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Trial from ANZCTR

A Phase II trial of durvalumab (Medi 4736) in advanced endometrial cancer A multi-centre Phase II trial to determine the activity and safety of durvalumab in advanced endometrial cancer

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 13/12/2017)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12617000106336

Date registered

19 January 2017

Health condition

Advanced endometrial cancer

Recruitment countries

Australia

Recruitment site location(s) (State)

New South Wales, Queensland, Western Australia, Victoria

Recruitment status

Recruiting

Anticipated date of first participant enrolment

01 February 2017

Ethics application status

Approved

Brief summary

The primary purpose of this trial is to evaluate the safety and efficacy of durvalumab for the treatment of advanced endometrial cancer.

Who is it for?
You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with advanced endometrial carcinoma which is suitable for chemotherapy.

Study details
All participants enrolled in this trial will receive an intravenous dose of durvalumab once every 28 days until the cancer is seen to have progressed, or until treatment side effects become intolerable. Participants will undergo continuous monitoring for side effects throughout treatment, as well as completing questionnaires and blood tests every four weeks, and CT scans every 8 to 12 weeks for the duration of treatment.

It is hoped that this trial will provide information on whether durvalumab is safe and effective for the treatment of advanced endometrial cancer.

Eligibility

Key inclusion criteria

Patients with advanced endometrial carcinoma suitable for chemotherapy
Adults, aged 18 years and older, with histologically or cytologically confirmed adenocarcinoma of endometrial origin
Advanced or recurrent disease that is not amenable to local therapy with curative intent such as surgical resection and/or radiotherapy
Assessment result for DNA mismatch repair (MMR) protein expression in tumour tissue by immunohistochemistry (IHC) must be available. This must include assessment for 4 MMR proteins: MLH1, MSH2, MSH6 and PMS2
Tumour tissue (FFPE) available for PD-L1 testing at a central laboratory
Agreement to undergo a repeat core biopsy of tumour tissue if the only available tumour tissue sample was obtained before previous chemotherapy or more than 1 year previously, and the investigator judges that the lesion can be biopsied without undue risk.
At least 1 target lesion according to RECIST v1.1
ECOG performance status of 0-2
Adequate bone marrow, renal and liver function
Willing and able to start treatment within 7 days of registration and to comply with all study requirements, including the timing and/or nature of the required treatment and assessments

Minimum age

18 Years

Maximum age

No limit

Gender

Females

Key exclusion criteria

Suspected brain or leptomeningeal metastases, untreated brain metastases or current clinical or radiological progression of known brain metastases, or requirement for steroid therapy for brain metastases. Patients with treated brain metastases are eligible if they have been stable and off steroids for 3 weeks or longer.

Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks before registration, or persisting adverse events (>Grade 1) due to a previously administered agent.

Any condition requiring systemic treatment with either corticosteroids (>10mg daily prednisone or equivalent dose of alternative corticosteroid) or other immunosuppressive medications within 28 days of durvalumab administration. Intranasal, inhaled or topical steroids are permitted in the absence of active autoimmune disease.

History of any known or suspected autoimmune disease other than vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to an autoimmune condition requiring only hormone replacement, or psoriasis not requiring systemic treatment within the last 2 years.

Prior allogeneic organ transplant, inflammatory bowel disease, pneumonitis, tuberculosis, or primary immunodeficiency.

Prior treatment with durvalumab, or with any other anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways.

Life expectancy of less than 12 weeks.

Systemic infection requiring IV antibiotics within 14 days before the first dose of durvalumab.

Receipt of live attenuated vaccination within 30 days prior to enrolment.

Known history of interstitial lung disease from any cause

Mean QT interval corrected for heart rate (QTc) greater than or equal to 470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia's Correction

Myocardial infarction with 6 months prior to enrolment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia, or active conduction system abnormalities.

History of another malignancy within 3 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 3 years after definitive primary treatment.

Significant infection, including chronic active hepatitis B, hepatitis C, or HIV.

Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.

Pregnancy, lactation, or inadequate contraception. Participants must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration.

Contact details and further information

Primary Sponsor

Type: University
Name: University of Sydney
Address: NHMRC Clinical Trials Centre
Level 6, Chris O'Brien Lifehouse
119-143 Missenden Road
CAMPERDOWN NSW 2050
Country: Australia

Contact person for information and recruitment

Ms John Stark
NHMRC CTC
Locked Bag 77
CAMPERDOWN NSW 1450
Australia
+61 2 9562 5000
phaedra@ctc.usyd.edu.au