Abstract 1645
Background
Melanoma patients with disease progression on immunotherapy have very limited treatment options. Low-dose azacitidine results in demethylation and increase in neoantigen expression and carboplatin increases DNA-damage and cellular stress. This trial is testing if sequential treatment with azacitidine and carboplatin “primes” for immunotherapy rechallenge with anti-PDL1 antibody Avelumab, via a decrease in the disease burden and re-establishment of immune sensitivity. Primary Objective: Quantify complete response (CR), partial response (PR), stable disease (SD), overall response rate (ORR) and clinical benefit rate (CBR) after 2 cycles of priming (1 cycle= azacitidine x 5 days followed by Carboplatin Day 8/28 days) according to RECIST 1.1 and 6 cycles of immunotherapy (1 cycle= 1 dose of Avelumab/14 days) according to irRECIST criteria. Secondary Objectives: 1. Determine DNA methylation levels before, and immediately after priming with azacitidine and carboplatin treatment i.e. at study entry and after 2 months; 2. Quantify immune-response markers (PDL-1, PD-1, CD4/CD8, and CD68) in blood, tumour and microenvironment and immune response in blood before treatment, after 2 priming cycles and after 6 immunotherapy cycles.
Trial design
Interventional early phase II study that consists of 2 cycles of azacitidine 40mg/m2 IV/day for 5 days followed by Carboplatin AUC 4.5 IV on D8/ 28 day cycle and RECIST1.1 after completion of priming; followed by Avelumab 10mg/kg IV/14 day cycle until disease progression according to irRECIST. A favourable or stable response in 20% patients and no grade 4 or persistent (>4 weeks) grade 3 treatment-related adverse events (TRAEs) is required for continuation of the trial. This early phase II study will assess the feasibility and determine outcome measures required to calculate sample sizes and develop a statistical plan for multi-centre Phase II study. This study has been approved by the Northern Sydney Local Health District HREC, reference number HREC/17/HAWKE/55’.
Clinical trial identification
ACTRN12618000053224; registered 16th January 2018.
Editorial acknowledgement
Legal entity responsible for the study
Andre van der Westhuizen.
Funding
Ramaciotti Foundation and Hunter Medical Research Institute, Australia.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
2494 - CAR-T Nursing Education at a UK Specialist Cancer Hospital
Presenter: Rose Ellard
Session: Poster Display session 3
Resources:
Abstract
2438 - Professional Quality of Life, Perceived Stress and Psychological Resistance Levels of Oncology-Hematology Nurses and the Factors Affecting
Presenter: Tugba Pehlivan
Session: Poster Display session 3
Resources:
Abstract
3541 - Representation of cancer survivors’ preferences in policies for supportive care: Implications for oncology nursing
Presenter: Samantha Mayo
Session: Poster Display session 3
Resources:
Abstract
5093 - Vaginal moisturizing post PDR-Pulse Dose Rate Brachytherapy.
Presenter: Pilar Fernández
Session: Poster Display session 3
Resources:
Abstract
1066 - The stomized, chemo and radiotreated patient vs untreated patient: complications and comparison with data literature
Presenter: Cristoforo Ferrero
Session: Poster Display session 3
Resources:
Abstract
1724 - Evaluating the role of clinical nurse specialist
Presenter: Anita Zeneli
Session: Poster Display session 3
Resources:
Abstract
3753 - Role of the Advanced Practice Nurse (APN) in a Functional Unit for Lung cancer at the Catalan Institute of Oncology
Presenter: Isabel Brao
Session: Poster Display session 3
Resources:
Abstract
2676 - A bottom-up approach for prioritising the scientific activities of the Italian Association of Cancer Nurses (AIIAO): rationale and topic identification
Presenter: Valentina Biagioli
Session: Poster Display session 3
Resources:
Abstract
575 - Investigating quality of care for people with cancer and dementia
Presenter: Naomi Farrington
Session: Poster Display session 3
Resources:
Abstract
5578 - Two years of BRCA1 and BRCA2 somatic External Quality Assessment with Gen&tiss Tiss scheme in France
Presenter: Kelly Dufraing
Session: Poster Display session 3
Resources:
Abstract