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Phase II Study of Suratadenoturev (OBP-301) in Combination with Pembrolizumab in Immunotherapy Refractory Esophagogastric Adenocarcinoma

Clinical Trial Details

The purpose of this study is to evaluate the safety and efficacy of OBP-301 with pembrolizumab in advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma (gastroesophageal adenocarcinoma).
   
OBP-301 is experimental, which means that it in combination with pembrolizumab is being tested and they are not yet approved by the United States Food and Drug Administration (FDA). 

In this study, an OBP-301 injection will be given every 2 weeks for a total of 4 injection encounters. Participants may receive up to 1 additional tumor injection encounter if the participant has not had disease progression and has had no grade 3 or 4 events related to OBP-301. Participants will also receive pembrolizumab 400 mg IV will be given for 6 weeks until disease progression or for a maximum of 2 years.
   
Participation is expected to last up to 24 months.

Key Eligibility: 
  1. Open to men and women above the age of 18 with histologically or cytologically confirmed advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma amenable to intra-tumoral injection.
  2. Participants cannot have a diagnosis of immunodeficiency or are receiving systemic steroid therapy.

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Li Mow
(646) 962-3378
mem9233@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2306026219

ClinicalTrials.gov:

NCT06340711

Sponsor:

WCM/IIT

Status

Open to Enrollment

Age Group

Adult

Sponsor