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 criteria). 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 SCARCE 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 treatment efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
97
Clinique de l'Europe
Amiens, France
Institut Sainte Catherine
Avignon, France
CHRU Jean Minjoz
Besançon, France
CHU Bordeaux - Hôpital Haut Lévêque
Bordeaux, France
Centre François Baclesse
Caen, France
Hôpitaux Civils de Colmar
Colmar, France
Clinique des Cèdres
Cornebarrieu, France
GHPSO Creil
Creil, France
Centre Georges François Leclerc
Dijon, France
Institut Hospitalier Franco-Britannique
Levallois-Perret, France
...and 21 more locations
Progression free survival rate (PFS)
PFS will be defined as the time interval between the date of randomization and the date of first progression (local, regional, metastatic, second cancer) or death regardless of the cause. Patients alive without progression will be censored at the time of the latest news
Time frame: at 12 months
Overall Survival (OS)
OS will be calculated between the date of randomization and the date of death from any cause. . Alive patients or lost to follow-up at the time of the analysis will be censored at the date of last follow-up.
Time frame: within 3 years after the initiation of the treatment
Progression free survival
PFS will be defined as the time interval between the date of randomization and the date of first progression (local, regional, metastatic, second cancer) or death regardless of the cause
Time frame: within 3 years after the initiation of the treatment
Quality of life related to heath
EORTC-QLQ-C30
Time frame: From the randomization to patient death or for maximum 3 years
Objective response rate (ORR)
Evaluated by RECIST criteria version 1.1
Time frame: within 3 years after the initiation of the treatment
Tolerance graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] criteria v4.03
graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] criteria v4.03
Time frame: within 3 years after the initiation of the treatment
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