Penile Cancer

Condition: Penile Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07384416

Sponsor: Sun Yat-sen University

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum 80 Years
• Gender: Male

Inclusion Criteria:

1. Age between 18 and 80 years.
2. Histologically or cytologically confirmed penile squamous cell carcinoma.
3. Previous treatment with chemotherapy, immunotherapy, and/or targeted therapy.
4. At least one measurable target lesion according to RECIST 1.1 criteria.
5. ECOG performance status score of ≤
6. Adequate bone marrow function: Hemoglobin (Hb) ≥ 75 g/L, White Blood Cell count (WBC) ≥ 3.0×10⁹/L, Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L, Platelet count (PLT) ≥ 100×10⁹/L.
7. Adequate organ function: Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), and Alkaline Phosphatase (ALP) ≤ 2.5 times the upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN. Serum creatinine ≤ 1.5 × ULN.
8. Life expectancy of ≥ 12 months.
9. No significant history of severe cardiac, pulmonary, hepatic, or other major organ diseases.
10. The patient understands the study procedures and provides written informed consent to participate in the study.

Exclusion Criteria:

• 1. Participation in any investigational drug study within 4 weeks prior to the start of treatment. 2. Concurrent active cancer other than penile squamous cell carcinoma, or a history of other malignancies within the past 5 years, except for the following:
• (1) Cured non-melanoma skin cancer;
• (2) Incidentally discovered, low-risk, and curative tumors, including but not limited to low-risk prostate cancer (T1a, Gleason score <6, PSA <0.5 ng/ml) and superficial bladder cancer;
• (3) Other solid tumors that have undergone curative treatment with no evidence of recurrence or metastasis for 5 years or more. 3. Other serious, poorly controlled concurrent illnesses that may be aggravated by the combination therapy, including but not limited to:
• (1) History of severe or acute exacerbation within the past 6 months involving the cardiovascular, hepatic, respiratory, renal, hematological, endocrine, or neuropsychiatric systems;
• (2) Active infection requiring antibiotic treatment within 2 weeks prior to enrollment;
• (3) Congestive heart failure (Class III-IV);
• (4) Unstable angina or myocardial infarction within the past 6 months;
• (5) Untreated active Hepatitis B virus (HBV) infection. *Note: Subjects with HBV meeting the following criteria are eligible: HBV viral load must be <1000 copies/ml (200 IU/ml) before the first dose, and the subject must receive anti-HBV therapy throughout the study treatment period to prevent reactivation. Subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-) do not require prophylactic anti-HBV therapy but require close monitoring for reactivation.*
• (6) Active Hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA level above the limit of detection). 4. Administration of a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1). *Inactivated seasonal influenza vaccines administered by injection are permitted within 30 days prior to the first dose; however, live attenuated influenza vaccines administered intranasally are not permitted.* 5. Diagnosis of immunodeficiency or receipt of systemic corticosteroid therapy (>10 mg/day prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first study dose. *Physiologic doses of corticosteroids (≤10 mg/day prednisone or equivalent) are permitted.* 6. History of Human Immunodeficiency Virus (HIV) infection (i.e., positive HIV1/2 antibody test). 7. Systemic treatment with Chinese herbal medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks prior to enrollment. 8. Active autoimmune disease that has required systemic treatment (e.g., with disease-modifying agents, corticosteroids, or immunosuppressants) within the past 2 years. 9. Any other history, disease, concurrent condition, therapy, or laboratory abnormality that, in the investigator's judgment, might compromise the results, interfere with the subject's full participation throughout the study, or make the subject unsuitable for study participation.

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Condition: Penile Cancer, Penile Neoplasms Malignant

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07378670

Sponsor: University Hospital Tuebingen

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• 1. Patient has provided written informed consent.
• 2. Male patient ≥ 18 years at time of signing the informed consent form.
• 3. Patient has histologically proven penile squamous cell carcinoma.
• 4. Patient has indication for prophylactic (intermediate or high-risk primary tumor and cN0) or therapeutic (cN1/2) inguinal lymphadenectomy, i.e.:
• pT1a, G2, cN0 OR
• pT1b- pT3, any G, cN0 OR
• pT1-pT3, any G, cN1-2
• 5. Patients has adequate hepatic, renal and bone marrow function:
• Hemoglobin ≥ 8.0 g/dL
• Absolute neutrophil count ≥ 1.5 x 109 /L
• Platelets ≥ 100 x 109 /L
• International normalized ratio (INR) / activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants. Anticoagulation is accepted according to the surgeon's practice.
• 6. Patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
• 7. Performance status of the patient is judged by the treating physician as appropriate to undergo surgery.

Exclusion Criteria:

• 1. Patients has inguinal bulky disease ≥ 4 cm (determined by ultrasound or cross-sectional imaging).
• 2. Patient has distant metastases.
• 3. Patient receives or is scheduled for neoadjuvant chemotherapy for PeCa.
• 4. Patient received previous major inguinal surgery (transabdominal laparoscopic inguinal hernia repair is permitted), lymph node resection or radiotherapy in the groin or pelvic area.
• 5. Patient participates in competing trials affecting the effects of the surgery or outcome measures.
• 6. Patient has addictive or other medical conditions that do not allow the subject to appreciate the nature and scope of the clinical trial and its potential consequences.
• 7. Patient has any co-existing medical condition that in the investigator's judgement will substantially increase the risk associated with the patient's participation in the study.
• 8. Patient has been incarcerated or involuntarily institutionalized by court order or by the authorities.
• 9. Patient is unable to consent because he does not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts.

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Condition: Penile Cancer, Penile Neoplasms Malignant

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07378670

Sponsor: University Hospital Tuebingen

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• 1. Patient has provided written informed consent.
• 2. Male patient ≥ 18 years at time of signing the informed consent form.
• 3. Patient has histologically proven penile squamous cell carcinoma.
• 4. Patient has indication for prophylactic (intermediate or high-risk primary tumor and cN0) or therapeutic (cN1/2) inguinal lymphadenectomy, i.e.:
• pT1a, G2, cN0 OR
• pT1b- pT3, any G, cN0 OR
• pT1-pT3, any G, cN1-2
• 5. Patients has adequate hepatic, renal and bone marrow function:
• Hemoglobin ≥ 8.0 g/dL
• Absolute neutrophil count ≥ 1.5 x 109 /L
• Platelets ≥ 100 x 109 /L
• International normalized ratio (INR) / activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants. Anticoagulation is accepted according to the surgeon's practice.
• 6. Patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
• 7. Performance status of the patient is judged by the treating physician as appropriate to undergo surgery.

Exclusion Criteria:

• 1. Patients has inguinal bulky disease ≥ 4 cm (determined by ultrasound or cross-sectional imaging).
• 2. Patient has distant metastases.
• 3. Patient receives or is scheduled for neoadjuvant chemotherapy for PeCa.
• 4. Patient received previous major inguinal surgery (transabdominal laparoscopic inguinal hernia repair is permitted), lymph node resection or radiotherapy in the groin or pelvic area.
• 5. Patient participates in competing trials affecting the effects of the surgery or outcome measures.
• 6. Patient has addictive or other medical conditions that do not allow the subject to appreciate the nature and scope of the clinical trial and its potential consequences.
• 7. Patient has any co-existing medical condition that in the investigator's judgement will substantially increase the risk associated with the patient's participation in the study.
• 8. Patient has been incarcerated or involuntarily institutionalized by court order or by the authorities.
• 9. Patient is unable to consent because he does not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts.

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Condition: Penile Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07054307

Sponsor: Jiyan Liu

Phase: Phase 1

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. Histologically and/or cytologically confirmed unresectable, locally advanced, or metastatic penile squamous cell carcinoma.
2. EGFR expression (defined as IHC 1+, 2+, or 3+) confirmed by the institutional pathology department using primary or metastatic tumor tissue samples.
3. No prior systemic therapy for advanced disease.
4. Male, aged ≥18 years.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with a life expectancy ≥3 months.
6. At least one measurable lesion per RECIST 1.1 criteria.
7. Adequate organ function (based on institutional laboratory reference ranges): Left ventricular ejection fraction (LVEF) ≥50%. Hematology: Hemoglobin (HGB) ≥90 g/L, White blood cell count (WBC) ≥3.0×10⁹/L, Absolute neutrophil count (ANC) ≥1.5×10⁹/L, Platelet count (PLT) ≥80×10⁹/L. Biochemistry: Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN), AST/ALT ≤2.5×ULN (≤5×ULN if liver metastases present), Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CrCl) ≥50 mL/min.
8. Willing to provide written informed consent, with full understanding of the study requirements and commitment to comply with trial procedures and follow-up visits.

Exclusion Criteria:

1. Patients who have received prior systemic therapy before enrollment.
2. History of other malignancies, except for cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or other malignancies that have been disease-free for at least 5 years.
3. Presence of central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may be eligible if they have been stable for at least 6 months, show no disease progression on imaging within 4 weeks before treatment, have no neurological symptoms, demonstrate no evidence of new or enlarging brain metastases, and have discontinued radiation, surgery, or steroid therapy for brain metastases at least 28 days prior to the first dose. Carcinomatous meningitis is excluded regardless of clinical stability.
4. Severe or uncontrolled concurrent diseases, including uncontrolled infections, active tuberculosis, uncontrolled diabetes, cardiovascular diseases (such as NYHA Class III or IV heart failure, second-degree or higher heart block, myocardial infarction within the past 12 months, unstable arrhythmia or angina, or cerebral infarction within the past 6 months), pulmonary diseases (such as interstitial lung disease, chronic obstructive pulmonary disease, or a history of symptomatic bronchospasm), deep vein thrombosis or pulmonary embolism within the past 12 months, or decompensated cirrhosis.
5. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within the past 2 years. Replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) are permitted.
6. Positive serological virology test results, including HIV positivity, HBsAg positivity with detectable HBV DNA (≥2000 copies/mL), or HCV antibody positivity (eligible only if HCV RNA PCR-negative).
7. Major surgery within 4 weeks before enrollment, or prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
8. Administration of or plans to receive anti-cancer vaccines within 4 weeks before enrollment or during the study.
9. Clinically significant pleural effusion or ascites, as determined by the investigator to be unsuitable for enrollment.
10. Any other condition considered by the investigator to make the patient ineligible for the clinical study.

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Condition: Penile Squamous Cell Carcinoma (PSCC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07110038

Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. Patient has ability to understand and the willingness to sign a written informed consent.
2. Patient is ≥ 18 years of age at time of signing the written informed consent.
3. Male patients with histologically confirmed diagnosis of penile squamous cell carcinoma.
4. Patients must be considered non-eligible for curative surgical management. Eligibility for trial inclusion should be based on the presence of either distant metastatic disease (M1) or at least one of the following scenarios based on the UICC/AJCC 8th edition TNM clinical and pathological classification of penile cancer:
5. Stage 3 (cT3) disease with a single lymph node involved (N1).
6. Stage 4 disease (cT4).
7. Any T stage with either N2 (involvement of multiple or bilateral inguinal nodes) or N3 (fixed inguinal nodal mass or pelvic lymphadenopathy) disease. Patients without distant metastases are eligible if multidisciplinary team review concludes that they are unsuitable for curative surgery.
8. Tumor material (archival or current) is available for local pathology testing (PD-L1, HPV).
9. Eastern Cooperative Oncology Group (ECOG) performance status of ≤
10. Measurable disease per RECIST 1.1 criteria.
11. No prior systemic therapy for metastatic or locally advanced PeCa in the palliative setting. NOTE: (Neo)adjuvant systemic therapy (without IO) is allowed at least 6 months before study enrollment.
12. Patients has adequate blood count, liver-enzymes, and renal function:
13. ANC (Absolute neutrophil count) > 1,500 cells/μL without the use of hematopoietic growth factors.
14. Platelet count ≥ 100 x 109/L (>100,000 per mm3).
15. Hemoglobin ≥ 9 g/dL.
16. Serum total bilirubin ≤ 1.5x institutional upper normal limit (ULN).
17. AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN (or ≤ 5 x ULN if liver metastases are present).
18. Creatinine clearance ≥ 30 mL/min as calculated by the Cockcroft- Gault equation (or local institutional standard method).
19. No other active malignancy within the past 3 years, except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin.
20. No history of significant cardiovascular disease (e.g., myocardial infarction, unstable angina) within the last 6 months.
21. Life expectancy of at least 3 months.
22. Willingness to comply with study requirements, including follow-up visits and procedures.
23. Patients with female partners of childbearing potential must agree to use an effective method of contraception during the study and for 4 months after the last dose of enfortumab vedotin or for at least 30 days after last avelumab treatment administration, whichever occurs last.

Exclusion Criteria:

1. Previous systemic therapy for metastatic or locally advanced PeCa in the palliative setting.
2. Previous treatment with investigational drugs or devices within 30 days prior to the first dose of trial treatment.
3. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
4. Active, known, or suspected autoimmune disease requiring systemic treatment within the past 2 years. Patients with controlled autoimmune d disease not requiring systemic immunosuppressive treatment including diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases are eligible.
5. Has ongoing sensory or motor neuropathy Grade 2 or higher.
6. Has a history of uncontrolled diabetes (HbA1c > 8%).
7. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
8. Active infection requiring systemic therapy. The following exceptions apply:
9. Patients with an HIV infection are eligible if they are on effective antiretroviral therapy with undetectable viral load within 6 months, provided there is no expected drug-drug interaction.
10. Patients with evidence of chronic HBV infection are eligible if the HBV viral load is undetectable on suppressive therapy (if indicated), and if they have ALT, AST, and total bilirubin levels < ULN, and provided there is no expected drug-drug interaction.
11. Patients with a history of HCV infection are eligible if they have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load, and if they have ALT, AST, and total bilirubin levels < ULN.
12. History of other malignancies within the past 3 years, with the exception of adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin.
13. Severe hepatic impairment (Child-Pugh Class C).
14. Severe renal impairment or requirement for dialysis.
15. History of keratitis and corneal ulceration in the last two years.
16. Active pneumonia, pneumonitis or pulmonary fibrosis.
17. Active tuberculosis.
18. Known prior severe hypersensitivity to the study drugs or any component of their formulations, known severe hypersensitivity reactions to monoclonal antibodies (NCT CTCAE Grade ≥ 3).
19. Inability or unwillingness to comply with study requirements, including follow-up visits and procedures.
20. Inability to provide informed consent.
21. Use of immunosuppressive medication within 14 days prior to the first dose of study treatment, with the exception of intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection), systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent, or steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
22. Prior organ transplantation including allogenic stem-cell transplantation.
23. Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines.
24. Persisting toxicity related to prior therapy (NCI CTCAE Grade > 1); however, alopecia or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
25. Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
26. Patient participated in another interventional clinical study according to Medicines Act within 28 days prior to study enrollment or participation in a clinical study according to Medicines Act at the same time as this study unless it is an observational / non-interventional study or during the follow- up period of an interventional study.

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Condition: Penile Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT05447273

Sponsor: Oslo University Hospital

Phase:

Eligibility:

• Age: minimum N/A maximum N/A
• Gender: Male

Inclusion Criteria:

• newly diagnosed penile squamous cell carcinoma (SCC)
• the patient will benefit from organ-sparing surgery (OSS)
• signed broad consent for cancer research

Exclusion Criteria:

• N/A

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Condition: Penile Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05526989

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Provide written, informed consent to participate in the study and follow the study procedures
• Histologically confirmed stage III (unresectable) or stage IV penile cancer, as per American Joint Committee on Cancer (AJCC) staging system.
• Life expectancy >12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1 (ECOG performance status 2 can be included after discussion with PI)
• Measurable disease per iRECIST
• Participants who have progressed or had tolerance problems to no more than one prior line of therapy in the locally advanced setting or post platinum-based chemotherapy, including in a neoadjuvant or adjuvant setting or in combination with radiation therapy.
• Participants must not have received any prior immune-oncology regimens, including but not limited to checkpoint inhibitors such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways, indoleamine 2,3-dioxygenase pathway inhibitors, cancer vaccines, adoptive cell therapies, or other cytokine therapies
• Demonstrated adequate organ function, as defined in protocol, within 28 days of treatment initiation
• Clinically significant toxic effect(s) of the most recent prior chemotherapy must be Grade 1 or resolved (except alopecia and sensory neuropathy that may be Grade 2).
• If the participant received major surgery or radiation therapy of > 30 Gy, they must have recovered from the toxicity and/or complications from the intervention.
• Participants and their female partners of childbearing potential must agree and commit to use a highly effective form of contraception (e.g., condom with spermicidal foam/gel/film/cream/suppository) throughout the duration of the study until 6 months (female participants) and 3 months (male participants and their female partners), respectively, following the last dose of study drug. Female partner may use either an intrauterine device or hormonal contraception and continue until 3 months following the last dose of study drug. This criterion may be waived for male patients who have had a vasectomy 90 days months before signing the informed consent form (ICF) or a penectomy.
• Participants must not have known active brain metastases.
• Participants with treated brain metastases are eligible if they have neurologically returned to baseline (except for residual signs or symptoms related to the cns treatment) for at least 4 weeks prior to the first dose of study drug(s).
• Participant cannot be receiving any chronic systemic steroids (prednisone or equivalent) > 20 mg daily, for at least 4 weeks prior to the first dose of study drug(s).
• Participants with small, untreated, asymptomatic central nervous system (CNS) metastases without associated edema, shift, or requirement for steroids are eligible after discussion with the Medical Monitor, i.e. the Principal Investigator.
• No stereotactic radiation or craniotomy within 4 weeks of Cycle 1 Day 1
• No new central nervous system lesions on repeat radiographic imaging 4 weeks or more from last treatment
• No clinically significant symptoms secondary to brain metastases
• Participants must also consent to allow acquisition of existing formalin-fixed paraffin-embedded (FFPE) material (archival tumor tissue), either a block or unstained slides for planned correlative studies.

Exclusion Criteria:

• Use of an investigational agent or an investigational device within 4 weeks or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, before administration of first dose of study drug.
• Active, known or suspected autoimmune disease requiring systemic treatment within the past 2 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents. (Exceptions include any patient on 10 mg or less of prednisone or equivalent, patients with vitiligo, hypothyroidism stable on hormone replacement, Type I diabetes, Graves' disease, Hashimoto's disease, alopecia areata, eczema, or with PI approval.)
• History of allergy or hypersensitivity to study drug components
• History of organ transplant that requires use of immune suppressive agents
• Current active pneumonitis within 90 days of planned start of the study or a known history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis requiring steroid treatment.
• Prior surgery or radiotherapy encompassing >20% of the bone marrow within 14 days of therapy. Patients must have recovered from all radiation-related toxicities.
• Active infection requiring systemic therapy; a known history of active tuberculosis.
• Has known active hepatitis B virus (HBV) infection (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C virus (HCV) infection (e.g., HCV ribonucleic acid [RNA] qualitative is detected)
• Has known immunodeficiency or active human immunodeficiency virus (HIV-1/2 antibodies) with CD 4 count < 400 for in the past 6 months.
• Prolonged corrected QT interval (QTcF) > 450 ms for men
• History of unstable or deteriorating cardiac disease within the previous 6 months prior to screening including but not limited to the following: 1. Unstable angina or myocardial infarction 2. Congestive heart failure (New York Heart Association [NYHA] Class III or IV) 3. Uncontrolled clinically significant arrhythmias
• Systolic BP >140 mmHg or diastolic BP >90 mmHg that has not been adequately treated or controlled. Need for > 2 antihypertensive medications for management of hypertension (excluding diuretics)
• Must not have received a transfusion (platelets or red blood cells) ' 4 weeks prior to initiating protocol therapy.
• Must not have received colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.
• Has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment.
• Must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
• Has experienced a Grade 3 or greater immune-related Adverse Event with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
• Has received a live vaccine within 30 days of initiating protocol therapy

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Condition: Metastatic Penile Squamous Cell Carcinoma, Stage III Penile Cancer AJCC v8, Stage IV Penile Cancer AJCC v8, Unresectable Penile Squamous Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06104618

Sponsor: Mayo Clinic

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Age ≥ 18 years
• Histological confirmation of squamous cell carcinoma of the penis (PSCC): NOTE: Biopsy confirmation of at least one site of metastasis is encouraged but not required.
• At least one site of metastatic or unresectable PSCC. NOTE: Prior therapy is not required for patients whose treatment is considered palliative (for example, presence of distant metastasis). NOTE: Patients who are potentially curable (any T, N1
• N3, M0) must have had tumor progression after standard chemotherapy, radiotherapy, or surgery, or be unable to receive such treatment. Eligible stages include:
• Any T, N1 (i.e., a palpable mobile unilateral inguinal lymph node), M0 OR
• Any T, N2 (i.e., palpable mobile multiple or bilateral inguinal lymph nodes), M0 OR
• Any T, N3 (i.e., fixed inguinal nodal mass or any pelvic lymphadenopathy), M0 OR
• Any T, any N, M1
• Patients with clinical N1, M0 mPSCC at protocol entry must be ineligible for surgery because of comorbidities or clinical T4 disease, or have refused surgery
• Patients with clinical N1
• N3, M0, and no prior systemic therapy must be:
• Unable to receive neoadjuvant (paclitaxel + ifosfamide + cisplatin) TIP because of comorbidities or refused TIP; AND
• Unable to receive radiotherapy with curative intent, or refused radiotherapy
• Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
• Prior therapy is allowed. Patients may be treatment-naïve or have had any number of prior anti-cancer treatments
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• Hemoglobin ≥ 9.0 g/dL obtained ≤15 days prior to registration
• Absolute neutrophil count (ANC) ≥ 1000/mm^3 obtained ≤ 15 days prior to registration
• Platelet count ≥ 100,000/mm^3 obtained ≤ 15 days prior to registration
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3 x ULN for patients with Gilbert's disease obtained ≤ 15 days prior to registration
• Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN obtained ≤ 15 days prior to registration
• Glomerular filtration rate (GFR) or calculated creatinine clearance ≥ 30 ml/min as estimated using the Cockcroft-Gault formula or as measured by 24-hour urine collection obtained ≤ 15 days prior to registration
• Provide written informed consent
• Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Exclusion Criteria:

• Pure verrucous carcinoma of the penis
• Non-squamous malignancy of the penis
• Squamous carcinoma of the urethra
• Preexisting sensory or motor neuropathy ≥ grade 2
• Active central nervous system (CNS) metastases. Exception: Treated CNS metastases are allowed if all of the following are true:
• CNS metastases are clinically stable for ≥ 6 weeks prior to registration
• If needed, steroid dose is stable and ≤ 20 mg/day of prednisone or equivalent for ≥ 2 weeks prior to registration
• Baseline imaging shows no evidence of new or enlarged brain metastasis
• No leptomeningeal disease
• History of uncontrolled diabetes mellitus ≤ 3 months prior to registration NOTE: Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥ 8.0% or HbA1c 7.0-7.9% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained
• Failure to recover from any of the following therapies prior to registration:
• Major surgery
• Radiotherapy, chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy
• Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive
• Uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection requiring systemic treatment
• History of cerebral vascular event (stroke or transient ischemic attack)
• Myocardial infarction or symptomatic congestive heart failure (New York Heart Association [NYHA] Class III-IV) ≤ 6 months prior to registration
• Unstable angina pectoris
• Cardiac arrhythmia
• Or psychiatric illness/social situations that would limit compliance with study requirements (e.g., history of substance abuse)
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
• Currently receiving systemic antimicrobial treatment for viral, bacterial or fungal infection. NOTE: Routine antimicrobial prophylaxis is allowed
• Known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or active hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid (RNA) [qualitative] is detected)
• Known active keratitis or corneal ulcerations. NOTE: Superficial punctate keratitis is allowed if the disorder is being adequately treated
• Known hypersensitivity to enfortumab vedotin or to any excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dihydrate and polysorbate 20) OR subject has known hypersensitivity to biopharmaceutical produced in Chinese hamster ovary cells
• Other active malignancy ≤ 2 years prior to registration. EXCEPTIONS: Locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, or carcinoma in situ of the breast or low risk Gleason 6 prostate cancer.
• History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
• Patients who are sexually active and unwilling to use effective contraception (if they are not already surgically sterile)
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Chemotherapy-naïve patients who are potentially curable (any T, N1
• N3, M0) in the absence of any condition that precludes cisplatin-based chemotherapy, such as low GFR, peripheral neuropathy, hearing impairment, or psychosocial considerations

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Condition: Urologic Neoplasms, Urogenital Neoplasms, Male Urogenital Diseases, Penile Cancer, Penile Squamous Cell Carcinoma, Locally Advanced Penile Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06353906

Sponsor: The Netherlands Cancer Institute

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• 1. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. 2. Histologically confirmed diagnosis of squamous cell carcinoma of the penis. 3. Patients have one of the following disease stages:
• cTxN2-3 or
• cTxN1 in case of central nodal necrosis and/or an irregular nodal border, or node >3cm, or
• Inguinal or pelvic lymph node recurrence that is potentially resectable. Any of the disease stages above, in combination with oligometastatic disease with a maximum of 2 distant metastases is allowed, as long as these metastases can be treated by resection or radiotherapy. This should be established in the multidisciplinary tumor board before enrolment. 4. Archival tumor tissue sample or newly obtained [core, incisional or excisional] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. 5. A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period. 6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 14 days prior to the first dose of study intervention. 7. Have adequate organ function defined as: absolute neutrophil count (ANC) ≥1.5 10e9 /L, platelets ≥100 10e9/L; hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L; creatinine ≤1.5 × ULN OR GFR>30 ml/min as per Cockcroft-Gault formula in patients with creatinine levels > 1.5x institutional ULN; total bilirubin 1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤2.5 × ULN; International normalized ratio (INR), prothrombin time (PT) OR activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants. Specimens must be collected within 14 days prior to the start of study intervention.

Exclusion Criteria:

1. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
2. Has received prior systemic anti-cancer therapy including investigational agents, or an investigational device, within 4 weeks prior to registration.
3. Has received prior radiotherapy within 4 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
4. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
5. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
6. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Exceptions: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Patients with low-risk prostate cancer (defined as Stage T1/T2a, Gleason score ≤ 6, and PSA ≤ 10 ng/mL) who are treatment-naive and undergoing active surveillance are eligible.
7. Has known active or treated CNS metastases and/or carcinomatous meningitis.
8. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
9. Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid). Patients with vitiligo, psoriasis or other mild skin disease can still be included.
10. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
11. Has an active infection requiring systemic therapy.
12. Has a known history of Human Immunodeficiency Virus (HIV) infection.
13. Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and/or Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. Hepatitis B and C screening tests are not required unless a patient has a known history of HBV or HCV infection. Participants must have completed curative anti-viral therapy at least 6 months prior to randomization.
14. Has not adequately recovered from major surgery or has ongoing surgical complications.
15. Major pelvic surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for the disease under study.
16. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
17. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
18. Is expecting to father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
19. Has had an allogenic tissue/solid organ transplant

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Condition: Penile Cancer, Advanced Cancer, Metastatic Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03391479

Sponsor: University Health Network, Toronto

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Histologically confirmed squamous cell carcinoma of the penis
• Measurable disease per Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST)
• Unresectable/metastatic disease that is unfit for platinum-based chemotherapy OR disease that has progressed on or after treatment with platinum-based chemotherapy
• ≥18 years of age
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

Exclusion Criteria:

• Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
• Major surgery ≤4 weeks or major radiation therapy ≤2 weeks prior to enrollment
• Known symptomatic central nervous system (CNS) metastases requiring steroids
• Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
• Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy

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Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
3. Metastatic lymph node involvement,
4. Patients M0 or Mx,
5. Age ≥18 ans,
6. Eastern Cooperative Oncology Group (ECOG) 0-1,
7. Leucocytes ≥1.5 g/L,
8. Hemoglobin ≥9 g/dL,
9. Platelets ≥100 000/mm³,
10. Normal calcemia and kaliemia,
11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
12. Creatinine clearance ≥60 mL/min (MDRD method),
13. Left ventricular ejection fraction (LVEF) >50%,
14. Patients having received, read the information note and signed consent,
15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
17. Patients undergoing a social security scheme.

Exclusion Criteria:

1. Fixed inguinal lymph nodes (cN3),
2. Iliac lymph nodes (cN3),
3. Patients pN3,
4. prior chemotherapy for squamous cell carcinoma of the penis,
5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
6. Patients treated with phenytoin,
7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
8. Patients with cardiopulmonary disease-indicating against overhydration,
9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
12. Patients deprived of their liberty or under court protection including guardianship,
13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
14. immunocompromised patients including with known seropositivity (HIV),
15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov

Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
3. Metastatic lymph node involvement,
4. Patients M0 or Mx,
5. Age ≥18 ans,
6. Eastern Cooperative Oncology Group (ECOG) 0-1,
7. Leucocytes ≥1.5 g/L,
8. Hemoglobin ≥9 g/dL,
9. Platelets ≥100 000/mm³,
10. Normal calcemia and kaliemia,
11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
12. Creatinine clearance ≥60 mL/min (MDRD method),
13. Left ventricular ejection fraction (LVEF) >50%,
14. Patients having received, read the information note and signed consent,
15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
17. Patients undergoing a social security scheme.

Exclusion Criteria:

1. Fixed inguinal lymph nodes (cN3),
2. Iliac lymph nodes (cN3),
3. Patients pN3,
4. prior chemotherapy for squamous cell carcinoma of the penis,
5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
6. Patients treated with phenytoin,
7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
8. Patients with cardiopulmonary disease-indicating against overhydration,
9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
12. Patients deprived of their liberty or under court protection including guardianship,
13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
14. immunocompromised patients including with known seropositivity (HIV),
15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov

Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
3. Metastatic lymph node involvement,
4. Patients M0 or Mx,
5. Age ≥18 ans,
6. Eastern Cooperative Oncology Group (ECOG) 0-1,
7. Leucocytes ≥1.5 g/L,
8. Hemoglobin ≥9 g/dL,
9. Platelets ≥100 000/mm³,
10. Normal calcemia and kaliemia,
11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
12. Creatinine clearance ≥60 mL/min (MDRD method),
13. Left ventricular ejection fraction (LVEF) >50%,
14. Patients having received, read the information note and signed consent,
15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
17. Patients undergoing a social security scheme.

Exclusion Criteria:

1. Fixed inguinal lymph nodes (cN3),
2. Iliac lymph nodes (cN3),
3. Patients pN3,
4. prior chemotherapy for squamous cell carcinoma of the penis,
5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
6. Patients treated with phenytoin,
7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
8. Patients with cardiopulmonary disease-indicating against overhydration,
9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
12. Patients deprived of their liberty or under court protection including guardianship,
13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
14. immunocompromised patients including with known seropositivity (HIV),
15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov

Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
3. Metastatic lymph node involvement,
4. Patients M0 or Mx,
5. Age ≥18 ans,
6. Eastern Cooperative Oncology Group (ECOG) 0-1,
7. Leucocytes ≥1.5 g/L,
8. Hemoglobin ≥9 g/dL,
9. Platelets ≥100 000/mm³,
10. Normal calcemia and kaliemia,
11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
12. Creatinine clearance ≥60 mL/min (MDRD method),
13. Left ventricular ejection fraction (LVEF) >50%,
14. Patients having received, read the information note and signed consent,
15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
17. Patients undergoing a social security scheme.

Exclusion Criteria:

1. Fixed inguinal lymph nodes (cN3),
2. Iliac lymph nodes (cN3),
3. Patients pN3,
4. prior chemotherapy for squamous cell carcinoma of the penis,
5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
6. Patients treated with phenytoin,
7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
8. Patients with cardiopulmonary disease-indicating against overhydration,
9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
12. Patients deprived of their liberty or under court protection including guardianship,
13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
14. immunocompromised patients including with known seropositivity (HIV),
15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov

Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
3. Metastatic lymph node involvement,
4. Patients M0 or Mx,
5. Age ≥18 ans,
6. Eastern Cooperative Oncology Group (ECOG) 0-1,
7. Leucocytes ≥1.5 g/L,
8. Hemoglobin ≥9 g/dL,
9. Platelets ≥100 000/mm³,
10. Normal calcemia and kaliemia,
11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
12. Creatinine clearance ≥60 mL/min (MDRD method),
13. Left ventricular ejection fraction (LVEF) >50%,
14. Patients having received, read the information note and signed consent,
15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
17. Patients undergoing a social security scheme.

Exclusion Criteria:

1. Fixed inguinal lymph nodes (cN3),
2. Iliac lymph nodes (cN3),
3. Patients pN3,
4. prior chemotherapy for squamous cell carcinoma of the penis,
5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
6. Patients treated with phenytoin,
7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
8. Patients with cardiopulmonary disease-indicating against overhydration,
9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
12. Patients deprived of their liberty or under court protection including guardianship,
13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
14. immunocompromised patients including with known seropositivity (HIV),
15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov

Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
3. Metastatic lymph node involvement,
4. Patients M0 or Mx,
5. Age ≥18 ans,
6. Eastern Cooperative Oncology Group (ECOG) 0-1,
7. Leucocytes ≥1.5 g/L,
8. Hemoglobin ≥9 g/dL,
9. Platelets ≥100 000/mm³,
10. Normal calcemia and kaliemia,
11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
12. Creatinine clearance ≥60 mL/min (MDRD method),
13. Left ventricular ejection fraction (LVEF) >50%,
14. Patients having received, read the information note and signed consent,
15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
17. Patients undergoing a social security scheme.

Exclusion Criteria:

1. Fixed inguinal lymph nodes (cN3),
2. Iliac lymph nodes (cN3),
3. Patients pN3,
4. prior chemotherapy for squamous cell carcinoma of the penis,
5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
6. Patients treated with phenytoin,
7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
8. Patients with cardiopulmonary disease-indicating against overhydration,
9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
12. Patients deprived of their liberty or under court protection including guardianship,
13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
14. immunocompromised patients including with known seropositivity (HIV),
15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov

Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
3. Metastatic lymph node involvement,
4. Patients M0 or Mx,
5. Age ≥18 ans,
6. Eastern Cooperative Oncology Group (ECOG) 0-1,
7. Leucocytes ≥1.5 g/L,
8. Hemoglobin ≥9 g/dL,
9. Platelets ≥100 000/mm³,
10. Normal calcemia and kaliemia,
11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
12. Creatinine clearance ≥60 mL/min (MDRD method),
13. Left ventricular ejection fraction (LVEF) >50%,
14. Patients having received, read the information note and signed consent,
15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
17. Patients undergoing a social security scheme.

Exclusion Criteria:

1. Fixed inguinal lymph nodes (cN3),
2. Iliac lymph nodes (cN3),
3. Patients pN3,
4. prior chemotherapy for squamous cell carcinoma of the penis,
5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
6. Patients treated with phenytoin,
7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
8. Patients with cardiopulmonary disease-indicating against overhydration,
9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
12. Patients deprived of their liberty or under court protection including guardianship,
13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
14. immunocompromised patients including with known seropositivity (HIV),
15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov

Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
3. Metastatic lymph node involvement,
4. Patients M0 or Mx,
5. Age ≥18 ans,
6. Eastern Cooperative Oncology Group (ECOG) 0-1,
7. Leucocytes ≥1.5 g/L,
8. Hemoglobin ≥9 g/dL,
9. Platelets ≥100 000/mm³,
10. Normal calcemia and kaliemia,
11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
12. Creatinine clearance ≥60 mL/min (MDRD method),
13. Left ventricular ejection fraction (LVEF) >50%,
14. Patients having received, read the information note and signed consent,
15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
17. Patients undergoing a social security scheme.

Exclusion Criteria:

1. Fixed inguinal lymph nodes (cN3),
2. Iliac lymph nodes (cN3),
3. Patients pN3,
4. prior chemotherapy for squamous cell carcinoma of the penis,
5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
6. Patients treated with phenytoin,
7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
8. Patients with cardiopulmonary disease-indicating against overhydration,
9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
12. Patients deprived of their liberty or under court protection including guardianship,
13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
14. immunocompromised patients including with known seropositivity (HIV),
15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov

Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
3. Metastatic lymph node involvement,
4. Patients M0 or Mx,
5. Age ≥18 ans,
6. Eastern Cooperative Oncology Group (ECOG) 0-1,
7. Leucocytes ≥1.5 g/L,
8. Hemoglobin ≥9 g/dL,
9. Platelets ≥100 000/mm³,
10. Normal calcemia and kaliemia,
11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
12. Creatinine clearance ≥60 mL/min (MDRD method),
13. Left ventricular ejection fraction (LVEF) >50%,
14. Patients having received, read the information note and signed consent,
15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
17. Patients undergoing a social security scheme.

Exclusion Criteria:

1. Fixed inguinal lymph nodes (cN3),
2. Iliac lymph nodes (cN3),
3. Patients pN3,
4. prior chemotherapy for squamous cell carcinoma of the penis,
5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
6. Patients treated with phenytoin,
7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
8. Patients with cardiopulmonary disease-indicating against overhydration,
9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
12. Patients deprived of their liberty or under court protection including guardianship,
13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
14. immunocompromised patients including with known seropositivity (HIV),
15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov

Condition: Penile Cancer, Squamous Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02817958

Sponsor: UNICANCER

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2,
3. Metastatic lymph node involvement,
4. Patients M0 or Mx,
5. Age ≥18 ans,
6. Eastern Cooperative Oncology Group (ECOG) 0-1,
7. Leucocytes ≥1.5 g/L,
8. Hemoglobin ≥9 g/dL,
9. Platelets ≥100 000/mm³,
10. Normal calcemia and kaliemia,
11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 upper limit of normal (ULN) ; total bilirubin ≤1.5 ULN (3 ULN in case of Gilbert disease); alkaline phosphatase (ALP) <2 ULN,
12. Creatinine clearance ≥60 mL/min (MDRD method),
13. Left ventricular ejection fraction (LVEF) >50%,
14. Patients having received, read the information note and signed consent,
15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol),
17. Patients undergoing a social security scheme.

Exclusion Criteria:

1. Fixed inguinal lymph nodes (cN3),
2. Iliac lymph nodes (cN3),
3. Patients pN3,
4. prior chemotherapy for squamous cell carcinoma of the penis,
5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
6. Patients treated with phenytoin,
7. Patients with hearing loss >Grade 1 (CTCAE V4.03),
8. Patients with cardiopulmonary disease-indicating against overhydration,
9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
12. Patients deprived of their liberty or under court protection including guardianship,
13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
14. immunocompromised patients including with known seropositivity (HIV),
15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

View trial on ClinicalTrials.gov