Phase
Condition
Esophageal Cancer
Esophageal Disorders
Digestive System Neoplasms
Treatment
Durvalumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males and females > 18 years of age.
Biopsy proven adenocarcinoma or squamous cell carcinoma of the esophagus orgastro-oesophageal junction
Oligometastatic disease (1-5 lesions outside the primary tumour radiotherapy fieldon FDG-PET scan), or locoregionally advanced disease unsuitable for either surgicalresection or radical chemoradiotherapy
Symptomatic dysphagia (Mellow score greater than 0)
ECOG performance status 0-2
Anticipated life expectancy of greater than 12 weeks.
Body weight of greater than 30kg.
Adequate bone marrow function, with values within the ranges specified below. Bloodtransfusions are permissible.
White blood cell count greater than or equal to 2 x (10 to the power of 9)/L
Absolute neutrophil count greater than or equal to 1.5 x (10 to the power of 9)/L
Platelets greater than or equal to 100 x (10 to the power of 9)/L
Haemoglobin greater than or equal to 90g/L
Adequate liver function, with values within the ranges specified below:
Alanine transferase less than or equal to 2.5 x upper limit of normal (ULN)
Aspartate transferase less than or equal to 2.5 x ULN
Total bilirubin less than or equal to 1.5 x ULN (except patients with Gilbert'sSyndrome, who can have total bilirubin less than or equal to 5 x ULN)
Adequate renal function, with values within the ranges specified below. Note that anestimated renal function of greater than 125mL/min by the Cockroft-Gault formulamust not be used for carboplatin dosing, and must instead be determined using adirect method.
Serum creatinine less than or equal to 1.5 x ULN
Creatinine clearance (CrCl) greater than or equal to 40 mL/min usingCockroft-Gault formula
Tumour tissue (formalin-fixed, paraffin embedded) should be available for PD-L1 andmismatch repair (MMR) protein expression and can be provided as a block or slides (archival tissue is acceptable). Blocks prepared from cytological samples, wheretumour cell number is sufficient, are also acceptable. Patients will not be selectedby PD-L1 or MMR status.
Willing and able to comply with all study requirements, including treatment, timingand/or nature of required assessments.
Signed, written and informed consent.
Exclusion
Exclusion Criteria:
Bulky or organ-threatening metastatic disease requiring upfront higher dosechemotherapy in the judgement of the treating clinician.
Known tumour HER2 positivity (IHC 2+ or more and HER2 gene amplification on in situhybridisation) if oligometastatic disease.
Previous systemic therapy for oesophageal or GOJ carcinoma.
Previous thoracic radiotherapy. Prior palliative radiotherapy to bony metastases ispermitted.
Esophageal stent in situ.
Known tracheo-oesophageal fistula.
Known leptomeningeal or brain metastases.
Major surgical procedure (as defined by the Investigator) within 28 days prior tofirst day of study treatment. Note: Local surgery of isolated lesions for palliativeintent is permitted.
History of another malignancy within the last 3 years, with the exception ofadequately treated non-melanomatous skin cancer, carcinoma in situ and superficialtransitional cell carcinoma of the bladder.
Prior therapy with an anti-PD1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or anyother antibody or drug specifically targeting T cell co-stimulation or immunecheckpoint pathways.
Sensory neuropathy of grade 2 or higher severity per CTCAE v5.0.
History of allergy or hypersensitivity to study drug components, or othercontraindications to any of the study drugs. Active or prior documented autoimmunedisorders (including inflammatory bowel disease [e.g., ulcerative colitis or Crohn'sdisease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis], Graves' disease, rheumatoid arthritis,hypophysitis, uveitis, etc). Patients with the following conditions are exceptionsto this criterion:
Vitiligo or alopecia.
Hypothyroidism (e.g., following Hashimoto syndrome) stable on thyroid hormonereplacement.
Any chronic skin condition (e.g. psoriasis) that does not require systemictherapy.
Type 1 diabetes mellitus.
Coeliac disease controlled by diet alone. Patients without active autoimmune disease in the last 5 years may also be includedbut only after consultation with the Chief Principal Investigators.
Any condition requiring continuous systemic treatment with either regularcorticosteroids (>10mg daily prednisone or equivalent dose of an alternativecorticosteroid) or other immunosuppressive medications within 14 days of study drugadministration. Intranasal, inhaled or topical steroids, and adrenal replacementsteroid doses >10mg daily oral prednisone equivalent, are permitted in the absenceof active autoimmune disease.
Positive test for hepatitis B surface antigen (HBsAg) indicating acute or chronicinfection. Participants with a past or resolved HBV infection (defined as thepresence of anti-HBc and absence of HBsAg) are eligible.
Positive test for hepatitis C virus antibody (HCV antibody) , unless polymerasechain reaction is negative for HCV RNA.
History of other significant, or active, infection, including HIV or tuberculosis (TB). HIV testing is not mandatory unless clinically indicated. Clinical evaluationfor active TB may include clinical history, physical examination and radiographicfindings, or tuberculosis testing in line with local practice.
Receipt of a transplanted solid organ (kidney, liver, heart or lung) or of anallogeneic bone marrow transplant.
Receipt of a live attenuated vaccine within 30 days prior to registration.
Use of alternative or traditional medicines within 14 days prior to registration.
Uncontrolled intercurrent illness, including but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, uncontrolled hypertension, unstableangina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronicgastrointestinal conditions associated with diarrhea, or psychiatric illness/socialsituations that would limit compliance with study requirement, substantiallyincrease risk of incurring adverse events or compromise the ability of the patientto give written informed consent.
Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal,infertile, or use a reliable means of contraception to avoid pregnancy for 90 daysafter the last dose of durvalumab. Women of childbearing potential must have anegative pregnancy test within 24 hours prior to trial registration. Men must havebeen surgically sterilized or use a double barrier method of contraception if theyare sexually active with a woman of childbearing potential for a period of 180 daysafter the last dose of durvalumab and chemotherapy, or 90 days after the last doseof durvalumab monotherapy (whichever is the longer time period). Sperm donation isnot permitted for 180 days after the last dose of durvalumab and chemotherapy, or 90days after the last dose of durvalumab monotherapy (whichever is the longer timeperiod).
Study Design
Study Description
Connect with a study center
Border Medical Oncology
Albury, New South Wales 2640
AustraliaActive - Recruiting
Calvary Mater Newcastle
Newcastle, New South Wales 2298
AustraliaActive - Recruiting
Royal Brisbane and Women's Hospital
Herston, Queensland 4029
AustraliaActive - Recruiting
Flinders Medical Centre
Bedford Park, South Australia
AustraliaActive - Recruiting
St Vincent's Hospital
Fitzroy, Victoria 3065
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaActive - Recruiting
Sir Charles Gairdner Hospital
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
Auckland Hospital
Grafton, Auckland 1023
New ZealandActive - Recruiting
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