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Trial record 1 of 1 for:    btcrc-ESO14-012
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A Study of Durvalumab (MEDI4736) in Esophageal Cancer

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Shadia Jalal, MD, Big Ten Cancer Research Consortium
Sponsor:
Collaborators:
MedImmune LLC
AstraZeneca
Big Ten Cancer Research Consortium
Information provided by (Responsible Party):
Shadia Jalal, MD, Big Ten Cancer Research Consortium
ClinicalTrials.gov Identifier:
NCT02639065
First received: December 21, 2015
Last updated: June 8, 2017
Last verified: June 2017
  Purpose

This is a phase II, open-label, single arm, single-stage study. A total of 23 evaluable patients will be enrolled. If total number of patients free of disease relapse at 1 year is less than or equal to 15, the drug would not be considered for further study in this setting. After six patients are treated with at least one dose of study drug, they will be observed for a minimum of 60 days. During the 60-day observation period, further accrual will be halted to evaluate "unacceptable toxicities warranting early closure of the trial" defined as:

  • Any definitive durvalumab-related death. A durvalumab-related death will be continuously monitored throughout the trial and the trial will be suspended for re-evaluation whenever such an event is confirmed.
  • Any unexpected and previously unreported grade 4 toxicities definitely related to durvalumab.

Condition Intervention Phase
Esophageal Cancer Drug: Durvalumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Masking Description:
Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Evaluating Safety and Efficacy of Durvalumab (MEDI4736) Following Multi-modality Therapy in Esophageal Cancer: Big Ten Cancer Research Consortium BTCRC-ESO14-012

Resource links provided by NLM:


Further study details as provided by Shadia Jalal, MD, Big Ten Cancer Research Consortium:

Primary Outcome Measures:
  • One-Year Relapse Free Survival (RFS) Rates with Post-Operative Adjuvant Durvalumab [ Time Frame: Assessed at one year post-surgery ]
    RFS defined as time from the date of surgery until criteria for disease relapse is met, per Response Evaluation Criteria In Solid Tumors (RECIST 1.1), or death occurs


Secondary Outcome Measures:
  • Number of Patients with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: From time of consent and up to 90 days after treatment discontinuation (est. 15 months) ]
    Assess toxicity and tolerability of durvalumab following trimodality therapy, per Common Terminology Criteria for Adverse Events (CTCAE) v4


Estimated Enrollment: 26
Study Start Date: April 2016
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Treatment
Durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
Drug: Durvalumab
1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
Other Name: MEDI4736

Detailed Description:

OUTLINE: This is a multi-center trial.

INVESTIGATIONAL TREATMENT:

Subjects will receive durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.

The following baseline labs must be completed within 28 days prior to registration for protocol therapy:

Hematopoietic:

  • White blood cell count (WBC) > 3 K/mm^3
  • Hemoglobin (Hgb) > 9 g/dL. Transfusion is allowed, if needed, since patients are post esophagectomy.
  • Platelets > 100 K/mm^3
  • Absolute neutrophil count (ANC) ≥ 1.5 K/mm^3

Renal:

  • Calculated creatinine clearance of >/= 40 cc/min using the Cockcroft-Gault formula or by 24-hour urine collection.

Hepatic:

  • Bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST, SGOT) </= 2.5 x ULN
  • Alanine aminotransferase (ALT, SGPT) </= 2.5 x ULN
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subject must meet all of the following applicable inclusion criteria to participate in this study:

  • Written informed consent and HIPAA authorization for release of protected health information obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  • Age ≥ 18 years at the time of consent.
  • ECOG Performance Status of 0-1 within 28 days prior to registration for protocol therapy.
  • Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 12 weeks after treatment discontinuation.
  • Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration for protocol therapy. NOTE: Female subjects are considered of child bearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are ≥60 years old and naturally postmenopausal for at least 12 consecutive months.
  • Histological evidence of persistent residual esophageal adenocarcinoma including gastroesophageal junction adenocarcinoma following definitive concurrent chemoradiotherapy (carboplatin and paclitaxel or cisplatin and 5-FU) in the surgical sample (esophagus or lymph node or both) obtained at the time of esophagectomy. NOTE: Persistent residual disease is defined as follows (modified from College of American Pathologists Guidelines):

    • No residual tumor (Grade 0, complete response, 0% tumor). This group will not be included in this study.
    • Marked response (Grade 1, 0-<10% residual tumor)
    • Moderate response (Grade 2, 10-50% residual tumor)
    • No definite response (Grade 3, >50% residual tumor)
  • Minimum of 1 month and maximum of 3 months from surgical resection with no evidence of disease progression at the time of enrollment.
  • Must have adequately recovered from surgery as judged by the treating investigator.
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Exclusion Criteria:

Subjects meeting any of the criteria below may not participate in the study:

  • Prior therapy with a PD-1, PD-L1, or CTLA-4 inhibitor or cancer-specific vaccine therapy.
  • Evidence of active autoimmune disease requiring systemic treatment within preceding 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions to this rule include vitiligo, resolved childhood asthma/atopy, requirement of intermittent bronchodilators or local steroid injections, hypothyroidism stable on hormone replacement, psoriasis not requiring systemic treatment (within the past 2 years), Graves's disease and Sjogren's syndrome.
  • Prior malignancy is not allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason score ≤ 7 prostate cancers, or other cancer for which the subject has been disease-free for at least 3 years.
  • Active or prior documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis).
  • Presence of interstitial lung disease or history of pneumonitis requiring treatment with corticosteroids.
  • Patients with diagnosis of primary immunodeficiency.
  • Patients receiving chronic systemic corticosteroid therapy or other immunosuppressive therapy within 28 days prior to registration for protocol therapy. Exceptions include intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
  • History of allogeneic organ or stem cell transplant.
  • Receipt of live attenuated vaccine within 30 days prior to registration for protocol therapy.
  • Mean QT interval corrected for heart rate (QTc) > 470 msec calculated from 3 ECGs by Bazett's Correction.
  • Ventricular arrhythmias requiring medication(s).
  • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, or active bleeding diatheses.
  • History of psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.
  • Known HIV infection or chronic hepatitis B or C.
  • Known history of previous clinical diagnosis of tuberculosis.
  • Clinically significant infections as judged by the treating investigator. Clinically significant is defined as an active infection requiring IV antibiotics.
  • Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued. In addition, breast milk cannot be stored for future use while the mother is being treated on study.
  • Treatment with any investigational agent within 28 days prior to registration for protocol therapy.
  • History of hypersensitivity to durvalumab or any excipient.
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
  • Previous enrollment in the present study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02639065

Contacts
Contact: Shadia Jalal, M.D. 317.274.3658 sjalal@iu.edu
Contact: Ahran Lee 317.634.5842 ext 14 alee@bigtencrc.org

Locations
United States, Illinois
University of Illinois Cancer Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary Hidde    312-413-1069    mhidde@uic.edu   
Principal Investigator: Rozina Chowhery, MD         
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Shadia Jalal, M.D.    317-278-8845    sjalal@iu.edu   
Contact: Maggie Uhrich    317.274.4505    muhrich@iu.edu   
United States, Iowa
Unversity of Iowa Hospital and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Janelle Born    319-356-4797    janelle-born@uiowa.edu   
Principal Investigator: Laith Abushahin, MD         
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Maria Moreno-Rollins    734-647-2148    mmorrol@med.umich.edu   
Principal Investigator: Bryan Schneider, MD         
Michigan State University Recruiting
Lansing, Michigan, United States, 48910
Contact: Karen Luellen    517-975-9534    Karen.Luellen@hc.msu.eduu.edu   
Principal Investigator: Borys Hrinczenko, M.D.         
Sponsors and Collaborators
Shadia Jalal, MD
MedImmune LLC
AstraZeneca
Big Ten Cancer Research Consortium
Investigators
Study Chair: Shadia Jalal, M.D. Big Ten Cancer Research Consortium
  More Information

Additional Information:
Responsible Party: Shadia Jalal, MD, Sponsor-Investigator, Big Ten Cancer Research Consortium
ClinicalTrials.gov Identifier: NCT02639065     History of Changes
Other Study ID Numbers: BTCRC-ESO14-012
Study First Received: December 21, 2015
Last Updated: June 8, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Shadia Jalal, MD, Big Ten Cancer Research Consortium:
Durvalumab
MEDI4736
PD-L1 inhibitor

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 27, 2017