Clinical Trials for Penile Cancer
This article provides information about 5 ongoing clinical trials for penile cancer. These studies are testing various treatment approaches including chemotherapy combinations, immunotherapy, and imaging techniques to improve diagnosis and treatment outcomes. Trials are being conducted in several European countries including the Netherlands, Belgium, France, and Spain.
Clinical trial locations
- Belgium
- France
- Netherlands
- Study on the Effectiveness of Carboplatin, Paclitaxel, and Pembrolizumab for Patients with Advanced Penile Cancer
- Study on the Use of Indocyanine Green and Technetium (99mTc) Nanocolloid for Sentinel Node Biopsy in Patients with Melanoma, Oral Cancer, or Penile Cancer
- Study on Using EMI-137 for Intraoperative Visualization in Patients with Penile and Tongue Cancer
- Spain
Study on the Effectiveness of Carboplatin, Paclitaxel, and Pembrolizumab for Patients with Advanced Penile Cancer
This trial is evaluating a combination treatment for locoregionally advanced disease. The study uses three medications given through intravenous infusion: pembrolizumab (an immunotherapy drug), paclitaxel, and carboplatin (both chemotherapy drugs).
Who can participate: Male patients over 18 years old with confirmed squamous cell carcinoma that has spread to lymph nodes or has specific high-risk features. Participants must have adequate organ function and a performance status score of 0 to 1, meaning they can carry out daily activities with minimal restrictions. A tumor tissue sample must be provided, and participants must agree to use birth control during treatment and for 180 days afterward.
Who cannot participate: Patients without locoregionally advanced disease or those from vulnerable populations cannot join the study.
Study focus: The main goal is to assess how well this three-drug combination works in treating cancer that has spread to nearby areas. Researchers will monitor whether the cancer can be completely removed or significantly reduced, while also tracking safety and side effects. The treatment aims to achieve a complete response with no detectable cancer remaining.
The trial is being conducted in the Netherlands and Belgium, with an expected completion date of June 2026.
Study on the Effects of Chemotherapy with Paclitaxel, Ifosfamide, and Cisplatin for Patients with Squamous Cell Carcinoma of the Penis and Lymph Node Metastasis
This French trial combines chemotherapy with surgery to prevent cancer from returning in the lymph nodes. The chemotherapy regimen, called TIP, includes three drugs: paclitaxel, ifosfamide, and cisplatin, all given through intravenous infusion.
Who can participate: Male patients over 18 with confirmed squamous cell carcinoma and specific lymph node involvement. Participants must have adequate kidney, liver, and heart function, with normal blood cell counts and mineral levels. They need a performance status of 0 to 1 and must agree to use two methods of birth control during the study and for 6 months after treatment.
Who cannot participate: Patients without lymph node metastases or those outside the specified age range cannot participate.
Study focus: The main objective is to evaluate survival without cancer returning to the lymph nodes over 24 months. Participants receive TIP chemotherapy every three weeks, followed by surgical removal of affected lymph nodes in the groin area (bilateral lymphadenectomy). Additional medications are given to manage side effects such as nausea and allergic reactions. Regular follow-up includes physical examinations and ultrasound imaging to check for cancer recurrence.
The study is expected to conclude by December 2027.
Study on the Use of Indocyanine Green and Technetium (99mTc) Nanocolloid for Sentinel Node Biopsy in Patients with Melanoma, Oral Cancer, or Penile Cancer
This Dutch trial is testing a new imaging method to identify sentinel lymph nodes, which are the first nodes to which cancer is likely to spread. The study uses a combination of Indocyanine Green and Technetium (99mTc) Nanocolloid as a hybrid tracer.
Who can participate: Patients over 18 with clinically confirmed disease who are scheduled for a sentinel node biopsy as part of their regular care. There must be no clinical evidence of cancer in the lymph nodes at the time of enrollment.
Who cannot participate: Patients not scheduled for a sentinel node biopsy cannot participate.
Study focus: The trial aims to validate whether this hybrid tracer can accurately identify sentinel nodes compared to the standard method. Before surgery, participants receive an injection of the tracer substances, followed by imaging using lymphoscintigraphy and SPECT/CT to visualize the nodes. During the biopsy procedure, both fluorescence and radioactive signals are used to ensure accurate removal of the sentinel nodes. The study compares the number and intensity of nodes detected by both methods to determine if the new approach is as effective as the current standard.
Study on Using EMI-137 for Intraoperative Visualization in Patients with Penile and Tongue Cancer
This Dutch trial is evaluating a fluorescent imaging agent called EMI-137, which helps surgeons see cancer cells more clearly during surgery by making them glow under special light.
Who can participate: Patients 18 years or older with T1 or higher stage squamous cell cancer who are scheduled for surgical removal of the primary tumor.
Who cannot participate: Patients without confirmed disease or those outside the specified age range cannot participate.
Study focus: EMI-137 is a special protein linked to a dye that attaches to the c-Met receptor, which is often found in cancer cells. When it attaches to these cells, they glow under special light during surgery. The medication is given as a powder that is mixed and injected into the bloodstream. During the operation, surgeons use fluorescence imaging to visualize the tumor and potentially affected lymph nodes more clearly. The glowing effect is compared to traditional laboratory methods for studying cancer cells. The study also aims to detect early tissue changes that might turn into cancer and identify cancer spread to nearby lymph nodes.
Study of TG4001 and Avelumab for Patients with Advanced HPV-16 Positive Cancers
This multi-center trial being conducted in France and Spain is testing a combination of two immunotherapy treatments for cancers linked to HPV-16, including those affecting the penis, cervix, vulva, vagina, head and neck, and anus.
Who can participate: Male and female patients at least 18 years old with HPV-16 positive cancer that has spread or returned after treatment. Women of childbearing age must have a negative pregnancy test, and all participants must use highly effective birth control during the study and for 3 months after. Participants must have a performance status of 0 or 1, a life expectancy of at least 3 months, and at least one measurable tumor lesion. Previous treatment requirements vary by study phase.
Who cannot participate: Patients with liver metastases at enrollment, those who are not HPV-16 positive, or those without recurrent or metastatic cancer cannot participate.
Study focus: The trial evaluates the combination of TG4001 (a therapeutic vaccine given by injection under the skin) and avelumab (a checkpoint inhibitor given by intravenous infusion). TG4001 helps the immune system recognize and attack HPV-16 positive cancer cells, while avelumab blocks a protein that prevents the immune system from effectively attacking cancer. The study is conducted in two phases: Phase Ib focuses on safety and tolerability, while Phase II evaluates effectiveness by measuring overall response rate and comparing progression-free survival between patients receiving the combination versus avelumab alone.
The trial is expected to conclude by December 2026.
Summary
These five clinical trials represent diverse approaches to improving outcomes for patients with this disease. Three trials are being conducted in the Netherlands, reflecting a concentration of research activity in this country. France and Belgium each host two trials, while Spain hosts one.
The trials span different aspects of cancer care, from active treatment to improved diagnostic techniques. Two studies focus on chemotherapy combinations (carboplatin/paclitaxel/pembrolizumab and the TIP regimen of paclitaxel/ifosfamide/cisplatin), both aimed at treating advanced or metastatic disease. Two trials investigate imaging technologies to help surgeons better identify and remove cancerous tissue during surgery. One study specifically targets HPV-16 positive cancers with immunotherapy.
Immunotherapy features prominently, with pembrolizumab, avelumab, and TG4001 being tested either alone or in combination with chemotherapy. This reflects the growing importance of treatments that harness the body’s immune system to fight cancer. The trials also emphasize personalized approaches, such as targeting specific viral causes (HPV-16) or using molecular markers (c-Met receptor) to guide treatment.
Most trials require participants to have adequate organ function and good performance status, ensuring they can tolerate the treatments being studied. All studies include careful monitoring for safety and effectiveness, with follow-up periods ranging from months to years to track long-term outcomes.
