Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04045028
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Non-Hodgkin Lymphoma B-Cell Lymphoma Drug: Tiragolumab Drug: Daratumumab Drug: Rituximab Phase 1

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021


Arm Intervention/treatment
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)
Drug: Tiragolumab
Administered by IV infusion at a fixed dose of 600 mg on Day 1 of each 21-day cycle (Q3W)

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
Drug: Tiragolumab
Administered by IV infusion at a fixed dose of 600 mg on Day 1 of each 21-day cycle (Q3W)

Experimental: Arm C (Phase Ib)
Participants with R/R MM will receive 600 mg Tiragolumab Q3W + Daratumumab by IV infusion
Drug: Tiragolumab
Administered by IV infusion at a fixed dose of 600 mg on Day 1 of each 21-day cycle (Q3W)

Drug: Daratumumab
Administered by IV infusion at a dose of 16 mg/kg actual body weight weekly for a total of 9 doses, then every 3 weeks for a total of 5 doses, then every 4 weeks from Week 25 onward until disease progression

Experimental: Arm D (Phase Ib)
Participants with R/R NHL will receive 600 mg Tiragolumab Q3W + Rituximab by IV infusion
Drug: Tiragolumab
Administered by IV infusion at a fixed dose of 600 mg on Day 1 of each 21-day cycle (Q3W)

Drug: Rituximab
Administered by IV infusion at a dose of 375 mg/m2 weekly (QW) for 8 doses




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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) ]
  2. 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

  3. 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

  4. 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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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 including chemotherapy, monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, hormonal therapy, and/or radiotherapy, within 4 weeks 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


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): NCT04045028


Contacts
Layout table for location contacts
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

Locations
Layout table for location information
United States, Colorado
Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
United States, Georgia
Emory Clinic Recruiting
Atlanta, Georgia, United States, 30322
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63128
United States, Ohio
Oncology Hematology Care, Inc.; Oncology Hematology Care, Inc. Not yet recruiting
Cincinnati, Ohio, United States, 45236
United States, Pennsylvania
University of Pennsylvania; School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
SCRI Recruiting
Nashville, Tennessee, United States, 37203
United States, Virginia
Virginia Cancer Specialists (Fairfax) - USOR Not yet recruiting
Fairfax, Virginia, United States, 22031
Korea, Republic of
Samsung Medical Center; Nephrology Department Not yet recruiting
Seoul, Korea, Republic of, 06351
Seoul St.Mary's Hospital; Medical Oncology Not yet recruiting
Seoul, Korea, Republic of, 137-807
Asan Medical Center; Internal Dept / Gastorenterology Not yet recruiting
Seoul, Korea, Republic of, 138-736
Seoul National University Hospital; Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Genentech, Inc.
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04045028     History of Changes
Other Study ID Numbers: GO41036
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
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).

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Daratumumab
Lymphoma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Rituximab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents