Table 4.

Ongoing clinical trials using immune checkpoint inhibitors in penile cancer, from ClinicalTrials.gov (11/07/2020)

Trial/drug	Phase	Setting	Intervention	Primary endpoint
Alpaca (NCT03391479)/avelumab	Phase II	Locally advanced or metastatic, after progression or unfit for chemotherapy	Avelumab alone	Objective response rate
Pulse (NCT03774901)/avelumab	Phase II	Advanced disease. Maintenance therapy	Maintenance avelumab after chemotherapy	Progression-free survival
Pericles(NCT03686332)/atezolizumab	Phase II	Arm A: Locally advanced (inoperable) Arm B: Metastatic	Arm A: atezolizumab + radiotherapy Arm B: atezolizumab	Progression-free survival at 1 year
Hercules (NCT04224740)/pembrolizumab	Phase II	Advanced disease first-line therapy	Pembrolizumab + standard-of-care chemotherapy	Overall response rate at week 24
NCT02496208/cabozantinib + nivolumab ± ipilimumab	Phase I	Metastatic genitourinary tumors (non-prostate)	Cabozantinib + nivolumab ± ipilimumab	Recommended phase II dose and incidence of adverse events
NCT03866382/cabozantinib + nivolumab + ipilimumab	Phase II	Metastatic rare genitourinary tumors	Cabozantinib + nivolumab + ipilimumab	Objective response rate
NCT04475016/TIP + nimotuzumab + triprilimab	Phase II	Locally advanced disease	TIP + nimotuzumab + triprilimab	Percentage of patients with pathological complete response
NCT03439085/durvalumab + MEDI0457	Phase II	Recurrent or metastatic HPV-related solid tumors	Durvalumab + MEDI0457	Anti-tumor activity
NCT03357757/avelumab + valproic Acid	Phase II	p16-positive squamous cell carcinoma	Avelumab + valproic Acid	Clinical response