Clinical trial NCT04498117: Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery
Official title: A Multicenter Phase 3, Double-Blind, Placebo-Controlled Study Comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin- Oregovomab) vs Chemotherapy (Paclitaxel-Carboplatin- Placebo) in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Carcinoma, Ovarian Epithelial
Ovarian Neoplasms
Ovarian Cancer
Ovarian Serous Adenocarcinoma
Fallopian Tube Neoplasms
Fallopian Tube Adenocarcinoma
Fallopian Tube Serous Adenocarcinoma
Peritoneal Cancer
Peritoneal Carcinoma
Peritoneal Neoplasms
Lead sponsor: CanariaBio Inc.
Sponsor class: INDUSTRY
Collaborators: name: Gynecologic Oncology Group
name: Iqvia Pty Ltd
First posted: 2020-08-04
Enrollment: 615
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to compare the safety and efficacy of oregovomab versus placebo, administered in combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of subjects with newly diagnosed advanced ovarian cancer who have undergone optimal debulking.

Detailed description: Phase 3 double-blind, placebo-controlled, multi-center study to compare the safety and efficacy of four administrations of oregovomab 2 mg IV versus placebo, administered in combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of subjects with newly diagnosed ovarian cancer who have undergone optimal debulking surgery and are either pending initiation of chemotherapy (Cohort 1 - Primary Surgery) or resumption of another three cycles of chemotherapy, having already completed three cycles of neoadjuvant chemotherapy (Cohort 2 - NACT + Interval Surgery).

For Cohort 1 - Primary Surgery, approximately 372 subjects randomized in a 1:1 ratio (i.e., chemotherapy with oregovomab or chemotherapy with placebo). For Cohort 2 - NACT + Interval Surgery, approximately 230 subjects will be randomized in a 1:1 ratio (i.e., chemotherapy with oregovomab or chemotherapy and placebo).

Eligibility criteria: Inclusion Criteria:

1. Adults 18 years old or older.
2. Newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease.
3. Histologic epithelial cell types: high grade serous adenocarcinoma, high grade endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).
4. Completed debulking surgery (either primary debulking surgery or interval debulking surgery at the discretion of the investigator). Debulking surgery must be optimal, R1 or R0 (defined as R1, macroscopic less than 1 cm in diameter, or R0, microscopic or no evidence of tumor). Assessment of debulking surgery will be determined at the time of the surgical procedure, not by post-surgical imaging.

   1. For Cohort 1, subject will undergo primary debulking surgery. Subject must receive initial dose of paclitaxel 175 mg/m\^2 given intravenously and carboplatin AUC 6 IV every 3 weeks for 6 cycles. Carboplatin total dose given as 5 consecutive daily pulse doses, for subjects who experiences significant grade 3 or higher emesis. Subsequent dose modifications will be instituted per protocol. Cycle 1 of chemotherapy ± oregovomab/placebo must be anticipated to occur within 6 weeks after primary debulking surgery
   2. For Cohort 2, subject will undergo interval debulking surgery (IDS). Prior to IDS, subjects must have receive 3 cycles of paclitaxel and carboplatin as neoadjuvant treatment. After IDS, subjects must receive paclitaxel 175 mg/m\^2 IV and carboplatin AUC 5-6 IV every 3 weeks, starting cycle 4. Cycle 4 of chemotherapy ± oregovomab/placebo must be anticipated to occur within 6 weeks after IDS.
5. Suitable venous access for the study-required procedures
6. Preoperative serum CA-125 levels ≥ 50 U/mL for Cohort 1, serum CA-125 levels ≥ 50 U/mL prior to first neoadjuvant chemotherapy for Cohort 2.
7. Adequate bone marrow function:

   1. Absolute neutrophil count (ANC) ≥ 1,500/µL
   2. Platelets ≥ 100,000/µL
8. Hemoglobin ≥ 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before first dose of study treatment).
9. Adequate liver function:

   1. Bilirubin \< 1.5 times upper limit normal (ULN)
   2. Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT \< 2.5 times ULN
10. Adequate renal function:

    a. Creatinine ≤ 1.5 times ULN
11. ECOG Performance Status of 0 or 1.
12. For women of childbearing potential, must be willing to avoid pregnancy by using highly effective method of contraception from the first dose of study treatment to 6 months after last dose of study treatment as defined per protocol. Belgium and South Korea only: Use of a highly effective method of contraception from 28 days before first dose.
13. Signed informed consent and authorization permitting release of personal health information.
14. Willingness and ability to complete patient quality of life questionnaires.

Exclusion Criteria:

1. BRCA1 or BRCA2 germline gene mutation test result with:

   1. Pathogenic, ambiguous or inconclusive result available within 28 days prior to starting study treatment (subjects with BRCA1 or BRCA 2 variants of uncertain significance can enroll onto the study as long as there is no intent to administer PARP inhibitors for front-line maintenance therapy), or
   2. Known BRCA1 and BRCA2 somatic mutations, if testing is performed
2. Known Somatic Homologous Recombination Deficiency (HRD) who will receive PARP inhibitor front-line maintenance therapy. Subjects with somatic HRD are eligible as long as there is no intent to administer PARP inhibitor front-line maintenance therapy.
3. Subjects with mucinous adenocarcinoma, carcinosarcoma, tumors with neuroendocrine features and low-grade adenocarcinoma.
4. Female subjects who are lactating and breastfeeding, or have a positive serum pregnancy test within 7 days prior to the first dose of study treatment (C1D1 for Cohort 1 or C4D1 for Cohort 2).
5. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
6. Active autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), or ankylosing spondylitis requiring active disease modifying treatment.
7. Known allergy to murine proteins or hypersensitivity to any of the excipients of the oregovomab, paclitaxel, or carboplatin.
8. Chronically treated with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), etc.
9. Chronic therapeutic corticosteroid use, defined as \> 5 days of prednisone or equivalent, with the exception of inhalers or those on a pre-planned steroid taper. (Note: Premedication with corticosteroids per institutional standard of care is allowed.)
10. Recognized acquired, hereditary, or congenital immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia.
11. Clinically significant active infection(s) at the time of screening.
12. Any of the following conditions (on-study testing is not required unless it is required by a specific participating country):

    1. Known HIV-infected subjects unless on effective anti-retroviral therapy with an undetectable viral load within 6 months, or
    2. Known or suspected hepatitis B if active infection (subjects with chronic hepatitis B infection must have an undetectable HBV viral load on suppressive therapy, if indicated; positive surface antibody alone is not an exclusion), or
    3. Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load).
13. Uncontrolled or life-threatening diseases compromising safety evaluation.
14. Diagnosed or treated for another malignancy within 5 years before the first dose, or previously diagnosed with another malignancy and have any evidence of residual disease including ductal carcinoma in situ of the breast. Subjects with non-melanoma skin cancer, other carcinoma in situ if have undergone complete resection or cervix carcinoma in situ are not excluded if they have undergone complete resection. Synchronous endometrial and prior diagnosis of endometrial cancer within 5 years is not excluded if all of the following conditions are met: Stage IA, superficial myometrial invasion, without lymphovascular invasion, and not poorly differentiated subtypes including papillary serous, clear cell lesions.
15. Contraindications to the use of pressor agents.
16. Undergone more than one surgical debulking or have not recovered from surgery.
17. Anticipated treatment with any other anti-cancer medications, including bevacizumab, PARP inhibitors, or any investigational agent(s) during the study.
18. History or evidence upon physical examination of CNS disease, seizures not controlled with standard medical therapy, or any brain metastases.
19. Any of the following cardiovascular conditions:

    1. Acute myocardial infarction within 6 months before the first dose of study treatment.
    2. Current history of New York Heart Association (NYHA) Class III or IV heart failure.
    3. Evidence of current uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or electrocardiographic clinically significant findings.
20. Unable to read or understand or unable to sign the necessary written consent before starting treatment.
21. May not receive any live, attenuated vaccine administered within 28 days (or 4 weeks) prior to enrollment, during the study, and for at least 90 days after the last dose of study treatment.
22. Subjects who receive Hyperthermic Intraperitoneal Chemotherapy (HIPEC), any other anti-cancer medications, including bevacizumab, PARP inhibitors, or any other investigational agent(s) with 3 cycles of paclitaxel and carboplatin neoadjuvant treatment prior to IDS.

Primary outcomes:
measure: Investigator Assessed Progression Free Survival
timeFrame: Date of randomization until date of first documented disease progression or date of death from any cause, whichever comes first, at up to approximately 6 years.
Secondary outcomes:
measure: Overall Survival
timeFrame: Date of randomization up until date of death from any cause, up to approximately 11 years
measure: Safety and Tolerability
timeFrame: Date of randomization up until date of discontinuation of treatment, date of significant physical examination changes, date of significant clinical changes, up to approximately 6 years
measure: Change in Quality of Life
timeFrame: Changes from baseline assessment, until date of discontinuation, or up to approximately 6 years
Other outcomes:
measure: Efficacy by times to subsequent therapies and time to next progression
timeFrame: Date of randomization, until date of subsequent therapy or death, or up to approximately 6 years
measure: Potential Biomarkers
timeFrame: Date of randomization, until date of discontinuation, or up to approximately 6 years
Locations:
city: Phoenix
country: United States
facility: Honor Health
state: Arizona
city: Tucson
country: United States
facility: The University of Arizona Cancer Center
state: Arizona
city: Concord
country: United States
facility: John Muir Health Clinical Research Center
state: California
city: Irvine
country: United States
facility: Kaiser Permanente Southern California
state: California
city: La Jolla
country: United States
facility: Moores UC San Diego Cancer Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Pleasant Hill
country: United States
facility: Epic Care
state: California
city: Riverside
country: United States
facility: Kaiser Permanente Riverside Medical Center
state: California
city: Sacramento
country: United States
facility: University of California, Davis Comprehensive Cancer Center
state: California
city: Walnut Creek
country: United States
facility: Contra Costa Oncology
state: California
city: Walnut Creek
country: United States
facility: John Muir Health Gynecologic Cancer Services
state: California
city: Aurora
country: United States
facility: University of Colorado Health
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: New Haven
country: United States
facility: Smilow Cancer Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Saint Petersburg
country: United States
facility: Women's Cancer Florida/Women's Cancer Associates
state: Florida
city: Savannah
country: United States
facility: Lewis Cancer & Research Pavilion at St. Joseph's Candler
state: Georgia
city: Honolulu
country: United States
facility: The Queens Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children/University of Hawaii
state: Hawaii
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Covington
country: United States
facility: Women's Cancer Care/Mary Bird Perkins Cancer Center
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Framingham
country: United States
facility: MetroWest Medical Center
state: Massachusetts
city: Lowell
country: United States
facility: Lowell General Hospital
state: Massachusetts
city: Stoneham
country: United States
facility: Tufts Medical Center Cancer Center in Stoneham
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Lansing
country: United States
facility: Sparrow Hospital
state: Michigan
city: Coon Rapids
country: United States
facility: Minnesota Oncology Hematology - Mercy Hospital
state: Minnesota
city: Edina
country: United States
facility: Minnesota Oncology Hematology
state: Minnesota
city: Maple Grove
country: United States
facility: University of Minnesota Health - Maple Grove Clinic
state: Minnesota
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro Minnesota Community Oncology Research Consortium
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Frauenshuh Cancer Center
state: Minnesota
city: Saint Paul
country: United States
facility: Minnesota Oncology Hematology
state: Minnesota
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Portsmouth
country: United States
facility: Portsmouth Regional Hospital
state: New Hampshire
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Paramus
country: United States
facility: The Valley Hospital (Valley Health)
state: New Jersey
city: Albany
country: United States
facility: Womens Cancer Care Associates
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center PRIME
state: New York
city: Lake Success
country: United States
facility: Mount Sinai - PRIME
state: New York
city: New York
country: United States
facility: Mount Sinai The Blavatnik Family Chelsea Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Raleigh
country: United States
facility: Duke Women's Cancer Care Raleigh
state: North Carolina
city: Chardon
country: United States
facility: SCC at UH Geauga Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Fairview Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Kettering
country: United States
facility: Grandview Medical Center/Kettering Medical Center
state: Ohio
city: Mayfield Heights
country: United States
facility: Cleveland Clinic Hillcrest Hospital
state: Ohio
city: Orange Village
country: United States
facility: UH Minoff Health Center - Seidman
state: Ohio
city: Westlake
country: United States
facility: SCC at St. John's Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialist and Research Institution, LLC
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C.-Portland-Rose Quarter
state: Oregon
city: Pittsburgh
country: United States
facility: Magee Women's Hospital of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center at UPMC Passavant
state: Pennsylvania
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island
state: Rhode Island
city: Sioux Falls
country: United States
facility: Sanford Research/USD-Sioux Falls
state: South Dakota
city: Austin
country: United States
facility: Texas Oncology, P.A. - Austin
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology, P.A. - Fort Worth
state: Texas
city: Houston
country: United States
facility: Memorial Herman Hospital
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology San Antonio Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health Systems
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates - Hampton
state: Virginia
city: Richmond
country: United States
facility: VCU Massey Cancer Center
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic Gynecological Oncology
state: Virginia
city: Auburn
country: United States
facility: MultiCare Regional Cancer Center - Auburn
state: Washington
city: Gig Harbor
country: United States
facility: MultiCare Regional Cancer Center-Gig Harbor Medical Park
state: Washington
city: Puyallup
country: United States
facility: MultiCare Institute for Research and Innovation
state: Washington
city: Tacoma
country: United States
facility: MultiCare Regional Cancer Center - Tacoma
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Córdoba
country: Argentina
facility: CEMAIC - Centro Medico Privado
state: Cordoba
city: Córdoba
country: Argentina
facility: Clínica Universitaria Privada Reina Fabiola
state: Cordoba
city: Rosario
country: Argentina
facility: Sanatorio de la Mujer
city: Salta
country: Argentina
facility: Sanatorio Parque S.A
city: San Juan
country: Argentina
facility: CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
city: Viedma
country: Argentina
facility: Clinicas Viedma S.A.
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Liège
country: Belgium
facility: Clinique CHC MontLégia
city: Blumenau
country: Brazil
facility: Centro de Pesquisas Clinica Reichow
city: Guimaraes
country: Brazil
facility: Oncosite - Centro de Pesquisa Clinica e Oncologia
city: Porto Alegre
country: Brazil
facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus
city: San Paolo
country: Brazil
facility: Fundação Doutor Amaral Carvalho
city: Santo André
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
city: Sao Paulo
country: Brazil
facility: Clínica São Germano - Oncologia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Laval
country: Canada
facility: City of Health Hospital at Laval (Cité de la Santé de Laval)
state: Quebec
city: Montréal
country: Canada
facility: CHUM Centre de Recherche (affiliated with University of Montreal)
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre/Glen Site/ Royal Victoria Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS - Hôpital Fleurimont
state: Quebec
city: Santiago
country: Chile
facility: Centro de Investigación Clínica Bradford Hill
city: Temuco
country: Chile
facility: Sociedad de Investigaciones Medicas Limitada
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Prague
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha
country: Czechia
facility: Fakultni nemocnice Bulovka
city: Praha
country: Czechia
facility: Fakultni nemocnice v Motole
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Megyei Oktatokorhaz
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Korhaz
city: Bangalore
country: India
facility: Fortis Hospital Ltd
city: Bengaluru
country: India
facility: Fortis Hospital Ltd
city: Delhi
country: India
facility: All India Institute of Medical Services
city: Mohali
country: India
facility: Max Super Specialty Hospital
city: Mumbai
country: India
facility: Sushrut Hospital
city: Noida
country: India
facility: Fortis Hospital
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital
city: Pune
country: India
facility: Ruby Hall Clinic
city: Monza
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Rome
country: Italy
facility: Università Campus Bio-Medico di Roma
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Soeul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Orizaba
country: Mexico
facility: Clinical Medical Research S.C.
state: Veracruz
city: La Paz
country: Mexico
facility: Investigacion Onco Farmaceutica S. de R.L. de C.V. (OncoTech)
city: Monterrey
country: Mexico
facility: Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
city: Querétaro
country: Mexico
facility: SMIQ S. de R.L. de C.V.
city: San Luis Potosi
country: Mexico
facility: Centro Potosino de Investigación Medica S.C.
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: L'Hospitalet De Llobregat
country: Spain
facility: ICO l'Hospitalet-Hospital Duran i Reynals
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia IVO
city: Taipei county
country: Taiwan
facility: Taipei Veterans General Hospital
state: Taipei
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: CanariaBio Inc.
name: Sunil Gupta, MD, FRCPC
role: STUDY_DIRECTOR
References: