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GlioblastomaPhase 3NCT03149003

A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy

A Phase 3 study testing DSP-7888 Dosing Emulsion and Bevacizumab in people with Glioblastoma, run by Sumitomo Pharma America, Inc. at 61 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is an event driven, adaptive design, a randomized, active-controlled, multicenter, open-label, parallel groups, Phase 3 study of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone in patients with recurrent or progressive glioblastoma multiforme (GBM) following treatment with first line therapy… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
DSP-7888 Dosing Emulsion and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
221 participants
Where
61 sitesin 5 countries
Study dates
8 Dec 2017to 30 Aug 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients or their legal representatives must be able to provide written informed consent.
  • Histologically confirmed diagnosis of supratentorial GBM (Grade 4 astrocytoma).
  • Radiographic evidence of first recurrence or progression of GBM following primary therapy consisting of surgery (biopsy or resection) and chemoradiation; patients may have undergone a second debulking surgery following initial recurrence or progression. Patients whose tumors are O6 methyl guanyl-methyltransferase (MGMT) methylated-promoter negative need not have received chemotherapy in the past to be eligible.
  • Human leukocyte antigen type HLA-A*02:01, HLA-A*02:06, or HLA-A*24:02.
  • Age ≥18.
  • KPS score of ≥60.
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  • Serum creatinine value <2X the upper limit of normal (ULN) for the reference laboratory.
  • Alanine aminotransferase/aspartate aminotransferase <3X the ULN and total bilirubin <2× the ULN for the reference laboratory.
  • Men and women of childbearing potential must agree to use a reliable method of contraception (oral contraceptives, implantable hormonal contraceptives, or double barrier method) or agree to completely refrain from heterosexual intercourse for the duration of the study and for 180 days following the last dose of DSP-7888 Dosing Emulsion.
  • Patients must have recovered from the effect of all prior therapy to Grade 2 or less.
  • Patients must be at least 28 days from any major surgery, and any surgery incisions or wounds must be completely healed.
  • Patients must be at least 12 weeks from the completion of prior radiation therapy (RT) in order to discriminate pseudo progression of disease from progression.
  • Patients must be at least 4 weeks from the completion of prior systemic or intracranial chemotherapy.
  • Patients must stop Novo-TTF treatment one day prior to study therapy (no washout period is needed). However, any wounds from TTF must be adequately healed per Inclusion Criterion #11.15. For patients who are not receiving therapeutic anticoagulation treatment, an international normalized ratio (INR) and a PTT ≤ 1.5 × the ULN; patients who are receiving anticoagulation treatment should be on a stable dose.
  • Patient's left ventricular ejection fraction (LVEF) > 40%. 17. Patient has a resting pulse oximetry of 90% or higher.

Who cannot join

  • Patients with any of the following will be excluded from the study:
  • Prior therapy with Bev.
  • Patients with secondary GBM.
  • Any anti-neoplastic therapy, including RT, for first relapse or recurrence.
  • Evidence of leptomeningeal spread of tumor or any history, presence, or suspicion of metastatic disease extracranially.
  • Evidence of impending herniation on imaging.
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  • Has known multifocal disease. Multifocal disease is defined as discrete sites of disease without contiguous T2/FLAIR abnormality that require distinct radiotherapy ports. Satellite lesions that are associated with a contiguous area of T2/FLAIR abnormality as the main lesion(s) and that are encompassed within the same radiotherapy port as the main lesion(s) are permitted.
  • Patients with infections that have required treatment with systemic antibiotics within 7 days of first dose of protocol therapy.
  • The need for systemic glucocorticoids in doses in excess of 4 mg/day of dexamethasone or in comparable doses with other glucocorticoids.
  • Treatment with any investigational agents within 5 half-lives of the agent in question or, if the half-life is unknown, within 28 days of enrollment.
  • Pregnant or lactating females.
  • Prior history of malignancy within 3 years of enrollment other than basal or squamous cell carcinoma of the skin, cervical intra-epithelial neoplasia, in situ carcinoma of the breast, or prostate cancer treated with surgery or RT with a prostate specific antigen of <0.01 ng/mL.
  • Patients with active autoimmune diseases within 2 years of enrollment into the study including, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome, Wegener's granulomatosis, ulcerative colitis, Crohn's disease, myasthenia gravis, Graves' disease, or uveitis except for psoriasis not requiring systemic therapy, vitiligo or alopecia areata, or hypothyroidism; if an autoimmune condition has been clinically silent for 12 months or greater, the patient may be eligible for enrollment.
  • Patients on immunosuppressive therapies; the use of topical, inhalational, ophthalmologic or intra articular glucocorticoids, or the use of physiologic replacement doses of glucocorticoids are permitted.
  • Patients with primary immunodeficiency diseases.
  • Patients with significant bleeding in the preceding 6 months or with known coagulopathies.
  • History of abdominal fistula, intestinal perforation, or intra-abdominal abscess in the preceding 12 months.
  • Positive serology for human immunodeficiency virus (HIV) infection, active hepatitis B*, or untreated hepatitis C; patients who have completed a course of anti-viral treatment for hepatitis C are eligible.
  • o In cases of negative results for HepB surface antigen with positive HepB core antibody, HBV DNA testing is required.
  • Patient has a medical history of frequent ventricular ectopy, e.g., non-sustained ventricular tachycardia (VT).
  • Significant cardiovascular disease, including New York Hospital Association Class III or IV congestive heart failure, myocardial infarction within 6 months of enrollment, unstable angina, poorly controlled cardiac arrhythmias, or stroke within the preceding 6 months.
  • Any other uncontrolled inter current medical condition, including systemic fungal, bacterial, or viral infection; uncontrolled hypertension; diabetes mellitus; or chronic obstructive pulmonary disease requiring 2 or more hospitalizations in the preceding 12 months.
  • Any psychiatric condition, substance abuse disorder, or social situation that would interfere with a patient's cooperation with the requirements of the study.
  • Known sensitivity to Bev or any of the components of DSP-7888 Dosing Emulsion.
  • Patient has a QTcF (QT corrected based on Fridericia's equation) interval > 480 msec (CTCAE = Grade 2) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) at screening. (Patients with bundle branch block and a prolonged QTc interval should be reviewed by the Medical Monitor for potential inclusion.)
  • Patient has dyspnea at rest (CTCAE ≥ Grade 3) or has required supplemental oxygen within 2 weeks of study enrollment.

Trial locations and contacts

61 sites in 5 countries.

61 sites in 5 countries

United States37 sites

  • Dent Neurosciences Research Center

    Amherst, New York, 14226

  • Piedmont brain tumor center

    Atlanta, Georgia, 30309

  • Texas Oncology Austin Midtown

    Austin, Texas, 78705

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Baylor Scott and White

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Houston Methodist

    Houston, Texas, 77030

  • Mischer Neuroscience Associates/Memorial Hermann Hospital

    Houston, Texas, 77030

  • University of Tennessee Academic Medical Center Cancer Institute

    Knoxville, Tennessee, 37920

  • UCSD- Moores Cancer Center

    La Jolla, California, 92093

  • University of Kentucky / Department of Internal Medicine / Markey Cancer Center

    Lexington, Kentucky, 40536

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • University of Wisconsin Hospital

    Madison, Wisconsin, 53792

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Weill Cornell Medicine

    New York, New York, 10021

  • Columbia University Medical Center/ Neurological Institute of NY

    New York, New York, 10032

  • Neuro-Oncology/ US Irvine Medical Center

    Orange, California, 92868

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvania, 15232

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Sansum Clinic

    Santa Barbara, California, 93105

  • John Wayne Cancer Institute

    Santa Monica, California, 90404

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Renovatio Clinical

    The Woodlands, Texas, 77380

  • University of Toledo

    Toledo, Ohio, 43606

  • Center for Neurosciences

    Tucson, Arizona, 85718

Other trials in United States

Japan12 sites

  • The University of Tokyo Hospital

    Bunkyo-ku, Tokyo, 113-8655

  • Niigata University Medical and Dental Hospital

    Chuo Ku, Niigata, 951-8520

  • Osaka International Cancer Institute

    Chuo Ku, Osaka, 541-8567

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Kagoshima University Hospital

    Kagoshima, Kagoshima-ken, 890-8520

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • National Hospital Organization Kyoto Medical Center

    Kyoto, 612-8555

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Tokyo Women's Medical University Hospital

    Shinjuku-Ku, 162-8666

  • Yamagata University Hospital

    Yamagata, 990-9585

Other trials in Japan

South Korea6 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Gangnam Severance Hospital

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

Other trials in South Korea

Canada3 sites

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec, H3A 2B4

  • University of Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Taiwan3 sites

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 100

  • Chang Gung Memorial Hospital

    Taoyuan City

Other trials in Taiwan

About this study

Official title: A Randomized, Multicenter, Adaptive Phase 3 Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab Versus Bevacizumab Alone in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy (WIZARD 201G)

This is an event driven, adaptive design, a randomized, active-controlled, multicenter, open-label, parallel groups, Phase 3 study of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone in patients with recurrent or progressive glioblastoma multiforme (GBM) following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.

Conditions
Glioblastoma
Being tested
DSP-7888 Dosing Emulsion, Bevacizumab
Keywords
Glioblastoma (GBM), Wilms Tumor 1 (WT1), Cancer Vaccines, Neoplasms, Astrocytoma, Glioma, Brain Cancer, Brain Tumor, Bevacizumab
Medical subject headings
Glioblastoma, Wilms Tumor, Neoplasms, Astrocytoma, Glioma, Brain Neoplasms

What participants receive

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

  • DSP-7888 Dosing EmulsionDrug

    Also called adegramotide and nelatimotide

    DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.

Study groups in NCT03149003
Study groupRoleWhat they receive
Arm 1: DSP-7888 Dosing Emulsion plus BevacizumabExperimentalNot described
Receives: Drug: DSP-7888 Dosing Emulsion; Drug: Bevacizumab
Arm 2: BevacizumabActive comparatorNot described
Receives: Drug: Bevacizumab

What is being measured

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

  1. Number of Participants Who Experienced a Dose-limiting Toxicity

    The number of participants with dose-limiting toxicity (DLT) who were enrolled into Part 1 - the safety set.

    Measured: Dose-limiting toxicity will be evaluated and applied from Day 1 through Day 29

  2. Overall Survival (OS) of Patients With Recurrent or Progressive Glioblastoma Multiforme (GBM) Treated With DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone

    The effect of DSP-7888 Dosing Emulsion plus BEV versus BEV alone on the OS of patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.

    Measured: 4 weeks after the patient has been off study treatment, every 3 months thereafter until death, the study closes, up to 24 months.

Secondary outcomes (6)

  1. Overall Survival (OS) of Patients With Recurrent or Progressive Glioblastoma Multiforme (GBM) Treated With DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone at 12 Months

    The effect of DSP-7888 dosing emulsion plus BEV versus BEV alone on the OS of patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.

    Measured: 12 months

  2. Progression Free Survival (PFS) of Patients With Recurrent or Progressive GBM

    The effect of DSP-7888 dosing emulsion plus Bevacizumab (BEV) versus BEV alone on the Progression Free Survival (PFS) of patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy. PFS is defined as the interval between randomization and progression or death from any cause any cause as determined by the central radiology body.

    Measured: The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause, up to 24 months

  3. Progression Free Survival (PFS) Rate in Patients With Recurrent or Progressive GBM at 6 Months

    The effect of DSP-7888 dosing emulsion plus Bevacizumab (BEV) versus BEV alone on the Progression Free Survival (PFS) rate in patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy. PFS is defined as the interval between randomization date and progression or death from any cause as determined by the central radiology body. The percentage of patients who achieved PFS at 6 months are summarized.

    Measured: The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause at 6 months

  4. The Effect of DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone on the Response Rate of Patients With Recurrent or Progressive GBM

    Assessment of the objective response rate (ORR) of DSP-7888 dosing emulsion plus BEV versus BEV alone in patients with recurrent or progressive GBM. The response rate is defined as the percentage of patients exhibiting a response (complete response [CR] plus partial response [PR]) based on the Modified Response Assessment in Neuro-Oncology (RANO) criteria as determined by the central radiology body.

    Measured: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 months

  5. Duration of Response in Patients With Recurrent or Progressive GBM Treated With DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone

    The effect of DSP-7888 dosing emulsion plus BEV versus BEV alone on the duration of response of patients with recurrent or progressive GBM. The duration of response is defined as the interval between first documented oncological response and progression of disease or death from any cause.

    Measured: From the date of first treatment up to 24 months

  6. Number of Participants With Adverse Events and Serious Adverse Events

    Assessment of safety of DSP7888 dosing emulsion plus Bevacizumab (BEV) versus BEV alone in patients with recurrent or progressive GBM

    Measured: The time from the date of first treatment, while the patient is on treatment, and for 30 days after stopping therapy, an average of 4 months

Timeline

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

  1. First posted11 May 2017
  2. Study start8 Dec 2017
  3. Primary completion30 Aug 2021
  4. Study completion30 Aug 2021

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03149003
Sponsor's protocol ID
BBI-DSP7888-201G
Status last verified
Nov 2023
First submitted
9 May 2017
Last updated
15 Nov 2023
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DSP-7888 Dosing Emulsion and Bevacizumab in people with Glioblastoma, run by Sumitomo Pharma America, Inc. at 61 sites in 5 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 15 inclusion and 26 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: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Japan, South Korea, Canada, Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Experienced a Dose-limiting Toxicity (time frame: Dose-limiting toxicity will be evaluated and applied from Day 1 through Day 29). The study lists 2 primary outcomes in all. 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 NCT03149003.

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 15 Nov 2023.

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