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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03332017




Registration number
NCT03332017
Ethics application status
Date submitted
31/10/2017
Date registered
6/11/2017
Date last updated
30/06/2020

Titles & IDs
Public title
A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
Scientific title
An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma
Secondary ID [1] 0 0
2017-001552-54
Secondary ID [2] 0 0
BGB-3111-212
Universal Trial Number (UTN)
Trial acronym
ROSEWOOD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Follicular Non-Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zanubrutinib
Treatment: Drugs - Obinutuzumab

Experimental: Arm A - Approximately 140 subjects to receive BGB-3111 and obinutuzumab

Experimental: Arm B - Approximately 70 subjects to receive obinutuzumab


Treatment: Drugs: Zanubrutinib
BGB-3111 will be administered as two 80-mg capsules by mouth twice a day (160 mg twice a day)

Treatment: Drugs: Obinutuzumab
Obinutuzumab will be administered 1,000 mg intravenously on days 1, 8, and 15 of cycle 1, then 1,000 mg on day 1 of cycles 2 to 6, then 1,000 mg every 8 weeks. 1 cycle = 28 days.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall response rate (ORR) as Assessed by Independent Central Review
Timepoint [1] 0 0
up to 3 years
Secondary outcome [1] 0 0
Overall response rate (ORR) as Assessed by the Investigator
Timepoint [1] 0 0
up to 3 years
Secondary outcome [2] 0 0
Duration of response (DOR)
Timepoint [2] 0 0
up to 3 years
Secondary outcome [3] 0 0
Progression free survival (PFS)
Timepoint [3] 0 0
up to 3 years
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
up to 3 years
Secondary outcome [5] 0 0
Complete Response Rate
Timepoint [5] 0 0
up to 3 years
Secondary outcome [6] 0 0
Complete Metabolic Response Rate
Timepoint [6] 0 0
up to 3 years
Secondary outcome [7] 0 0
Health-Related Quality of Life (HRQOL) as Assessed by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Timepoint [7] 0 0
up to 3 years
Secondary outcome [8] 0 0
Health-Related Quality of Life (HRQOL) as Assessed by The 5-level EQ-5D version (EQ-5D-5L)
Timepoint [8] 0 0
up to 3 years
Secondary outcome [9] 0 0
Time to response (TTR)
Timepoint [9] 0 0
up to 3 years
Secondary outcome [10] 0 0
Occurrence and severity of treatment-emergent adverse events (TEAEs) - Safety and Tolerability
Timepoint [10] 0 0
up to 3 years

Eligibility
Key inclusion criteria
Key

1. Histologically confirmed diagnosis of B-cell follicular lymphoma

2. =2 prior systemic treatments for follicular lymphoma.

3. Previously received an anti-CD20 antibody and an appropriate alkylator-based
combination therapy.

4. Disease progression after completion of most recent therapy or refractory disease.

5. Presence of measurable disease.

6. Availability of archival tissue confirming diagnosis.

7. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.

8. Adequate renal and hepatic function.

Key
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.

2. Known central nervous system involvement by leukemia or lymphoma.

3. Evidence of transformation from follicular lymphoma to other aggressive histology.

4. Allogeneic hematopoietic stem cell transplantation within 12 months of enrollment

5. Prior malignancy within the past 2 years, except for curatively treated basal or
squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix
of breast, or localized Gleason score 6 prostate

6. Clinically significant cardiovascular disease.

7. Major surgery or significant injury = 4 weeks prior to start of study treatment.

8. Active fungal, bacterial or viral infection requiring systemic treatment.

9. History of severe bleeding disorder.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Saint Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Icon Cancer Care - Wesley - Auchenflower
Recruitment hospital [6] 0 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [7] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 0 0
Monash Health - Clayton
Recruitment hospital [9] 0 0
Saint Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [10] 0 0
Peninsula Private Hospital - Frankston
Recruitment hospital [11] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [12] 0 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Waratah
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment postcode(s) [5] 0 0
- Auchenflower
Recruitment postcode(s) [6] 0 0
- South Brisbane
Recruitment postcode(s) [7] 0 0
- Adelaide
Recruitment postcode(s) [8] 0 0
- Clayton
Recruitment postcode(s) [9] 0 0
- Fitzroy
Recruitment postcode(s) [10] 0 0
- Frankston
Recruitment postcode(s) [11] 0 0
- Perth
Recruitment postcode(s) [12] 0 0
- Garran
Recruitment outside Australia
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United States of America
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Georgia
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United States of America
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Illinois
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Maryland
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Nevada
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New Jersey
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United States of America
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North Carolina
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United States of America
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Texas
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Belarus
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Gomel
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Belarus
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Minsk
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Belarus
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Vitebsk
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Bulgaria
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Sofiya-grad
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Bulgaria
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Sofiya
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Canada
State/province [15] 0 0
Ontario
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Canada
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Quebec
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Canada
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Edmonton
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China
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Beijing
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China
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Guangzhou
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China
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Hubei
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China
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Jiangsu
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China
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Shanghai
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China
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Sichuan
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China
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Tianjin
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China
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Zhejiang
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China
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Chongqing
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China
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Guandong
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China
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Heilongjiang
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China
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Henan
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Czechia
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Jihormoravsky KRAJ
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Czechia
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Praha
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Czechia
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Vychodocesky KRAJ
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Czechia
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Opava
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France
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Aquitaine
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France
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Ile-de-france
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Limousin, Lorraine
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France
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Nord-pas-de-calais
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Picardie
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Poitou-charentes
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France
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Provence Alpes COTE D'azur
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France
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Rhone-alpes
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Germany
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Baden-wuerttemberg
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Germany
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Bayern
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Italy
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Varese
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Italy
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Bari
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Italy
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Bologna
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Italy
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Milano
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Italy
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Ravenna
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Korea, Republic of
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Chungcheongnam-do
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Gyeongsangbuk-do
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Korea, Republic of
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Jeollanam-do
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Korea, Republic of
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Daegu
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Seoul
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New Zealand
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Auckland
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Christchurch
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Dolnoslaskie
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Lodzkie
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Lubelskie
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Malopolskie
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Opolskie
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Pomorskie
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Slaskie
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Kemerovo
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Saint Petersburg
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Russian Federation
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Sochi
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Russian Federation
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Tula
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Russian Federation
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Volgograd
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Russian Federation
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Yekaterinburg
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Spain
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Barcelona
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Madrid
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Cadiz
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Salamanca
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Spain
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Zaragoza
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Taiwan
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Tainan CITY
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Changhua
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Kaohsiung
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New Taipei City
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Taipei
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United Kingdom
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England
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Gillingham
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Leeds
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United Kingdom
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Norwich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to evaluate the efficacy, safety and tolerability and of BGB-3111
plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory
non-Hodgkin follicular lymphoma.
Trial website
https://clinicaltrials.gov/show/NCT03332017
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
William Reed, MD
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BeiGene
Address 0 0
Country 0 0
Phone 0 0
+1-877-828-5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03332017