Posted
March 21, 2019
Last Updated
June 7, 2023
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03887702
Brief Title
Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 17, 2020 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
February 28, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
Detailed Description
PRIMARY OBJECTIVES: I. 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. II. 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: I. 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. II. 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: I. 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. II. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B Infection, Malignant Solid Neoplasm

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
444 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (TAF, TDF, entecavir)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B (TAF, TDF, entecavir)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group C (TAF, TDF, entecavir, usual care)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive best practice
Intervention Type
Drug
Intervention Name(s)
Entecavir
Other Intervention Name(s)
Baraclude, BMS-200475-01, ETV, SQ-34676, SQ34676
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Tenofovir Alafenamide
Other Intervention Name(s)
GS 7340, GS-7340, TFV Alafenamide
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Tenofovir Disoproxil Fumarate
Other Intervention Name(s)
PMPA Prodrug, TDF, Tenofovir DF, Viread
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Time until adverse liver outcome, assessed by incidence of adverse liver outcome
Description
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.
Time Frame
From the start of study treatment up to 24 months
Secondary Outcome Measure Information:
Title
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
Description
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).
Time Frame
Up to 24 months
Title
HBV reactivation rate
Description
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.
Time Frame
Up to 24 months
Title
Hepatitis flare
Description
Defined as alanine aminotransferase (ALT) > 3 x baseline and > 100 U/L.
Time Frame
Up to 24 months
Title
Initiation of upon indication tenofovir alafenamide (TAF) therapy
Time Frame
Up to 24 months
Title
Cancer therapy interruption
Description
Defined as dose reduction, treatment delay, or termination of anti-cancer therapy due to hepatic-related reasons other than disease progression in the liver.
Time Frame
Up to 24 months
Title
Death due to any cause
Time Frame
From date of randomization up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica P Hwang
Organizational Affiliation
SWOG Cancer Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Hospital Fort Smith
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72903
Country
United States
Facility Name
Kaiser Permanente-Anaheim
City
Anaheim
State/Province
California
ZIP/Postal Code
92806
Country
United States
Facility Name
Kaiser Permanente-Deer Valley Medical Center
City
Antioch
State/Province
California
ZIP/Postal Code
94531
Country
United States
Facility Name
Kaiser Permanente-Baldwin Park
City
Baldwin Park
State/Province
California
ZIP/Postal Code
91706
Country
United States
Facility Name
Kaiser Permanente-Bellflower
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Epic Care-Dublin
City
Dublin
State/Province
California
ZIP/Postal Code
94568
Country
United States
Facility Name
Kaiser Permanente Dublin
City
Dublin
State/Province
California
ZIP/Postal Code
94568
Country
United States
Facility Name
Bay Area Breast Surgeons Inc
City
Emeryville
State/Province
California
ZIP/Postal Code
94608
Country
United States
Facility Name
Epic Care Partners in Cancer Care
City
Emeryville
State/Province
California
ZIP/Postal Code
94608
Country
United States
Facility Name
Kaiser Permanente-Fontana
City
Fontana
State/Province
California
ZIP/Postal Code
92335
Country
United States
Facility Name
Kaiser Permanente-Fremont
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Fresno Cancer Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Kaiser Permanente-Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Kaiser Permanente - Harbor City
City
Harbor City
State/Province
California
ZIP/Postal Code
90710
Country
United States
Facility Name
Kaiser Permanente-Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Tibor Rubin VA Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Los Angeles County-USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Kaiser Permanente West Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90034
Country
United States
Facility Name
Contra Costa Regional Medical Center
City
Martinez
State/Province
California
ZIP/Postal Code
94553-3156
Country
United States
Facility Name
Kaiser Permanente-Modesto
City
Modesto
State/Province
California
ZIP/Postal Code
95356
Country
United States
Facility Name
USC Norris Oncology/Hematology-Newport Beach
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Alta Bates Summit Medical Center - Summit Campus
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Bay Area Tumor Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Kaiser Permanente Oakland-Broadway
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Kaiser Permanente-Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Kaiser Permanente-Ontario
City
Ontario
State/Province
California
ZIP/Postal Code
91761
Country
United States
Facility Name
Kaiser Permanente - Panorama City
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Keck Medical Center of USC Pasadena
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Kaiser Permanente-Rancho Cordova Cancer Center
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Kaiser Permanente-Redwood City
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Kaiser Permanente-Richmond
City
Richmond
State/Province
California
ZIP/Postal Code
94801
Country
United States
Facility Name
Kaiser Permanente-Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
Rohnert Park Cancer Center
City
Rohnert Park
State/Province
California
ZIP/Postal Code
94928
Country
United States
Facility Name
Kaiser Permanente-Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
The Permanente Medical Group-Roseville Radiation Oncology
City
Roseville
State/Province
California
ZIP/Postal Code
95678
Country
United States
Facility Name
Kaiser Permanente Downtown Commons
City
Sacramento
State/Province
California
ZIP/Postal Code
95814
Country
United States
Facility Name
Kaiser Permanente-South Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
South Sacramento Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Kaiser Permanente - Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Kaiser Permanente-San Diego Zion
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Kaiser Permanente-San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente-Santa Teresa-San Jose
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
Kaiser Permanente San Leandro
City
San Leandro
State/Province
California
ZIP/Postal Code
94577
Country
United States
Facility Name
Kaiser Permanente-San Marcos
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
Kaiser Permanente-San Rafael
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Facility Name
Kaiser San Rafael-Gallinas
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Facility Name
Kaiser Permanente Medical Center - Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Kaiser Permanente-Santa Rosa
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Kaiser Permanente Cancer Treatment Center
City
South San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States
Facility Name
Kaiser Permanente-South San Francisco
City
South San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States
Facility Name
Kaiser Permanente-Stockton
City
Stockton
State/Province
California
ZIP/Postal Code
95210
Country
United States
Facility Name
Kaiser Permanente Medical Center-Vacaville
City
Vacaville
State/Province
California
ZIP/Postal Code
95688
Country
United States
Facility Name
Kaiser Permanente-Vallejo
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Kaiser Permanente-Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
Epic Care Cyberknife Center
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94597
Country
United States
Facility Name
Kaiser Permanente-Woodland Hills
City
Woodland Hills
State/Province
California
ZIP/Postal Code
91367
Country
United States
Facility Name
Broward Health North
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Broward Health Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Hawaii Cancer Care - Savio
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Pali Momi Medical Center
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Queen's Cancer Center - Pearlridge
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
The Cancer Center of Hawaii-Pali Momi
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
The Queen's Medical Center - West Oahu
City
'Ewa Beach
State/Province
Hawaii
ZIP/Postal Code
96706
Country
United States
Facility Name
Hawaii Cancer Care Inc - Waterfront Plaza
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Island Urology
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Queen's Cancer Cenrer - POB I
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Straub Clinic and Hospital
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
University of Hawaii Cancer Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Hawaii Cancer Care Inc-Liliha
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Hawaii Diagnostic Radiology Services LLC
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Kuakini Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Queen's Cancer Center - Kuakini
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
The Cancer Center of Hawaii-Liliha
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Kaiser Permanente Moanalua Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Castle Medical Center
City
Kailua
State/Province
Hawaii
ZIP/Postal Code
96734
Country
United States
Facility Name
Wilcox Memorial Hospital and Kauai Medical Clinic
City
Lihue
State/Province
Hawaii
ZIP/Postal Code
96766
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center-Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center-Caldwell
City
Caldwell
State/Province
Idaho
ZIP/Postal Code
83605
Country
United States
Facility Name
Kootenai Health - Coeur d'Alene
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Walter Knox Memorial Hospital
City
Emmett
State/Province
Idaho
ZIP/Postal Code
83617
Country
United States
Facility Name
Idaho Urologic Institute-Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Saint Alphonsus Medical Center-Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Kootenai Clinic Cancer Services - Post Falls
City
Post Falls
State/Province
Idaho
ZIP/Postal Code
83854
Country
United States
Facility Name
Kootenai Cancer Clinic
City
Sandpoint
State/Province
Idaho
ZIP/Postal Code
83864
Country
United States
Facility Name
Saint Anthony's Health
City
Alton
State/Province
Illinois
ZIP/Postal Code
62002
Country
United States
Facility Name
Rush - Copley Medical Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Carle on Vermilion
City
Danville
State/Province
Illinois
ZIP/Postal Code
61832
Country
United States
Facility Name
Carle Physician Group-Effingham
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Carle Physician Group-Mattoon/Charleston
City
Mattoon
State/Province
Illinois
ZIP/Postal Code
61938
Country
United States
Facility Name
Good Samaritan Regional Health Center
City
Mount Vernon
State/Province
Illinois
ZIP/Postal Code
62864
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
The Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Rush-Copley Healthcare Center
City
Yorkville
State/Province
Illinois
ZIP/Postal Code
60560
Country
United States
Facility Name
Cancer Center of Kansas - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Central Care Cancer Center - Garden City
City
Garden City
State/Province
Kansas
ZIP/Postal Code
67846
Country
United States
Facility Name
Central Care Cancer Center - Great Bend
City
Great Bend
State/Province
Kansas
ZIP/Postal Code
67530
Country
United States
Facility Name
Cancer Center of Kansas-Independence
City
Independence
State/Province
Kansas
ZIP/Postal Code
67301
Country
United States
Facility Name
Cancer Center of Kansas-Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Lawrence Memorial Hospital
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66044
Country
United States
Facility Name
Kansas Institute of Medicine Cancer and Blood Center
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Minimally Invasive Surgery Hospital
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Cancer Center of Kansas-Liberal
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67905
Country
United States
Facility Name
Cancer Center of Kansas-Manhattan
City
Manhattan
State/Province
Kansas
ZIP/Postal Code
66502
Country
United States
Facility Name
Cancer Center of Kansas - McPherson
City
McPherson
State/Province
Kansas
ZIP/Postal Code
67460
Country
United States
Facility Name
Cancer Center of Kansas - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Menorah Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Cancer Center of Kansas - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Cancer Center of Kansas - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Cancer Center of Kansas - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates In Womens Health
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas-Wichita Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Ochsner LSU Health Monroe Medical Center
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71202
Country
United States
Facility Name
LSU Health Sciences Center at Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Fairview Ridges Hospital
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Minnesota Oncology - Burnsville
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Cambridge Medical Center
City
Cambridge
State/Province
Minnesota
ZIP/Postal Code
55008
Country
United States
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Fairview Clinics and Surgery Center Maple Grove
City
Maple Grove
State/Province
Minnesota
ZIP/Postal Code
55369
Country
United States
Facility Name
Minnesota Oncology Hematology PA-Maplewood
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Saint John's Hospital - Healtheast
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Health Partners Inc
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Monticello Cancer Center
City
Monticello
State/Province
Minnesota
ZIP/Postal Code
55362
Country
United States
Facility Name
New Ulm Medical Center
City
New Ulm
State/Province
Minnesota
ZIP/Postal Code
56073
Country
United States
Facility Name
Fairview Northland Medical Center
City
Princeton
State/Province
Minnesota
ZIP/Postal Code
55371
Country
United States
Facility Name
North Memorial Medical Health Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Park Nicollet Clinic - Saint Louis Park
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Saint Francis Regional Medical Center
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Facility Name
Lakeview Hospital
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Facility Name
Ridgeview Medical Center
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
Facility Name
Rice Memorial Hospital
City
Willmar
State/Province
Minnesota
ZIP/Postal Code
56201
Country
United States
Facility Name
Minnesota Oncology Hematology PA-Woodbury
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Fairview Lakes Medical Center
City
Wyoming
State/Province
Minnesota
ZIP/Postal Code
55092
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Saint Louis Cancer and Breast Institute-Ballwin
City
Ballwin
State/Province
Missouri
ZIP/Postal Code
63011
Country
United States
Facility Name
Central Care Cancer Center - Bolivar
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Facility Name
Cox Cancer Center Branson
City
Branson
State/Province
Missouri
ZIP/Postal Code
65616
Country
United States
Facility Name
Centerpoint Medical Center LLC
City
Independence
State/Province
Missouri
ZIP/Postal Code
64057
Country
United States
Facility Name
Freeman Health System
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
Mercy Hospital Joplin
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Delbert Day Cancer Institute at PCRMC
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Mercy Clinic-Rolla-Cancer and Hematology
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Heartland Regional Medical Center
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Saint Louis Cancer and Breast Institute-South City
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Mercy Hospital South
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Mercy Hospital Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
CoxHealth South Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Mercy Hospital Washington
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Community Hospital of Anaconda
City
Anaconda
State/Province
Montana
ZIP/Postal Code
59711
Country
United States
Facility Name
Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Benefis Healthcare- Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Saint Peter's Community Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Community Medical Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Mercy Hospital Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Saint Alphonsus Medical Center-Baker City
City
Baker City
State/Province
Oregon
ZIP/Postal Code
97814
Country
United States
Facility Name
Saint Alphonsus Medical Center-Ontario
City
Ontario
State/Province
Oregon
ZIP/Postal Code
97914
Country
United States
Facility Name
Kaiser Permanente Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Prisma Health Cancer Institute - Spartanburg
City
Boiling Springs
State/Province
South Carolina
ZIP/Postal Code
29316
Country
United States
Facility Name
Prisma Health Cancer Institute - Easley
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
Prisma Health Cancer Institute - Butternut
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Prisma Health Cancer Institute - Faris
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Prisma Health Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Prisma Health Cancer Institute - Eastside
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Prisma Health Cancer Institute - Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Prisma Health Cancer Institute - Seneca
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Kaiser Permanente Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Cancer Center of Western Wisconsin
City
New Richmond
State/Province
Wisconsin
ZIP/Postal Code
54017
Country
United States
Facility Name
Billings Clinic-Cody
City
Cody
State/Province
Wyoming
ZIP/Postal Code
82414
Country
United States
Facility Name
Welch Cancer Center
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States
Facility Name
FHP Health Center-Guam
City
Tamuning
ZIP/Postal Code
96913
Country
Guam

12. IPD Sharing Statement

Learn more about this trial

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

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