Anal carcinoma - exploring the epidemiology, risk factors, pathophysiology, diagnosis, and treatment

Table 5 Ongoing clinical trials investigating the use of anti-programmed cell death-1 agents in anal squamous cell carcinoma

NCT number	Official title	Interventions	Study type	Phase	Status	Location
NCT04719988	Ezabenlimab (BI 754091) and mDCF (Docetaxel, Cisplatin, and 5-fluorouracil) Followed by Chemoradiotherapy in Patients With Stage III Squamous Cell Anal Carcinoma. A Phase II Study	Biological: Blood sample collection	Interventional	Phase 2	Active	France
		Procedure: Biopsy
NCT04894370	Spartalizumab, mDCF (Docetaxel, Cisplatin, and 5-fluorouracil) and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma. A Phase IIA Study	Biological: Sample collection	Interventional	Phase 2	Recruiting	France
NCT04708470	A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers	Drug: Bintrafusp Alfa	Interventional	Phases 1 and 2	Recruiting	United States
		Drug: NHS-IL12
		Drug: Entinostat
NCT04432597	Phase I/II Trial of HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PD-L1/TGF-Beta Trap (M7824) in Subjects With HPV-Positive Cancers	Biological: PRGN-2009 (Phase I)	Interventional	Phases 1 and 2	Active	United States
		Biological: PRGN-2009 (Phase II)
		Biological: M7824
		Diagnostic test: MRI
		Diagnostic test: Bone scan
		Diagnostic test: CT scan
		Diagnostic test: Brain CT
		Diagnostic test: Brain MRI
		Procedure: Biopsy (Phase I)
		Procedure: Biopsy (Phase II)
NCT05544929	A Phase I, Open-label, Multicenter Study of KFA115 as a Single Agent and in Combination With Pembrolizumab in Patients With Select Advanced Cancers	Drug: KFA115	Interventional	Phase 1	Recruiting	United States
		Drug: Pembrolizumab
NCT04357873	Phase II Basket Trial Evaluating the Efficacy of a Combination of Pembrolizumab and Vorinostat in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma	Drug: Pembrolizumab; vorinostat	Interventional	Phase 2	Active	France
NCT04802876	Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors Defined by a Single and Pre-specified Cutoff	Drug: Spartalizumab	Interventional	Phase 2	Recruiting	Spain
		Drug: Tislelizumab

CT: Computed tomography; HPV: Human papillomavirus; mDCF: Modified DCF regimen; MRI: Magnetic resonance imaging; PD1: Programmed cell death 1; PD-L1: Programmed cell death ligand 1; TGF: Transforming growth factor.