Esophagogastric AdenocarcinomaPhase 2NCT03921021
Phase 2 Study of Telomelysin (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma
A Phase 2 study testing Telomelysin in people with Esophagogastric Adenocarcinoma, run by Weill Medical College of Cornell University at 3 sites in United States.
Trial summary
This is a phase II study of OBP-301 with pembrolizumab in advanced gastric and gastroesophageal junction adenocarcinoma that has progressed on at least 2 lines of prior therapy for advanced disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagogastric Adenocarcinoma
- What is being tested?
- Telomelysin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 May 2019to 20 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Be willing and able to provide written informed consent for the trial.
- Be >18 years of age on the day of signing the informed consent.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Have histologically or cytologically confirmed advanced or metastatic gastroesophageal adenocarcinoma, at least 1 cm in size and amenable to intratumoral injection.
- Patient must have received at least 2 line of systemic therapy for advanced disease.
- Tumor must be PD-L1 positive, as defined by a combined positive score (CPS).
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- Have one or more measurable lesions based on iRECIST.
- Be willing to provide tissue; newly obtained biopsy specimens or formalin-fixed, paraffin-embedded (FFPE) block specimens.
- Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. If a serum pregnancy test is required it can be performed on the same day as the urine pregnancy test. The serum pregnancy test must also be completed 7 days prior to enrollment. And male / female subjects of childbearing potential must agree to use an adequate method of contraception starting with signing the informed consent through 120 days after the last dose of study medication.
- Demonstrated adequate organ function as defined in following criteria. All screening labs should be performed within 14 days of enrollment. Note: Subject must not have taken transfusion, hematopoietic agent; granulocyte-colony stimulating factor (GCSF) etc., and/or oxygen supplementation within 7 days before the screening labs.
- Absolute neutrophil count (ANC)>1,000 /mm3
- Platelets>100,000 /mm3
- Hemoglobin>8.0 g/dL
- Serum total bilirubin<2.0 mg/dL
- Aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT)< 3x Upper limit of normal (ULN). For subjects with liver metastases< 5x ULN.
- Serum creatinine< 2.0 mg/dL; or if serum creatinine > 2.0 mg/dL, measured or calculated creatinine/clearance >45 mL/min (Cockcroft-Gault formula).
- Life expectancy of ≥ 4 months from the first OBP-301 treatment.
- Understand the study requirements and the treatment procedures, and is willing to comply with all specified follow-up evaluations, and provides written informed consent before any study-specific tests or procedures are performed.
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 4 weeks of study Day 1.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (greater than equivalent of prednisone 20 mg/day) or any other form of immune-suppressive 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 of first injection of OBP-301 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 within 30 days of planned start of study therapy.
- Patients known to have acute or chronic active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Has any evidence of active, non-infectious pneumonitis or interstitial lung disease requiring steroids.
- Has an active infection requiring systemic therapy within 2 weeks of Day 1.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
- Previous severe hypersensitivity to another monoclonal antibody
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/psychological incompetence, whereby in the opinion of the Investigator the patient is assessed as being unable to provide information, consent, or comply with the study requirements and procedures.
- Patients who are pregnant or breastfeeding, or expecting to conceive or father children within the projected timeframe of the study, starting from the time of the Screening Visit through 4 months (120 days) after the last OBP-301 administration. Females of childbearing potential must have a negative serum or urine pregnancy test at Screening. A female not of childbearing potential is one who has undergone bilateral oophorectomy or who has had no menses for 12 consecutive months.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Weill Cornell Medical College
New York, New York, 10021
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This is a phase II study of OBP-301 with pembrolizumab in advanced gastric and gastroesophageal junction adenocarcinoma that has progressed on at least 2 lines of prior therapy for advanced disease.
Read the detailed description
This is a phase II study of OBP-301 with pembrolizumab in advanced gastric and gastroesophageal junction adenocarcinoma that has progressed on at least 2 lines of prior therapy for advanced disease. Pembrolizumab has recently received FDA approval for PD-L1 positive gastric and GEJ adenocarcinoma based on the Keynote-059 study. The efficacy of pembrolizumab monotherapy is modest in PD-L1 positive patients (defined as a combined positive score, CPS, of > 1), with only a ~15% overall response rate. This study will examine the addition of the oncolytic virus, OBP-301, administered prior to pembrolizumab in this patient population. Patients will be enrolled in a two-stage design, with 18 patients in the first stage. All patients will receive OBP-301 at 2x1012 viral particles (VP)/ tumor injection administered every two weeks x 4 injections as well as standard dose pembrolizumab 200 mg IV every 3 weeks. The tumor will be injected with OBP-301 four times (d1, d15, d29, d43). The preference is to inject the primary tumor endoscopically. Metastatic lesions may be injected on a case-by-case basis after discussion with the PI (Shah). All patients treated with OBP-301 will be eligible for the safety cohort.
Primary Endpoints:
- To examine the efficacy of OBP-301 with pembrolizumab in PD-L1 positive advanced gastric and gastroesophageal junction adenocarcinoma in the 3rd or 4th line setting, as assessed by the RECIST response rate.
- To examine the safety of multiple OBP-301 intratumoral injections in combination with pembrolizumab in advanced gastroesophageal adenocarcinoma.
Secondary Endpoint:
- To examine other measures of efficacy of the combination of OBP-301 with pembrolizumab in advanced gastric and esophageal adenocarcinoma including the disease control rate, duration of response, overall survival and progression free survival.
- Conditions
- Esophagogastric Adenocarcinoma
- Being tested
- Telomelysin
- Keywords
- Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelomelysinDrug
Also called OBP-301
OBP-301, the investigational product (IP) is formulated in 20 mM Tris pH 8.0, 25 mM NaCl with 2.5% glycerin, USP by volume. OBP-301 will be injected into the target tumor lesions.
| Study group | Role | What they receive |
|---|---|---|
| Telomelysin (OBP-301) | Experimental | All patients will receive Telomelysin (OBP-301) at 2x10^12 viral particles (VP)/ tumor injection administered every two weeks x 4 injections as well as standard dose pembrolizumab 200 mg IV every 3 weeks. The tumor will be injected with OBP-301 four times (d1, d15, d29, d43). The preference is to inject the primary tumor endoscopically. Metastatic lesions may be injected on a case-by-case basis after discussion with the PI (Shah). Receives: Drug: Telomelysin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate, as Assessed by Radiographic Imaging
The examination of patients with a partial or complete response is reported as the number of patients who achieved either a complete or partial response (CR + PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Per RECIST v1.1, for target lesions assessed by MRI or CT Chest Abdomen and Pelvis with Contrast, a Complete Response (CR) is the disappearance of all target lesions, and a Partial Response (PR) is a ≥30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) is defined as the sum of CR and PR.
Measured: 1 year
Secondary outcomes (4)
Disease Control Rate, as Assessed by Radiographic Imaging
Examination of subjects with stable disease, a partial response, or complete response reported as the number of participants who maintained stable disease, partial response, or complete response as per iRECIST through 1 year (SD + PR + CR). The examination of patients with a partial or complete response is reported as the number of patients who achieved either a complete or partial response (CR + PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Per RECIST v1.1, for target lesions assessed by MRI or CT Chest Abdomen and Pelvis with Contrast, a Complete Response (CR) is the disappearance of all target lesions, and a Partial Response (PR) is a ≥30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) is defined as the sum of CR and PR.
Measured: 1 year
Duration of Response, as Assessed by Radiographic Imaging
Defined as the duration that subjects who have responded to combination therapy remain without disease progression. The examination of patients with a partial or complete response is reported as the number of patients who achieved either a complete or partial response (CR + PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Per RECIST v1.1, for target lesions assessed by MRI or CT Chest Abdomen and Pelvis with Contrast, a Complete Response (CR) is the disappearance of all target lesions, and a Partial Response (PR) is a ≥30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) is defined as the sum of CR and PR.
Measured: 2.5 years
Overall Survival Rate, as Assessed by Survival
Defined as the number of participants who survived until 1 year from enrollment
Measured: 1 year
Progression Free Survival Rate, as Assessed by Radiographic Imaging and Survival.
The number of participants who did not progress as determined by iRECIST, or die by 1 year. The examination of patients with a partial or complete response is reported as the number of patients who achieved either a complete or partial response (CR + PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Per RECIST v1.1, for target lesions assessed by MRI or CT Chest Abdomen and Pelvis with Contrast, a Complete Response (CR) is the disappearance of all target lesions, and a Partial Response (PR) is a ≥30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) is defined as the sum of CR and PR.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start9 May 2019
- Primary completion20 Jun 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Esophagogastric 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Oncolys BioPharma Inc
- Responsible party
- Sponsor
- Investigators
- Manish Shah, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921021
- Sponsor's protocol ID
- 1807019403
- Status last verified
- May 2024
- First submitted
- 16 Apr 2019
- Last updated
- 25 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Telomelysin (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03921021
- Acronym / sponsor ID
- 1807019403
- Conditions
- Esophagogastric Adenocarcinoma
- Keywords
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Oncolys BioPharma Inc
- Study start
- 9 May 2019 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Posted 25 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II study of OBP-301 with pembrolizumab in advanced gastric and gastroesophageal junction adenocarcinoma that has progressed on at least 2 lines of prior therapy for advanced disease.
Detailed description
This is a phase II study of OBP-301 with pembrolizumab in advanced gastric and gastroesophageal junction adenocarcinoma that has progressed on at least 2 lines of prior therapy for advanced disease. Pembrolizumab has recently received FDA approval for PD-L1 positive gastric and GEJ adenocarcinoma based on the Keynote-059 study. The efficacy of pembrolizumab monotherapy is modest in PD-L1 positive patients (defined as a combined positive score, CPS, of > 1), with only a ~15% overall response rate. This study will examine the addition of the oncolytic virus, OBP-301, administered prior to pembrolizumab in this patient population. Patients will be enrolled in a two-stage design, with 18 patients in the first stage. All patients will receive OBP-301 at 2x1012 viral particles (VP)/ tumor injection administered every two weeks x 4 injections as well as standard dose pembrolizumab 200 mg IV every 3 weeks. The tumor will be injected with OBP-301 four times (d1, d15, d29, d43). The preference is to inject the primary tumor endoscopically. Metastatic lesions may be injected on a case-by-case basis after discussion with the PI (Shah). All patients treated with OBP-301 will be eligible for the safety cohort.
Primary Endpoints:
- To examine the efficacy of OBP-301 with pembrolizumab in PD-L1 positive advanced gastric and gastroesophageal junction adenocarcinoma in the 3rd or 4th line setting, as assessed by the RECIST response rate.
- To examine the safety of multiple OBP-301 intratumoral injections in combination with pembrolizumab in advanced gastroesophageal adenocarcinoma.
Secondary Endpoint:
- To examine other measures of efficacy of the combination of OBP-301 with pembrolizumab in advanced gastric and esophageal adenocarcinoma including the disease control rate, duration of response, overall survival and progression free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telomelysin (OBP-301) | Experimental | Drug: TelomelysinAll patients will receive Telomelysin (OBP-301) at 2x10^12 viral particles (VP)/ tumor injection administered every two weeks x 4 injections as well as standard dose pembrolizumab 200 mg IV every 3 weeks. The tumor will be injected with OBP-301 four times (d1, d15, d29, d43). The preference is to inject the primary tumor endoscopically. Metastatic lesions may be injected on a case-by-case basis after discussion with the PI (Shah). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Be willing and able to provide written informed consent for the trial.
- Be >18 years of age on the day of signing the informed consent.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Have histologically or cytologically confirmed advanced or metastatic gastroesophageal adenocarcinoma, at least 1 cm in size and amenable to intratumoral injection.
- Patient must have received at least 2 line of systemic therapy for advanced disease.
Key exclusion criteria (16 listed)
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of study Day 1.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (greater than equivalent of prednisone 20 mg/day) or any other form of immune-suppressive 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 |
|---|---|---|
| TelomelysinAlso: OBP-301OBP-301, the investigational product (IP) is formulated in 20 mM Tris pH 8.0, 25 mM NaCl with 2.5% glycerin, USP by volume. OBP-301 will be injected into the target tumor lesions. | Drug | Telomelysin (OBP-301) |
Primary outcome
Overall Response Rate, as Assessed by Radiographic Imaging
Time frame: 1 year
The examination of patients with a partial or complete response is reported as the number of patients who achieved either a complete or partial response (CR + PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Per RECIST v1.1, for target lesions assessed by MRI or CT Chest Abdomen and Pelvis with Contrast, a Complete Response (CR) is the disappearance of all target lesions, and a Partial Response (PR) is a ≥30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) is defined as the sum of CR and PR.
4 secondary outcomes
Disease Control Rate, as Assessed by Radiographic Imaging
Time frame: 1 year
Duration of Response, as Assessed by Radiographic Imaging
Time frame: 2.5 years
Overall Survival Rate, as Assessed by Survival
Time frame: 1 year
Progression Free Survival Rate, as Assessed by Radiographic Imaging and Survival.
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Manish Shah, MD principal investigator
Weill Medical College of Cornell University
3 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 Telomelysin in people with Esophagogastric Adenocarcinoma, run by Weill Medical College of Cornell University at 3 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 18 inclusion and 16 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: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 25 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate, as Assessed by Radiographic Imaging (time frame: 1 year). 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 25 Jun 2024.