Trial of Pembrolizumab and Radiotherapy in Melanoma

Sponsor
Royal Marsden NHS Foundation Trust
Study ID
NCT02562625
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Powder solution for infusion
  • Radiotherapy — RADIATION
    24Gy

Study Details

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.

Key Dates

Start date
Aug 11, 2016
Status verified
Apr 2026
Primary completion
Mar 31, 2020
Completion
Oct 31, 2021

Study Design

Enrollment
17 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab Alone
    If the patient is randomised to the Pembrolizumab Arm Only then they will receive 200mg of pembrolizumab every 3 weeks.
  • Experimental: Pembrolizumab plus Radiotherapy
    If The patient is randomised to this arm they will receive 200mg of pembrolizumab every 3 weeks in combination with a radiotherapy dosage of 24Gy in 3 fractions to be given over 3 consecutive days (only).

Primary Outcome Measure

Objective: To Evaluate if Radiotherapy Will Enhance the Efficacy of Pembrolizumab in the Treatment of Patients With Metastatic Melanoma by Induction of an Abscopal Effect. [ Time Frame: From date of randomisation until week 12 from start of treatment ]

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