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Anal CancerPhase 2SCARCENCT03519295

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

A Phase 2 study testing MPDL3280A and mDCF in people with Anal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 31 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anal Cancer
What is being tested?
MPDL3280A and mDCF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
31 sitesFrance
Study dates
3 Jul 2018to 20 Sep 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
  • CT scan performed within 28 days prior inclusion,
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  • PET scan performed within 28 days prior inclusion,
  • 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.

Who cannot join

  • 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)
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  • 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,
  • Current participation in a study of an investigational agent or in the period of exclusion,
  • 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,
  • HIV positive with CD4 count under 400 cells/mm3 (VIH test is mandatory before inclusion),
  • 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),
  • Active tuberculosis,
  • Concomitant treatment with CYP3A4 inhibitor like ritonavir, indinavir, or ketoconazole, etc. Replacement by another drug before randomization, whenever is possible, is allowed,
  • Known hypersensitivity or contraindication to any of the study chemotherapy drugs (taxanes, cisplatin, 5FU), according with the SmPC of each drug
  • Uncontrolled infection or another life-risk condition,
  • Known hearing impairment that contraindicates cisplatin administration,
  • Administration of a live (attenuated) vaccine within 28 days of planned start of study therapy of known need for this vaccine during treatment,
  • Administration of prophylactic phenytoin,
  • Inadequate laboratory values: creatinine clearance (CrCl by Modification of Diet in Renal Disease [MDRD] formula) <60 ml/min, neutrophil count <1500 /mm3, platelets <100000/mm3, bilirubin 2.5 x upper limit of normal (ULN), aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 x ULN or 5 x ULN with liver metastasis.
  • Patient with known dihydropyridine dehydrogenase (DPD) deficiency or history of severe and unexpected reactions to a fluoropyrimidine-containing regimen, or in case of clinically significant active heart disease or myocardial infarction within 6 months or if patient treated with sorivudine or its clinically related analogues, such as brivudine
  • Non-eligible to immunotherapy:
  • Any immunosuppressive therapy (i.e. corticosteroids >10mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study therapy,
  • Active autoimmune disease that has required a systemic treatment in past 2 years (i.e. corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin) is allowed.
  • Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, (see Annex 7 for a more comprehensive list of autoimmune diseases and immune deficiencies) with the following exceptions:
  • Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study,
  • Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study,
  • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
  • Rash must cover < 10% of body surface area,
  • Disease is well controlled at baseline and requires only low-potency topical corticosteroids,
  • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months,
  • Prior allogeneic bone marrow transplantation or prior solid organ transplantation,
  • Known active central nervous system metastases and/or carcinomatous meningitis. Subject with previously treated brain metastases and with radiological and clinical stability are allowed,
  • Previously received an anti-PD1, anti-PDL1, or anti-CTLA4 agent,
  • Known hypersensitivity or allergy to Chinese hamster ovary cell products or any component of atezolizumab formulation,
  • History of colorectal inflammatory disease,
  • History of idiopathic or secondary pulmonary fibrosis (history of radiation pneumonitis in the radiation field fibrosis is permitted), or evidence of active pneumonitis requiring a systemic treatment with 28 days before the planned start of study therapy,
  • Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study,
  • Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia,
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

France31 sites

  • Clinique de l'Europe

    Amiens

  • Institut Sainte Catherine

    Avignon

  • CHRU Jean Minjoz

    Besançon, 25000

  • CHU Bordeaux - Hôpital Haut Lévêque

    Bordeaux

  • Centre François Baclesse

    Caen

  • Hôpitaux Civils de Colmar

    Colmar

  • Clinique des Cèdres

    Cornebarrieu

  • GHPSO Creil

    Creil

  • Centre Georges François Leclerc

    Dijon

  • Institut Hospitalier Franco-Britannique

    Levallois-Perret

  • Centre Oscar Lambert

    Lille

  • Centre Léon Bérard

    Lyon

  • Hôpital Jean Mermoz

    Lyon

  • CHU Timone

    Marseille

  • Hopital Montbéliard

    Montbéliard

  • ICM Val d'Aurelle

    Montpellier

  • CHU Nantes

    Nantes

  • Centre Antoine Lacassagne

    Nice

  • Hôpital Saint Antoine

    Paris, 7514

  • Groupe Hospitalier Diaconesses Crois Saint Simon

    Paris

  • Groupe Hospitalier Saint Joseph

    Paris

  • Hôpital Européen Georges Pompidou

    Paris

  • Hôpital Henri Mondor

    Paris

  • Hôpital saint Louis

    Paris

  • Insitut Curie

    Paris

  • Centre CARIO

    Plérin

  • CHU Poitiers

    Poitiers

  • CHU Robert Debré Reims

    Reims

  • CH Saint Quentin

    Saint-Quentin

  • Centre Paul Strauss

    Strasbourg

  • CHU Tours

    Tours

Other trials in France

About this study

Official title: 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

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.

Read the detailed description

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.

Conditions
Anal Cancer
Being tested
MPDL3280A, mDCF
Keywords
Epidermoid Cancers of the Anal Canal
Medical subject headings
Anus Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MPDL3280ADrug

    Also called atezolizumab

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

  • mDCFDrug

    Also called modified docetaxel, cisplatin, and fluorouracil

    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

Study groups in NCT03519295
Study groupRoleWhat they receive
ARM A - mDCF + AtezolizumabExperimental* 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
Receives: Drug: MPDL3280A; Drug: mDCF
ARM B - mDCFActive comparatorPatients 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.
Receives: Drug: mDCF

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: at 12 months

Secondary outcomes (5)

  1. 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.

    Measured: within 3 years after the initiation of the treatment

  2. 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

    Measured: within 3 years after the initiation of the treatment

  3. Quality of life related to heath

    EORTC-QLQ-C30

    Measured: From the randomization to patient death or for maximum 3 years

  4. Objective response rate (ORR)

    Evaluated by RECIST criteria version 1.1

    Measured: within 3 years after the initiation of the treatment

  5. 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

    Measured: within 3 years after the initiation of the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2018
  2. Study start3 Jul 2018
  3. Primary completion7 Feb 2023
  4. Study completion20 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03519295
Sponsor's protocol ID
SCARCE C17-02
Acronym
SCARCE
Status last verified
Jun 2025
First submitted
26 Apr 2018
Last updated
27 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38547895

  • 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.

    PubMed 32334548

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MPDL3280A and mDCF in people with Anal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 31 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival rate (PFS) (time frame: at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03519295, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.

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