Clinical trial NCT03215030: A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma
Official title: A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients With Relapsed Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-07-12
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The main aims of this 3-part study are as follows:

Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found.

Part 2: To assess clinical activity of one or more dosing schedules of modakafusp alfa alone in participants with relapsed/refractory multiple myeloma. Dexamethasone standard dose will be administered with one or more selected dose of modakafusp alfa in selected group of participants.

Part 3: To find the optimal dose with the more favorable risk-benefit profile of modakafusp alfa.

Participants will receive modakafusp alfa at one of two doses which will be given through a vein.

Detailed description: The drug being tested in this study, and which will be given through a vein, is called modakafusp alfa (TAK-573 ) as single agent or in combination with dexamethasone. The study will determine the safety, tolerability, and efficacy of modakafusp alfa as single agent and in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (RRMM). The study consists of 3 Parts:

Part 1: Dose Escalation, Part 2: Dose Expansion, Part 3: Dose Extension

The study will enroll approximately 65 participants in Part 1, 35 in Part 2, and 236 in Part 3. Participants will be assigned to one of the following treatment groups in Parts 1 and 2 of the study. Participants will be randomly assigned in Part 3 of the study as given below:

* Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.001 Up to 14 mg/kg
* Part 1 (Dose Escalation) Schedule B: Modakafusp alfa TBD
* Part 1 (Dose Escalation) Schedule C: Modakafusp alfa TBD
* Part 1 (Dose Escalation) Schedule D: Modakafusp alfa TBD
* Part 2 (Dose Expansion): Modakafusp alfa TBD + Dexamethasone 40 mg
* Part 3 (Dose Extension): Modakafusp alfa 120 mg
* Part 3 (Dose Extension): Modakafusp alfa 240 mg

The Part 1 (Dose Escalation) portion of the study will follow a 3+3 dose escalation design to evaluate once-weekly up to 4 different schedules of administration of modakafusp alfa starting at 0.001 mg/kg for dose limiting toxicity (DLT) evaluation and to determine the maximum tolerated dose (MTD) or an optimal biological dose (OBD) for assessments in Part 2.

The Part 2 (Dose Expansion) will further assess the safety profile of modakafusp alfa and its efficacy at MTD or OBD.

For Part 3 (Dose Extension) participants will be randomized 1:1 to receive single-agent modakafusp alfa 120 mg or 240 mg Q4W.

Parts 1 and 2 will be conducted at multiple centers in the United States. Part 3 will be conducted worldwide. The maximum treatment duration in this study is up to 12 months (Parts 1 and 2) or until disease progression (Part 3) and overall time to participate in the study is approximately up to 90 months. Participants with clinical benefit may continue treatment after sponsor approval.

Eligibility criteria: Inclusion Criteria:

For Parts 1 and 2:

1. Has MM defined by the IMWG criteria with evidence of disease progression and:

* In need of additional myeloma therapy as determined by the investigator.
* Has previously received at least 3 lines of myeloma therapy (for example, containing an Immunomodulatory imide drug \[IMiD\], a proteasome inhibitor \[PI\], an alkylating agent, and/or an anti-CD38 as single agents or in combination).
* Is either refractory to or intolerant of at least 1 PI and a least 1 IMiD.

For Part 3:

1. Has MM defined by the IMWG criteria with evidence of disease progression and:

   * In need of additional myeloma therapy as determined by the investigator.
   * Has previously received at least 3 lines of myeloma therapy.
   * Is refractory to at least 1 IMiD (ie, lenalidomide or pomalidomide \[thalidomide excluded\]), at least 1 PI (ie, bortezomib, ixazomib, or carfilzomib), and refractory to at least 1 anti-CD38 antibody (ie, daratumumab or isatuximab) and has demonstrated disease progression with the last therapy. Participants who are primary refractory, meaning they never achieved at least a MR with any previous treatment line, are not eligible.
2. For participants in Part 2 and 3 only: Measurable disease is defined as :

   1. Serum M-protein ≥500 mg/dL (≥5 g/L)
   2. Urine M-protein ≥200 mg/24 hours.
   3. Serum free light chain (FLC) assay, with involved FLC level ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal.
3. During Part 1 only, participants not meeting the above criteria for measurable disease should, at least, have measurable bone marrow plasmacytosis (greater than or equal to \[≥ \] 10 percent \[%\]) and/or plasmacytoma (≥1 centimeter \[cm\] in diameter) detected by physical examination or imaging.
4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.

Exclusion Criteria:

For Parts 1 and 2:

1. Has polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenstrom macroglobulinemia or immunoglobulin M (IgM) myeloma, or lymphoplasmacytic lymphoma (LPL).
2. Who have received autologous stem cell transplant (SCT) 60 days before first infusion of modakafusp alfa or participants who have received allogeneic SCT 6 months before first infusion. Graft-versus-host disease that is active or requires ongoing systemic immunosuppression.
3. Has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE less than or equal to (≤) Grade 1 or baseline, except for sensory or motor neuropathy which should have recovered to ≤ Grade 2 or baseline.
4. Has clinical signs of central nervous system involvement of MM.

For Part 3:

* Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]. Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[anti-HBc\] and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of HBV DNA levels. Those who are PCR positive will be excluded.
* In addition to the above criteria, participants must not have plasma cell leukemia or have had primary refractory MM, current central nervous system involvement of MM, myelodysplastic syndrome, myeloproliferative syndrome, or have had a second malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the participant is not on active anticancer therapy.

Primary outcomes:
measure: Part 1: Percentage of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 90 months
measure: Part 1: Percentage of Participants With Dose-limiting Toxicities (DLTs)
timeFrame: Up to Cycle 1 (cycle length is 28 days for Schedule A, B and D; 21 days for Schedule C)
measure: Part 1: Percentage of Participants Reporting one or More Grade 3 TEAEs
timeFrame: Up to approximately 90 months
measure: Part 1: Percentage of Participants Reporting one or More Serious Adverse Events (SAEs)
timeFrame: Up to approximately 90 months
measure: Part 1: Percentage of Participants Who Discontinue the Treatment Because of TEAE
timeFrame: Up to approximately 90 months
measure: Part 1: Percentage of Participants With Dose Modifications: Dose Delay
timeFrame: Up to approximately 90 months
measure: Part 1: Percentage of Participants With Dose Modifications: Dose Interruptions
timeFrame: Up to approximately 90 months
measure: Part 1: Percentage of Participants With Dose Modifications: Dose Reductions
timeFrame: Up to approximately 90 months
measure: Part 1: Percentage of Participants With Clinically Significant Laboratory Values
timeFrame: Up to approximately 90 months
measure: Part 1: Percentage of Participants With Clinically Significant Vital Signs Measurements
timeFrame: Up to approximately 90 months
measure: Part 2: Overall Response Rate (ORR)
timeFrame: Up to approximately 90 months
measure: Part 3: Overall Response Rate (ORR) Assessed by Independent Review Committee (IRC)
timeFrame: Up to approximately 90 months
Secondary outcomes:
measure: Part 1 and 2: Percentage of Participants With Dose-limiting Toxicities (DLTs)- Like Events
timeFrame: Up to approximately 90 months
measure: Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp alfa
timeFrame: Schedule A Cycle(C)1-13,Day(D)1,8,15,22; Schedule B C1-13,D1,15; Schedule C C1-17,D1; Schedule D C1-13,D1: Pre-infusion and at multiple times post-infusion (cycle length is 28 days for Schedule A, B and D; 21 days for Schedule C)
measure: Part 1: Tmax: Time to Reach the Cmax for Modakafusp alfa
timeFrame: Schedule A Cycle(C)1-13,Day(D)1,8,15,22; Schedule B C1-13,D1,15; Schedule C C1-17,D1; Schedule D C1-13,D1: Pre-infusion and at multiple times post-infusion (cycle length is 28 days for Schedule A, B and D; 21 days for Schedule C)
measure: Part 1: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Modakafusp alfa
timeFrame: Schedule A Cycle(C)1-13,Day(D)1,8,15,22; Schedule B C1-13,D1,15; Schedule C C1-17,D1; Schedule D C1-13,D1: Pre-infusion and at multiple times post-infusion (cycle length is 28 days for Schedule A, B and D; 21 days for Schedule C)
measure: Part 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp alfa
timeFrame: A Cycle(C)1-13,Day(D)1,8,15,22; Schedule B C1-13,D1,15; Schedule C C1-17,D1; Schedule D C1-13,D1: Pre-infusion and at multiple times post-infusion (cycle length is 28 days for Schedule A, B and D; 21 days for Schedule C)
measure: Part 1: λz: Terminal Disposition Rate Constant for Modakafusp alfa
timeFrame: Schedule A Cycle(C)1-13,Day(D)1,8,15,22; Schedule B C1-13,D1,15; Schedule C C1-17,D1; Schedule D C1-13,D1: Pre-infusion and at multiple times post-infusion (cycle length is 28 days for Schedule A, B and D; 21 days for Schedule C)
measure: Part 1: T1/2: Terminal Elimination Half-life for Modakafusp alfa
timeFrame: Schedule A Cycle(C)1-13,Day(D)1,8,15,22; Schedule B C1-13,D1,15; Schedule C C1-17,D1; Schedule D C1-13,D1: Pre-infusion and at multiple times post-infusion (cycle length is 28 days for Schedule A, B and D; 21 days for Schedule C)
measure: Part 1: CL: Clearance for Modakafusp alfa
timeFrame: Schedule A Cycle(C)1-13,Day(D)1,8,15,22; Schedule B C1-13,D1,15; Schedule C C1-17,D1; Schedule D C1-13,D1: Pre-infusion and at multiple times post-infusion (cycle length is 28 days for Schedule A, B and D; 21 days for Schedule C)
measure: Part 1: Vss: Volume of Distribution at Steady State for Modakafusp alfa
timeFrame: Schedule A Cycle(C)1-13,Day(D)1,8,15,22; Schedule B C1-13,D1,15; Schedule C C1-17,D1; Schedule D C1-13,D1: Pre-infusion and at multiple times post-infusion (cycle length is 28 days for Schedule A, B and D; 21 days for Schedule C)
measure: Parts 1, 2 and 3: Percentage of Participants with Positive Anti-drug Antibodies (ADA)
timeFrame: Up to approximately 90 months
measure: Part 1: Objective Response Rate (ORR)
timeFrame: Up to approximately 90 months
measure: Parts 1 and 2: Clinical Benefit Rate (CBR)
timeFrame: Up to approximately 90 months
measure: Parts 1 and 2: Disease Control Rate (DCR)
timeFrame: Up to approximately 90 months
measure: Parts 1, 2 and 3: Duration of Response (DOR)
timeFrame: Up to approximately 90 months
measure: Parts 1 and 2: Time to Response
timeFrame: Up to approximately 90 months
measure: Parts 1, 2 and 3: Progression Free Survival (PFS)
timeFrame: Up to approximately 90 months
measure: Parts 2 and 3: Overall Survival (OS)
timeFrame: Up to approximately 90 months
measure: Part 2: Cmax: Maximum Observed Serum Concentration for Modakafusp alfa
timeFrame: Up to approximately 90 months
measure: Part 2: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Modakafusp alfa
timeFrame: Up to approximately 90 months
measure: Part 2: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp alfa
timeFrame: Up to approximately 90 months
measure: Part 2: λz: Terminal Disposition Rate Constant for Modakafusp alfa
timeFrame: Up to approximately 90 months
measure: Part 2: Tmax: Time to Reach the Cmax for Modakafusp alfa
timeFrame: Up to approximately 90 months
measure: Part 2: CL: Clearance for Modakafusp alfa
timeFrame: Up to approximately 90 months
measure: Part 2: Vss: Volume of Distribution at Steady State for Modakafusp alfa
timeFrame: Up to approximately 90 months
measure: Part 2: T1/2z: Terminal Elimination Half-life for Modakafusp alfa
timeFrame: Up to approximately 90 months
measure: Part 3: Objective Response Rate (ORR) by Investigator Assessment
timeFrame: Up to approximately 90 months
measure: Part 3: Clinical Benefit Rate (CBR) by IRC and Investigator assessment
timeFrame: Up to approximately 90 months
measure: Part 3: Duration of Clinical Benefit
timeFrame: Up to approximately 90 months
measure: Part 3: Disease Control Rate (DCR) by IRC and Investigator Assessment
timeFrame: Up to approximately 90 months
measure: Part 3: Duration of Disease Control
timeFrame: Up to approximately 90 months
measure: Part 3: Time to Progression (TTP) by IRC and Investigator Assessment
timeFrame: Up to approximately 90 months
measure: Part 3: Rate of Minimal Residual Disease (MRD) Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR
timeFrame: Up to approximately 90 months
measure: Part 3:Duration of MRD Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR
timeFrame: Up to approximately 90 months
measure: Part 3: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to approximately 90 months
measure: Part 3: Percentage of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to approximately 90 months
measure: Part 3: Percentage of Participants With Clinically Significant Laboratory Values
timeFrame: Up to approximately 90 months
measure: Part 3: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Status
timeFrame: Up to approximately 90 months
measure: Part 3: Health Care Utilization: Length of Hospital Stays
timeFrame: Up to approximately 90 months
measure: Part 3: Percentage of Participants With Neutralizing Antibodies (NAb)
timeFrame: Up to approximately 90 months
measure: Part 3: Health Care Utilization: Number of Participants With at Least One Medical Encounter
timeFrame: Up to approximately 90 months
measure: Part 3: Patient-reported Outcome (PRO): Instrument European Organisation for Research and Treatment of Cancer QLQ Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20)
timeFrame: Up to approximately 90 months
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Glendale
country: United States
facility: Los Angeles Cancer Network - Glendale Adventist Medical Center
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: West Hollywood
country: United States
facility: Office of James R. Berenson MD
state: California
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale New Haven
state: Connecticut
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medicine - Northwestern Medical Group
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Noblesville
country: United States
facility: Investigative Clinical Research of Indiana, LLC
state: Indiana
city: Sioux City
country: United States
facility: June E. Nylen Cancer Center
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Omaha
country: United States
facility: Univeristy of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: USOR - Comprehensive Cancer Centers of Nevada - Central Valley
state: Nevada
city: Hackensack
country: United States
facility: John Theurer Cancer Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Center
state: North Carolina
city: Concord
country: United States
facility: Levine Cancer Institute - Concord
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Cancer Center - Memphis - Walnut Grove
state: Tennessee
city: Houston
country: United States
facility: Lumi Research
state: Texas
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency Vancouver Centre
state: British Columbia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Centre de Recherche du CHUM
state: Quebec
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis Jewish General Hospital
state: Quebec
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University - Suzhou First People's Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Fourth People's Hospital
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Strasbourg
country: France
facility: Institut de cancerologie Strasbourg Europe
state: Alsace
city: Creteil Cedex
country: France
facility: Centre Hospitalier Universitaire Henri Mondor
state: Ile-de-france
city: Paris Cedex 12
country: France
facility: Hopital Saint-Antoine
state: Ile-de-france
city: Paris
country: France
facility: Hopital Necker-Enfants Malades
state: Ile-de-france
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse Hopital Purpan
state: Midi-pyrenees
city: Lille Cedex
country: France
facility: Hopital Saint-Vincent de Paul - Lille
state: NORD Pas-de-calais
city: Lille Cedex
country: France
facility: Centre Hospitalier Regional Universitaire de Lille
state: NORD Pas-de-calais
city: Nantes Cedex 1
country: France
facility: Centre Hospitalier Universitaire Nantes - Hotel Dieu
state: PAYS DE LA Loire
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
state: Poitou-charentes
city: Argenteuil Cedex
country: France
facility: Centre Hospitalier d'Argenteuil - Centre Hospitalier Victor Dupouy
city: Tuebingen
country: Germany
facility: Universitatsklinik Tubingen
state: Baden-wuerttemberg
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
state: Sachsen
city: Athens
country: Greece
facility: Evaggelismos General Hospital
state: Attica
city: Athens
country: Greece
facility: Alexandra General Hospital of Athens
state: Attica
city: Patra
country: Greece
facility: University Regional General Hospital of Patras
state: Peloponnese
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
state: Tel Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Alessandria
country: Italy
facility: AON SS Antonio e Biagio e Cesare Arrigo
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant'Orsola-Malpighi
city: Catania
country: Italy
facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Gifu-shi
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Kyoto-City
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
state: Kyoto
city: Okayama-city
country: Japan
facility: National Hospital Organization Okayama Medical Center
state: Okayama
city: Tokyo
country: Japan
facility: Japanese Red Cross Medical Center
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea - Seoul St. Mary's Hospital
city: Oslo
country: Norway
facility: Oslo Universitetssykehus-Ulleval Hospital
city: Ponce
country: Puerto Rico
facility: Ad-Vance Medical Research
city: San Juan
country: Puerto Rico
facility: Hospital Espanol Auxilio Mutuo
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
state: Taipei CITY
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Yenimahalle
country: Turkey
facility: Ankara Universitesi
state: Ankara
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi Tp Fakultesi
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
state: England
city: Cornwell
country: United Kingdom
facility: Royal Cornwall Hospital NHS Trust
state: England
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
state: England
city: Milton Keynes
country: United Kingdom
facility: Genesis Care - Milton Keynes
state: England
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
state: England
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: England
city: Windsor
country: United Kingdom
facility: Genesis Care Windsor - Genesis Care UK Ltd.
state: England
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: