Phase II Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in PD-L1-Negative or Immunotherapy-refractory Esophagogastric Adenocarcinoma
Weill Medical College of Cornell University
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically confirmed advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma amenable to intra-tumoral injection (i.e. at least 1 cm in size) * Tumor must be examined forPD-L1 assessment as defined by a Combined Positive Score (CPS), and approved commercial diagnostic assay * If the PD-L1 CPS score is \> 1, patients must have received at least one line of systemic therapy for advanced disease that includes a PD-1 or PD-L1 inhibitor. 1. Patients must have clinical or radiographic disease progression on 1L therapy, or…
Interventions
- DrugOBP-301
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
- DrugPembrolizumab
400 mg IV given every 6 weeks starting on day 4 of the study and given for up to 2 years
Locations (2)
- Weill Cornell Medicine/NewYork-Presbyterian HospitalNew York, New York
- Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania