EPIC Trial

• Research type

  Research Study

• Full title

  A Phase II Trial of Cemiplimab alone or in combination with Standard of Care Chemotherapy in Locally Advanced or Metastatic Penile Carcinoma

• IRAS ID

  288077

• Contact name

  Amit Bahl

• Contact email

  amit.bahl@uhbw.nhs.uk

• Sponsor organisation

  University Hospitals Bristol and Weston NHS Foundation Trust

• Eudract number

  2020-004871-42

• Duration of Study in the UK

  6 years, 0 months, 1 days

• Research summary

  Cancer of the penis is rare in the UK. It is treated with potential of cure by surgery or radiotherapy. However, in some cases the cancer can spread to the lymph nodes (glands) in the adjoining areas including the pelvis (locally
  advanced) and other areas of the body (metastatic disease). Locally advanced and/or metastatic penile squamous cell carcinoma (SCC) is treated with chemotherapy to control the cancer and potentially improve survival. The combination of cisplatin and 5-flurouracil (PF) is widely regarded as the standard of care in this setting. However, a retrospective series suggested a response rate of just 32%. More recent studies using the TPF combination (docetaxel, cisplatin and 5FU) and the chemotherapy Vinflunine (VinCap trial) showed improved patient outcomes but still below 50%.
  There is therefore a need to further improve the outcomes for these patients. Immunotherapy treatments have shown efficacy in patients with many different types of cancer and the novel immune checkpoint inhibitor cemiplimab has shown benefit in patients with metastatic cutaneous SCC. Preliminary studies also suggest that penile SCC may respond to immunotherapy treatment. This study will evaluate the safety and efficacy of cemiplimab in combination with standard of care chemotherapy or alone in patients with locally advanced and/or metastatic cancer of the penis with the aim to improve outcomes and provide further treatment options for this patient group.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  21/EE/0028

• Date of REC Opinion

  12 Mar 2021

• REC opinion

  Further Information Favourable Opinion