A clinical trial to look at how safe, and how well mosunetuzumab alone or in combination with polatuzumab vedotin works in people with diffuse large B-cell lymphoma

  • Cancer
  • Non Hodgkin Lymphoma (NHL)
  • Diffuse Large B-Cell Lymphoma (DLBCL)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Active, not recruiting

This trial runs in
Cities
  • Ann Arbor
  • Baltimore
  • Barcelona
  • Be'er Sheva
  • Birmingham
  • Busan
  • Chicago
  • Cáceres
  • Daegu
  • Dallas
  • Durham
  • Fort Wayne
  • Gdańsk
  • Gdynia
  • Haifa
  • Incheon
  • Jerusalem
  • Kefar Sava
  • Kraków
  • L'Hospitalet de Llobregat
  • Louisville
  • Lublin
  • Madrid
  • Miami
  • Netanya
  • New Taipei City
  • New York
  • Opole
  • Petah Tikva
  • Philadelphia
  • Portland
  • Providence
  • Ramat Gan
  • Rehovot
  • Santa Monica
  • Seoul
  • Sevilla
  • Tainan City
  • Taipei City
  • Tampa
  • Tel Aviv-Yafo
  • València
  • Warszawa
Trial Identifier:

NCT03677154 GO40554

      Show trial locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      This study will evaluate mosunetuzumab alone and in combination with polatuzumab in a type of lymphoma called Diffuse Large B-Cell Lymphoma (DLBCL). This study will evaluate how safe the drugs are, how well they work, and how the body processes each drug. The patients will participate in one of 3 different study groups depending on the specific criteria for each group. Please continue reading below for further details on the study.

      Hoffmann-La Roche Sponsor
      Phase 1/Phase 2 Phase
      NCT03677154,GO40554 Trial Identifier
      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers

      1. Why is the GO40554 clinical trial needed?

      Diffuse large B-cell lymphoma (DLBCL) is the most common type of lymphoma. DLBCL affects a type of white blood cells called B lymphocytes (or B cells). Normally, B cells help protect the body from infection. In DLBCL, B cells become abnormal and collect in the lymph nodes and spleen. This causes lymph nodes to swell and form tumours. Standard treatment for DLBCL is a combination of chemotherapy and immunotherapy (known as ‘chemoimmunotherapy’). Immunotherapies are medicines that help the immune system find and destroy cancers. For some people their cancer does not respond to treatment or it comes back after their first treatment. Some people are not well enough to be given chemotherapy. New drug combinations are needed against DLBCL.

      Mosunetuzumab is an experimental drug, which means it has not been approved by health authorities for treating DLBCL. Mosunetuzumab is an antibody that attaches to CD20 – a protein found on some types of cancer cells. It also attaches to a protein called CD3 found on cancer-killing cells of the immune system. This pulls the cancer-killing cells closer to cancer cells, making them easier to destroy. Mosunetuzumab alone or in combination with a medicine called polatuzumab vedotin (which is used to treat DLBCL) may work well as a treatment for DLBCL. This clinical trial aims to test the safety of mosunetuzumab alone or in combination with polatuzumab vedotin at different doses, to see how well they work against DLBCL, and to understand how the body processes mosunetuzumab and polatuzumab vedotin.

      2. How does the GO40554 clinical trial work?

      This clinical trial is recruiting people with DLBCL. People who take part will be placed into a treatment group (A, B, or C). This will depend on their age, health, and prior DLBCL treatment. Group A will involve people who have had a treatment for their DLBCL that stopped their cancer from getting worse before. Group B and C will involve people who have not had treatment for their DLBCL, and who are elderly or not well enough to have full dose chemoimmunotherapy. People who take part in this clinical trial (participants) will be given the clinical trial treatment mosunetuzumab alone or with polatuzumab vedotin for around 6 months. Participants in Groups B and C may receive a further 6 months of clinical trial treatment. This depends on how well they respond to their first 6 months of treatment.

      The clinical trial doctor will see them every week during the first 6 weeks, and then every 3 weeks while treatment is given. These hospital visits will include checks to see how the participant responds to the treatment and any side effects they may have. Participants will be seen for follow-up appointments about 1 month after their last dose of treatment then every 3–6 months for up to 2 years. Participants will stop clinical trial treatment if their cancer progresses or they start new treatment for DLBCL. The total time of participation in the clinical trial will be up to 2 and a half years. Participants can stop trial treatment and leave the clinical trial at any time.

      3. What are the main endpoints of the GO40554 clinical trial?

      The main clinical trial endpoints (the main results measured in the trial to see if the drug has worked) are:

      • The number of participants whose cancer disappears (all groups) or shrinks (Group B and C) on scans
      • The number and seriousness of side effects
      • How the body breaks down and gets rid of mosunetuzumab and polatuzumab vedotin

      The other clinical trial endpoints include: 

      • The amount of time a participant’s cancer shrinks or disappears on scans before the cancer worsens
      • The amount of time between the start of trial treatment and the progression of a participants’ cancer getting worse 
      • How long participants live (all groups)
      • The number of participants in Group B or C who have an improvement in physical ability after treatment (health-related quality of life) and the amount of time this lasts before physical ability, tiredness (fatigue), or DLBCL symptoms get worse
      • How trial treatment affects the immune system

      4. Who can take part in this clinical trial?

      People with DLBCL can take part in Group A of this trial if they are at least 18 years old. Their lymphoma must have got better or stayed the same after chemoimmunotherapy treatment. People with untreated DLBCL can take part in Groups B or C if they are at least 80 years old, or aged between 65–79 years old and are not well enough to have full dose chemoimmunotherapy.

      People may not be able to take part in this trial if they have DLBCL that affects the brain or spinal cord. Or, have other medical conditions like certain infections, another cancer type, autoimmune, lung, liver or heart disease. They cannot have had certain treatments before, including mosunetuzumab or a stem cell transplant. People in Group A may not be able to take part in this trial if they are pregnant or breastfeeding.

      5. What treatment will participants be given in this clinical trial?

      Everyone who joins this clinical trial will join 1 of 3 groups depending on the specific criteria for each group. Treatment will be given in 3-week (21-day) ‘cycles’. A treatment cycle is the period of treatment and recovery time before the next dose of treatment is given.

      • Group A: mosunetuzumab, given as an infusion (into the vein) every 3 weeks for 8 cycles 
      • Group B: mosunetuzumab, given as an infusion (into the vein) every 3 weeks for 8 cycles 
      • Group C: mosunetuzumab, given as an injection (under the skin) every 3 weeks for 8 cycles AND polatuzumab vedotin given as an infusion (into the vein) every 3 weeks for 6 cycles

      Participants in Group B and C whose cancer shrinks or stays the same after 8 cycles may be given another 9 cycles of treatment. Group B participants whose cancer disappears after 8 cycles of treatment and then comes back may be given a further 8 cycles. Participants may also receive tocilizumab as an infusion into the vein if they experience a certain side effect called ‘cytokine release syndrome’ during the clinical trial.

      This is an open-label trial, which means everyone involved, including the participant and the clinical trial doctor, will know the clinical trial treatment the participant has been given. 

      6. Are there any risks or benefits in taking part in this clinical trial?

      The safety or effectiveness of the experimental treatment or use may not be fully known at the time of the trial. Most trials involve some risks to the participant. However, it may not be greater than the risks related to routine medical care or the natural progression of the health condition. People who would like to participate will be told about any risks and benefits of taking part in the clinical trial, as well as any additional procedures, tests, or assessments they will be asked to undergo. All of these will be described in an informed consent document (a document that provides people with the information they need to decide to volunteer for the clinical trial). 

      Risks associated with the clinical trial drugs

      Participants may have side effects (an unwanted effect of a drug or medical treatment) from the drugs used in this clinical trial. Side effects can be mild to severe, even life-threatening, and vary from person to person. Participants will be closely monitored during the clinical trial; safety assessments will be performed regularly. Participants will be told about the known side effects of mosunetuzumab, polatuzumab vedotin and tocilizumab and possible side effects based on human and laboratory studies or knowledge of similar drugs. Participants will be told about any known side effects of infusions into the vein (intravenous infusions) or injections under the skin (subcutaneous injections). 

      Potential benefits associated with the clinical trial

      Participants' health may or may not improve from participation in the clinical trial. Still, the information collected may help other people with similar medical conditions in the future.

      Trial Summary

      This study will evaluate mosunetuzumab alone and in combination with polatuzumab in a type of lymphoma called Diffuse Large B-Cell Lymphoma (DLBCL). This study will evaluate how safe the drugs are, how well they work, and how the body processes each drug. The patients will participate in one of 3 different study groups depending on the specific criteria for each group. Please continue reading below for further details on the study.

      Hoffmann-La Roche Sponsor
      Phase 1/Phase 2 Phase
      NCT03677154,GO40554 Trial Identifier
      Mosunetuzumab Intravenous (IV), Mosunetuzumab Subcutaneous (SC), Polatuzumab Vedotin, Tocilizumab Treatments
      Diffuse Large B-cell Lymphoma Condition
      Official Title

      A phase I/II trial of mosunetuzumab (BTCT4465A) as consolidation therapy in patients with diffuse large B-cell lymphoma following first-line immunochemotherapy and as monotherapy or in combination with polatuzumab vedotin in elderly/unfit patients with previously untreated diffuse large B-cell lymphoma

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria

      Inclusion Criteria for All Cohorts

      • At least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest diameter
      • Adequate hematologic function
      • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2; with the exception of South Korea, where participants 80 years or older with ECOG >/= 2 will not be eligible

      Inclusion Criteria Specific to Cohort A

      Participants in Cohort A must also meet the following criteria for study entry:

      • Histologically confirmed DLBCL according to World Health Organization (WHO) 2016 expected to express the cluster of differentiation-20 (CD20) antigen
      • One prior therapy with any systemic anthracycline-based chemoimmunotherapy containing regimen for previously untreated DLBCL
      • Best response of SD or PR to prior systemic chemoimmunotherapy at the end of induction treatment in accordance with the Lugano 2014 criteria

      Inclusion Criteria Specific to Cohorts B and C

      Participants in Cohorts B and C must also meet the following criteria for study entry:

      • Previously untreated, histologically confirmed, DLBCL according to WHO 2016 classification
      • Age >/= 80 years, or
      • Age 65-79 years and considered ineligible for chemoimmuotherapy (R-CHOP) with at least one of the following: Impairment in at least two activity of daily living (ADL) components as defined in the protocol; impairment in at least two instrumental ADL components as defined in the protocol; cumulative illness rating scale - geriactic (CIRS-G) score of at least one cormorbidity with a severity score of 3-4 (not including lymphoma and hematologic deficiencies due to lymphoma) or a score of 2 in >/= 8 comorbidities; impairment in cardiac function, renal function, liver function, or other comorbidities such that the participant is unfit for full-dose immunochemotherapy, such as rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)
      • Participants with an initial ECOG performance status of 3 may be considered during screening if the performance status is DLBCL-related and if pre-phase treatment during the screening phase (not more than 100 mg/day up to 7 days prior to Cycle 1 Day 1) results in an improvement of ECOG performance status to </= 2 prior to enrollment
      Exclusion Criteria

      Exclusion Criteria for All Cohorts

      Participants who meet any of the following criteria will be excluded from study entry:

      • Transformed lymphoma
      • CNS lymphoma
      • Prior treatment with mosunetuzumab
      • Prior stem cell transplant (autologous and allogeneic)
      • History of confirmed progressive multifocal leukoencephalopathy (PML)
      • Known or suspected chronic active Epstein Barr virus (CAEBV), hepatitis B, hepatitis C (HCV), or Human Immunodeficiency Virus (HIV)
      • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
      • Positive SARS-CoV-2 antigen or PCR test within 30 days prior to Cycle 1 Day 1
      • Prior solid organ transplantation
      • Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
      • Clinically significant history of liver disease
      • Prior treatment with radiotherapy within 2 weeks prior to Cycle 1, Day 1 (C1D1)
      • Significant cardiovascular disease

      Exclusion Criteria Specific to Cohort A

      Participants in Cohort A who meet the following criteria will be excluded from study entry:

      • Prior anti-lymphoma treatment with chemotherapy, immunotherapy, or biologic therapy 4 weeks prior to C1D1

      Exclusion Criterion Specific to Cohorts B and C

      Participants in Cohorts B and C who meet the following criterion will be excluded from study entry:

      • Prior treatment for DLBCL with chemotherapy, immunotherapy, and biologic therapy

      Exclusion Criteria Specific to Cohort C

      Participants in Cohort C who meet the following criteria will be excluded from study entry:

      • Current Grade >1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease

      About Clinical Research

      What is a clinical trial? Why should I consider taking part in a clinical trial? And why does Genentech conduct clinical trials?

      Find out now