Actively Recruiting
Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma
Led by Centre Hospitalier Universitaire de Besancon · Updated on 2023-12-22
34
Participants Needed
5
Research Sites
229 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Besancon
Lead Sponsor
N
National Cancer Institute, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically confirmed metastatic or locally advanced recurrent squamous cell carcinoma of the anus
- Presence of at least one measurable lesion on CT or MRI scans according to RECIST v1.1 criteria
- Eligible for treatment with the modified DCF chemotherapy regimen
- CT scan performed within 30 days before study inclusion
- PET scan performed within 30 days before study inclusion
- Life expectancy of at least 12 months
- Adequate organ function as shown by laboratory tests within 14 days before starting treatment, including specified blood counts and liver and kidney function
- Signed informed consent agreeing to participate and comply with study requirements
- Affiliated with or beneficiary of the French social security system
- Ability to follow the study protocol as judged by the investigator
You will not qualify if you...
- HIV positive with CD4 count less than 400 cells/mm3
- Diagnosis of another cancer within 2 years before inclusion except for certain low-risk or treated skin cancers or tumors
- Any medical or psychiatric condition making participation inappropriate
- Current participation in another investigational study or within exclusion period
- Receipt of any cytotoxic, biologic, or systemic anticancer therapy within 4 weeks before starting study treatment
- Radiation therapy for bone metastasis within 2 weeks or other radiation within 4 weeks before treatment; unresolved complications from prior radiation
- Pregnancy, breastfeeding, or unwillingness to use effective contraception during and for 6 months after treatment
- Under legal guardianship or protection
- Inability to receive radiotherapy
- Untreated or symptomatic central nervous system lesions unless treated and stable as specified
- Use of certain growth factors or immunosuppressive therapies within specified timeframes before treatment
- Use of live vaccines within 4 weeks before treatment
- Elevated cardiac troponin levels above twice the normal limit
- Systemic steroid or immunosuppressive therapy exceeding defined doses within 7 days before treatment
- Active or history of autoimmune disease except controlled conditions noted
- History of bone marrow or solid organ transplant
- History of severe allergic reaction to monoclonal antibodies
- Pre-existing neuropathy, hearing, or heart/lung conditions preventing cisplatin use
- Recent heart attack or significant heart disease
- Recent or ongoing treatment with brivudine
- Persistent toxicities from prior treatments above grade 1
- History or current interstitial lung disease or non-infectious pneumonitis
- Major surgery within 28 days before treatment
- Active infection
- Active Hepatitis B or C infection
- Positive pregnancy test within 72 hours before treatment
- Women of childbearing potential not using highly effective contraception during and for 7.5 months after spartalizumab treatment
- Complete or partial deficiency in dihydropyrimidine dehydrogenase (DPD) activity
- Active inflammatory bowel disease or active inflammation if history present
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Centre Hospitalier Universitaire de Besançon
Besançon, France, 25000
Actively Recruiting
2
Centre Georges-François Leclerc (CGFL)
Dijon, France
Actively Recruiting
3
Hôpital Franco-Britannique
Levallois-Perret, France
Withdrawn
4
Centre Léon Bérard
Lyon, France, 69000
Withdrawn
5
Hôpital Nord Franche Comté
Montbéliard, France
Actively Recruiting
Research Team
S
Stefano KIM, Pr
CONTACT
C
Christophe BORG, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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