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Bevacizumab

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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.

DSP-7888 Dosing Emulsion

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

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.

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

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)

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

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.

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.

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.

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.

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.

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.

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

Sumitomo Pharma America, Inc.

In part 2 of the trial, 109 patients were randomized to arm 1, however 1 patient did not receive study drug and did not complete the trial. Therefore, the 108 patients in arm 1 who were randomized and received study drug were at risk for AEs or SAEs. In part 2 - arm 2, 108 patients were randomized, however 18 patients did not receive study drug and did not complete the trial. Therefore, the 90 patients in arm 2 who were randomized and received study drug were at risk for AEs or SAEs.

Drug: DSP-7888 Dosing Emulsion 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.

Other Name: adegramotide and nelatimotide

Drug: Bevacizumab Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg. Other Name: Avastin

Part 1 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab

DSP-7888 Dosing Emulsion: 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.

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

Part 2 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab

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

Part 2 - Arm 2: Bevacizumab

Total

Age, Categorical

Sex: Female, Male

Native Aboriginal (including First Nations, Metis, Inuit)

Caucasian

Asian

Black (including African, Caribbean descent)

Native Americans or Alaskan Native

Native Hawaiian or Other Pacific Islander

Other

Race/Ethnicity, Customized

HLA Class I Type

Sheila Dhaskali

Analysis limited to patients enrolled into Part 1 - the safety set.

Number of Participants Who Experienced a Dose-limiting Toxicity

Analysis limited to patients randomized into Part 2 - the intent-to-treat set.

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

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

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

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 Response Rate of Patients With Recurrent or Progressive GBM

Analysis limited to patients randomized into Part 2 - the intent-to-treat set. NE signifies "Not Estimable" in the results.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy	NCT03149003	Glioblastoma	DSP-7888 Dosing... Bevacizumab	18 Years -	Sumitomo Pharma America, Inc.
A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy	NCT03149003	Glioblastoma	DSP-7888 Dosing... Bevacizumab	18 Years -	Sumitomo Pharma America, Inc.

Spots Global Cancer Trial Database for wilms tumor 1 (wt1)