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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02500407




Registration number
NCT02500407
Ethics application status
Date submitted
14/07/2015
Date registered
16/07/2015
Date last updated
3/05/2024

Titles & IDs
Public title
A Safety, Efficacy and Pharmacokinetic Study of BTCT4465A (Mosunetuzumab) as a Single Agent and Combined With Atezolizumab in Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
Scientific title
An Open-Label, Multicenter, Phase I/II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Escalating Doses of Mosunetuzumab (BTCT4465A) as a Single Agent and Combined With Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia
Secondary ID [1] 0 0
GO29781
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphocytic Leukemia, Chronic 0 0
Lymphoma, Non Hodgkin 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
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BTCT4465A (Mosunetuzumab) IV
Treatment: Drugs - Atezolizumab
Treatment: Drugs - BTCT4465A (Mosunetuzumab) SC

Experimental: Dose Escalation - Participants will receive BTCT4465A (Mosunetuzumab) via intravenous (IV) infusion or subcutaneous (SC) injection as a single-agent or in combination with atezolizumab. Dose escalation will be guided by the observed incidence of DLTs at each dose level.

Experimental: Dose Expansion - Participants will receive BTCT4465A (Mosunetuzumab) as a single-agent or in combination with atezolizumab.


Treatment: Drugs: BTCT4465A (Mosunetuzumab) IV
Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via IV infusion.

Treatment: Drugs: Atezolizumab
Participants assigned to an atezolizumab combination group will receive atezolizumab 1200 mg administered as an IV infusion in combination with BTCT4465A (Mosunetuzumab).

Treatment: Drugs: BTCT4465A (Mosunetuzumab) SC
Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via SC injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Tolerated Dose (MTD) of BTCT4465A (Mosunetuzumab)
Timepoint [1] 0 0
BTCT4465A (Mosunetuzumab) single agent: Cycle 1; BTCT4465A (Mosunetuzumab) in combination with atezolizumab: during the first cycle that BTCT4465A (Mosunetuzumab) and atezolizumab are administered concurrently (cycle length = 21 days)
Primary outcome [2] 0 0
Percentage of Participants With Adverse Events
Timepoint [2] 0 0
Cycle 1 Day 1 until 90 days after the last infusion (cycle length = 21 days; up to approximately 14 months)
Primary outcome [3] 0 0
BTCT4465A (Mosunetuzumab) Serum Concentration
Timepoint [3] 0 0
Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months)
Primary outcome [4] 0 0
Atezolizumab Serum Concentration
Timepoint [4] 0 0
Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months)
Primary outcome [5] 0 0
Percentage of Participants with Complete Response as Assessed Using Standard Criteria for NHL
Timepoint [5] 0 0
Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal)
Secondary outcome [1] 0 0
Duration of Response as Assessed Using Standard Criteria for NHL
Timepoint [1] 0 0
Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal)
Secondary outcome [2] 0 0
Progression-Free Survival (PFS) as Assessed Using Standard Criteria for NHL
Timepoint [2] 0 0
Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, withdrawal, or death from any cause)
Secondary outcome [3] 0 0
Overall Survival
Timepoint [3] 0 0
Baseline until death from any cause (up to approximately 4 years)
Secondary outcome [4] 0 0
European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Scores to Assess Health-Related Quality of Life (HRQoL)
Timepoint [4] 0 0
Baseline until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 4 years).
Secondary outcome [5] 0 0
Objective Response Rate (ORR)
Timepoint [5] 0 0
Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal)

Eligibility
Key inclusion criteria
Key

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- B-cell hematologic malignancies expected to express the cluster of differentiation 20
(CD20) antigen who have relapsed after or failed to respond to at least one prior
treatment regimen and for whom there is no available therapy expected to improve
survival

- Adequate hepatic, hematologic, and renal function

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or lactating women

- Monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, chemotherapy, or
other investigational anti-cancer agent within 4 weeks prior to study drug

- Treatment with radiotherapy within 2 weeks prior to the first BTCT4465A
(Mosunetuzumab) administration

- Systemic immunosuppressive medication within 2 weeks prior to study drug

- Autologous stem cell transplantation (SCT) within 100 days prior to study drug, or any
prior allogeneic SCT or solid organ transplantation

- Autoimmune disease with the exception of controlled/treated hypothyroidism,
disease-related immune thrombocytopenic purpura, or hemolytic anemia

- History of central nervous system (CNS) lymphoma or other CNS disease

- Significant cardiovascular or pulmonary disease

- Hepatitis B or C or human immunodeficiency virus (HIV)

- Receipt of a live attenuated vaccine within 4 weeks prior to study drug

- Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days
before first BTCT4465A (Mosunetuzumab) administration

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/11/2025
Actual
Sample size
Target
836
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Wollongong Hospital; Cancer Care Centre - Wollongong
Recruitment hospital [3] 0 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Royal Adelaide Hospital; Haematology Clinical Trials - Adelaide
Recruitment hospital [6] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [7] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [8] 0 0
Monash Health Clinical Trial Pharmacy department - Clayton
Recruitment hospital [9] 0 0
The Alfred - Melbourne
Recruitment hospital [10] 0 0
Linear Clinical Research Limited - Nedlands
Recruitment hospital [11] 0 0
The Perth Blood Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
3124 - Melbourne
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Canada
State/province [12] 0 0
British Columbia
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Germany
State/province [15] 0 0
Bremen
Country [16] 0 0
Germany
State/province [16] 0 0
Dortmund
Country [17] 0 0
Germany
State/province [17] 0 0
Heidelberg
Country [18] 0 0
Germany
State/province [18] 0 0
Koln
Country [19] 0 0
Germany
State/province [19] 0 0
Mainz
Country [20] 0 0
Germany
State/province [20] 0 0
München
Country [21] 0 0
Germany
State/province [21] 0 0
Münster
Country [22] 0 0
Germany
State/province [22] 0 0
Würzburg
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seoul
Country [24] 0 0
Spain
State/province [24] 0 0
Navarra
Country [25] 0 0
Spain
State/province [25] 0 0
Barcelona
Country [26] 0 0
Spain
State/province [26] 0 0
Madrid
Country [27] 0 0
Spain
State/province [27] 0 0
Salamanca
Country [28] 0 0
United Kingdom
State/province [28] 0 0
London
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Manchester
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 1/2 dose-escalation study of BTCT4465A (Mosunetuzumab) administered as a
single agent and in combination with atezolizumab in participants with relapsed or refractory
B-cell NHL and CLL. The study will consist of a dose-escalation stage and an expansion stage
where participants will be enrolled into indication-specific cohorts.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02500407
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02500407