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A Safety 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)

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ClinicalTrials.gov Identifier: NCT02500407
Recruitment Status : Recruiting
First Posted : July 16, 2015
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE July 14, 2015
First Posted Date  ICMJE July 16, 2015
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE September 15, 2015
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2018)
  • Maximum Tolerated Dose (MTD) of BTCT4465A (Mosunetuzumab) [ Time Frame: 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) ]
  • Percentage of Participants With Adverse Events [ Time Frame: From Cycle 1 Day 1 until 90 days after the last infusion (cycle length = 21 days; up to approximately 14 months) ]
  • BTCT4465A (Mosunetuzumab) Serum Concentration [ Time Frame: Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months) ]
  • Atezolizumab Serum Concentration [ Time Frame: Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months) ]
  • Percentage of Participants with Complete Response as Assessed Using Standard Criteria for NHL [ Time Frame: 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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
  • Incidence of dose-limiting toxicities (DLTs) [ Time Frame: During Cycle 1 (up to 21 days) ]
  • Incidence of adverse events [ Time Frame: From Cycle 1 Day 1 until 90 days after the last infusion (up to approximately 9 months) ]
  • Area Under the Concentration-time Curve (AUC) of BTCT4465A [ Time Frame: Pre-dose and post-dose on Days 1, 8, and 15 on Cycle 1 and on Days 1 and 8 of Cycles 2, 4, 6, and 8 and within 30 days after the last infusion (up to approximately 7 months) ]
  • Maximum serum concentration (Cmax) of BTCT4465A [ Time Frame: Pre-dose and post-dose on Days 1, 8, and 15 on Cycle 1 and on Days 1 and 8 of Cycles 2, 4, 6, and 8 and within 30 days after the last infusion (up to approximately 7 months) ]
  • Minimum serum concentration (Cmin) of BTCT4465A [ Time Frame: Pre-dose and post-dose on Days 1, 8, and 15 on Cycle 1 and on Days 1 and 8 of Cycles 2, 4, 6, and 8 and within 30 days after the last infusion (up to approximately 7 months) ]
  • Clearance (CL) of BTCT4465A [ Time Frame: Pre-dose and post-dose on Days 1, 8, and 15 on Cycle 1 and on Days 1 and 8 of Cycles 2, 4, 6, and 8 and within 30 days after the last infusion (up to approximately 7 months) ]
  • Volume of distribution at steady state (Vss) of BTCT4465A [ Time Frame: Pre-dose and post-dose on Days 1, 8, and 15 on Cycle 1 and on Days 1 and 8 of Cycles 2, 4, 6, and 8 and within 30 days after the last infusion (up to approximately 7 months) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2018)
  • Duration of Response as Assessed Using Standard Criteria for NHL [ Time Frame: 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) ]
  • Progression-Free Survival (PFS) as Assessed Using Standard Criteria for NHL [ Time Frame: 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) ]
  • Overall Survival [ Time Frame: Baseline until death from any cause (up to approximately 4 years) ]
  • 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) [ Time Frame: Baseline until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 4 years). ]
    The Functional Assessment of Cancer Therapy-Lymphoma (FACT-lym) Subscale, and the EuroQol 5 Dimension-5 Level (EQ-5D-5L) Questionnaire scores will also be used to assess HRQoL
  • Objective Response Rate (ORR) [ Time Frame: 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
  • Incidence of objective tumor response [ Time Frame: At Screening and every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 3 years) ]
  • Duration of objective tumor response [ Time Frame: At Screening and every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 3 years) ]
  • Progression-free survival (PFS) [ Time Frame: At Screening and every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 3 years) ]
  • Incidence of anti-therapeutic antibodies (ATAs) to BTCT4465A [ Time Frame: Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 8 and within 30 days after the last infusion (up to approximately 7 months) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety 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)
Official Title  ICMJE An Open-Label, Multicenter, Phase I/IB Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of 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
Brief Summary This is a Phase 1/1b 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphocytic Leukemia, Chronic
  • Lymphoma, Non Hodgkin
Intervention  ICMJE
  • Drug: BTCT4465A (Mosunetuzumab) IV
    Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via IV infusion.
  • Drug: Atezolizumab
    Participants assigned to an atezolizumab combination group will receive atezolizumab 1200 mg administered as an IV infusion in combination with BTCT4465A (Mosunetuzumab).
    Other Name: Tecentriq
  • Drug: BTCT4465A (Mosunetuzumab) SC
    Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via SC injection.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: BTCT4465A (Mosunetuzumab) IV
    • Drug: Atezolizumab
    • Drug: BTCT4465A (Mosunetuzumab) SC
  • Experimental: Dose Expansion
    Participants will receive BTCT4465A (Mosunetuzumab) at the RP2D as a single-agent or in combination with atezolizumab.
    Interventions:
    • Drug: BTCT4465A (Mosunetuzumab) IV
    • Drug: Atezolizumab
    • Drug: BTCT4465A (Mosunetuzumab) SC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2020)
746
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2015)
170
Estimated Study Completion Date  ICMJE October 30, 2021
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • 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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: GO29781 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Australia,   Canada,   France,   Germany,   Korea, Republic of,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02500407
Other Study ID Numbers  ICMJE GO29781
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP