NCT04045028

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 atezolizumab and/or daratumumab or rituximab in participants with relapsed or refractory (R/R) multiple myeloma (MM) or R/R non-Hodgkin lymphoma (NHL).

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1 multiple-myeloma

Timeline
Completed

Started Jul 2019

Geographic Reach
2 countries

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 22, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2023

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

3.7 years

First QC Date

July 22, 2019

Last Update Submit

April 6, 2023

Conditions

Multiple MyelomaNon-Hodgkin LymphomaB-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Adverse Events

    Determined according to the NCI CTCAE Version 5.0

    Through study completion, an average of 1 year

Secondary Outcomes (6)

  • Serum Concentration of Tiragolumab

    Cycles 1, 2, 3, 4, 8, 12, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years)

  • Serum Concentration of Atezolizumab

    Cycles 1, 2, 3, 4, 8, 12, 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

    Through study completion, an average of 1 year

  • ORR for R/R NHL

    Through study completion, an average of 1 year

  • Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab

    Cycles 1, 2, 4, 8, 12, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years)

  • +1 more secondary outcomes

Study Arms (5)

Arm A: Tiragolumab R/R MM

EXPERIMENTAL

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

Arm B: Tiragolumab R/R NHL

EXPERIMENTAL

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

Arm C: Tiragolumab + Daratumumab R/R MM

EXPERIMENTAL

Participants with R/R MM will receive 600 mg tiragolumab Q3W + daratumumab by subcutaneous (SC) injection.

Drug: TiragolumabDrug: Daratumumab/rHuPH20

Arm D: Tiragolumab + Rituximab R/R NHL

EXPERIMENTAL

Participants with R/R NHL will receive 600 mg tiragolumab Q3W + rituximab by IV infusion and SC injection (optional).

Drug: TiragolumabDrug: Rituximab

Arm E: Tiragolumab + Atezolizumab + Daratumumab R/R MM

EXPERIMENTAL

Participants with R/R MM will receive 600 mg tiragolumab Q3W + atezolizumab by IV infusion Q3W + daratumumab by SC injection.

Drug: TiragolumabDrug: Daratumumab/rHuPH20Drug: Atezolizumab

Interventions

TiragolumabDRUG

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

Arm A: Tiragolumab R/R MMArm B: Tiragolumab R/R NHLArm C: Tiragolumab + Daratumumab R/R MMArm D: Tiragolumab + Rituximab R/R NHLArm E: Tiragolumab + Atezolizumab + Daratumumab R/R MM
Daratumumab/rHuPH20DRUG

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

Arm C: Tiragolumab + Daratumumab R/R MMArm E: Tiragolumab + Atezolizumab + Daratumumab R/R MM
RituximabDRUG

Administered for a total of 8 doses. 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).

Arm D: Tiragolumab + Rituximab R/R NHL
AtezolizumabDRUG

Administered by IV infusion at a fixed dose of 1200 mg Q3W

Arm E: Tiragolumab + Atezolizumab + Daratumumab R/R MM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy of \>/= 12 weeks
  • 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
  • Arms C and E only: Participants with R/R MM who have received at least 3 prior lines of therapy.
  • Measurable disease defined by laboratory test results.
  • 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.

You may not qualify if:

  • 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 12 weeks 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 (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection within 4 weeks prior to first study drug administration
  • Primary or secondary plasma cell leukemia
  • Current or history of CNS involvement by MM
  • Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
  • Current or history of CNS lymphoma
  • Current eligibility for ASCT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center

Denver, Colorado, 80218, United States

Location

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Washington University

St Louis, Missouri, 63128, United States

Location

Clinical Research Alliance

Westbury, New York, 11590, United States

Location

Oncology Hematology Care, Inc.

Cincinnati, Ohio, 45236, United States

Location

University of Pennsylvania; School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

SCRI

Nashville, Tennessee, 37203, United States

Location

Virginia Cancer Specialists (Fairfax) - USOR

Fairfax, Virginia, 22031, United States

Location

Samsung Medical Center; Nephrology Department

Seoul, 06351, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Yonsei Cancer Center; Yonsei Uni Coll. Med.

Seoul, 120-752, South Korea

Location

Seoul St.Mary's Hospital; Medical Oncology

Seoul, 137-807, South Korea

Location

Asan Medical Center; Internal Dept / Gastorenterology

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Multiple MyelomaLymphoma, Non-HodgkinLymphoma, B-Cell

Interventions

TiragolumabdaratumumabRituximabatezolizumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphomaLymphatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2019

First Posted

August 5, 2019

Study Start

July 22, 2019

Primary Completion

March 28, 2023

Study Completion

March 28, 2023

Last Updated

April 7, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). 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).

Locations

US(9)KR(5)