Table 3.
Ongoing clinical trials enrolling patients with penile cancer according to population, type of intervention and countries involved
| Identifier | Phase | Diagnosis (planned n) | Intervention | Study dates | Sites | Country |
|---|---|---|---|---|---|---|
| Studies enrolling only patients with penile cancer (n = 8) | ||||||
| NCT03686332 (PERICLES) | II | Unresectable penile carcinoma (32) | Atezolizumab + radiotherapy | 2018–2022 | 1 | Netherlands |
| NCT04475016 | II | Neoadjuvant locally advanced penile carcinoma (29) | Albumin-bound paclitaxel + ifosfamide + cisplatin + nimotuzumab + triprilimab | 2020–2025 | 1 | China |
| NCT04224740 (HERCULES) | II | Advanced penile carcinoma (33) | Pembrolizumab + standard-of-care chemotherapy | 2020–2025 | 4 | Brazil |
| NCT02817958 (AFU-GETUG 25 MEGACEP) | II | Node-positive penile carcinoma eligible to lymph-node dissection (37) | Paclitaxel + ifosfamide + cisplatin | 2016–2022 | 17 | France |
| NCT03391479 | II | Unresectable/metastatic penile carcinoma (24) | Avelumab + best supportive care | 2018–2022 | 1 | Canada |
| NCT03774901 (PULSE) | II | Advanced penile carcinoma after PBT (32) | Avelumab | 2019–2022 | 1 | France |
| NCT04231981 (ORPHEUS) | II | Unresectable/metastatic penile carcinoma (18) | INCMGA0012 | 2020–2022 | 12 | Italy, Spain |
| NCT02305654 (InPACT) | III | Node-positive penile carcinoma (400) | Multi-arm, two randomizations (chemotherapy, lymph-node dissection, radiotherapy) | 2017–2022 | 17 | UK, USA |
| Studies enrolling patients with HPV-associated or virus-associated malignancies, including penile cancer (n = 5) | ||||||
| NCT03427411 | II | HPV-associated cancers (120) | M7824 | 2018–2023 | 1 | USA |
| NCT03439085 | II | HPV-associated cancers (77) | INO-3312 + durvalumab | 2018–2022 | 1 | USA |
| NCT02379520 (HESTIA) | I | HPV-associated cancers (32) | HPV-specific LyT ± (cisplatin + 5-fluorouracil + nivolumab) | 2015–2021 | 1 | USA |
| NCT04180215 | I–II | HPV-16-confirmed cancers (140) | TheraT HPV 16 + vectors | 2019–2022 | 16 | USA |
| NCT03357757 (LATENT) | II | Virus-associated cancers (39) | Valproic acid + avelumab | 2018–2027 | 1 | Canada |
| Studies enrolling patients with advanced malignancies including penile cancer (n = 10) | ||||||
| NCT02496208 | I | Metastatic genitourinary malignancies (152) | Cabozantinib + nivolumab ± ipilimumab | 2015–2021 | 8 | USA |
| NCT03866382 | II | Rare genitourinary malignancies (224) | Cabozantinib + nivolumab ± ipilimumab | 2019–2023 | 525 | USA |
| NCT04357873 (PEVOsq) | II | Progressive advanced mucosal cancers (111) | Pembrolizumab + vorinostat | 2020–2024 | 14 | France |
| NCT02721732 | II | Inoperable or metastatic rare tumours (225) | Pembrolizumab | 2016–2020 | 1 | USA |
| NCT03333616 | II | Advanced rare genitourinary tumours (57) | Nivolumab + ipilimumab | 2017–2025 | 6 | USA |
| NCT02834013 (DART) | II | Rare tumours (818) | Nivolumab + ipilimumab | 2017–2021 | 944 | USA |
| NCT02012699 (iCaRe2) | – | 50 different tumour types, including solid and haematological cancers | Longitudinal database (no intervention) | 2013–2099 | 78 | USA |
| NCT03517488 (DUET-2) | I | Advanced solid tumours (154) | XmAb20217 | 2018–2021 | 17 | USA |
| NCT03221400 | I–II | Advanced solid malignancies (290) | PEN-866 ± 5-fluorouracil | 2017–2022 | 10 | USA |
| NCT02571036 | I | Advanced malignancies (320) | Ripertinib | 2015–2022 | 28 | USA, Austria, Canada, Germany, Italy, Netherlands, Spain, UK |
HPV, human papilloma virus; PBT, proton beam therapy.