Background Metastatic Squamous cell Penile Carcinoma (mSCPC) is an orphan disease with a virally induced oncogenesis. PD-L1 expression rate is around 60% with a strong correlation between PD-L1 in the primary tumour and metastases. The first line systemic treatment relies on platinum-based chemotherapies with a median progression free survival and overall survival around 7.5 and 16 months, respectively. Immunotherapies targeting PD-1/PD-L1 axis are effective in other squamous cell or HPV related cancers. Methods PULSE is a prospective multicenter open label single arm phase II study. Thirty-two patients will be enrolled after a radiological assessment showing a non-progressive disease after 3 to 6 cycles of a first line platinum-based polychemotherapy. Patients will receive Avelumab injections 10mg/ kg every two weeks until progression or unacceptable toxicity. The primary endpoint will be the progression free survival (PFS) according to RECIST v1.1 criteria. Secondary endpoints will include PFS according to iRECIST criteria, overall survival, quality of life, safety. Ancillary explorations will include assessing blood and tissue biomarkers for association with clinical benefit. Discussion After the first line, the prognosis remains poor with no consensus on a second line systemic treatment in locally advanced or mSCPC. PULSE trial is the first study that assess an anti PD-L1 immunotherapy in maintenance among patients with locally advanced or mSCPC. NCT NUMBER : NCT03774901.
Bulletin du cancer. 2020 Jun [Epub]
Noémie Gassian, Alexandre Frontczak, Guillaume Mouillet, Dewi Vernerey, Ouiza Manseur, Morgan Goujon, Aurelia Meurisse, Diane Berthod, Elise Robert, Fabien Calcagno, Antoine Thiery-Vuillemin
Oncologie médicale, Centre Hospitalier Universitaire, Besançon, 25030 Besançon cedex, France; / Medical Oncology, University Hospital, Besançon, France. Electronic address: ., Unité de méthodologie de qualité de vie en cancérologie, Centre Hospitalier Universitaire, Besançon / Methodology and quality of life unit in oncology, University Hospital, Besançon, France; INSERM, UMR1098, Besançon, France; Nanomedicine Lab, Imagery and Therapeutics (EA 4662) SFR FED 4234, University of Franche-Comté, Besançon, France., Oncologie médicale, Centre Hospitalier Universitaire, Besançon, 25030 Besançon cedex, France; / Medical Oncology, University Hospital, Besançon, France; Unité de méthodologie de qualité de vie en cancérologie, Centre Hospitalier Universitaire, Besançon / Methodology and quality of life unit in oncology, University Hospital, Besançon, France; INSERM, UMR1098, Besançon, France., Unité de méthodologie de qualité de vie en cancérologie, Centre Hospitalier Universitaire, Besançon / Methodology and quality of life unit in oncology, University Hospital, Besançon, France; INSERM, UMR1098, Besançon, France., Oncologie médicale, Centre Hospitalier Universitaire, Besançon, 25030 Besançon cedex, France; / Medical Oncology, University Hospital, Besançon, France., Oncologie médicale, Centre Hospitalier Universitaire, Besançon, 25030 Besançon cedex, France; / Medical Oncology, University Hospital, Besançon, France; Unité de méthodologie de qualité de vie en cancérologie, Centre Hospitalier Universitaire, Besançon / Methodology and quality of life unit in oncology, University Hospital, Besançon, France., Délégation à la Recherche Clinique et à l'Innovation (DRCI) University Hospital, Besançon, France., Oncologie médicale, Centre Hospitalier Universitaire, Besançon, 25030 Besançon cedex, France; / Medical Oncology, University Hospital, Besançon, France; INSERM, UMR1098, Besançon, France.