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.
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 Simon's 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
2×10(12) viral particles per injection given intratumorally every 2 weeks for a total of 4 injections starting on Day 1 of the study
400 mg IV given every 6 weeks starting on day 4 of the study and given for up to 2 years
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York, United States
RECRUITINGOverall response rate as assessed by the RECIST v1.1
Overall response is defined as the sum of partial responses plus complete responses as defined by RECIST v1.1 criteria.
Time frame: Until disease progression or death, or for a maximum of approximately 2 years
Number of serious adverse events (SAEs) tabulated by severity and classification per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
All SAEs will be recorded and coded by CTCAE v5 term and reported by severity and potential relatedness to study drugs
Time frame: Until 90 days after the last dose of study drug
Number of adverse events (AEs) tabulated by severity and classification per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
All AEs will be recorded and coded by CTCAE v5 term and reported by severity and potential relatedness to study drugs
Time frame: Until 30 days after the last dose of study drug
Disease control rate (DCR)
Disease control rate is defined as the percentage of patients who have achieved complete response, partial response or stable disease.
Time frame: Until disease progression or death, for a maximum of approximately 2 years from start of treatment
Duration of response (DoR)
Duration of response is defined as the duration that subjects who have responded to combination therapy remain without disease progression
Time frame: Until disease progression or death, or for a maximum of approximately 2 years from start of treatment
Overall Survival (OS)
Overall Survival is defined as the time from registration to death due to any cause.
Time frame: Until death or a maximum of 96 weeks from end of treatment (for a maximum of approximately 4 years from start of treatment)
Progression free survival (PFS)
Progression-free survival (PFS) is defined as time from registration to progression or death due to any cause. Progression is defined as radiologic progression of disease by RECIST v1.1 criteria.
Time frame: Until disease progression or death, or for a maximum of approximately 2 years from start of treatment
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