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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Immunomonitoring and Biomarker Research in Patients With Squamous Cell Anal Carcinoma

Clinicaltrials.gov identifier NCT03942900

Recruitment Status Not yet recruiting

First Posted May 8, 2019

Last update posted January 31, 2020

Study Description

Brief summary:

Even if squamous cell carcinoma of the anal canal (SCCA) is a rare disease, its incidence increases worldwide. SCCA is mostly induced by Human papillomavirus (HPV) infections and HPV-related oncoproteins (E6 and E7) are expressed in more than 90% of SCCA. T stage and N stage are recognized prognostic factors for local and/or distant recurrence in SCCA patients treated by chemoradiotherapy. In fact, ≥T3 or ≥N1 anal cancers are associated with as high as 50% of disease recurrence rate at 2 years. The University Hospital of Besançon with the Gercor conducted a prospective clinical trial (Epitopes HPV02 study) including 69 advanced SCCA patients and established a new standard of care based on Docetaxel, Cisplatin and 5-FU (5-FluoroUracil) chemotherapy (DCF). Among 69 patients treated with DCF regimen, 66 patients were evaluable for efficacy end-points. The objective response rate was 86% including 44% of complete response, and 47% of patients were progression-free at 12 months of follow-up from the first cycle of DCF treatment. Thus, the "Epitopes-HPV02" trial has demonstrated a high response rate of the DCF regimen with a higher than expected 12 months progression-free survival rate.These results raised the hypothesis of DCF being an immunogenic chemotherapy and in that demonstrating a possibly new role of taxane-based chemotherapy in SCCA patients. More than 50% of patients in complete remission had a detectable immunological response against peptides derived from HPV oncoproteins (E6 or E7) or from the telomerase antigen (which is transactivated by E6). LAND study will enroll patients with locally advanced SCCA enrolled in OPTIMANAL clinical trial. OPTIMANAL study will assess the feasibility and efficacy to combine nivolumab to mDCF chemotherapy, followed by the standard chemo-radiotherapy, in high risk locally advanced SCCA patients with T3/T4 N1a or N1b/N1c disease. LAND study is an exploratory translational study, which will analyze the biological mechanisms of action and our ability to track the immune responses against HPV and telomerase. The investigator group will take advantage of the presence of HPV antigens in most patients 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-PD1 (Programmed Death-1), and to identify valuable biomarkers of treatment efficacy.

  • Condition or Disease:Anal Canal Cancer
  • Intervention/Treatment: Other: Additional biological samples
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 59 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Immunomonitoring and Biomarker Research Based on Tumor and Blood Samples in Patients With Squamous Cell Anal Carcinoma
  • Estimated Study Start Date: April 2020
  • Estimated Primary Completion Date: September 2023
  • Estimated Study Completion Date: April 2024
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Cohort LAND
Patients enrolled in OPTIMANAL clinical trial
Other: Additional biological samples
Biomonitoring blood sample will be collected: 6 EDTA tubes (6 mL) for PBMC (peripheral blood mononucleated cell), 1 EDTA tube (6 mL) for plasma freezing and 2 EDTA tubes (4 mL) for ctDNA: at baseline, at first tumor assessment (phase 2 in OPTIMANAL study), at second tumor assessment (phase 4 in OPTIMANAL study), at end-point visit. A tumor biopsy or archived tumor sample will be mandatory at baseline.
Outcome Measures
  • Primary Outcome Measures: 1. Peripheral CD4 anti-telomerase immunity and MDSC (Myeloid-Derived Suppressor Cells) analysis [ Time Frame: 24 months ]
    Correlation of both peripheral CD4 anti-telomerase immunity and MDSC with progression-free survival.
  • Biospecimen Retention: Samples With DNA

    - A tumor biopsy or archived tumor sample will be mandatory at baseline. Tumor samples will be collected for HPV, p53 testing and translational research. - Biomonitoring blood sample will be collected: 6 EDTA (ethylenediaminetetraacetic acid) tubes (6 mL) for PBMC, 1 EDTA tube (6 mL) for plasma freezing and 2 EDTA tubes (4 mL) for circulating tumor DNA (ctDNA): - at baseline, - at first tumor assessment (phase 2 in OPTIMANAL study), - at second tumor assessment (phase 4 in OPTIMANAL study), - at end-point visit

Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Probability Sample
  • Study Population: Patients with locally advanced squamous cell anal carcinoma enrolled in OPTIMANAL clinical trial, and given consent for LAND-translational study
Criteria

Inclusion Criteria:

1. Male or female, age ≥18 years,

2. Patients enrolled in OPTIMANAL trial

3. Signed and dated informed consent for LAND-translational study

4. Histologically proved squamous cell anal carcinoma.

Exclusion Criteria:

1. Patient with any medical or psychiatric condition or disease, which would make the
patient inappropriate for entry into this study,

2. Patient under guardianship, curators or under the protection of justice.

Contacts and Locations
Contacts

Contact: Stefano KIM, Dr 0381668166 stefanokim@gmail.com

Contact: Christophe BORG, Pr 0381668166 christophe.borg@efs.sante.fr

Locations

France
Centre Hospitalier Universitaire de Besançon
Besançon

France
Hôpital Nord Franche-Comté
Montbéliard

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

Study Director: Christophe BORG, Pr CHU Besançon

More Information