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CANCER:

Penile Cancer

7d
A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males (clinicaltrials.gov)
P3, N=9000, Active, not recruiting, Shanghai Bovax Biotechnology Co., Ltd. | Recruiting --> Active, not recruiting
Enrollment closed
15d
HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA (clinicaltrials.gov)
P1, N=32, Active, not recruiting, Baylor College of Medicine | Trial primary completion date: Oct 2024 --> Oct 2025
Trial primary completion date
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Opdivo (nivolumab) • cyclophosphamide • fludarabine IV
15d
Nectin-4 Positivity in Genitourinary Malignancies: A Systematic Review. (PubMed, JCO Precis Oncol)
Non-UC malignancies seem to have a lower N4 positivity rate than UC. N4 positivity in bladder cancer appears to vary according to stage and presence of HS. The predictive and prognostic role of N4 must be further characterized in larger and prospective studies.
Review • Journal
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NECTIN4 (Nectin Cell Adhesion Molecule 4)
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NECTIN4 expression
20d
Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma (clinicaltrials.gov)
P2, N=25, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Oct 2026 --> Nov 2027 | Trial primary completion date: Oct 2025 --> Nov 2026
Trial completion date • Trial primary completion date
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Zejula (niraparib) • Jemperli (dostarlimab-gxly)
21d
Identification of new tissue markers for the monitoring and standardization of penile cancer according to the degree of differentiation. (PubMed, Histol Histopathol)
The findings suggest a differential expression of molecules according to the degree of cell differentiation, with a higher differential expression of molecules according to the degree of cell differentiation, suggesting that the proteins studied could have predictive value. The study highlights the complexity of PSCC and the need for future studies to explore translational applications and search for new biomarkers to improve clinical management and understanding of this disease.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • RB1 (RB Transcriptional Corepressor 1) • CCND1 (Cyclin D1) • CDK4 (Cyclin-dependent kinase 4) • CTNNB1 (Catenin (cadherin-associated protein), beta 1) • NLRP3 (NLR Family Pyrin Domain Containing 3) • AIF1 (Allograft Inflammatory Factor 1)
21d
Gene Expression Profiling of the Peritumoral Immune Cell Infiltrate of Penile Squamous Cell Carcinomas. (PubMed, Int J Mol Sci)
Among these cases, the genes GZMA, MICB, and GNLY were significantly upregulated, suggesting their involvement in an increased immune response. The role of HPV infection status in our cases with regard to the peritumoral immune cell infiltrate remains inconclusive.
Journal • Immune cell
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KIT (KIT proto-oncogene, receptor tyrosine kinase) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • CD68 (CD68 Molecule) • IRF4 (Interferon regulatory factor 4) • GZMA (Granzyme A) • MICB (MHC Class I Polypeptide-Related Sequence B)
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nCounter® PanCancer Immune Profiling Panel
24d
Defining the Clinical Potential of Mass Response As a Biomarker for Patient Tumor Sensitivity to Drugs (clinicaltrials.gov)
P=N/A, N=0, Withdrawn, Travera Inc | N=630 --> 0 | Not yet recruiting --> Withdrawn
Enrollment change • Trial withdrawal
30d
Systematic comparison of fluorescence imaging in the near-infrared and shortwave-infrared spectral range using clinical tumor samples containing cetuximab-IRDye800CW. (PubMed, J Biomed Opt)
Background fluorescence in the SWIR region, resulting in a higher background signal, limits SWIR imaging in HNSCC samples. However, SWIR shows potential in increasing the contrast of tumor borders in PSCC samples, as shown by a higher aCNR over a line.
Clinical • Journal
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EGF (Epidermal growth factor)
1m
Human Papillomavirus (HPV) Genotypes in Mixed Squamous Cell Carcinoma of the Penis: A Study of 101 Tumors. (PubMed, Int J Surg Pathol)
Apparently, the presence of a non-HPV component in an otherwise typical HPV-associated type tumor does adversely affect the prevalence of HPV positivity. Any amount of HPV-associated morphology superior to 20% in a mixed tumor is sufficient to classify them as HPV-associated, a WHO requirement.
Journal
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CDKN2A (Cyclin Dependent Kinase Inhibitor 2A)
1m
New P2 trial • Metastases
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cisplatin • albumin-bound paclitaxel • cyclophosphamide • ifosfamide
2ms
GSTM1 and GSTT1 deletions in penile cancer are associated with TNM stage but not with HPV DNA status. (PubMed, Pathol Res Pract)
These findings indicate that GSTT1 and GSTM1 deletions are common in HPV+ and HPV- penile cancers. GSTM1 deletions in the presence of wild-type GSTT1 seems to be associated with tumor progression, and additional studies are warranted to confirm its potential as a prognostic marker in penile cancer.
Journal
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GSTM1 (Glutathione S-transferase mu 1) • GSTT1 (Glutathione S-transferase theta 1)
2ms
Human papillomavirus (HPV) and Epstein-Barr virus (EBV) in Penile Cancer in Thailand. (PubMed, Asian Pac J Cancer Prev)
One-third of penile cancer patients were positive for HPV-induced p16INK4A expression and there was a trend toward better survival in HPV-positive patients. EBV infection was infrequent in penile cancer in Thailand.
Journal
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CDKN2A (Cyclin Dependent Kinase Inhibitor 2A)
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CDKN2A overexpression
2ms
Elevated Microsatellite Alterations at Selected Tetranucleotide Repeats (EMAST) in Penile Squamous Cell Carcinoma-No Evidence for a Role in Carcinogenesis. (PubMed, Curr Oncol)
Furthermore, these findings are in full agreement with our previous study showing a very low frequency of MSI and further support the thesis that EMAST and MSI are strongly interconnected forms of genomic instability. Further research is needed to explore novel therapeutic targets and predictive biomarkers for immunotherapy in this patient population.
Journal • Tumor mutational burden • IO biomarker
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • MSH3 (MutS Homolog 3) • MYCL (MYCL Proto-Oncogene BHLH Transcription Factor)
2ms
Pseudomyogenic hemangioendothelioma presenting as a penile lesion. (PubMed, Virchows Arch)
Immunohistochemistry demonstrated invariable co-expression of keratins, endothelial markers (CD31 and/or ERG), and FOSB. In conclusion, penile PHE is rare but should be considered in the differential diagnosis of penile lesions with spindle cell and/or rhabdomyoblast-like morphology affecting young to middle-aged adult patients.
Journal
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CD31 (Platelet and endothelial cell adhesion molecule 1) • PECAM1 (Platelet And Endothelial Cell Adhesion Molecule 1)
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CD31 expression
2ms
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=105, Terminated, Incyte Corporation | Trial completion date: Jun 2026 --> Aug 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2026 --> Aug 2024; A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.
Trial completion date • Trial termination • Trial primary completion date • Metastases
2ms
A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy (clinicaltrials.gov)
P2, N=24, Recruiting, University Health Network, Toronto | Trial primary completion date: Jun 2024 --> Dec 2024
Trial primary completion date
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Bavencio (avelumab)
2ms
EARN: Enhanced Assistance During Radiotherapy for Unmet Essential Needs (clinicaltrials.gov)
P=N/A, N=33, Recruiting, Washington University School of Medicine | Not yet recruiting --> Recruiting
Enrollment open
3ms
The impact of the tumor microenvironment on the survival of penile cancer patients. (PubMed, Sci Rep)
After deciphering relevant interdependencies, the HPV + CD147 + CD15 + status was the most potent profile predicting metastasis-free survival of PeCa patients. The results of this report underscore the need for analysis of the TME and the development of multi-parameter composite scores that reflect fundamental cancer-immune relationships to tailor therapeutic interventions based on actual cancer immune dynamics.
Journal
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CXCL8 (Chemokine (C-X-C motif) ligand 8) • DKK1 (dickkopf WNT signaling pathway inhibitor 1) • TP63 (Tumor protein 63) • BSG (Basigin (Ok Blood Group))
3ms
Construction and validation of a prediction model for inguinal lymph node metastasis of penile malignancy. (PubMed, Transl Androl Urol)
Moreover, internal leave-one-way cross-validation was used to construct a nomogram showing consistency, with an AUC of 0.75. The diagnosis of ILNM in penile malignant tumors can be predicted through clinicopathological features, biochemical tests, and prediction models based on tumor markers.
Journal
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IL2 (Interleukin 2) • IL4 (Interleukin 4)
3ms
LncRNA sequencing reveals an essential role for the lncRNA-mediated ceRNA network in penile squamous cell carcinoma. (PubMed, Genes Immun)
Our study identified a lncRNA-miRNA-mRNA ceRNA network for PSCC, revealing possible molecular mechanisms involved in the regulation of PSCC progression by key lncRNAs and their connections to the immunosuppressive tumor microenvironment. The ceRNA network provides a novel perspective for elucidating the pathogenesis of PSCC.
Journal
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TP63 (Tumor protein 63) • PVT1 (Pvt1 Oncogene) • MIAT (Myocardial Infarction Associated Transcript) • MIR205 (MicroRNA 205) • TFAP2A (Transcription Factor AP-2 Alpha) • TFAP2C (Transcription Factor AP-2 Gamma)
4ms
Molecular characterization of metastatic penile squamous cell carcinoma in developing countries and its impact on clinical outcomes: LACOG 2018 translational study. (PubMed, Oncologist)
This study demonstrated that molecular alterations in mPSCC from developing countries are similar to those from developed countries. Predictive biomarkers for immunotherapy response such as TMB high or MSI were not identified. Specific gene mutations may identify patients with worse prognoses and open new avenues for therapeutic development.
Clinical data • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Metastases
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PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • NOTCH1 (Notch 1) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B)
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PD-L1 expression • NOTCH1 mutation • CDKN2B deletion
4ms
EARN: Enhanced Assistance During Radiotherapy for Unmet Essential Needs (clinicaltrials.gov)
P=N/A, N=33, Not yet recruiting, Washington University School of Medicine
New trial
4ms
The first case of Lynch syndrome associated penile cancer harboring a heterozygous PMS2 frameshift variant. (PubMed, Urol Int)
These observations provided evidence suggesting that PSCC could be part of the LS spectrum.
Journal • Tumor mutational burden • MSi-H Biomarker
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • PMS2 (PMS1 protein homolog 2)
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TMB-H • MSI-H/dMMR • PMS2 mutation
4ms
New trial • Surgery
4ms
Penile hemangiosarcoma as a cause of stranguria in a dog: clinical presentation, imaging findings, treatment and outcome. (PubMed, Iran J Vet Res)
The dog was treated with amputation of the penis, scrotal urethrostomy, and five adjuvant doses of doxorubicin along with thalidomide. Penile hemangiosarcoma seems to share the same aggressive behavior with other hemangiosarcomas seen in other anatomical locations. Therefore, surgery and chemotherapy may improve survival time in dogs with penile hemangiosarcoma as well.
Journal
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PECAM1 (Platelet And Endothelial Cell Adhesion Molecule 1)
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doxorubicin hydrochloride • thalidomide
4ms
Expression of CD44highCD24Low cells, SOX2, and STAT3 transcription factors on peripheral blood and tumor tissue of penile squamous cell carcinoma. (PubMed, J Surg Oncol)
CD44, CD24, and SOX2 molecules were markers of advanced disease associated with the worst prognosis in CaPe. However, pSTAT3 and T cells were associated with a more favorable prognosis in this study.
Journal
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STAT3 (Signal Transducer And Activator Of Transcription 3) • SOX2 • CD24 (CD24 Molecule)
4ms
PRIAM: Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer (clinicaltrials.gov)
P2, N=27, Recruiting, The Netherlands Cancer Institute | Not yet recruiting --> Recruiting
Enrollment open • Metastases
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Keytruda (pembrolizumab) • carboplatin • paclitaxel
4ms
SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas (clinicaltrials.gov)
P1, N=18, Recruiting, The Affiliated Hospital of Qingdao University
New P1 trial • Metastases
4ms
First report of a neurofibrosarcoma in the penis of a bull. (PubMed, J Comp Pathol)
Results showed positivity to vimentin, neuron specific enolase, proliferating cell nuclear antigen, S100 and glial fibrillary acidic protein. This suggested that the tumour was a neoplasm of neural origin, classified as neurofibrosarcoma, a peripheral nerve sheath tumour, here reported in the penis of a bull for the first time.
Journal
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VIM (Vimentin) • PCNA (Proliferating cell nuclear antigen) • GFAP (Glial Fibrillary Acidic Protein)
5ms
p53 Immunohistochemistry Defines a Subset of Human Papillomavirus-Independent Penile Squamous Cell Carcinomas With Adverse Prognosis. (PubMed, Am J Surg Pathol)
In conclusion, compared with patients with HPV-associated and HPV-independent/p53-normal PSCC, patients with HPV-independent/p53 abnormal PSCC have worse clinical outcomes. p53 IHC results define 2 prognostic categories in HPV-independent PSCC: HPV-independent/p53-normal tumors as low-risk tumors, whereas HPV-independent/p53-abnormal tumors as aggressive neoplasms.
Journal
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TP53 (Tumor protein P53)
5ms
A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers (clinicaltrials.gov)
P1/2, N=107, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Jun 2024 --> Dec 2025
Trial completion date • Trial primary completion date • Metastases
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PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
|
Jingzhuda (entinostat) • bintrafusp alfa (M7824) • PDS01ADC
5ms
New P1/2 trial
|
cyclophosphamide • fludarabine IV
5ms
A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males (clinicaltrials.gov)
P3, N=9000, Recruiting, Shanghai Bovax Biotechnology Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open
5ms
SWOG S1609: Nivolumab and Ipilimumab in Treating Patients With Rare Tumors (clinicaltrials.gov)
P2, N=818, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: May 2033 --> May 2026 | Trial primary completion date: May 2033 --> May 2026
Trial completion date • Trial primary completion date
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CD4 (CD4 Molecule)
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Opdivo (nivolumab) • Yervoy (ipilimumab) • ABP 206 (nivolumab biosimilar)
5ms
SWOG S1609: Nivolumab and Ipilimumab in Treating Patients With Rare Tumors (clinicaltrials.gov)
P2, N=818, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: May 2026 --> May 2033 | Trial primary completion date: May 2026 --> May 2033
Trial completion date • Trial primary completion date
|
CD4 (CD4 Molecule)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • ABP 206 (nivolumab biosimilar)
5ms
Enrollment change • Trial termination • Metastases
|
CD4 (CD4 Molecule)
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Imfinzi (durvalumab) • MEDI0457
5ms
Characterising Metastatic Penile Cancer Using Molecular Imaging - Hybrid MRI-PET [MRI-PET] (clinicaltrials.gov)
P=N/A, N=107, Completed, Queen Mary University of London | Unknown status --> Completed
Trial completion • Metastases
6ms
Safety, Tolerability and Pharmacokinetics Investigation of Stimotimagene Copolymerplasmid (clinicaltrials.gov)
P1, N=21, Completed, Gene Surgery LLC | Recruiting --> Completed | N=12 --> 21 | Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Dec 2023 --> Apr 2024
Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Metastases
6ms
Immune-based Therapies for Penile Cancer. (PubMed, Urol Clin North Am)
This review supports the use of personalized medicine in treating PSCC. It stresses the need for collaborative studies and data sharing to create specific treatment plans and achieve better outcomes.
Review • Journal • IO biomarker
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PD-L1 (Programmed death ligand 1)
6ms
Bioinformatics Analysis Reveals E6 and E7 of HPV 16 Regulate Metabolic Reprogramming in Cervical Cancer, Head and Neck Cancer, and Colorectal Cancer through the PHD2-VHL-CUL2-ELOC-HIF-1α Axis. (PubMed, Curr Issues Mol Biol)
Here, we propose some miRNAs targeting PHD2, VHL, CUL2, and ELOC mRNAs. The effect of E6 and E7 may be the non-hydroxylation and non-ubiquitination of HIF-1α, which may regulate metabolic processes involved in metabolic reprogramming in cancer upon stabilization, non-degradation, and translocation to the nucleus.
Journal
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HIF1A (Hypoxia inducible factor 1, alpha subunit) • CUL2 (Cullin 2)