Trial of Pembrolizumab and Radiotherapy in Melanoma (NCT02562625) | Clinical Trial Compass
TerminatedPhase 2
Trial of Pembrolizumab and Radiotherapy in Melanoma
Stopped: Slow Recruitment
United Kingdom17 participantsStarted 2016-08-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Be willing and able to provide written informed consent for the trial
✓. Have a diagnosis of stage III (unresectable) or stage IV cutaneous melanoma or melanoma of unknown primary, as per AJCC staging system
✓. Informed metastatic disease by diagnostic biopsy
✓. Be more than 18 years of age on day of signing informed consent
✓. Have at least one lesion and a maximum of 3 which are appropriate targets for high dose radiotherapy. This lesion must be 1cm-5cm in size and measurable by RECIST v1.1
✓. Have in addition at least one other lesion which will not be irradiated but must be measurable by RECIST v1.1 to assess the abscopal effect of the treatment
✓. Have a performance status of 0 or 1 on the ECOG performance scale
✓. Demonstrate adequate organ function as defined in table 1 below. All screening labs should be performed within 7 days of randomisation
Exclusion criteria
What they're measuring
1
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.
Timeframe: From date of randomisation until week 12 from start of treatment
. Has lesions that if irradiated would result in unacceptable radiation induced toxicity to normal tissue, in particular to the CNS and bowel
✕. Requires palliative radiotherapy for symptom control
✕. Is currently participating in or has participated in a study of an investigational agent or device within 4 weeks of the first dose of trial treatment
✕. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
✕. Has had a monoclonal antibody within 4 weeks prior to the first dose of trial treatment or who has not recovered (i.e. ≤Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
✕. Has had chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to the first dose of trial treatment or who has not recovered (i.e., ≤Grade 1 or at baseline) from adverse events due to a previously administered agent
✕. Has history of severe colitis related to previous immunotherapy treatment
✕. Has a known additional malignancy that is progressing or requires active treatment Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy