SCARCE is a non-comparative randomized, 2:1 phase II study. The purpose of this study is to
assess the progression-free survival rate at 12 months. (evaluation according with RECISTv1.1
For all patients, CT scan will be planned at baseline, and every 8 weeks until 12 months from
randomization (or disease progression), and every 12 weeks thereafter.
PET scan will be performed at baseline, at the end of mDCF treatment, and at 12 months after
randomization (in absence of disease progression).
CT scan and PET scan will be collected for a centralized review.
Squamous cell carcinoma of the anal canal (SCCA) is a rare disease, its incidence increases
worldwide and no standard therapy is currently available to treat metastatic or relapsing
cases. SCCA is mostly induced by human papillomavirus (HPV) infections with HPV-related
oncoproteins (E6 and E7) expressed in more than 90% of cases.
Based on the preliminary results of the Epitope-HPV02 study and although it provide proof of
concept data on taxane-based chemotherapy efficacy in SCCA, complete responses observed after
6-8 cycles of chemotherapy has not translated into long-term remissions .
Combining immunogenic chemotherapy with anti-PD-1/PD-L1 might be a convenient way to increase
the diversity of antigens released by tumor and T cells.
So for the SCARCE study, we hypothesized that combination of mDCF (8 cycles) with MPDL32801
(12 months) might induce synergy and improve the rate of long-term PFS rate.
The aim of the SARCE study is to provide a valuable proof of concept to establish immunogenic
chemotherapy and anti-PDL1 as a standard of care for SCCA patients with poor clinical
outcomes and to take advantage of the presence of HPV antigens in most patients (HPV 16 and
18 genotypes are involved in 90% of SCCA) to set up a specific immunomonitoring program based
on tumor samples and blood-derived lymphocytes to better understand the potential synergisms
between immunogenic chemotherapy and anti-PDL1 and to identify valuable biomarkers of
Clinical Study Identifier
GERCOR - Multidisciplinary Oncology Cooperative Group
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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