Ignite Creation Date:
2024-05-06 @ 10:38 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03311334
Status:
TERMINATED
Last Update Posted:
2024-04-18
First Post:
2017-10-09
Brief Title:
A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors
Sponsor:
Sumitomo Pharma America Inc
Organization:
Sumitomo Pharma America Inc
Study Overview
Official Title:
A Phase 1b2 Multicenter Open-Label Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors Nivolumab or Pembrolizumab in Adult Patients With Advanced Solid Tumors
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsors decision to terminate development of the program
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1b2 open-label multicenter study of DSP-7888 Dosing Emulsion in combination with checkpoint inhibitors nivolumab or pembrolizumab in adult patients with solid tumors that consists of 2 parts dose search part of the study Phase 1b and Phase 1b Enrichment Cohort and the dose expansion part of the study Phase 2 In Phase 1b of this study there will be 2 arms Arm 1 and Arm 2 In Arm 1 there will be 6 to 12 patients who will be dosed with DSP-7888 Dosing Emulsion and nivolumab and in Arm 2 there will be 6 to 12 patients who will be dosed with DSP-7888 Dosing Emulsion and pembrolizumab In addition an enrichment cohort of a further 10 patients who have locally advanced or metastatic Renal Cell Carcinoma or Urothelial Cancer with primary or acquired resistance to previous checkpoint inhibitors will be enrolled into Phase 1b of the study to help evaluate the preliminary antitumor activity of DSP-7888 Dosing Emulsion at the safe dose level identified in the dose-search part of the study and will be dosed with DSP-7888 Dosing Emulsion and nivolumab or DSP-7888 Dosing Emulsion and pembrolizumab as per the investigators preference At the safe recommended dose determined in Phase 1b platinum-resistant ovarian cancer PROC patients will be enrolled in Phase 2 of the study with DSP-7888 Dosing Emulsion exploring the combination with pembrolizumab Arm 2 In Phase 2 approximately 40 patients with PROC will be initially enrolled additional patients may be enrolled to further assess anti-tumor activities but the total sample size will not exceed 60 patients This brings the total maximum study population to approximately 84 patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None