Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Anus Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Anal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Fluorouracil

Cisplatin

Atezolizumab

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

* MPDL3280A (atezolizumab) will be administered every 2 weeks at 800 mg for 12 months.
* Patients will receive 8 cycles of mDCF (docetaxel 40 mg/m2 day 1, cisplatin 40 mg/m2 day 1 and 5FU at 1200 mg/m2/day for 2 days) every 2 weeks

Patients will receive 8 cycles of mDCF (docetaxel 40 mg/m2 day 1, cisplatin 40 mg/m2 day 1 and 5FU at 1200 mg/m2/day for 2 days) every 2 weeks.

MPDL3280A administered every 2 weeks at 800 mg for 12 months.

MPDL3280A

8 cycles of mDCF (docetaxel 40 mg/m2 day 1, cisplatin 40 mg/m2 day 1 and 5-FU at 1200 mg/m2/day for 2 days) every 2 weeks

mDCF

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.

A Study of mDCF in Combination or Not With Atezolizumab in Advanced Squamous Cell Anal Carcinoma

A Non-comparative Randomized 2:1 Phase II Study of Docetaxel, Cisplatin, and 5-fluorouracil in Combination or Not With Atezolizumab in Patients With Metastatic or Unresectable Locally Advanced Squamous Cell Anal Carcinoma

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

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.

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

graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] criteria v4.03

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of mDCF in Combination or Not With Atezolizumab in Advanced Squamous Cell Anal Carcinoma	NCT03519295	Anal Cancer	MPDL3280A mDCF	18 Years -	GERCOR - Multidisciplinary Oncology Cooperative Group
A Study of mDCF in Combination or Not With Atezolizumab in Advanced Squamous Cell Anal Carcinoma	NCT03519295	Anal Cancer	MPDL3280A mDCF	18 Years -	GERCOR - Multidisciplinary Oncology Cooperative Group

Spots Global Cancer Trial Database for epidermoid cancers of the anal canal