Penile cancer: options by country

In clinical trials

• Surgery; radiation therapy; chemotherapy; palliative surgery/radiation; phase I/II clinical trials of new drugs, biological therapy, or surgical techniquesClinical trialClinical trialReported in a clinical trialUnited States · HPV association discussed as disease biology context; no biomarker-required systemic therapy recorded from fetched source; Stage 0-IV penile cancer; stage III/IV clinical-trial context; stage IV palliative context. · NCI PDQ is an evidence summary, not a regulator/payer source. No U.S. FDA-approved penile-cancer-specific systemic therapy was verified in this cycle. Immunotherapy is recorded as a treatment type under clinical-trial/testing context, not as a penile-cancer-specific approval. Confidence/conflicts: High for U.S. treatment framework; FDA-approved systemic options remain source-pending. National Cancer Institute (NCI) — national cancer agency evidence summary
• Surgery; radiation therapy; chemotherapy; palliative surgery/radiation; phase I/II clinical trials of new drugs, biological therapy, or surgical techniquesClinical trialClinical trialReported in a clinical trialUnited States · HPV association discussed as disease biology context; no biomarker-required systemic therapy recorded from fetched source; Stage 0-IV penile cancer; stage III/IV clinical-trial context; stage IV palliative context. · NCI PDQ is an evidence summary, not a regulator/payer source. No U.S. FDA-approved penile-cancer-specific systemic therapy was verified in this cycle. Immunotherapy is recorded as a treatment type under clinical-trial/testing context, not as a penile-cancer-specific approval. Confidence/conflicts: High for U.S. treatment framework; FDA-approved systemic options remain source-pending. National Cancer Institute (NCI) — national cancer agency evidence summary
• Surgery; radiation therapy; chemotherapy; palliative surgery/radiation; phase I/II clinical trials of new drugs, biological therapy, or surgical techniquesClinical trialClinical trialReported in a clinical trialUnited States · HPV association discussed as disease biology context; no biomarker-required systemic therapy recorded from fetched source; Stage 0-IV penile cancer; stage III/IV clinical-trial context; stage IV palliative context. · NCI PDQ is an evidence summary, not a regulator/payer source. No U.S. FDA-approved penile-cancer-specific systemic therapy was verified in this cycle. Immunotherapy is recorded as a treatment type under clinical-trial/testing context, not as a penile-cancer-specific approval. Confidence/conflicts: High for U.S. treatment framework; FDA-approved systemic options remain source-pending. National Cancer Institute (NCI) — national cancer agency evidence summary
• Surgery; radiation therapy; chemotherapy; palliative surgery/radiation; phase I/II clinical trials of new drugs, biological therapy, or surgical techniquesClinical trialClinical trialReported in a clinical trialUnited States · HPV association discussed as disease biology context; no biomarker-required systemic therapy recorded from fetched source; Stage 0-IV penile cancer; stage III/IV clinical-trial context; stage IV palliative context. · NCI PDQ is an evidence summary, not a regulator/payer source. No U.S. FDA-approved penile-cancer-specific systemic therapy was verified in this cycle. Immunotherapy is recorded as a treatment type under clinical-trial/testing context, not as a penile-cancer-specific approval. Confidence/conflicts: High for U.S. treatment framework; FDA-approved systemic options remain source-pending. National Cancer Institute (NCI) — national cancer agency evidence summary
• Surgery; radiation therapy; chemotherapy; palliative surgery/radiation; phase I/II clinical trials of new drugs, biological therapy, or surgical techniquesClinical trialClinical trialReported in a clinical trialUnited States · HPV association discussed as disease biology context; no biomarker-required systemic therapy recorded from fetched source; Stage 0-IV penile cancer; stage III/IV clinical-trial context; stage IV palliative context. · NCI PDQ is an evidence summary, not a regulator/payer source. No U.S. FDA-approved penile-cancer-specific systemic therapy was verified in this cycle. Immunotherapy is recorded as a treatment type under clinical-trial/testing context, not as a penile-cancer-specific approval. Confidence/conflicts: High for U.S. treatment framework; FDA-approved systemic options remain source-pending. National Cancer Institute (NCI) — national cancer agency evidence summary
• Surgery; radiation therapy; chemotherapy; palliative surgery/radiation; phase I/II clinical trials of new drugs, biological therapy, or surgical techniquesClinical trialClinical trialReported in a clinical trialUnited States · HPV association discussed as disease biology context; no biomarker-required systemic therapy recorded from fetched source; Stage 0-IV penile cancer; stage III/IV clinical-trial context; stage IV palliative context. · NCI PDQ is an evidence summary, not a regulator/payer source. No U.S. FDA-approved penile-cancer-specific systemic therapy was verified in this cycle. Immunotherapy is recorded as a treatment type under clinical-trial/testing context, not as a penile-cancer-specific approval. Confidence/conflicts: High for U.S. treatment framework; FDA-approved systemic options remain source-pending. National Cancer Institute (NCI) — national cancer agency evidence summary
• Topical therapy; laser ablation; excisional surgery; external beam radiotherapy; brachytherapy; surgery; chemotherapy; clinical trialsClinical trialClinical trialInvestigationalEuropean Union · No biomarker requirement stated in fetched EAU guideline page; Small/localized penile cancer local treatment; broader diagnosis/staging/treatment/follow-up guideline context. · EAU/ESMO are guideline sources, not EMA regulator approval pages. No EMA-approved penile-cancer-specific systemic therapy was verified in this cycle. Country-specific reimbursement in Germany/France remains unresolved. Confidence/conflicts: High for European guideline framework; regulator approvals and reimbursement remain active gaps. European Association of Urology (EAU) — professional guideline
• Topical therapy; laser ablation; excisional surgery; external beam radiotherapy; brachytherapy; surgery; chemotherapy; clinical trialsClinical trialClinical trialInvestigationalEuropean Union · No biomarker requirement stated in fetched EAU guideline page; Small/localized penile cancer local treatment; broader diagnosis/staging/treatment/follow-up guideline context. · EAU/ESMO are guideline sources, not EMA regulator approval pages. No EMA-approved penile-cancer-specific systemic therapy was verified in this cycle. Country-specific reimbursement in Germany/France remains unresolved. Confidence/conflicts: High for European guideline framework; regulator approvals and reimbursement remain active gaps. European Association of Urology (EAU) — professional guideline
• Topical therapy; laser ablation; excisional surgery; external beam radiotherapy; brachytherapy; surgery; chemotherapy; clinical trialsClinical trialClinical trialInvestigationalEuropean Union · No biomarker requirement stated in fetched EAU guideline page; Small/localized penile cancer local treatment; broader diagnosis/staging/treatment/follow-up guideline context. · EAU/ESMO are guideline sources, not EMA regulator approval pages. No EMA-approved penile-cancer-specific systemic therapy was verified in this cycle. Country-specific reimbursement in Germany/France remains unresolved. Confidence/conflicts: High for European guideline framework; regulator approvals and reimbursement remain active gaps. European Association of Urology (EAU) — professional guideline
• Topical therapy; laser ablation; excisional surgery; external beam radiotherapy; brachytherapy; surgery; chemotherapy; clinical trialsClinical trialClinical trialInvestigationalEuropean Union · No biomarker requirement stated in fetched EAU guideline page; Small/localized penile cancer local treatment; broader diagnosis/staging/treatment/follow-up guideline context. · EAU/ESMO are guideline sources, not EMA regulator approval pages. No EMA-approved penile-cancer-specific systemic therapy was verified in this cycle. Country-specific reimbursement in Germany/France remains unresolved. Confidence/conflicts: High for European guideline framework; regulator approvals and reimbursement remain active gaps. European Association of Urology (EAU) — professional guideline
• Topical therapy; laser ablation; excisional surgery; external beam radiotherapy; brachytherapy; surgery; chemotherapy; clinical trialsClinical trialClinical trialInvestigationalEuropean Union · No biomarker requirement stated in fetched EAU guideline page; Small/localized penile cancer local treatment; broader diagnosis/staging/treatment/follow-up guideline context. · EAU/ESMO are guideline sources, not EMA regulator approval pages. No EMA-approved penile-cancer-specific systemic therapy was verified in this cycle. Country-specific reimbursement in Germany/France remains unresolved. Confidence/conflicts: High for European guideline framework; regulator approvals and reimbursement remain active gaps. European Association of Urology (EAU) — professional guideline
• Paclitaxel + ifosfamide + cisplatin (TIP) plus toripalimab/triplizumab; albumin-paclitaxel with ifosfamide and cisplatin; becotatug vedotin plus pucotenlimab; albumin-bound paclitaxel + ifosfamide + cisplatin + nimotuzumab + triprilimab; HRYZ-T101 injection or HRYZ-T101 TCR-T cell with fludarabine + cyclophosphamide; MRG003 plus HX008; QL1706 plus lenvatinib; ivonescimab broad advanced-tumor cohort noted as a newly discovered China gap pending direct fetchClinical trial · NCT06415318Clinical trialTrial only (registry)China · EGFR-positive for the MRG003 + HX008 study; HPV18-positive for HRYZ-T101 studies; otherwise not biomarker-selected in the fetched registry text; Neoadjuvant locally advanced penile cancer for TIP plus toripalimab/triplizumab, becotatug vedotin plus pucotenlimab, and TIP plus nimotuzumab plus triprilimab; rare advanced tumors including penile cancer for albumin-paclitaxel/ifosfamide/cisplatin; HPV18-positive solid tumors including carcinoma of penis for HRYZ-T101; first-line EGFR-positive locally advanced or metastatic penile squamous cell carcinoma for MRG003 plus HX008; previously treated penile cancer for QL1706 plus lenvatinib. · Registry statuses vary: recruiting, not yet recruiting, completed, and unknown. Several records are basket or multi-cohort studies rather than penile-cancer-only trials. Registry text does not prove regulatory approval or access outside the named study sites. Confidence/conflicts: High that the fetched registry records support China-site investigational options in the listed settings; no NMPA approval claim is made. Ivonescimab NCT06683846 was surfaced in registry search as a China penile-cancer-relevant broad advanced-tumor study but is held as a gap until directly fetched for this disease cell. reimbursement not established in this jurisdiction trial-registry listing only — does not establish approval, reimbursement, or eligibility ClinicalTrials.gov — clinical-trial registry
• Paclitaxel + ifosfamide + cisplatin (TIP) plus toripalimab/triplizumab; albumin-paclitaxel with ifosfamide and cisplatin; becotatug vedotin plus pucotenlimab; albumin-bound paclitaxel + ifosfamide + cisplatin + nimotuzumab + triprilimab; HRYZ-T101 injection or HRYZ-T101 TCR-T cell with fludarabine + cyclophosphamide; MRG003 plus HX008; QL1706 plus lenvatinib; ivonescimab broad advanced-tumor cohort noted as a newly discovered China gap pending direct fetchClinical trial · NCT06415318Clinical trialTrial only (registry)China · EGFR-positive for the MRG003 + HX008 study; HPV18-positive for HRYZ-T101 studies; otherwise not biomarker-selected in the fetched registry text; Neoadjuvant locally advanced penile cancer for TIP plus toripalimab/triplizumab, becotatug vedotin plus pucotenlimab, and TIP plus nimotuzumab plus triprilimab; rare advanced tumors including penile cancer for albumin-paclitaxel/ifosfamide/cisplatin; HPV18-positive solid tumors including carcinoma of penis for HRYZ-T101; first-line EGFR-positive locally advanced or metastatic penile squamous cell carcinoma for MRG003 plus HX008; previously treated penile cancer for QL1706 plus lenvatinib. · Registry statuses vary: recruiting, not yet recruiting, completed, and unknown. Several records are basket or multi-cohort studies rather than penile-cancer-only trials. Registry text does not prove regulatory approval or access outside the named study sites. Confidence/conflicts: High that the fetched registry records support China-site investigational options in the listed settings; no NMPA approval claim is made. Ivonescimab NCT06683846 was surfaced in registry search as a China penile-cancer-relevant broad advanced-tumor study but is held as a gap until directly fetched for this disease cell. reimbursement not established in this jurisdiction trial-registry listing only — does not establish approval, reimbursement, or eligibility ClinicalTrials.gov — clinical-trial registry
• Paclitaxel + ifosfamide + cisplatin (TIP) plus toripalimab/triplizumab; albumin-paclitaxel with ifosfamide and cisplatin; becotatug vedotin plus pucotenlimab; albumin-bound paclitaxel + ifosfamide + cisplatin + nimotuzumab + triprilimab; HRYZ-T101 injection or HRYZ-T101 TCR-T cell with fludarabine + cyclophosphamide; MRG003 plus HX008; QL1706 plus lenvatinib; ivonescimab broad advanced-tumor cohort noted as a newly discovered China gap pending direct fetchClinical trial · NCT06415318Clinical trialTrial only (registry)China · EGFR-positive for the MRG003 + HX008 study; HPV18-positive for HRYZ-T101 studies; otherwise not biomarker-selected in the fetched registry text; Neoadjuvant locally advanced penile cancer for TIP plus toripalimab/triplizumab, becotatug vedotin plus pucotenlimab, and TIP plus nimotuzumab plus triprilimab; rare advanced tumors including penile cancer for albumin-paclitaxel/ifosfamide/cisplatin; HPV18-positive solid tumors including carcinoma of penis for HRYZ-T101; first-line EGFR-positive locally advanced or metastatic penile squamous cell carcinoma for MRG003 plus HX008; previously treated penile cancer for QL1706 plus lenvatinib. · Registry statuses vary: recruiting, not yet recruiting, completed, and unknown. Several records are basket or multi-cohort studies rather than penile-cancer-only trials. Registry text does not prove regulatory approval or access outside the named study sites. Confidence/conflicts: High that the fetched registry records support China-site investigational options in the listed settings; no NMPA approval claim is made. Ivonescimab NCT06683846 was surfaced in registry search as a China penile-cancer-relevant broad advanced-tumor study but is held as a gap until directly fetched for this disease cell. reimbursement not established in this jurisdiction trial-registry listing only — does not establish approval, reimbursement, or eligibility ClinicalTrials.gov — clinical-trial registry
• Paclitaxel + ifosfamide + cisplatin (TIP) plus toripalimab/triplizumab; albumin-paclitaxel with ifosfamide and cisplatin; becotatug vedotin plus pucotenlimab; albumin-bound paclitaxel + ifosfamide + cisplatin + nimotuzumab + triprilimab; HRYZ-T101 injection or HRYZ-T101 TCR-T cell with fludarabine + cyclophosphamide; MRG003 plus HX008; QL1706 plus lenvatinib; ivonescimab broad advanced-tumor cohort noted as a newly discovered China gap pending direct fetchClinical trial · NCT06415318Clinical trialTrial only (registry)China · EGFR-positive for the MRG003 + HX008 study; HPV18-positive for HRYZ-T101 studies; otherwise not biomarker-selected in the fetched registry text; Neoadjuvant locally advanced penile cancer for TIP plus toripalimab/triplizumab, becotatug vedotin plus pucotenlimab, and TIP plus nimotuzumab plus triprilimab; rare advanced tumors including penile cancer for albumin-paclitaxel/ifosfamide/cisplatin; HPV18-positive solid tumors including carcinoma of penis for HRYZ-T101; first-line EGFR-positive locally advanced or metastatic penile squamous cell carcinoma for MRG003 plus HX008; previously treated penile cancer for QL1706 plus lenvatinib. · Registry statuses vary: recruiting, not yet recruiting, completed, and unknown. Several records are basket or multi-cohort studies rather than penile-cancer-only trials. Registry text does not prove regulatory approval or access outside the named study sites. Confidence/conflicts: High that the fetched registry records support China-site investigational options in the listed settings; no NMPA approval claim is made. Ivonescimab NCT06683846 was surfaced in registry search as a China penile-cancer-relevant broad advanced-tumor study but is held as a gap until directly fetched for this disease cell. reimbursement not established in this jurisdiction trial-registry listing only — does not establish approval, reimbursement, or eligibility ClinicalTrials.gov — clinical-trial registry
• Paclitaxel + ifosfamide + cisplatin (TIP) plus toripalimab/triplizumab; albumin-paclitaxel with ifosfamide and cisplatin; becotatug vedotin plus pucotenlimab; albumin-bound paclitaxel + ifosfamide + cisplatin + nimotuzumab + triprilimab; HRYZ-T101 injection or HRYZ-T101 TCR-T cell with fludarabine + cyclophosphamide; MRG003 plus HX008; QL1706 plus lenvatinib; ivonescimab broad advanced-tumor cohort noted as a newly discovered China gap pending direct fetchClinical trial · NCT06415318Clinical trialTrial only (registry)China · EGFR-positive for the MRG003 + HX008 study; HPV18-positive for HRYZ-T101 studies; otherwise not biomarker-selected in the fetched registry text; Neoadjuvant locally advanced penile cancer for TIP plus toripalimab/triplizumab, becotatug vedotin plus pucotenlimab, and TIP plus nimotuzumab plus triprilimab; rare advanced tumors including penile cancer for albumin-paclitaxel/ifosfamide/cisplatin; HPV18-positive solid tumors including carcinoma of penis for HRYZ-T101; first-line EGFR-positive locally advanced or metastatic penile squamous cell carcinoma for MRG003 plus HX008; previously treated penile cancer for QL1706 plus lenvatinib. · Registry statuses vary: recruiting, not yet recruiting, completed, and unknown. Several records are basket or multi-cohort studies rather than penile-cancer-only trials. Registry text does not prove regulatory approval or access outside the named study sites. Confidence/conflicts: High that the fetched registry records support China-site investigational options in the listed settings; no NMPA approval claim is made. Ivonescimab NCT06683846 was surfaced in registry search as a China penile-cancer-relevant broad advanced-tumor study but is held as a gap until directly fetched for this disease cell. reimbursement not established in this jurisdiction trial-registry listing only — does not establish approval, reimbursement, or eligibility ClinicalTrials.gov — clinical-trial registry
• Stimotimagene copolymerplasmid plus ganciclovirClinical trial · NCT05578820Clinical trialTrial only (registry)Russia · Phase 1 safety, tolerability, and pharmacokinetics investigation in multiple tumor types including penile neoplasms. · The trial is completed and broad across several cancers. The registry text does not state a penile-cancer-specific cohort result, standard-of-care role, or active availability. Confidence/conflicts: Medium-high for the existence of a Russia-site broad tumor-type registry cell including penile neoplasms; low for penile-specific treatment relevance beyond investigational context. No regulator approval claim is made. reimbursement not established in this jurisdiction trial-registry listing only — does not establish approval, reimbursement, or eligibility ClinicalTrials.gov — clinical-trial registry
• Stimotimagene copolymerplasmid plus ganciclovirClinical trial · NCT05578820Clinical trialTrial only (registry)Russia · Phase 1 safety, tolerability, and pharmacokinetics investigation in multiple tumor types including penile neoplasms. · The trial is completed and broad across several cancers. The registry text does not state a penile-cancer-specific cohort result, standard-of-care role, or active availability. Confidence/conflicts: Medium-high for the existence of a Russia-site broad tumor-type registry cell including penile neoplasms; low for penile-specific treatment relevance beyond investigational context. No regulator approval claim is made. reimbursement not established in this jurisdiction trial-registry listing only — does not establish approval, reimbursement, or eligibility ClinicalTrials.gov — clinical-trial registry
• Stimotimagene copolymerplasmid plus ganciclovirClinical trial · NCT05578820Clinical trialTrial only (registry)Russia · Phase 1 safety, tolerability, and pharmacokinetics investigation in multiple tumor types including penile neoplasms. · The trial is completed and broad across several cancers. The registry text does not state a penile-cancer-specific cohort result, standard-of-care role, or active availability. Confidence/conflicts: Medium-high for the existence of a Russia-site broad tumor-type registry cell including penile neoplasms; low for penile-specific treatment relevance beyond investigational context. No regulator approval claim is made. reimbursement not established in this jurisdiction trial-registry listing only — does not establish approval, reimbursement, or eligibility ClinicalTrials.gov — clinical-trial registry
• Pembrolizumab; platinum-based therapy plus pembrolizumab investigational contextClinical trialClinical trialInvestigationalMSI-H status may identify a responsive case in the fetched pembrolizumab case-series source; no broad biomarker claim made; Advanced penile SCC investigational systemic therapy context. · This is not a regulator approval, guideline recommendation, or availability claim. It should only be cataloged as an option to discuss in trial/biomarker context; no superiority or routine access implied. Confidence/conflicts: Medium; evidence is case-series/investigational and not a jurisdictional approval. Peer-reviewed literature / PMC — peer-reviewed case series
• Pembrolizumab; platinum-based therapy plus pembrolizumab investigational contextClinical trialClinical trialInvestigationalMSI-H status may identify a responsive case in the fetched pembrolizumab case-series source; no broad biomarker claim made; Advanced penile SCC investigational systemic therapy context. · This is not a regulator approval, guideline recommendation, or availability claim. It should only be cataloged as an option to discuss in trial/biomarker context; no superiority or routine access implied. Confidence/conflicts: Medium; evidence is case-series/investigational and not a jurisdictional approval. Peer-reviewed literature / PMC — peer-reviewed case series
• Pembrolizumab; platinum-based therapy plus pembrolizumab investigational contextClinical trialClinical trialInvestigationalMSI-H status may identify a responsive case in the fetched pembrolizumab case-series source; no broad biomarker claim made; Advanced penile SCC investigational systemic therapy context. · This is not a regulator approval, guideline recommendation, or availability claim. It should only be cataloged as an option to discuss in trial/biomarker context; no superiority or routine access implied. Confidence/conflicts: Medium; evidence is case-series/investigational and not a jurisdictional approval. Peer-reviewed literature / PMC — peer-reviewed case series