Trial of Pembrolizumab and Radiotherapy in Melanoma — PERM  

Melanoma Clinical Trial

Official title: Randomised Phase II Trial of Pembrolizumab and Radiotherapy in Melanoma

Status Terminated

Clinical Trial Summary

Around 13,000 participants are diagnosed with melanoma in the UK each year and that number is growing quicker than any other cancer. About 20% of participants will see their cancer return following their initial treatment and at present would survive a median time of 912 months. In recent years, the development of new effective drugs has revolutionised the treatment of advanced melanoma, However, response rates are still low and new therapeutic approaches are needed.

This is a phase II study to look at the effectiveness and safety of the combination of a new drug called pembrolizumab plus radiotherapy compared to pembrolizumab alone. The purpose of this study is to see if the addition of radiotherapy to pembrolizumab is better than pembrolizumab alone by measuring how long these treatments can control the growth of the cancer. Also it will assess if by adding radiotherapy the investigators can see its effects not only in the tumour that has had radiotherapy but also in other tumours in the rest of the body.

Clinical Trial Description

1. Risk and burden for participants Participants in this study have cancer but may still be eligible for standard therapy and may not show any benefit from the trial drug. If this is the case will be withdrawn from the trial and will receive standard care. The study itself carries a number of potential burdens:

• Study drug and Radiotherapy. Although the dose and safety effects of the drug have been previously assessed in phase I trials and the radiotherapy used is considered standard of care, it is possible for participants to experience some side effects. To ensure any side effects are treated appropriately all participants will be reviewed regularly by experienced clinicians while having the study treatment. Comprehensive assessments for safety will be carried out.

• Burden of frequent hospital visits and tests. Participants in this study must attend hospital every 3 weeks to check for any side effects of the drug, have routine blood and clinical biochemistry tests, clinical examinations and administer the next dose of pembrolizumab. Additionally, for research purposes some participants may consent to have additional tumour biopsies and blood tests. These will not be mandatory for all participants.

2. Recruitment Participants will be offered information about this study by their clinical teams if they are considered to meet the entry criteria and express interest in taking part in the study. It will be made clear that there will not necessarily be a therapeutic benefit from taking part in the study. It will also be made clear that, should participants decide not to take part their future care will not be affected. Participants will be given sufficient time and information to make an informed decision about entering the trial, all participants entering the trial will give written informed consent.

3. Confidentiality Participants will be linked to a unique identifier the code for which will be held on a password protected database held only by the study team. This study will run across twenty two hospital sites. Tumour data will be analysed at Manchester University and research blood will be analysed at Leeds University. Sample processing will take place using the trial ID only. No other patient identifiable information will be available on study samples. Investigators will have access to patient identifiable information on password protected NHS hospital notes and databases only.

4. Conflict of Interest Participants may be recruited to the study by those involved in their prior clinical care. Investigators do not expect conflict of interest between research and healthcare duties for a number of reasons: participants must give their full informed consent before entering the study, specifically regarding the unknown efficacy of the study drug. Those participants who do not continue in the study will maintain a relationship with the clinical team if required for symptom control. At the end of the study, participants will be able to access the results if they wish, through the Royal Marsden Website. They will also be sent a written summary of the results if they indicate this.

5. Use of tissue samples in future research If participants give their consent, any leftover blood or tissue samples which are not required for this study will be stored for future unspecified research in line with the human tissue act regulations. Access and use of samples for research purposes will require appropriate ethical approval. Future researchers will not be able to identify individual participants from their biobank data, demographic and clinical information will be available. ;

Related Conditions & MeSH terms

• Melanoma

• NCT number: NCT02562625
• Study type: Interventional
• Source: Royal Marsden NHS Foundation Trust
• Status: Terminated
• Phase: Phase 2
• Start date: February 2016
• Completion date: March 2020