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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 : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Lymphocytic Leukemia, Chronic Lymphoma, Non Hodgkin Drug: BTCT4465A (Mosunetuzumab) IV Drug: Atezolizumab Drug: BTCT4465A (Mosunetuzumab) SC Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 665 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 30, 2015
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020


Arm Intervention/treatment
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.
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.

Experimental: Dose Expansion
Participants will receive BTCT4465A (Mosunetuzumab) at the RP2D as a single-agent or in combination with atezolizumab.
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.




Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. BTCT4465A (Mosunetuzumab) Serum Concentration [ Time Frame: Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months) ]
  4. Atezolizumab Serum Concentration [ Time Frame: Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months) ]
  5. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. Overall Survival [ Time Frame: Baseline until death from any cause (up to approximately 4 years) ]
  4. 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

  5. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500407


Contacts
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

Locations
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
University of California San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92037
United States, Connecticut
Yale University School Of Medicine Recruiting
New Haven, Connecticut, United States, 06510
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University Medical Center Not yet recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
Commack, New York, United States, 11725
New York Uni Medical Center Recruiting
New York, New York, United States, 10016
United States, Pennsylvania
University of Pennsylvania; School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States
Australia, Victoria
Peter MacCallum Cancer Centre-East Melbourne Withdrawn
Melbourne, Victoria, Australia, 3000
Canada, British Columbia
BC Cancer Agency Vancouver Centre - PARENT Recruiting
Vancouver, British Columbia, Canada, V5Z 1H3
Canada, Ontario
Princess Margaret Hospital; Department of Med Oncology Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Jewish General Hospital; Research Unit Recruiting
Montréal, Quebec, Canada, H3T 1E2
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02500407     History of Changes
Other Study ID Numbers: GO29781
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs