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

ConditionsEsophageal AdenocarcinomaGastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • OBP-301

    Drug

    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

  • Pembrolizumab

    Drug

    400 mg IV given every 6 weeks starting on day 4 of the study and given for up to 2 years

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: OBP-301 Plus PembrolizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Until disease progression or death, or for a maximum of approximately 2 years
2

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

Time frame
Until 90 days after the last dose of study drug
3

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

Time frame
Until 30 days after the last dose of study drug

Secondary outcomes

1

Disease control rate (DCR)

Disease control rate is defined as the percentage of patients who have achieved complete response, partial response or stable disease.

Time frame
Until disease progression or death, for a maximum of approximately 2 years from start of treatment
2

Duration of response (DoR)

Duration of response is defined as the duration that subjects who have responded to combination therapy remain without disease progression

Time frame
Until disease progression or death, or for a maximum of approximately 2 years from start of treatment
3

Overall Survival (OS)

Overall Survival is defined as the time from registration to death due to any cause.

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)
4

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.

Time frame
Until disease progression or death, or for a maximum of approximately 2 years from start of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Oncolys BioPharma Inc

Collaborator

Source ClinicalTrials.gov
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