Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340711
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-03-25
Brief Title:
Study of Suratadenoturev OBP-301 in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Phase II Study of Suratadenoturev OBP-301 in Combination With Pembrolizumab in Immunotherapy Refractory Esophagogastric Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to learn about of the research study drug telomelysin OBP-301 in combination with pembrolizumab in advanced or metastatic gastric or gastroesophageal junction GEJ cancer The main question it aims to answer is whether this combination is safe and effective in this type of cancer
Participants will receive 5 injections of OBP-301 approximately every 2 weeks OBP-301 will be injected directly into the tumor during an esophagogastroduodenoscopy EGD At the same time as the injection a tumor biopsy will be taken Participants will also receive pembrolizumab infusions every 6 weeks until disease progression or for a maximum of two years Pembrolizumab infusions will occur on different days than OBP-301 injections
Participants will receive 5 injections of OBP-301 approximately every 2 weeks OBP-301 will be injected directly into the tumor during an esophagogastroduodenoscopy EGD At the same time as the injection a tumor biopsy will be taken Participants will also receive pembrolizumab infusions every 6 weeks until disease progression or for a maximum of two years Pembrolizumab infusions will occur on different days than OBP-301 injections
Detailed Description:
This is a phase II study of suratadenoturev OBP-301 with pembrolizumab in advanced or metastatic gastric gastroesophageal junction or esophageal adenocarcinoma that has progressed on at least 1 line of prior therapy for advanced disease Patients must have received prior immunotherapy anti PD-1 therapy This study will examine the addition of OBP-301 with pembrolizumab patients who are refractory to first line immunotherapy
Patients will undergo intra-tumoral injection of OBP-301 followed 2-4 days later by the administration of pembrolizumab The OBP-301 injection will then be repeated every two weeks for 4 planned treatments and up to one additional optional treatment Pembrolizumab will be administered every 6 weeks until disease progression
The primary endpoint is objective response rate with the target response rate of 20 to examine the hypothesis that OBP-301 can overcome checkpoint resistance The expected response to continuing anti-PD-1 therapy in this patient population would anticipated to be 5 As a key secondary endpoint the investigators will also examine duration of response and progression free survival In a previous trial of OBP-301 and pembrolizumab in the third line setting two patients who had a partial response are now off therapy and without evidence of disease with a duration of response 33 months and 20 months The third patient with a partial response has been on therapy for 15 months
This trial utilizes a Simons two-stage Minimax design In the first stage of the trial 13 patients will be accrued If there are 0 responses in these 13 patients the study will be stopped Otherwise 14 additional patients will be accrued for a total of 27 patients
Patients will undergo intra-tumoral injection of OBP-301 followed 2-4 days later by the administration of pembrolizumab The OBP-301 injection will then be repeated every two weeks for 4 planned treatments and up to one additional optional treatment Pembrolizumab will be administered every 6 weeks until disease progression
The primary endpoint is objective response rate with the target response rate of 20 to examine the hypothesis that OBP-301 can overcome checkpoint resistance The expected response to continuing anti-PD-1 therapy in this patient population would anticipated to be 5 As a key secondary endpoint the investigators will also examine duration of response and progression free survival In a previous trial of OBP-301 and pembrolizumab in the third line setting two patients who had a partial response are now off therapy and without evidence of disease with a duration of response 33 months and 20 months The third patient with a partial response has been on therapy for 15 months
This trial utilizes a Simons two-stage Minimax design In the first stage of the trial 13 patients will be accrued If there are 0 responses in these 13 patients the study will be stopped Otherwise 14 additional patients will be accrued for a total of 27 patients
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