Cancer-Killing virus combined with keytruda shows promise in stubborn tumors
NCT ID NCT06340711
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 study tests a new approach for people with advanced stomach, esophageal, or gastroesophageal junction cancer that is either PD-L1-negative or has stopped responding to immunotherapy. Participants receive injections of a cancer-killing virus (OBP-301) directly into their tumor during a scope procedure, plus infusions of the immunotherapy drug pembrolizumab (Keytruda). The goal is to see if this combination is safe and effective in shrinking tumors or controlling the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OBP-301 (a virus injected into the tumor) and pembrolizumab (Keytruda, an immunotherapy drug)
- What this could lead to
- If it works, this combination could offer a new treatment option for people with hard-to-treat stomach or esophageal cancers that don't respond to standard immunotherapy.
- What could go wrong
- This is a small, early-phase trial with only 27 participants, so results may not apply to everyone. The virus injection requires a scope procedure, and side effects from both drugs are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 27 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 within three months of the last dose of immunotherapy 2. Patients must be eligible for immunotherapy (i.e. have not had a Grade 3 or 4 immunotherapy related gastrointestinal or pulmonary toxicity, or other immune-related adverse event that excludes them from receiving future immunotherapy per PI discretion) * If the PD-L1 CPS score is \< 1, patients must not have received prior anti-PD-1 or PD-L1 therapy and must have received at least one line of systemic therapy for advanced disease. Exclusion Criteria: * 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. * 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. * 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. * 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. * Is known to have acute or chronic active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) * Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Has an active infection requiring systemic therapy within 2 weeks of Day 1. * Is unable to comply with protocol procedures * Previous severe hypersensitivity (≥ Grade 3) to any monoclonal antibody * Has not adequately recovered from major surgery or has ongoing surgical complications. * Has had an allogenic tissue/solid organ transplant * Has certain uncontrolled illnesses * Is pregnant or breastfeeding or planning to become pregnant or start breast feeding during the study time period * Is expecting to get someone else pregnant during the study time period
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Abramson Cancer Center of the University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Weill Cornell Medicine/NewYork-Presbyterian Hospital
RECRUITINGNew York, New York, 10065, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- One small incision vs several: robotic stomach cancer surgery put to the test
- Can PET scans reveal which stomach cancers will respond to immunotherapy?
- Can a direct hit to tumors make immunotherapy work better?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a new drug boost immunotherapy against Hard-to-Treat stomach cancer?
- Can a vaccine stop GI cancers from returning?