R2810-ONC-1606, Treatment-naïveUnresectable Stag III/IV Melanoma

• Research type

  Research Study

• Full title

  An exploratory tumor biopsy-driven study to understand the relationship between biomarkers and indicators of clinical response in immunomodulatory treatment-naïve unresectable stage III/IV melanoma patients receiving REGN2810 (anti-PD-1).

• IRAS ID

  215817

• Contact name

  Mark Middleton

• Contact email

  mark.middleton@oncology.ox.ac.uk

• Sponsor organisation

  Regeneron Pharmaceuticals, Inc.

• Eudract number

  2016-002755-16

• Clinicaltrials.gov Identifier

  32134, NIHR Study Registration

• Duration of Study in the UK

  2 years, 4 months, 13 days

• Research summary

  The purpose of this study is to characterise the types and dynamics of changes in the tumours of patients with stage III/IV melanoma following treatment with REGN2810 (anti-PD-1) and to assess their relationship to the clinical response as defined by the changes in tumour volume.
  Despite an impressive increase in progression-free survival in a portion of patients treated with immunotherapy, the exact mechanisms of action of these therapeutic agents remain largely unknown. However, treatment with REGN2810 is believed to induce substantial changes in the tumour microenvironment, which may correlate with magnitude and duration of clinical response. Understanding molecular and cellular underpinnings of response to PD-1 blockade is critical especially in order to design complementary immunomodulatory approaches to be used in sequence or combination.
  
  Melanoma is the least common form of skin cancer but it is the most serious. It is the one most likely to spread to other parts of the body. There are about 9,000 new cases of melanoma each year in the UK. The number of cases has about doubled over a period of 20 years or so. Melanoma is the second most common cancer in people aged 15-34.

  In this study, there will be 30 patients recruited for this trial. The study will take place in Europe and South Korea. The study will last approximately 3 years.

  After a screening period of up to 28 days, Each patient will receive 3 mg/kg REGN2810 every 14 days (Q2W) given as a 30-minute infusion. Tumour assessments will be made every 8 weeks by imaging. Extensive safety evaluations will occur every 8 weeks; routine safety evaluations will be conducted at each REGN2810 dosing visit.
  A patient will receive treatment until the 48-week treatment period is complete, or until disease progression, unacceptable toxicity, withdrawal of consent, or confirmed complete response(CR).Patients who discontinue study treatment will be followed for survival approx every 3 months until death, lost to follow-up, or study termination.Patients with confirmed CR after a minimum of 24 weeks of treatment may elect to discontinue treatment

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  16/SC/0567

• Date of REC Opinion

  14 Dec 2016

• REC opinion

  Further Information Favourable Opinion