Esophageal AdenocarcinomaPhase 2NCT06340711
Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma
A Phase 2 study testing OBP-301 and Pembrolizumab in people with Esophageal Adenocarcinoma and Gastric Adenocarcinoma, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Adenocarcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- OBP-301 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Apr 2024to Apr 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Myriam Elizaire-Williams contact
United States2 sites, 2 recruiting
- Recruiting
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York, 10065
Casey Owens, cdo4001@med.cornell.edu
Manish Shah, M.D.
- Recruiting
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Jennifer Eads, MD, 215-662-3141, jennifer.eads@pennmedicine.upenn.edu
About this study
Official title: Phase II Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in PD-L1-Negative or Immunotherapy-refractory Esophagogastric Adenocarcinoma
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.
Read the detailed 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 every two weeks for 4 planned treatments, and up to one additional optional treatment. Pembrolizumab will be administered every 6 weeks until disease progression.
The primary endpoint is objective response rate, with the target response rate of 20%, to examine the hypothesis that OBP-301 can overcome checkpoint resistance. The expected response to continuing anti-PD-1 therapy in this patient population would anticipated to be <5%. As a key secondary endpoint, the investigators will also examine duration of response and progression free survival. In a previous trial of OBP-301 and pembrolizumab in the third line setting, two patients who had a partial response are now off therapy and without evidence of disease, with a duration of response 33+ months and 20+ months. The third patient with a partial response has been on therapy for 15+ months.
This trial utilizes a Simon's two-stage Minimax design. In the first stage of the trial, 13 patients will be accrued. If there are 0 responses in these 13 patients, the study will be stopped. Otherwise, 14 additional patients will be accrued for a total of 27 patients.
- Conditions
- Esophageal Adenocarcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- Being tested
- OBP-301, Pembrolizumab
- Keywords
- Pembrolizumab, OBP-301, Immunotherapy
- Medical subject headings
- Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBP-301Drug
Also called Suratadenoturev
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
PembrolizumabDrug
Also called Keytruda
400 mg IV given every 6 weeks starting on day 4 of the study and given for up to 2 years
| Study group | Role | What they receive |
|---|---|---|
| OBP-301 Plus Pembrolizumab | Experimental | All participants will receive 4 intratumoral injections of OBP-301 with each injection occurring approximately 2 weeks apart. All participants will also receive infusions of pembrolizumab every 6 weeks until disease progression or for a maximum of 2 years. Receives: Drug: OBP-301; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate as assessed by the RECIST v1.1
Overall response is defined as the sum of partial responses plus complete responses as defined by RECIST v1.1 criteria.
Measured: Until disease progression or death, or for a maximum of approximately 2 years
Number of serious adverse events (SAEs) tabulated by severity and classification per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
All SAEs will be recorded and coded by CTCAE v5 term and reported by severity and potential relatedness to study drugs
Measured: Until 90 days after the last dose of study drug
Number of adverse events (AEs) tabulated by severity and classification per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
All AEs will be recorded and coded by CTCAE v5 term and reported by severity and potential relatedness to study drugs
Measured: Until 30 days after the last dose of study drug
Secondary outcomes (4)
Disease control rate (DCR)
Disease control rate is defined as the percentage of patients who have achieved complete response, partial response or stable disease.
Measured: Until disease progression or death, for a maximum of approximately 2 years from start of treatment
Duration of response (DoR)
Duration of response is defined as the duration that subjects who have responded to combination therapy remain without disease progression
Measured: Until disease progression or death, or for a maximum of approximately 2 years from start of treatment
Overall Survival (OS)
Overall Survival is defined as the time from registration to death due to any cause.
Measured: Until death or a maximum of 96 weeks from end of treatment (for a maximum of approximately 4 years from start of treatment)
Progression free survival (PFS)
Progression-free survival (PFS) is defined as time from registration to progression or death due to any cause. Progression is defined as radiologic progression of disease by RECIST v1.1 criteria.
Measured: Until disease progression or death, or for a maximum of approximately 2 years from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start25 Apr 2024
- Primary completionApr 2028 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Oncolys BioPharma Inc
- Responsible party
- Sponsor
- Investigators
- Manish Shah, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340711
- Sponsor's protocol ID
- 23-06026219
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in PD-L1-Negative or Immunotherapy-refractory Esophagogastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06340711
- Acronym / sponsor ID
- 23-06026219
- Conditions
- Esophageal Adenocarcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- Keywords
- Pembrolizumab, OBP-301, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Oncolys BioPharma Inc
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 every two weeks for 4 planned treatments, and up to one additional optional treatment. Pembrolizumab will be administered every 6 weeks until disease progression.
The primary endpoint is objective response rate, with the target response rate of 20%, to examine the hypothesis that OBP-301 can overcome checkpoint resistance. The expected response to continuing anti-PD-1 therapy in this patient population would anticipated to be <5%. As a key secondary endpoint, the investigators will also examine duration of response and progression free survival. In a previous trial of OBP-301 and pembrolizumab in the third line setting, two patients who had a partial response are now off therapy and without evidence of disease, with a duration of response 33+ months and 20+ months. The third patient with a partial response has been on therapy for 15+ months.
This trial utilizes a Simon's two-stage Minimax design. In the first stage of the trial, 13 patients will be accrued. If there are 0 responses in these 13 patients, the study will be stopped. Otherwise, 14 additional patients will be accrued for a total of 27 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OBP-301 Plus Pembrolizumab | Experimental | Drug: OBP-301, Drug: PembrolizumabAll participants will receive 4 intratumoral injections of OBP-301 with each injection occurring approximately 2 weeks apart. All participants will also receive infusions of pembrolizumab every 6 weeks until disease progression or for a maximum of 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OBP-301Also: Suratadenoturev2×10(12) viral particles per injection given intratumorally every 2 weeks for a total of 4 injections starting on Day 1 of the study | Drug | OBP-301 Plus Pembrolizumab |
| PembrolizumabAlso: Keytruda400 mg IV given every 6 weeks starting on day 4 of the study and given for up to 2 years | Drug | OBP-301 Plus Pembrolizumab |
Primary outcome
Overall response rate as assessed by the RECIST v1.1
Time frame: Until disease progression or death, or for a maximum of approximately 2 years
Overall response is defined as the sum of partial responses plus complete responses as defined by RECIST v1.1 criteria.
Number of serious adverse events (SAEs) tabulated by severity and classification per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time frame: Until 90 days after the last dose of study drug
All SAEs will be recorded and coded by CTCAE v5 term and reported by severity and potential relatedness to study drugs
Number of adverse events (AEs) tabulated by severity and classification per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time frame: Until 30 days after the last dose of study drug
All AEs will be recorded and coded by CTCAE v5 term and reported by severity and potential relatedness to study drugs
4 secondary outcomes
Disease control rate (DCR)
Time frame: Until disease progression or death, for a maximum of approximately 2 years from start of treatment
Duration of response (DoR)
Time frame: Until disease progression or death, or for a maximum of approximately 2 years from start of treatment
Overall Survival (OS)
Time frame: Until death or a maximum of 96 weeks from end of treatment (for a maximum of approximately 4 years from start of treatment)
Progression free survival (PFS)
Time frame: Until disease progression or death, or for a maximum of approximately 2 years from start of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Myriam Elizaire-Williams contact
Manish Shah, M.D. principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OBP-301 and Pembrolizumab in people with Esophageal Adenocarcinoma and Gastric Adenocarcinoma, run by Weill Medical College of Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Casey Owens (646-962-6046, cdo4001@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate as assessed by the RECIST v1.1 (time frame: Until disease progression or death, or for a maximum of approximately 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.