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Squamous Cell Anal CarcinomaPhase 2SPARTANANCT04894370

Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma

A Phase 2 study testing Sample collection in people with Squamous Cell Anal Carcinoma and Metastatic Squamous Cell Carcinoma, run by Centre Hospitalier Universitaire de Besancon at 4 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study evaluates the feasibility of the combination of radiotherapy, chemotherapies (docetaxel, cisplatin and 5-fluorouracil) and spartalizumab (anti-PD-1 therapy) in patients with metastatic squamous cell anal carcinoma Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sample collection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
4 sitesFrance
Study dates
9 Jun 2022to Jan 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 metastatic or locally advanced recurrent squamous cell carcinoma of anus (SCCA)
  • Presence of a evaluable lesion on CT-scan/MRI assessed by RECIST v1.1 criteria,
  • Patient eligible to the mDCF regimen
  • CT scan performed within 30 days prior inclusion,
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  • PET scan performed within 30 days prior inclusion
  • Life expectancy ≥12 months,
  • Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment:
  • Absolute neutrophil count (ANC) ≥ 1500/mm3 (≥ 1.5 GI/L) without granulocyte colony-stimulating factor support.
  • White blood cell count ≥ 2500/mm3 (≥ 2.5 GI/L).
  • Platelets ≥ 100,000/mm3 (≥ 100 GI/L) without transfusion.
  • Hemoglobin ≥ 9 g/dL (≥ 90 g/L).
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN), or ≤ 5 x ULN with documented liver metastases.
  • Total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert's disease ≤ 3 x ULN).
  • Serum albumin ≥ 2.8 g/dl.
  • Calculated creatinine clearance ≥ 60 mL/min (using the MDRD formula):
  • Urine protein/creatinine ratio (UPCR) ≤ 1 g/g
  • Signed and dated informed consent, to participate indicating that the subject has understood the purpose and the procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions inherent in this study
  • Patient affiliated to or beneficiary of French social security system
  • Ability to comply with the study protocol, in the Investigator's judgment

Who cannot join

  • HIV positive patient , CD4 count < 400 cells/mm3 (HIV test mandatory before inclusion)
  • Diagnosis of additional malignancy within 2 years prior to the inclusion with the exception for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy,
  • 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,
  • Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment,
  • Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible,
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  • 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,
  • Patient under guardianship, curatorship or under the protection of justice.
  • Inability to perform radiotherapy
  • Untreated or symptomatic central nervous system (CNS) lesion. However, patients are eligible if: a) all known CNS lesions have been treated with radiotherapy or surgery and b) patient remained without evidence of CNS disease progression ≥ 4 weeks after treatment and c) patients must be off corticosteroid therapy for ≥ 2 weeks
  • Use of hematopoietic colony-stimulating growth factors (e.g. G-CSF, GMCSF, M-CSF), thrombopoietin mimetics or erythroid stimulating agents ≤ 2 weeks prior start of study treatment. If erythroid stimulating agents were initiated more than 2 weeks prior to the first dose of study treatment and the patient is on a stable dose, they can be maintained.
  • Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment
  • Elevated Cardiac troponin T (cTnT) or cardiac troponin I (cTnI) elevation > 2x ULN
  • Systemic chronic steroid therapy (> 10mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date of first dose of study treatment.
  • Note: Topical, inhaled, nasal and ophthalmic steroids are allowed. For patients with adrenal insufficiency, replacement dose of prednisone > 10 mg/ day or equivalent are permitted
  • Active, known or suspected autoimmune disease or a documented history of autoimmune disease Note: Patients with vitiligo, controlled type I diabetes mellitus on stable insulin dose, residual autoimmune-related hypothyroidism only requiring hormone replacement or psoriasis not requiring systemic treatment are permitted.
  • Allogenic bone marrow or solid organ transplant
  • History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction
  • Pre-existing neuropathy, hearing problem, or cardiorespiratory pathology, which prevent the administration of cisplatin.
  • clinically significant active heart disease or myocardial infarction within 6 months
  • recent or concomitant treatment with brivudine
  • persistent toxicities related to prior treatment of grade greater than 1
  • History or current interstitial lung disease or non-infectious pneumonitis
  • History of major surgery within 28 days before treatment
  • Active infection
  • Active Hepatitis B infection (HBsAg positive)
  • Active hepatitis C (HCV RNA positive)
  • Pregnant or nursing (lactating) women confirmed by a positive hCG laboratory test within 72 hours prior to initiating study treatment.
  • Note: Low levels of hCG may also be considered a tumor marker, therefore if low hCG levels are detected, another blood sample at least 4 days later must be taken to assess the kinetics of the increase and transvaginal ultrasound must be performed to rule out pregnancy.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 7.5 months after stopping treatment with Spartalizumab.
  • Complete or partial deficit in dihydropyrimidine dehydrogenase (DPD) activity
  • Active inflammatory bowel disease Note: In case of a history of inflammatory bowel disease, it is advisable to take the advice of the referring gastroenterologist of the patient to ensure the absence of the evolution of inflammatory bowel disease (inflammatory thrust in progress) before the initiation of docetaxel treatment

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Centre Hospitalier Universitaire de Besançon

    Besançon, 25000

  • Centre Georges-François Leclerc (CGFL)

    Dijon

  • Centre Léon Bérard

    Lyon, 69000

  • Hôpital Nord Franche Comté

    Montbéliard

Other trials in France

About this study

Official title: Spartalizumab, mDCF (Docetaxel, Cisplatin and 5-fluorouracil) and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma. A Phase IIA Study

This study evaluates the feasibility of the combination of radiotherapy, chemotherapies (docetaxel, cisplatin and 5-fluorouracil) and spartalizumab (anti-PD-1 therapy) in patients with metastatic squamous cell anal carcinoma

Read the detailed description

In SCCA (squamous cell carcinoma of anus) about 15% of patients are diagnosed in metastatic stage, and around 25-40% of patients will experience disease progression after curative intent chemoradiotherapy (CRT) for localized disease. In patients with non-resectable local recurrences or with distant metastases, the systemic chemotherapy is the standard approach. Recently, taxane-based combination chemotherapy regimens have demonstrated high efficacy or better tolerance than non-taxane based regimens, and became standards based in prospective trials. First, the modified DCF (docetaxel, cisplatin and 5-fluorouracil) showed a high efficacy in Epitopes-HPV02 trial conducted by investigators including 66 patients and became the first validated chemotherapy regimen in advanced SCCA. Then, the pooled analysis of 115 patients confirmed the mDCF regimen as the standard treatment in all fit patients with advanced SCCA.

The combination of different chemotherapy regimens and an anti-PD1/PD-L1 (Programmed cell Death-1/Programmed cell Death-Ligand1) were feasible with improved survival in first-line advanced small-cell and non-small-cell lung cancers. In anal carcinoma, Epitopes-HPV02 trial showed that mDCF regimen was feasible with 53% of grade 3-4 adverse-event, with no grade 4 non-hematological toxicity and no febrile neutropenia. And also considering its property to enhance the anti-tumor immune response, mDCF was recommended as an interesting candidate to be evaluated as a backbone chemotherapy for immunotherapy combinations in SCCA.

In anal carcinoma, investigators are currently conducting a randomized prospective trial promoted by GERCOR (cooperator group) evaluating the association of mDCF and an anti-PD-L1 in metastatic setting. All patients (100) were already enrolled, and no particular safety alert signal was observed at the Data Safety Monitoring Board (DSMB)..

Among different factors that confers a primary resistance to immunotherapy, the lack of antigenic proteins capable to induce immune response, and the downregulation of major histocompatibility complex class 1 (MHC-1) are probably the most important. In fact, the next-generation sequencing (NGS) techniques has demonstrated the correlation between tumor mutation burden (TMB) and response to CKI (checkpoint Inhibitor). Hence, most of "hot" tumors with high TMB could be treated with CKI alone, while "cold" tumors probably need combination strategies. Besides, primary or secondary resistances to CKI caused by downregulation of MHC-1 are well described.

Radiation causes random point mutations and double-stranded breaks in the DNA and modulates the peptide repertoire, increasing tumour-related antigens and TMB to enhance anti-tumour immunity. Radiotherapy has also demonstrated to enhances MHC class I expression.

Investigators decided to associate radiotherapy, PD-1 (Programmed cell Death-1) inhibitor and mDCF (docetaxel, cisplatin and 5-fluorouracil) chemotherapy regimen to improve the efficacy with higher rate of long-lasting progression-free survivors and complete remissions. In addition, the associated extensive ancillary biomarker studies in tissues and peripheral blood will provide a unique opportunity to find out the potential synergic effect mechanism between mDCF, CKI and radiotherapy, as well as to improve our knowledge about underlying resistances.

Being tested
Sample collection
Keywords
immunotherapy, chemotherapy, radiotherapy, anti-PD1
Medical subject headings
Anus Neoplasms, Carcinoma, Squamous Cell

What participants receive

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

  • Sample collectionBiological

    PBMC collection at baseline, after radiotherapy 8 Gy (gray), at 6 months and at 12 months from inclusion: 6 EDTA tubes of 6 ml of peripheral blood mononuclear cell [PBMC] will be sent to the central laboratory (Biomonitoring Platform of Besançon, CHRU de Besançon located at Etablissement Français du Sang) at room temperature within 24 hours via an approved carrier for their processing, storage and immunomonitoring analysis. A sending sheet of the samples will be attached to each single sample.

    Plasma collection at baseline, after radiotherapy 8 Gy, at 6 months and at 12 months from inclusion: One 6 ml EDTA tube should be frozen in each investigation center for plasma collection.

    Plasma for circulating tumoral DNA (ctDNA) collection at baseline, at 2, 6 and 12 months from inclusion: two EDTA tube of 4 ml should be frozen in each investigation center for ctDNA collection.

Study groups in NCT04894370
Study groupRoleWhat they receive
ExperimentalExperimentalPhase 1: Radiotherapy (8 Gy on target lesions) Phase 2: Combination immunotherapy and mDCF regimen mDCF regimen every 2 weeks for 8 cycles * Docetaxel (40 mg/m², day 1), * Cisplatin (40 mg/m², day 1) * 5-FU (1200 mg/m²/day for 2 days) Spartalizumab: 400 mg intravenous will be administrated every 4 weeks Phase 3 : Multimodal treatment of residual disease The multimodal treatment is recommended in oligometastatic anal cancer. The support by ablative treatment (surgery, hypofractionnated radiotherapy or by radiofrequency) improve survival. In absence of progression disease: * Ablative treatment: surgery, hypofractionnated radiotherapy or by radiofrequency of residual metastases * and Chemo-radiotherapy (CRT) for local disease Phase 4: Maintenance treatment with Spartalizumab 400 mg intravenous every 4 weeks for 12 months from enrolment maximum
Receives: Biological: Sample collection

What is being measured

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

  1. Progression-Free Survival (PFS) rate at 1 year.

    PFS rate at 1 year is defined as the number of patients alive without progression at 1 year divided by the overall number of patients evaluable for PFS status at 1 year.

    A patient is evaluable for PFS status at 1 year if he dies during the 1 year of follow up or if he is alive with a RECIST evaluation available at 1 year.

    Measured: 12 months from enrollment

Secondary outcomes (3)

  1. Objective response rate (ORR)

    Addition of complete response (CR) and partial response (PR) rates.

    Measured: 12 months from enrollment

  2. Overall survival (OS)

    Delay from the date of inclusion to death from any cause , or the date of the last follow-up, at which point data will be censored

    Measured: through study completion, an average of 3 years

  3. Progression-Free Survival (PFS) median.

    Delay from the date of inclusion to the disease progression or death from any cause, whichever occurs first , or the date of the last follow-up, at which point data will be censored

    Measured: through study completion, an average of 3 years

Timeline

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

  1. First posted20 May 2021
  2. Study start9 Jun 2022
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2028 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04894370
Sponsor's protocol ID
2020/538
Acronym
SPARTANA
Status last verified
Nov 2026
First submitted
17 May 2021
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim S, Francois E, Andre T, Samalin E, Jary M, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouche O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, De La Fouchardiere C, Smith D, Deberne M, Spehner L, Badet N, Adotevi O, Anota A, Meurisse A, Vernerey D, Taieb J, Vendrely V, Buecher B, Borg C. Docetaxel, cisplatin, and fluorouracil chemotherapy for metastatic or unresectable locally recurrent anal squamous cell carcinoma (Epitopes-HPV02): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2018 Aug;19(8):1094-1106. doi: 10.1016/S1470-2045(18)30321-8. Epub 2018 Jul 2.

    PubMed 30042063

  • Kim S, Meurisse A, Spehner L, Stouvenot M, Francois E, Buecher B, Andre T, Samalin E, Jary M, Nguyen T, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouche O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, de la Fouchardiere C, Boulbair F, Lakkis Z, Klajer E, Jacquin M, Taieb J, Vendrely V, Vernerey D, Borg C. Pooled analysis of 115 patients from updated data of Epitopes-HPV01 and Epitopes-HPV02 studies in first-line advanced anal squamous cell carcinoma. Ther Adv Med Oncol. 2020 Dec 4;12:1758835920975356. doi: 10.1177/1758835920975356. eCollection 2020.

    PubMed 33329760

  • 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 Sample collection in people with Squamous Cell Anal Carcinoma and Metastatic Squamous Cell Carcinoma, run by Centre Hospitalier Universitaire de Besancon at 4 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 21 inclusion and 32 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

This study is still under way. Results are not available in the source record yet.

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 (PFS) rate at 1 year. (time frame: 12 months from enrollment). 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 NCT04894370, which also lists 3 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 4 Nov 2026.

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