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

NCT03519295 | Completed Phase 2 DMC

• 1 other identifier: SCARCE C17-02
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 31

Brief Summary

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.

Conditions

Anal Cancer

Keywords

Epidermoid Cancers of the Anal Canal

Outcome Measures

Primary Outcomes (1)

• 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

  at 12 months

Secondary Outcomes (5)

• Overall Survival (OS)

  within 3 years after the initiation of the treatment

• Progression free survival

  within 3 years after the initiation of the treatment

• Quality of life related to heath

  From the randomization to patient death or for maximum 3 years

• Objective response rate (ORR)

  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

  within 3 years after the initiation of the treatment

Study Arms (2)

ARM A - mDCF + Atezolizumab

EXPERIMENTAL

* 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

Drug: MPDL3280A; Drug: mDCF

ARM B - mDCF

ACTIVE COMPARATOR

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.

Drug: mDCF

Interventions

MPDL3280A DRUG

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

Also known as: atezolizumab

ARM A - mDCF + Atezolizumab

mDCF DRUG

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

Also known as: modified docetaxel, cisplatin, and fluorouracil

ARM A - mDCF + Atezolizumab; ARM B - mDCF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥18 years,
• Performance status Eastern Cooperative Oncology Group World Health Organization (ECOG-WHO) ≤1,
• Histologically proven and unresectable locally advanced recurrent or metastatic squamous cell anal carcinoma,
• Presence of a target lesion on CT-scan assessed by RECIST v1.1 criteria,
• Patient eligible to the mDCF regimen,
• Signed and dated informed consent,
• Patient affiliated to or beneficiary of French social security system,
• Ability to comply with the study protocol, in the Investigator's judgment,
• Life expectancy ≥ 6 months,
• Adequate hematologic and end-organ function.
• Previous concomitant chemoradiotherapy is permitted if completed before 28 days of starting treatment.

You may not qualify if:

• Non-eligibility to clinical trials if one of the following parameter is reported:
• Previously received chemotherapy for metastatic disease,
• Previously received cisplatin except for concomitant chemoradiotherapy,
• Previously received taxanes (paclitaxel or docetaxel) or another spindle poison (navelbine) in the treatment of SCCA,
• Previously received anti-tumor immunotherapy (HPV vaccination is allowed),
• Previous radiotherapy within 28 days of randomization (14 days if radiotherapy of bone metastases)
• Diagnosis of additional malignancy within 3 years prior to the randomization with the exception for curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical or breast cancer,
• Any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study,
• Pregnancy, breast-feeding or absence/refusal of adequate contraception for fertile patients during the period of treatment and for 6 months from the last treatment administration, men must refrain from donating sperm during this same period.
• Patient under guardianship, curatorship or under the protection of justice.
• Non-eligible to chemotherapy:
• Inadequate organ functions: uncontrolled cardiac condition, known cardiac failure, unstable coronaropathy, respiratory failure, and Chronic Obstructive Pulmonary Disease (COPD),
• Diabetes with vascular or neurovascular complications,
• Preexistent peripheral neuropathy or impaired audition,
• Active hepatitis B or C virus (HBV or HCV) infection (chronic or acute), (Defined as having a positive HBV surface antigen (HBsAg) test at screening. Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total HBV core antibody (HBcAb) test at screening, are eligible for the study. HCV infection, defined as having a positive HCV antibody test followed by a positive HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test),

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead
• Roche Pharma AG: collaborator

Study Sites (31)

Clinique de l'Europe

Amiens, France

Location

Institut Sainte Catherine

Avignon, France

Location

CHRU Jean Minjoz

Besançon, 25000, France

Location

CHU Bordeaux - Hôpital Haut Lévêque

Bordeaux, France

Location

Centre François Baclesse

Caen, France

Location

Hôpitaux Civils de Colmar

Colmar, France

Location

Clinique des Cèdres

Cornebarrieu, France

Location

GHPSO Creil

Creil, France

Location

Centre Georges François Leclerc

Dijon, France

Location

Institut Hospitalier Franco-Britannique

Levallois-Perret, France

Location

Centre Oscar Lambert

Lille, France

Location

Centre Léon Bérard

Lyon, France

Location

Hôpital Jean Mermoz

Lyon, France

Location

CHU Timone

Marseille, France

Location

Hopital Montbéliard

Montbéliard, France

Location

ICM Val d'Aurelle

Montpellier, France

Location

CHU Nantes

Nantes, France

Location

Centre Antoine Lacassagne

Nice, France

Location

Hôpital Saint Antoine

Paris, 7514, France

Location

Groupe Hospitalier Diaconesses Crois Saint Simon

Paris, France

Location

Groupe Hospitalier Saint Joseph

Paris, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Hôpital Henri Mondor

Paris, France

Location

Hôpital saint Louis

Paris, France

Location

Insitut Curie

Paris, France

Location

Centre CARIO

Plérin, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Robert Debré Reims

Reims, France

Location

CH Saint Quentin

Saint-Quentin, France

Location

Centre Paul Strauss

Strasbourg, France

Location

CHU Tours

Tours, France

Location

Related Publications (2)

• Kim S, Ghiringhelli F, de la Fouchardiere C, Evesque L, Smith D, Badet N, Samalin E, Lopez-Trabada Ataz D, Parzy A, Desrame J, Baba Hamed N, Buecher B, Tougeron D, Bouche O, Dahan L, Chibaudel B, El Hajbi F, Mineur L, Dubreuil O, Ben Abdelghani M, Pecout S, Bibeau F, Herfs M, Garcia ML, Meurisse A, Vernerey D, Taieb J, Borg C. Atezolizumab plus modified docetaxel, cisplatin, and fluorouracil as first-line treatment for advanced anal cancer (SCARCE C17-02 PRODIGE 60): a randomised, non-comparative, phase 2 study. Lancet Oncol. 2024 Apr;25(4):518-528. doi: 10.1016/S1470-2045(24)00081-0.

  PMID: 38547895 DERIVED

• Kim S, Buecher B, Andre T, Jary M, Bidard FC, Ghiringhelli F, Francois E, Taieb J, Smith D, de la Fouchardiere C, Desrame J, Samalin E, Parzy A, Baba-Hamed N, Bouche O, Tougeron D, Dahan L, El Hajbi F, Jacquin M, Rebucci-Peixoto M, Spehner L, Vendrely V, Vernerey D, Borg C. Atezolizumab plus modified docetaxel-cisplatin-5-fluorouracil (mDCF) regimen versus mDCF in patients with metastatic or unresectable locally advanced recurrent anal squamous cell carcinoma: a randomized, non-comparative phase II SCARCE GERCOR trial. BMC Cancer. 2020 Apr 25;20(1):352. doi: 10.1186/s12885-020-06841-1.

  PMID: 32334548 DERIVED

MeSH Terms

Conditions

Anus Neoplasms

Interventions

atezolizumab; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stefano KIM, MD

  University Hospital of Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 8, 2018
• Study Start: July 3, 2018
• Primary Completion: February 7, 2023
• Study Completion: September 20, 2023
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (31)