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Trial record 1 of 1 for:    NCT04045028
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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Activity of Tiragolumab in Participants With Relapsed or Refractory Multiple Myeloma or With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT04045028
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE July 22, 2019
First Posted Date  ICMJE August 5, 2019
Last Update Posted Date July 29, 2020
Actual Study Start Date  ICMJE July 22, 2019
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2019)
Percentage of Participants With Adverse Events [ Time Frame: Through study completion, an average of 1 year ]
Determined according to the NCI CTCAE Version 5.0
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2019)
  • Serum Concentration of Tiragolumab [ Time Frame: Cycles 1, 2, 3, 4, 8, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years) ]
  • Objective Response Rate (ORR) for R/R MM [ Time Frame: Through study completion, an average of 1 year ]
    Proportion of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR), as defined by the International Myeloma Working Group (IMWG) criteria
  • ORR for R/R NHL [ Time Frame: Through study completion, an average of 1 year ]
    Proportion of participants with a CR or PR on two consecutive occasions >/= 4 weeks apart, according to the Lugano classification
  • Percentage of Participants With Anti-Drug Antibodies (ADA) to Tiragolumab [ Time Frame: Cycles 1, 2, 4, 8, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Activity of Tiragolumab in Participants With Relapsed or Refractory Multiple Myeloma or With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Official Title  ICMJE A Phase Ia/Ib Open-Label, Multicenter Study Evaluating The Safety and Pharmacokinetics of Tiragolumab as a Single Agent and In Combination With Daratumumab In Patients With Relapsed Or Refractory Multiple Myeloma, and As a Single Agent and In Combination With Rituximab In Patients With Relapsed Or Refractory B-Cell Non-Hodgkin Lymphoma
Brief Summary This is a Phase I open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary activity of tiragolumab administered as a single agent or in combination with daratumumab or rituximab in participants with relapsed or refractory (R/R) multiple myeloma (MM) or R/R non-Hodgkin lymphoma (NHL).
Detailed Description

In the Phase Ia part of the study, tiragolumab is administered as a single agent in participants with R/R MM or R/R NHL.

In the Phase Ib part of the study, tiragolumab is administered in combination with daratumumab in participants with R/R MM or with rituximab in participants with R/R NHL for whom combination therapy is considered an acceptable treatment option.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Myeloma
  • Non-Hodgkin Lymphoma
  • B-Cell Lymphoma
Intervention  ICMJE
  • Drug: Tiragolumab
    Administered by IV infusion at a fixed dose of 600 mg on Day 1 of each 21-day cycle (Q3W)
  • Drug: Daratumumab/rHuPH20
    Administered by SC injection 1800 mg/30,000 U rHuPH20 weekly for a total of 6 doses, then every 3 weeks for a total of 16 doses (first dose given at Week 7), then every 4 weeks from Week 55 onward until disease progression.
  • Drug: Rituximab
    Participants will receive a total of 8 doses of rituximab. Rituximab will be administered by IV infusion for the first dose at a dose of 375 mg/m^2. After administration of at least one full infusion of IV rituximab, the SC formulation of rituximab (rituximab and rHuPH20) may be used for the remaining doses per institutional guidelines. SC rituximab will be administered at a dose of 1400 mg rituximab/23400 U rHuPH20 once weekly (QW).
Study Arms  ICMJE
  • Experimental: Arm A (Phase Ia)
    Participants with relapsed or refractory (R/R) Multiple Myeloma (MM) will receive a single dose of 600 mg Tiragolumab by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W).
    Intervention: Drug: Tiragolumab
  • Experimental: Arm B (Phase Ia)
    Participants with relapsed or refractory (R/R) non-Hodgkin Lymphoma (NHL) will receive a single dose of 600 mg Tiragolumab by IV infusion Q3W.
    Intervention: Drug: Tiragolumab
  • Experimental: Arm C (Phase Ib)
    Participants with R/R MM will receive 600 mg Tiragolumab Q3W + Daratumumab by subcutaneous (SC) injection.
    Interventions:
    • Drug: Tiragolumab
    • Drug: Daratumumab/rHuPH20
  • Experimental: Arm D (Phase Ib)
    Participants with R/R NHL will receive 600 mg Tiragolumab Q3W + Rituximab by IV infusion and SC injection (optional).
    Interventions:
    • Drug: Tiragolumab
    • Drug: Rituximab
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: August 2, 2019)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

General Inclusion Criteria (All Participants):

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy of >/= 12 weeks

Inclusion Criteria Specific to Arms A and C (R/R MM)

  • Arm A only: Must have R/R MM for which no established therapy for MM is appropriate and available or be intolerant to those established therapies
  • Arm C only: Participants with R/R MM who have received at least 3 prior lines of therapy.
  • Measurable disease defined by laboratory test results.

Inclusion Criteria Specific to Arms B and D (R/R NHL)

  • Participants with histologically confirmed B-cell NHL who have relapsed or failed to respond to at least two prior systemic treatment regimens and for which no suitable therapy of curative intent or higher priority exists.
  • Must have at least one bi-dimensionally measurable lesion.

Exclusion Criteria:

General Exclusion Criteria (All Participants)

  • Any anti-cancer therapy, whether investigational or approved, including chemotherapy, monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, hormonal therapy, and/or radiotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to initiation of study treatment
  • Prior treatment with any anti-TIGIT agent
  • Prior treatment with chimeric antigen receptor-T (CAR-T) therapy within 30 days before first study drug administration
  • Autologous Stem-Cell Transplantation (ASCT) within 100 days prior to first study drug administration
  • Active or history of autoimmune disease or immune deficiency
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection within 4 weeks prior to first study drug administration

Exclusion Criteria Specific to Arms A and C (R/R MM)

  • Primary or secondary plasma cell leukemia
  • Current or history of CNS involvement by MM

Exclusion Criteria Specific to Arms B and D (R/R NHL)

  • Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
  • Current or history of CNS lymphoma
  • Current eligibility for ASCT

Other protocol defined inclusion/exclusion criteria could apply

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: GO41036 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 Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04045028
Other Study ID Numbers  ICMJE GO41036
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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 July 2020

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