Clinical trial NCT04674683: Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma
Official title: A Multicenter, Randomized, Double-Blind Phase 3 Study of HBI-8000 Combined With Nivolumab Versus Placebo With Nivolumab in Patients With Unresectable or Metastatic Melanoma Not Previously Treated With PD-1 or PD-L1 Inhibitors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Unresectable or Metastatic Melanoma
Progressive Brain Metastasis
Keywords: HBI-8000
nivolumab
melanoma
brain metastasis
Lead sponsor: HUYABIO International, LLC.
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2020-12-19
Enrollment: 450
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double-blind, placebo-controlled Phase 3 study of HBI-8000 or Placebo combined with nivolumab.
Primary purpose: TREATMENT

Brief summary: This is a clinical study to compare the efficacy and safety of HBI-8000 combined with nivolumab to Placebo combined with nivolumab in patients with unresectable or metastatic melanoma. A separate open-label cohort of adults with new, progressive brain metastasis or adolescents with or without new progressive brain metastasis receive HBI-8000 combined with nivolumab.

Detailed description: This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study of HBI-8000 or Placebo combined with nivolumab. Randomization of eligible patients will be stratified by PD-L1 expression (positive, ≥1% expression level versus negative, \<1% expression level) and LDH (normal versus elevated) in the main study. Adults with new, progressive brain metastasis, or adolescents with or without new progressive brain metastasis will be enrolled in a separate, non-randomized, open-label cohort to receive the combination of HBI-8000 and nivolumab.

In the main study, eligible patients will be randomized within the appropriate stratum at a 1:1 ratio to the Test arm or the Control arm. Study treatment will be initiated within 3 days of randomization.

A treatment cycle consists of 28 days. Patients will be treated with one of the following:

Test arm: HBI-8000 30 mg oral BIW + nivolumab IV at specific doses on specific days

Control arm: Placebo oral BIW + nivolumab IV at specific doses on specific days

The Study Treatment (HBI-8000 or Placebo) is administered approximately 30 minutes after a full meal.

The Study Treatment (HBI-8000 or Placebo) will be administered twice a week on the following days of every 28-day cycle:

* CxW1: Days 1, 4
* CxW2: Days 8, 11
* CxW3: Days 15, 18
* CxW4: Days 22, 25

Study treatment must commence within 3 days after randomization and continue up to 2 years or until disease progression (confirmed), unacceptable toxicity or patient withdrawal of consent.

In addition to Study Treatment, nivolumab is administered at specific doses on specific days as an intravenous infusion over approximately 30 minutes. Nivolumab will be administered on Day 1 of each cycle.

For non-randomized cohort for special population, eligible subjects will receive HBI-8000 30 mg oral BIW and nivolumab IV at specific doses on specific days, under the same schedule as described above. For adolescents weighing \< 40 kg, nivolumab will be dosed at specific doses every 4 weeks. Nivolumab will be administered on Day 1 of each cycle.

Eligibility criteria: Inclusion Criteria:

1. Histopathologically confirmed diagnosis of non-uveal, Stage III (unresectable), or Stage IV (metastatic) melanoma according to AJCC staging system (8th edition).
2. Known BRAF V600 mutation status or consent to BRAF V600 mutation testing before randomization.
3. Tumor tissue available for PD-L1 testing at central lab or local laboratory; results must be obtained prior to randomization. In the event when archived tumor tissue is not available, new tumor biopsy or historical PD-L1 test results may be used for randomization, however tumor tissue, either taken previously or newly acquired, must be provided for central biomarker confirmation for final data analyses.

   PD-L1 expression level is required for randomization. In order to be randomized, a patient must be classified as PD-L1 positive or PD-L1 negative according to the following criteria:
   * PD-L1 positive (≥ 1% tumor cell membrane staining in a minimum of a hundred evaluable tumor cells) vs
   * PD-L1 negative (\< 1% tumor cell membrane staining in a minimum of a hundred evaluable tumor cells).

   Note: If an insufficient amount of tumor tissue is available prior to the start of the screening phase, patients must consent to allow the acquisition of additional tumor tissue for performance of biomarker analyses.
4. Males or females 12 years of age or older.
5. ECOG performance status ≤1 for age ≥18 years, Lansky performance status ≥80% for age 12 to 17 years.
6. At least one measurable lesion defined by RECIST 1.1 criteria, (separate from the lesion to be used for tumor tissue collection) not counting brain metastasis with:

   * Longest diameter ≥10 mm by CT (when slice thickness is ≤5 mm); or ≥ 2× slice thickness (when slice thickness is \>5 mm)
   * Pathologically enlarged lymph node: ≥15 mm in short axis by CT (when slice thickness is ≤5 mm)
   * Clinical: ≥10 mm (that can be accurately measured with calipers).
7. Have not received anti-PD-1, anti-PD-L1 or other systemic therapy for unresectable or metastatic melanoma, except for the following, provided that the patient has recovered from all treatment-related toxicities:

   * BRAF mutation targeting therapy \> 4 weeks before administration of Study Treatment.
   * Adjuvant or neoadjuvant therapy with PD-1 or PD-L1 inhibitors or anti-cytotoxic T lymphocyte-associated protein 4 (anti-CTLA-4) is allowed if disease progression/or recurrence had occurred at least 6 months after the last dose of neoadjuvant/adjuvant therapy and prior to receiving the first dose on this study and no clinically significant immune related toxicities leading to treatment discontinuation were observed
   * Adjuvant interferon therapy must have been completed \> 6 weeks before administration of Study Treatment
8. Any prior radiotherapy or minor surgery must be completed at least 2 weeks and 1 week respectively before Day 1 dosing and recovered from all treatment related toxicities
9. Screening laboratory results within 14 days prior to randomization:

   * Hematology: WBC ≥3000/μL, neutrophils ≥1500/μL, platelets ≥100 × 103/μL, hemoglobin ≥10.0 g/dL independent of transfusion. The use of erythropoietic growth factor to achieve hemoglobin (Hgb) ≥ 10 g/dl is acceptable.
   * The CrCL≥ 30 mL/min using Cockcroft-Gault formula.
   * AST and ALT ≤3 × ULN, alkaline phosphatase ≤2.5 × ULN unless bone metastases present (patients with documented bone metastases: alkaline phosphatase \<5 x ULN), bilirubin ≤ 1.5 × ULN (unless known Gilbert's disease where it must be ≤ 3 × ULN), serum albumin ≥ 3.0 g/dL).
10. Negative serum pregnancy test at baseline for women of childbearing potential.
11. Females of childbearing potential (non-surgically sterile or premenopausal female capable of becoming pregnant) and all males (due to potential risk of drug exposure through the ejaculate) must agree to use adequate birth control measures from study start, during the study and for 5 months after the last dose of Study Drug. Acceptable methods of birth control in this trial include two highly effective methods of birth control (as determined by the Investigator; one of the methods must be a barrier technique) or abstinence.
12. Have the ability to understand and the willingness to sign a written informed consent document, comply with study scheduled treatment, visits and assessments.

Exclusion Criteria:

1. History of ≥ Grade 3 hypersensitivity reactions to monoclonal antibodies.
2. Previous treatment with a PD-1, PD-L1, PD-L2, CTLA-4 inhibitor, or any other agents targeting T-cell co-stimulation or immune checkpoint pathways for unresectable or metastatic melanoma.
3. Recipient of solid organ transplant.
4. History of a cardiovascular illness including: congestive heart failure (New York Heart Association Grade III or IV); unstable angina or myocardial infarction within the previous 6 months prior to first dose of Study Treatment; or symptomatic cardiac arrhythmia despite medical management. QT interval corrected by heart rate using QTcF \>450 ms in males or \>470 ms in females, or congenital long QT syndrome.
5. Uncontrolled hypertension, systolic blood pressure (SBP) \>160 mmHg or diastolic blood pressure (DBP) \>100 mmHg.
6. Patients with new, active, or progressive brain metastases or leptomeningeal disease with except when considered for a separate special open-label cohort.
7. History of hemorrhagic diarrhea, inflammatory bowel disease, active uncontrolled peptic ulcer, or bowel resection that affects absorption of orally administered drugs.
8. Active, known, or suspected autoimmune disease, except for Type I diabetes mellitus, hypothyroidism requiring only hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic therapy.
9. Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
10. Known history of testing positive for HIV, known AIDS.
11. Hepatitis B surface antigen positive or hepatitis C antibody positive. Further investigation per institutional practices may be performed to exclude active infection.
12. Patients with a condition requiring chronic systemic treatment with either corticosteroids (\>10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days before administration of Study Treatment. Inhaled or topical steroids, or adrenal replacement dose of corticosteroids at dose ≤ 10 mg/day prednisone equivalent are permitted.
13. Use of another investigational agent (drug or vaccine not marketed for any indication) within 28 days or before administration of Study Treatment. If the investigational agent is a monoclonal antibody then within 3 months before administration of Study Treatment
14. Pregnant or breast-feeding women.
15. Have a history of any other malignancy unless in remission for 2 years or locally curable cancers that have been treated with curative intent with no evidence of recurrence, such as:

    * Basal or squamous cell skin cancer
    * Superficial bladder cancer
    * Carcinoma in situ of cervix or breast
    * Incidental prostate cancer
    * Non melanomatous skin cancer
    * Prostate cancer treated with curative intent with serum prostate specific antigen (PSA) \< 2.0 ng/mL
16. Patients with medical conditions requiring administration of strong cytochrome P450 (CYP), CYP3A4 Inducers and Inhibitors with no alternative therapy.
17. Uncontrolled adrenal insufficiency or active chronic liver disease.
18. Has received approved live vaccine/live attenuated vaccines within 30 days of planned Cycle 1 Day 1. Inactivated viral vaccines or vaccines based upon subviral component are allowed; however intranasal influenza vaccines (e.g. Flu-Mist) are not allowed. COVID-19 vaccination should be administered at least 7 days before Cycle 1 Day 1.
19. Underlying medical conditions that, in the Investigator's opinion, will make the administration of Study Treatment hazardous or obscure the interpretation of toxicity determination or AEs.
20. Patients with a history of or active interstitial lung disease (ILD) or non-infectious pneumonitis.
21. Patients with prior organ or hematopoietic cell transplant (HCT), including allogeneic HCT.
22. Patients with known sensitivity to any of the ingredients of the Study Treatment.
23. Patients who received radiation therapy within 14 days of the first dose of the Study Treatment.
24. Patients who take drugs that prolong the QT interval or cause torsades de pointes or produce significant ventricular dysrhythmias.
25. Patients that are unwilling or unable to comply with procedures required in this protocol.

Primary outcomes:
measure: Primary Outcome
timeFrame: From date of randomization to the earliest date of documented progressive disease (PD), assessed up to 48 months
Secondary outcomes:
measure: Objective Response Rate
timeFrame: From date of randomization until disease progression or unacceptable toxicity, assessed up to 48 months
measure: Overall Survival
timeFrame: From date of randomization to death due to any cause, assessed up to 48 months
measure: Safety, defined as the incidence rate of AEs
timeFrame: From date of screening until the end of study, assessed up to 48 months
Other outcomes:
measure: Duration of Response
timeFrame: Assessed up to 48 months
measure: Disease Control Rate
timeFrame: Assessed up to 48 months
measure: Time to Response
timeFrame: Assessed up to 48 months
measure: Time to Progression
timeFrame: Assessed up to 48 months
Locations:
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Pasadena
country: United States
facility: Innovative Clinical Research Institute (ICRI)
state: California
city: Redlands
country: United States
facility: Emad Ibrahim, MD, INC
state: California
city: Riverside
country: United States
facility: Kaiser Permanente Oncology Research
state: California
city: San Marcos
country: United States
facility: California Cancer Associates for Research and Excellence, Inc. (cCARE)
state: California
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital, Lynn Cancer Institute
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Pensacola
country: United States
facility: Ascension Sacred Heart Medical Oncology
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Goshen
country: United States
facility: Goshen Center for Cancer Care
state: Indiana
city: Edgewood
country: United States
facility: St. Elizabeth Healthcare
state: Kentucky
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Frederick
country: United States
facility: Frederick Memorial Healthcare System
state: Maryland
city: Bridgeton
country: United States
facility: St Louis Cancer Care
state: Missouri
city: Kansas City
country: United States
facility: AMR Kansas City
state: Missouri
city: Saint Joseph
country: United States
facility: Medisearch Clinical Trials
state: Missouri
city: Billings
country: United States
facility: St. Vincent - Frontier Cancer Center
state: Montana
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University Medical Oncology Clinic
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
city: Lancaster
country: United States
facility: Carolina Blood and Cancer Care Associates
state: South Carolina
city: The Woodlands
country: United States
facility: Renovatio Clinical
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Milwaukee
country: United States
facility: Froedtert Hospital, Medical College of Wisconsin
state: Wisconsin
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
state: New South Wales
city: Buderim
country: Australia
facility: University of the Sunshine Coast
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Centre Wesley
state: Queensland
city: Ballarat
country: Australia
facility: Ballarat Health Services
state: Victoria
city: Shepparton
country: Australia
facility: Goulburn Valley Health
state: Victoria
city: Brisbane
country: Australia
facility: Royal Brisband and Women's Hospital
city: Liverpool
country: Australia
facility: Liverpool Hospital
city: Nedlands
country: Australia
facility: Affinity Clinical Research
city: Tweed Heads
country: Australia
facility: Tweed Hospital
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
city: Graz
country: Austria
facility: Medical University of Graz Department of Dermatology and Venerology
city: Innsbruck
country: Austria
facility: Univ.-Lkinik für Dermatologie, Venerologie und Allergologie
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Brussels
country: Belgium
facility: Cliniques Universitaires
city: Ghent
country: Belgium
facility: AZ Maria Middelares
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Liège
country: Belgium
facility: Hospital de la Citadelle
city: Ottignies
country: Belgium
facility: Clinique Saint-Pierre
city: Salvador
country: Brazil
facility: Ensino e Terapia de Inovação Clίnica AMO-ETICA
state: Bahia
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer,
state: Paraná
city: Londrina
country: Brazil
facility: Hospital do Câncer de Londrina
state: Paraná
city: Centro
country: Brazil
facility: Hospital São Vicente de Paulo
state: Rio Grande Do Sul
city: Lajeado
country: Brazil
facility: Hospital Bruno Born
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Centro Gaúcho Integrado de Oncologia, Hematologia
state: Rio Grande Do Sul
city: Santa Cruz Do Sul
country: Brazil
facility: Hospital de Clίnίcas de Porto Alegre
state: Rio Grande Do Sul
city: São Cristóvão
country: Brazil
facility: Oncosite-Centro de Pesquisa Clίnica em Oncologia
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Hopital de Câncer de Barretos-Fundação Pio XII
state: Sao Paulo
city: Santo André
country: Brazil
facility: CEPHO-Centro de Estudos e Pesquisas de Hematologia e Oncologia
state: São Paulo,
city: Jaú
country: Brazil
facility: Fundação Doutor Amaral Carvalho
state: São Paulo
city: São José Do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
state: São Paulo
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de São Paulo - "Octavio Frias de Oliveira"-ICESP
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomoue
city: Ostrava-Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava Kozni oddeleni
city: Prague
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Besançon
country: France
facility: CHU de Besançon - Hôpital Jean MINJOZ
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré
city: Dijon
country: France
facility: CHU de Dijon, Service de dermatologie
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: Lille
country: France
facility: CHRU Lille - Hôpital Claude Huriez, Clinique de Dermatologie
city: Marseille
country: France
facility: Hôpital La Timone
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rouen
country: France
facility: CHU de Rouen-Hôpital
city: Villejuif
country: France
facility: Institut Gustave Roussy, Service de Dermatologie
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte
city: Berlin
country: Germany
facility: Vivantes Klinikum Spandau, Dermatologie und Allergologie
city: Dresden,
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU Dresden, Klinik und Poliklinik f. Dermatologie
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt, Dermatologie und Allergologie
city: Essen
country: Germany
facility: Universitatsklinikum Essen Klinik fur Dermatologie Studienambulanz
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg, Klinik fuer Dermatologie und Venerologie
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg, NCT-Dermatoonkologie
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln, Dermatologie und Venerologie,
city: Leipzig
country: Germany
facility: Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig Holstein - Campus Luebeck
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Hautklinik
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim, Klinik f. Dermatologie, Venerologie, Allergologle,
city: Tuebingen
country: Germany
facility: Studienzentrum Dermao-Onkologie, Universitaetsklinikum Tuebingen
city: Milan
country: Italy
facility: Fondazione IRCCS CA'Granda Ospedale Maggiore Policlinico-Oncologia Medica
state: Milano
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Milano
city: Bari
country: Italy
facility: IRCCS Giovanni Paolo II Oncologia Medica
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
city: Misterbianco
country: Italy
facility: Humanitas Istituto Clinico Catanese, U.O. Oncologia Medica
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione G. Pascale, Oncologia Medica e Terapia Innovativa
city: Palermo
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone - U.O. Oncologia Medica
city: Perugia
country: Italy
facility: A.O.S. Maria della Misericordia, Oncologia Medica
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Siena
country: Italy
facility: A.O.U Senese Policlinico Santa Maria alle Scotte-UOC Immunoterapia Oncologica
city: Verona
country: Italy
facility: Policlinico G.B. Rossi-Borgo Roma-Centro Ricerche Cliniche di Verona
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Chuo Ku
country: Japan
facility: National Hospital Organization Osaka National Hospital
state: Osaka
city: Nagaizumi-cho
country: Japan
facility: Shizuoka Cancer Center
state: Sunto-gun
city: Koto-Ku
country: Japan
facility: The Cancer Institute Hospital of JFCR
state: Tokho
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Osaka Prefectural Hospital Organization Osaka International Cancer Institute
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Cha University Bundang Medical Center
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Younsei University Health System,
state: Gyeonggi
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
state: Jung-gu
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
city: Rio Piedras
country: Puerto Rico
facility: Hospial Oncologico, Puerto Rico Medical Center
city: Singapore
country: Singapore
facility: National Cancer Centre
city: Johannesburg
country: South Africa
facility: The Medical Oncology Centre of Rosebank
state: Gauteng
city: Pretoria
country: South Africa
facility: Wilgers Oncology Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: Curo Oncology
state: Gauteng
city: Roodepoort
country: South Africa
facility: West Rand Oncology Centre Flora Clinic
state: Gauteng
city: George
country: South Africa
facility: Excellentis Clinical Trial Consultants
state: Western Cape
city: Kraaifontein
country: South Africa
facility: Cape Town Oncology Trials Cape Gate Oncology Centre
state: Western Cape
city: Rondebosch
country: South Africa
facility: Cancercare Rondebosch Oncology
state: Western Cape
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Catalan Institute of Oncology
city: Barcelona
country: Spain
facility: ICO Badalona-Hospital Universitari Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jimenez Diaz
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Eastleigh
country: United Kingdom
facility: Nuffield Health Wessex Hospital
state: Hampshire
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Center Western General Hospital
Study officials:
affiliation: HUYABIO International, LLC.
name: Gloria Lee, MD, PhD
role: STUDY_DIRECTOR
References: