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Multiple MyelomaPhase 1NCT04045028

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

A Phase 1 study testing Tiragolumab, Daratumumab/rHuPH20 and Rituximab in people with Multiple Myeloma and Non-Hodgkin Lymphoma, run by Genentech, Inc. at 14 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tiragolumab, Daratumumab/rHuPH20 and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
14 sitesin 2 countries
Study dates
22 Jul 2019to 28 Mar 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion Criteria (All Participants):
  • 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.

Who cannot join

  • 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 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
Show all 13Show fewer
  • 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
  • Other protocol defined inclusion/exclusion criteria could apply

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

United States9 sites

  • Emory Clinic

    Atlanta, Georgia, 30322

  • University of Maryland

    Baltimore, Maryland, 21201

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45236

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

    Denver, Colorado, 80218

  • Virginia Cancer Specialists (Fairfax) - USOR

    Fairfax, Virginia, 22031

  • SCRI

    Nashville, Tennessee, 37203

  • University of Pennsylvania; School of Medicine

    Philadelphia, Pennsylvania, 19104

  • Washington University

    St Louis, Missouri, 63128

  • Clinical Research Alliance

    Westbury, New York, 11590

Other trials in United States

South Korea5 sites

  • Samsung Medical Center; Nephrology Department

    Seoul, 06351

  • Seoul National University Hospital

    Seoul, 110-744

  • Yonsei Cancer Center; Yonsei Uni Coll. Med.

    Seoul, 120-752

  • Seoul St.Mary's Hospital; Medical Oncology

    Seoul, 137-807

  • Asan Medical Center; Internal Dept / Gastorenterology

    Seoul, 138-736

Other trials in South Korea

About this study

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 Atezolizumab and/or 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

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).

Read the 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 atezolizumab and/or daratumumab in participants with R/R MM or with rituximab in participants with R/R NHL.

Being tested
Tiragolumab, Daratumumab/rHuPH20, Rituximab, Atezolizumab
Medical subject headings
Multiple Myeloma, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TiragolumabDrug

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

  • 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

  • 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).

  • AtezolizumabDrug

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

Study groups in NCT04045028
Study groupRoleWhat they receive
Arm A: Tiragolumab R/R MMExperimentalParticipants 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).
Receives: Drug: Tiragolumab
Arm B: Tiragolumab R/R NHLExperimentalParticipants with relapsed or refractory (R/R) non-Hodgkin Lymphoma (NHL) will receive a single dose of 600 mg tiragolumab by IV infusion Q3W.
Receives: Drug: Tiragolumab
Arm C: Tiragolumab + Daratumumab R/R MMExperimentalParticipants with R/R MM will receive 600 mg tiragolumab Q3W + daratumumab by subcutaneous (SC) injection.
Receives: Drug: Tiragolumab; Drug: Daratumumab/rHuPH20
Arm D: Tiragolumab + Rituximab R/R NHLExperimentalParticipants with R/R NHL will receive 600 mg tiragolumab Q3W + rituximab by IV infusion and SC injection (optional).
Receives: Drug: Tiragolumab; Drug: Rituximab
Arm E: Tiragolumab + Atezolizumab + Daratumumab R/R MMExperimentalParticipants with R/R MM will receive 600 mg tiragolumab Q3W + atezolizumab by IV infusion Q3W + daratumumab by SC injection.
Receives: Drug: Tiragolumab; Drug: Daratumumab/rHuPH20; Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Adverse Events

    Determined according to the NCI CTCAE Version 5.0

    Measured: Through study completion, an average of 1 year

Secondary outcomes (6)

  1. Serum Concentration of Tiragolumab

    Measured: 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)

  2. Serum Concentration of Atezolizumab

    Measured: 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)

  3. Objective Response Rate (ORR) for R/R MM

    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

    Measured: Through study completion, an average of 1 year

  4. ORR for R/R NHL

    Proportion of participants with a CR or PR on two consecutive occasions >/= 4 weeks apart, according to the Lugano classification

    Measured: Through study completion, an average of 1 year

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

    Measured: 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)

  6. Percentage of Participants With ADAs to Atezolizumab

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2019
  2. Study start22 Jul 2019
  3. Primary completion28 Mar 2023
  4. Study completion28 Mar 2023

Why it stopped: Slow recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04045028
Sponsor's protocol ID
GO41036
Other IDs
2021-006032-92
Status last verified
Apr 2023
First submitted
22 Jul 2019
Last updated
7 Apr 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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).

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tiragolumab, Daratumumab/rHuPH20 and Rituximab in people with Multiple Myeloma and Non-Hodgkin Lymphoma, run by Genentech, Inc. at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04045028.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.

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