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  • SOLACE2

    Acronym: 

    SOLACE2

    ACTRN/NCT /ethics: 

    ACTRN12618000686202

    Scientific title: 

    A phase II randomised trial comparing immune priming by low dose oral cyclophophamide plus olaparib versus priming byolaparib alone, prior to combination therapy with olaparib plus durvalumab, versus sungle agent olaparib alone, in asympyomatic platinum-sensitive recurrent ovarian, fallopian tube or primary peritoneal cancers with homologous recombination repair defects.

    Summary of trial and patient characteristics

    Cancer Type Gynaecological
    Trial Type Treatment
    Phase Phase II Tumour Stream Ovarian/ Peritoneal
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced
    Sex Both Anticipated Start Date 2018-07-15
    Molecular Target Anticipated End Date 2020-07-31
    Cancer Type Gynaecological
    Trial Type Treatment
    Phase Phase II
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Ovarian/ Peritoneal
    Cancer Stage Locally Recurrent or Locally Advanced
    Anticipated Start Date 2018-07-15
    Anticipated End Date 2020-07-31

    Trial Summary

    Study purpose The purpose of this study is to test new combinations of drugs for ovarian cancer that has come back after first-line treatment. The new combinations of treatment include olaparib given by itself, olaparib given with an antibody (durvalumab), or olaparib given with chemotherapy (cyclophosphamide) and then with an antibody (durvalumab). These new combinations may slow the progression of the cancer and delay the time until chemotherapy treatment is needed. Who is it for? You may be eligible for this study if you are a female aged over 18 years and have a histologically proven diagnosis of high-grade serous or carcinoma of the ovary, fallopian tube or peritoneum, at first asymptomatic CA125 progression which responded to platinum-based chemotherapy. Study details Participants will be randomly assigned (by chance) to one of three treatment groups. One group will receive two medications, olaparib taken by mouth twice a day, followed by durvalumab given into a vein and at the same time olaparib, then olaparib only. The second group will receive three medications, olaparib taken by mouth twice a day and at the same time cyclophosphamide taken by mouth once daily for 5 days of every week, followed by durvalumab given into a vein and at the same time olaparib, then olaparib only. The third group will receive one medication, olaparib taken by mouth twice a day. Participants will attend a number of hospital visits to give blood and answer questionnaires about their quality of life. It is hoped that this research may help people in the future who have the same kind of cancer as you have.

    Lay Summary

    A phase II randomised trial comparing immune priming by low dose oral cyclophophamide plus olaparib versus priming byolaparib alone, prior to combination therapy with olaparib plus durvalumab, versus sungle agent olaparib alone, in asympyomatic platinum-sensitive recurrent ovarian, fallopian tube or primary peritoneal cancers with homologous recombination repair defects.

    Sponsor / Cooperative group

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Flinders Medical Centre Alex Scott-Hoy alex.scott-hoy@sa.gov.au 08 8204 4830 Ganessan Kichenadasse Not Yet Recruiting
    Royal Adelaide Hospital Anne Milton anne.milton@sa.gov.au 08 7074 2342 Not Yet Recruiting