RECRUITING

Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma

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Conditions

Esophageal AdenocarcinomaGastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaPembrolizumabOBP-301Immunotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-25
Study Completion:2028-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06340711

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Tumor must be PD-L1 positive as defined by a combined positive score (CPS), i.e. CPS ≥ 1 by approved, commercial diagnostic assay
  3. * Tumor must be HER2 negative as determined by a CLIA-approved laboratory
  1. * 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.
  2. * Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)
  3. * 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.
  4. * Has known active central nervous system metastases and/or carcinomatous meningitis.
  5. * Has had prior anti-cancer monoclonal antibody chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1, who has not recovered from adverse events due to a previously administered agent.
  6. * Has a known additional malignancy within 3 years before the first OBP-301 administration that is progressing or requires active treatment, with the exception of prostate cancer controlled with androgen deprivation therapy.
  7. * Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
  8. * Is known to have acute or chronic active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
  9. * Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  10. * Has an active infection requiring systemic therapy within 2 weeks of Day 1.
  11. * Is unable to comply with protocol procedures
  12. * Previous severe hypersensitivity (≥ Grade 3) to any monoclonal antibody
  13. * Has not adequately recovered from major surgery or has ongoing surgical complications.
  14. * Has had an allogenic tissue/solid organ transplant
  15. * Has certain uncontrolled illnesses
  16. * Is pregnant or breastfeeding or planning to become pregnant or start breast feeding during the study time period
  17. * Is expecting to get someone else pregnant during the study time period

Contacts and Locations

Study Contact

Casey Owens
CONTACT
646-962-8189
cdo4001@med.cornell.edu
Myriam Elizaire-Williams
CONTACT
mye4001@med.cornell.edu

Principal Investigator

Manish Shah, M.D.
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Manish Shah, M.D., PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-25
Study Completion Date2028-04

Study Record Updates

Study Start Date2024-04-25
Study Completion Date2028-04

Terms related to this study

Keywords Provided by Researchers

  • Pembrolizumab
  • OBP-301
  • Immunotherapy

Additional Relevant MeSH Terms

  • Esophageal Adenocarcinoma
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma