OncoMatch/Clinical Trials/NCT04894370
Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma
Is NCT04894370 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sample collection for squamous cell anal carcinoma.
Treatment: Sample collection — 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
Check if I qualifyExtracted eligibility criteria
Disease stage
Metastatic disease required
Histologically proven metastatic or locally advanced recurrent squamous cell carcinoma of anus (SCCA)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: cytotoxic, biologic or other systemic anticancer therapy (including investigational)
Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment
Cannot have received: radiation therapy for bone metastasis
Radiation therapy for bone metastasis within 2 weeks
Cannot have received: radiation therapy (other)
any other radiation therapy within 4 weeks before first dose of study treatment
Cannot have received: systemic treatment with radionuclides
Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment
Lab requirements
Blood counts
ANC ≥ 1500/mm3 without G-CSF support; WBC ≥ 2500/mm3; Platelets ≥ 100,000/mm3 without transfusion; Hemoglobin ≥ 9 g/dL
Kidney function
Calculated creatinine clearance ≥ 60 mL/min (using the MDRD formula); Urine protein/creatinine ratio (UPCR) ≤ 1 g/g
Liver function
ALT, AST ≤ 3 x 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
Cardiac function
Elevated Cardiac troponin T (cTnT) or cardiac troponin I (cTnI) elevation > 2x ULN [excluded]; clinically significant active heart disease or myocardial infarction within 6 months [excluded]
Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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