RecruitingPhase 2NCT04894370

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

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


Sponsor

Centre Hospitalier Universitaire de Besancon

Enrollment

34 participants

Start Date

Jun 9, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of spartalizumab (an immunotherapy drug), chemotherapy (mDCF: modified docetaxel, cisplatin, and fluorouracil), and radiation therapy in patients with metastatic or locally advanced recurring squamous cell cancer of the anus. **You may be eligible if...** - You are 18 or older with a confirmed metastatic or locally recurrent squamous cell carcinoma of the anus - You have good performance status (ECOG ≤1) - You have measurable disease on imaging - You are eligible for the chemotherapy regimen used in this trial (mDCF) - You have adequate organ function - You are affiliated with the French social security system **You may NOT be eligible if...** - You are HIV-positive with a low CD4 count (below 400 cells/mm³) - You have another active cancer (diagnosed within 2 years, with limited exceptions) - You have received anti-cancer treatment in the past 4 weeks - You are pregnant or breastfeeding - You have active autoimmune disease, active serious infections, or inflammatory bowel disease - You have significant heart disease or neuropathy that prevents cisplatin use - You have active hepatitis B or C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSample collection

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.


Locations(5)

Centre Hospitalier Universitaire de Besançon

Besançon, France

Centre Georges-François Leclerc (CGFL)

Dijon, France

Hôpital Franco-Britannique

Levallois-Perret, France

Centre Léon Bérard

Lyon, France

Hôpital Nord Franche Comté

Montbéliard, France

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NCT04894370


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