Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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.

Patients must have clinical or radiographic disease progression on 1L therapy, or within three months of the last dose of immunotherapy

Disqualifiers

Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 3 weeks of study Day 1.

Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)

Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (greater than equivalent of 20 mg/day) or any other form of immunosuppressive therapy within 7 days prior to study Day 1.

Has known active central nervous system metastases and/or carcinomatous meningitis.

Trial design

Treatments tested in this trial

  • OBP-301
  • Pembrolizumab

Treatment groups

27 Participants
are divided into 1 treatment group

Locations

2
Weill Cornell Medicine/NewYork-Presbyterian Hospital10065, New YorkNew York, United States
Abramson Cancer Center of the University of Pennsylvania19104, PhiladelphiaPennsylvania, United States

Sponsors and collaborators

Weill Medical College of Cornell University

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Oncolys BioPharma Inc

Collaborator

Source ClinicalTrials.gov