Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sample collection · 1 trial · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| Experimental | EXPERIMENTAL | Phase 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 |
| Name | Type | Description |
|---|---|---|
| Sample collection | BIOLOGICAL | 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. |
Inclusion Criteria: 1. Male or female, aged ≥18 years, 2. Performance status Eastern Cooperative Oncology Group World Health Organization (ECOG-WHO) ≤1, 3. Histologically proven metastatic or locally advanced recurrent squamous cell carcinoma of anus (SCCA) 4. Presence of a evaluable lesion on CT-s...