Abstract 4310
Background
mSCPC is an orphan disease with a poor prognosis. First line systemic treatment relies on platinum-based polychemotherapies (PBPC). These combinations remain poorly effective with median progression-free survival (PFS) and overall survival (OS) around 7.5 months and 16 months respectively [Pagliaro 2010; Nicholson 2013]. SCPC is a disease with a virally induced oncogenesis, moreover PD-L1 is commonly expressed with an expression rate of 62.2% in primary tumours and a strong correlation between PD-L1 in the primary tumour and metastases [Udager 2016]. Immunotherapies targeting the PD-1/PD-L1 axis are effective in other squamous cell or HPV related cancers. There is no consensus on a second line systemic treatment in mSCPC. Tumour mass is assumed to be reduced as a result of the first line chemotherapy. PBPC are known to be able to trigger immunogenic cell death. The maintenance strategy after systemic chemotherapy which has controlled the disease is a validated concept in many tumour models. Maintenance treatment with immunotherapy after initial PBPC may help to maintain disease control in mSCPC setting.
Trial design
PULSE trial is a prospective multicenter open label phase II study that will enroll 32 patients. Patients with unresectable locally advanced or metastatic SCPC must have carried out a radiological assessment showing a non-progressive disease after 3 to 6 cycles of a first line PBPC. Patients previously treated by an immunotherapy are excluded. A minimal period of 3 weeks washout after chemotherapy is required before starting intravenous maintenance Avelumab. It will be administered every two weeks at the dose of 10mg/kg until progression or unacceptable toxicity. The primary objective is to assess PFS according to RECIST 1.1 criteria. Secondary objectives are overall survival, impact of PL-L1 expression, safety, quality of life. Exploratory endpoints include blood immune-response monitoring, correlation of tumour immune infiltrate and PD-L1 expression on PFS. Screening across ∼15 sites in France is being conducted with first site initiated in February 2019.
Clinical trial identification
NCT03774901.
Editorial acknowledgement
Legal entity responsible for the study
Thiery-Vuillemin.
Funding
Pfizer.
Disclosure
N. Gassian: Travel / Accommodation / Expenses: Ipsen; Travel / Accommodation / Expenses: Astellas; Travel / Accommodation / Expenses: Novartis Pharma SAS; Travel / Accommodation / Expenses: Pfizer. G. Mouillet: Travel / Accommodation / Expenses: Sanofi; Travel / Accommodation / Expenses: Ipsen; Travel / Accommodation / Expenses: Merck Serono; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Janssen Cilag; Travel / Accommodation / Expenses: Bristol-Myers Squibb; Travel / Accommodation / Expenses: Astellas Pharma; Travel / Accommodation / Expenses: Pfizer. F. Calcagno: Travel / Accommodation / Expenses: Ipsen; Travel / Accommodation / Expenses: Bayer HealthCare SAS; Travel / Accommodation / Expenses: Pfizer; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Bristol-Myers Squibb; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Sanofi. A. Thiery-Vuillemin: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche/ Genentech; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy: Astellas Pharma. All other authors have declared no conflicts of interest.
Resources from the same session
5517 - Molecular fingerprinting in breast cancer (BC) screening using Quantum Optics (QO) technology combined with an artificial intelligence (AI) approach applying the concept of “molecular profiles at n variables (MPnV)”: a prospective pilot study.
Presenter: Jean-Marc Nabholtz
Session: Poster Display session 3
Resources:
Abstract
2152 - Inferring the correlation between incidence rates of melanoma and the average tumor-specific epitope binding ability of HLA class I molecules in different populations
Presenter: Istvan Miklos
Session: Poster Display session 3
Resources:
Abstract
4382 - Thermal Liquid Biopsy as a Valuable Tool in Lung Cancer Screening Programs
Presenter: Alberto Rodrigo
Session: Poster Display session 3
Resources:
Abstract
2465 - Towards a screening test for cancer by circulating DNA analysis
Presenter: Rita Tanos
Session: Poster Display session 3
Resources:
Abstract
3788 - Evaluation of a successful launch of the MammaPrint and BluePrint NGS kit
Presenter: Leonie Delahaye
Session: Poster Display session 3
Resources:
Abstract
3863 - Analysis of prognostic factors on overall survival in elderly women treated for early breast cancer using data mining and machine learning
Presenter: Pierre Heudel
Session: Poster Display session 3
Resources:
Abstract
1993 - Circulating tumor cell detection in epithelial ovarian cancer using dual-component antibodies targeting EpCAM and FRα
Presenter: Na Li
Session: Poster Display session 3
Resources:
Abstract
4281 - CEUS of the breast: Is it feasible in improved performance of BI-RADS evaluation of critical breast lesions?——A multi-center prospective study in China
Presenter: Jun Luo
Session: Poster Display session 3
Resources:
Abstract
2268 - Classification of abnormal findings on ring-type dedicated breast PET for detecting breast cancer
Presenter: Shinsuke Sasada
Session: Poster Display session 3
Resources:
Abstract
4035 - Prediction of benign and malignant breast masses using digital mammograms texture features
Presenter: Cui Yanhua
Session: Poster Display session 3
Resources:
Abstract