Penile Cancer

VWH--particularly those with low CD4 counts, detectable HIV viral loads, or history of condyloma--are at increased risk of penile cancer, suggesting the penile cancer prevention activities are needed in this population.

P1, N=11, Completed, University Medical Center Groningen | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> Apr 2024

P1/2, N=107, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2025

Herein, we add to the sparce literature regarding tumor gene characteristics of rare GU malignancies. MDR testing appears to be a useful adjunct in postoperative rare GU malignancy surveillance. MDR may anticipate recurrence or progression compared to standard techniques and correlation with response to systemic therapy.

P1, N=90, Completed, Shanghai Bovax Biotechnology Co., Ltd. | Recruiting --> Completed | Trial completion date: Sep 2024 --> Nov 2023 | Trial primary completion date: Sep 2024 --> Nov 2023

P2, N=27, Not yet recruiting, The Netherlands Cancer Institute

P=N/A, N=60, Recruiting, Oslo University Hospital | Trial primary completion date: Jun 2024 --> Jun 2025

P1/2, N=150, Active, not recruiting, Transgene | Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

P=N/A, N=20, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2026

No abstract available

A higher APOBEC mutational fraction was found in HPV+ versus HPV- PDX tissues (p = 0.044), and significant transcriptomic and proteomic expression differences based on HPV status included p16 (CDKN2A), RRM2, and CDC25C. These models will allow for the direct testing of targeted therapies in PSCC and determine their response in correlation to HPV status.

P2, N=37, Completed, Latin American Cooperative Oncology Group | Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Nov 2023

Our data shows that tumor-informed serum ctDNA levels are concordant with surveillance imaging and pathologic staging for PUC and pSCC. Monitoring serial ctDNA results may characterize treatment response and disease progression better than conventional methods which can help tailor patient specific therapy and improve outcomes.

PDL-1 immunoexpression in PSC appears to be associated with high-risk features and worse clinical outcomes. It is noteworthy the clinical significance of lymph node involvement in PD-L1+ cases and the considerable difference in the overall survival between the two groups. This is in line with the current literature, although we didn’t find any studies with this string correlation with lymph node involvement.

P2, N=269, Completed, UNICANCER | Active, not recruiting --> Completed

1. Ours is the first study to demonstrate that SP263 and E3L1N can reliably be used to evaluate PD-L1 in PCs as there is good concordance with the reference clone 22C3. 2.

P2, N=100, Active, not recruiting, Dana-Farber Cancer Institute | Trial primary completion date: Dec 2023 --> Dec 2024

P2, N=112, Active, not recruiting, UNICANCER | Trial completion date: Oct 2024 --> Jan 2025

P2, N=224, Recruiting, National Cancer Institute (NCI) | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025

P2, N=24, Recruiting, University Health Network, Toronto | Trial completion date: Jun 2023 --> Dec 2024 | Trial primary completion date: Jun 2023 --> Jun 2024

This is the first report of penile cancer with BRCA2 mutation, receiving a combination treatment with olaparib and experiencing a benefit for 9 months. This case underscores the pivotal role of BRCA2 in influencing treatment response in PSCC, providing valuable insights into the application of targeted therapies in managing recurrent PSCC with BRCA2 alterations. This elucidation establishes a crucial foundation for further research and clinical considerations in similar cases.

P1, N=11, Active, not recruiting, University Medical Center Groningen | Recruiting --> Active, not recruiting

P1/2, N=32, Completed, University of Southampton | Active, not recruiting --> Completed

P1, N=32, Recruiting, HRYZ Biotech Co. | Not yet recruiting --> Recruiting

We identified that expanded clonotypes were predominantly in the CD8 + T cell compartment, which presented with an exhausted phenotype. Overall, we comprehensively compared TCR repertoire between penile tumor and normal tissues and demonstrated the presence of distinct T cell immune microenvironments in patients with PSCC.

We observed an increase in the density of immune effector cells in node-negative tumors and a progressive rise in inhibitory immune players such as type 2 macrophages and upregulation of the PD-L1 checkpoint in men with N1 and N2-3 disease. There were no differences in immune cell densities with HPV status.

P1, N=100, Recruiting, TScan Therapeutics, Inc. | Initiation date: Nov 2023 --> Feb 2024

Only two cases were MSI high. The results support the hypothesis of two aetiological pathways in pSCC cancerogenesis: (1) SCC linked to HPV infection characterised by low TMB, less common PD-L1 expression, and a lower number of TILs; and (2) SCC linked to chronic inflammation leading to a high number of acquired mutations (high TMB), HPV negativity, increased neoantigen production (i.e., PD-L1), and high immune cell infiltration.

P2, N=37, Recruiting, UNICANCER

P2, N=28, Recruiting, Mayo Clinic | Not yet recruiting --> Recruiting

Our study shows that the SPP1 gene might be an effective biomarker for predicting the prognosis and the efficacy of immunotherapy in PSCC patients.

P1, N=32, Active, not recruiting, Baylor College of Medicine | Trial primary completion date: Oct 2023 --> Oct 2024

P3, N=200, Recruiting, Institute of Cancer Research, United Kingdom | Trial completion date: Aug 2025 --> May 2026

P2, N=818, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2024 --> May 2026 | Trial primary completion date: Oct 2024 --> May 2026

P1, N=74, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024

He was treated with adjuvant TIP (paclitaxel, ifosfamide, and cisplatin) with subsequent ctDNA clearance. Our data suggests that a personalized, tumor-informed ctDNA assay is not only useful for MRD monitoring, but also highly predictive of treatment response and imaging-based progression in patients with penile SCC. In our sample, MRD status correlated with both radiographic progression and clinical outcomes. Prospective studies are needed to better understand how ctDNA can be used to guide neoadjuvant and adjuvant approaches, including treatment intensification or de-escalation, in patients with penile SCC.

This translational study demonstrated that molecular alterations in mPC in developing countries are similar to those in patients from developed countries. Predictive biomarkers for immunotherapy, such as TMB high or MSI, were not identified in this study cohort. Specific gene mutations may identify patients with worse prognoses and open new avenues for therapeutic development.

P2, N=60, Not yet recruiting, National Cancer Institute (NCI)

ROC analysis of a single (miR-376a-2-5p), paired (miR-376a-2-5p, miR-551b-3p) or combination of five miRDEs (miR-99a-5p, miR-150-5p, miR-155-5p, let-7c-5p, miR-342-3p) showed robust discriminatory power (AUC = 0.9; P = 0.0114, for each). Strikingly, miR-376a-2-5p exhibited the highest values of sensitivity and specificity, with 100% and 83.3%, respectively, indicating this miRNA as a potential prognostic marker in hrHPV-penile carcinogenesis.

P1/2, N=39, Active, not recruiting, National Cancer Institute (NCI) | N=20 --> 39 | Trial completion date: Oct 2023 --> Nov 2025

Our study suggests that Her-2 is an available therapeutic biomarker for PSCC. Her-2-targeted ADC might have the potential to improve clinical outcomes in high-risk Her-2-positive advanced PSCC patients and provide precious second-line clinical choice for appropriate cisplatin-based chemoresistance patients.

High expression of TROP2 and nectin-4 in pSCC support evaluation of these markers as therapeutic targets pending validation of our findings.