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
2421 - Lenvatinib plus PD-1 blockade in advanced bile tract carcinoma.
Presenter: Jianzhen Lin
Session: Poster Display session 3
Resources:
Abstract
5368 - Durvalumab and Paclitaxel Combination for treatment of metastatic triple negative breast cancer is safe with very promising efficacy
Presenter: Hazem Ghebeh
Session: Poster Display session 3
Resources:
Abstract
1520 - A prospective cohort study on the pharmacokinetics of nivolumab in metastatic non-small cell lung cancer, melanoma, and renal cell cancer patients
Presenter: Daan Hurkmans
Session: Poster Display session 3
Resources:
Abstract
1603 - Safety and clinical activity of subcutaneously (SC) administered anti-PD-1 antibody PF-06801591 in phase I dose-expansion cohorts of locally advanced or metastatic non-small-cell lung cancer (NSCLC) and urothelial carcinoma (UC)
Presenter: Byoung Cho
Session: Poster Display session 3
Resources:
Abstract
3922 - Development of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM): A scale to measure quality of life in cancer patients treated with ICMs
Presenter: Aaron Hansen
Session: Poster Display session 3
Resources:
Abstract
2408 - Immune checkpoint inhibitors (ICIs) as “chemotherapy (Ctx) sensitization” strategy in advanced solid tumors
Presenter: Francisco Javier Ros Montana
Session: Poster Display session 3
Resources:
Abstract
3612 - Validation of progression-free survival (PFS) as surrogate endpoint in randomised trials of immune checkpoint inhibitors in advanced solid cancers
Presenter: Peey Sei Kok
Session: Poster Display session 3
Resources:
Abstract
3827 - Pharmacokinetic (PK) analysis of weight-based and fixed dose cemiplimab in patients (pts) with advanced malignancies
Presenter: Michael Migden
Session: Poster Display session 3
Resources:
Abstract
2120 - A burst of highly differentiated CD4 TL identifies a subset of fast progressors, and correlates with hyperprogressive disease in NSCLC patients treated with ICI
Presenter: Hugo Arasanz
Session: Poster Display session 3
Resources:
Abstract
4254 - Nivolumab treatment in advanced non-small cell lung cancer (aNSCLC): a French nationwide retrospective cohort (UNIVOC Study)
Presenter: Christos Chouaid
Session: Poster Display session 3
Resources:
Abstract