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Advanced Esophageal AdenocarcinomaPhase 1NCT04391049

Testing the Addition of the Anti-cancer Viral Therapy Telomelysin™ to Chemoradiation for Patients With Advanced Esophageal Cancer and Are Not Candidates for Surgery

A Phase 1 study testing Carboplatin, Paclitaxel and Radiation Therapy in people with Advanced Esophageal Adenocarcinoma and Advanced Gastroesophageal Junction Adenocarcinoma, run by NRG Oncology at 17 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This phase I trial studies the side effects of OBP-301 when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with esophageal or gastroesophageal cancer that invades local or regional structures. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carboplatin, Paclitaxel and Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
17 sitesUnited States
Study dates
2 Dec 2021to 6 Oct 2029
Phase
Phase 1

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

  • Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma or squamous cell carcinoma (SCC) of the esophagus or gastroesophageal junction (GEJ) within 90 days prior to registration
  • Gastroesophageal junction tumors must be Siewert type I/II
  • Required diagnostic workup for study entry:
  • History/physical examination prior to registration
  • Computed tomography (CT) of the chest/abdomen with intravenous contrast within 28 days prior to registration; If CT contrast is contraindicated magnetic resonance imaging (MRI) of the chest/abdomen without contrast is permitted
  • Bronchoscopy for squamous cell carcinoma (SCC) tumors that are adjacent to the airway to exclude a tracheoesophageal fistula within 42 days prior to registration
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  • Endoscopic ultrasound (if technically feasible) within 90 days prior to registration
  • Whole body positron emission tomography (PET)/CT scan within 42 days prior to registration: Note: scan will be used for radiation treatment planning, in addition to ruling out metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 14 days prior to registration
  • Adequate hematologic function within 14 days prior to registration defined as follows Absolute neutrophil count ≥ 1,500/mcL (within 14 days prior to registration) Hemoglobin ≥ 9 gm/dL (within 14 days prior to registration) Platelets ≥ 100,000/mcL (within 14 days prior to registration)
  • Adequate renal function within 14 days prior to registration defined as follows Creatinine clearance of ≥ 50 ml/min (as calculated by Cockcroft-Gault equation) (within 14 days prior to registration)
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 14 days prior to registration)
  • AST/ALT ≤ 2.5 x ULN
  • Patients for whom non-operative management is a viable option in the opinion of a thoracic surgeon and/or multidisciplinary team and are candidates for chemoradiation; this does not preclude patients from receiving surgery after chemoradiation if felt to me medically indicated;
  • Patients must, in the opinion of a treating gastroenterologist, have a tumor that is amenable to intratumoral injection with at least 1 mL (1 x 10^12 vp/mL) of OBP-301 and be a candidate for 3 endoscopy procedures
  • Female patients of child bearing potential must have a negative serum/urine pregnancy test within 14 days prior to study entry. A female not of childbearing potential is one who has undergone a hysterectomy, bilateral oophorectomy, tubal ligation, or who has had no menses for 12 consecutive months
  • Patients of reproductive potential must agree to use effective contraception for the duration of study treatment as well as 6 months (for women) or 12 months (for men) after the last administered injection of OBP-301. Effective contraception includes oral contraceptives, implantable hormonal contraception, double-barrier method or intrauterine device
  • The patient must provide study-specific informed consent prior to study entry
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Known acute or chronic hepatitis B or C infection (testing not required prior to study entry in patients with no known history of hepatitis B or C)
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • For patients with a history of hepatitis C virus (HCV) infection, they must (i) have been treated and cured, (ii) for patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to study entry are eligible for this trial

Who cannot join

  • Definitive clinical or radiologic evidence of metastatic disease including:
  • Positive malignant cytology of the pleura, pericardium or peritoneum
  • Radiographic evidence of involvement of any adjacent mediastinal structure, e.g. aorta, trachea, which would increase the risk of repeated endoscopic interventions
  • Tracheoesophageal fistula
  • Radiographic evidence of distant organ involvement
  • Non-regional lymph nodes that cannot be contained within a radiation field
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  • More than 1 esophageal lesion
  • Prior systemic chemotherapy for the study cancer
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Biopsy-proven tumor invasion of the tracheobronchial tree or presence of tracheoesophageal fistula or recurrent laryngeal or phrenic nerve paralysis
  • For patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, a New York Heart Association functional classification 2C or worse
  • Uncontrolled diabetes
  • Infection requiring IV antibiotics at the time of registration
  • Patients requiring immunosuppressive medications including chronic suppressive steroid therapy (greater than the equivalent of 20 mg/day of prednisone), methotrexate, azathioprine and TNF-alpha blockers within 7 days prior to study entry
  • Received live vaccine within 30 days prior to registration
  • Received a blood transfusion, hematopoietic agent; granulocyte-colony stimulating factor (G-CSF), and/or oxygen supplementation within 7 days before the screening lab
  • Breast feeding females

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • University of Kansas Clinical Research Center

    Fairway, Kansas, 66205

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • City of Hope South Pasadena

    South Pasadena, California, 91030

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

  • City of Hope Upland

    Upland, California, 91786

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: Phase I Trial With Expansion Cohort of OBP-301 (Telomelysin™) and Definitive Chemoradiation for Patients With Locally Advanced Esophageal and Gastroesophageal Cancer Who Are Not Candidates for Surgery

This phase I trial studies the side effects of OBP-301 when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with esophageal or gastroesophageal cancer that invades local or regional structures. OBP-301 is a virus that has been designed to infect and destroy tumor cells (although there is a small risk that it can also infect normal cells). Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving OBP-301 with chemotherapy and radiation therapy may work better than standard chemotherapy and radiation therapy in treating patients with esophageal or gastroesophageal cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine if the addition of OBP-301 to chemoradiation with carboplatin/paclitaxel is safe.

SECONDARY OBJECTIVES:

  1. To assess toxicities associated with the addition of OBP-301 to chemoradiation.

II. To assess the number of clinical complete responses (cCR).

III. To assess the number of patients alive/without progression (progression-free survival [PFS]) and the number of patients alive (overall survival [OS]) at 1 and 2 years.

EXPLORATORY OBJECTIVE:

  1. To report correlate outcomes - cCR, PFS and OS - with immune and virus-based correlative assays.

OUTLINE:

This study will evaluate an initial dose of OBP-301 and a de-escalated dose, if needed.

Patients receive OBP-301 by intratumoral injection via endoscopy on days -3, 12, and 26. Patients also receive carboplatin intravenously (IV) over 30 minutes and paclitaxel IV over 60 minutes on days 1, 8, 15, 22, and 29, and undergo radiation therapy on Monday through Friday beginning day 1 for 28 fractions over 5.5 weeks. All treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 and 6-8 weeks, then every 3 months for 2 years.

Being tested
Carboplatin, Paclitaxel, Radiation Therapy, Telomerase-specific Type 5 Adenovirus OBP-301
Keywords
OBP-301, viral therapy
Medical subject headings
Carcinoma, Squamous Cell, Neoplasms, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Intravenously (IV)

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Intravenously (IV)

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Irradiate, Irradiated, Irradiation

    Daily fractions

  • Telomerase-specific Type 5 Adenovirus OBP-301Biological

    Also called OBP-301, Telomelysin ™

    Intra-tumoral injection

Study groups in NCT04391049
Study groupRoleWhat they receive
Treatment (OBP-301, carboplatin, paclitaxel, radiation)ExperimentalPatients receive OBP-301 (1×10^12 vp/mL) by intra-tumoral injection via endoscopy on days -3, 12, and 26. Patients also receive paclitaxel IV (50 mg/m^2) over 60 minutes followed by carboplatin IV (AUC 2) over 30 minutes and on days 1, 8, 15, 22, and 29, and undergo radiation therapy (1.8 Gy/faction) on Monday through Friday beginning day 1 for 28 fractions (50.4 Gy total) over 5.5 weeks. All treatment continues in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Carboplatin; Drug: Paclitaxel; Radiation: Radiation Therapy; Biological: Telomerase-specific Type 5 Adenovirus OBP-301

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing Any Dose-Limiting Toxicities (DLTs)

    Adverse events are graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, which grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. A DLT is defined as the following that are definitely or probably attributed to OBP-301:

    • Any grade ≥3 adverse event EXCEPT for the following:
    • Grade 3 nausea/vomiting
    • Grade 3 esophagitis or dehydration
    • The first occurrence of grade 3/4 neutropenia
    • Grade 3/4 lymphopenia (since this is a known toxicity of chemoradiation and OBP-301)
    • Any toxicity that leads to a >14-day cumulative delay in chemoradiation.

    If 0 or 1 participants of 6 participants experienced a DLT, then the treatment regimen would be considered safe (and 9 more would be accrued for secondary endpoints). Otherwise, the regimen would be deemed too toxic and a second cohort of six participants would be accrued to a lower dose of OBP-301 (1 x 10^11 vp/mL).

    Measured: From start of protocol treatment until 30 days after the completion of chemoradiation, approximately 10 weeks.

Secondary outcomes (4)

  1. Number of Participants by Highest Grade Adverse Event Reported

    The Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

    Measured: From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months.

  2. Number of Participants With Clinical Complete Response (cCR)

    Clinical complete response is defined as grossly free of disease as determined by a visual inspection or if the visual inspection was not certain, then a negative biopsy. The number of participants is determined for two populations:

    • Complete case analysis only includes eligible participants who started protocol treatment and were assessed for cCR;
    • Sensitivity analysis includes all eligible participants who started protocol treatment and counts participants without an assessment as not achieving a cCR.

    Measured: 6-8 weeks after completion of chemoradiation, approximately 11.5-13.5 weeks from baseline.

  3. Number of Participants Alive Without Progression at 1 and 2 Years

    Progression is defined as pathologically confirmed recurrence of local disease or clinical evidence of distant disease.

    Measured: At 1 and 2 years

  4. Number of Participants Alive at 1 and 2 Years

    Measured: At 1 and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2020
  2. Study start2 Dec 2021
  3. Primary completion6 Oct 2024
  4. Study completion6 Oct 2029 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04391049
Sponsor's protocol ID
NRG-GI007
Other IDs
NCI-2020-02320, NRG-GI007, NRG-GI007, U10CA180868
Status last verified
Sep 2026
First submitted
12 May 2020
Last updated
1 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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