Status:
UNKNOWN
The Combination of Anti-PD-1 With Radiotherapy in Previously Untreated Metastatic Melanoma
Lead Sponsor:
Yonsei University
Conditions:
Melanoma
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
Brief Summary
Currently, the first line treatment options for surgically unresectable metastatic melanoma includes anti-PD1 agents such as nivolumab and pembrolizumab. In western countries, UV associated cutaneous ...
Eligibility Criteria
Inclusion
- 1\. Subject has provided informed consent prior to initiation of any study-specific activities/procedures
- 2\. Male or female age \> 20 years at the time of informed consent
- 3\. Histologically confirmed diagnosis of unresectable stage III or IV melanoma as per AJCC staging system 8th edition
- 4\. Subject with no prior systemic treatment
- 5\. Eastern Cooperative Oncology Group (ECOG) Performance Status \< 1
- 6\. Screening labs performed within 7 days of randomization demonstrating adequate hematologic, coagulation, liver, and kidney functions
- 7\. Indications for radiotherapy
- 8\. BRAF status must be checked, but patient is eligible regardless of BRAF mutations (BRAF V600 wild type or BRAF V600 mutation positive are both eligible)
Exclusion
- 1\. Ocular melanoma
- 2\. Active brain metastasis (stable after 1 month of radiotherapy, gamma knife surgery or surgery)
- 3\. Requires palliative radiotherapy
- 4\. Previous treatment with chemotherapy, a CTLA-4 or PD-1/PD-L1 antagonist agent, including treatment in adjuvant setting
- 5\. Autoimmune disease requiring chronic treatment with systemic corticosteroids or any other immunosuppressive agents 7 days prior to inclusion. (physiologic dose of prednisolone 10mg or equivalent are accepted)
- 6\. Concurrent medical disease which would significantly limit full compliance with the study such as, but not limited to the following: heart failure (III, IV as per NYHA classification), renal insufficiency, active infection (requires negative gest for clinically suspected HIV, hepatitis B virus, hepatitis C virus).
- If positive results are not indicative of true active or chronic infection, the subject may enter the study after discussion and agreement between the investigator and medical director.
- 7\. Has known malignancy that is progressing and requires active treatment
- 8\. Has known psychiatric or substance abuse disorders that would interfere with cooperation requirements of the trial
- 9\. Lack of availability for clinical follow-up assessments
Key Trial Info
Start Date :
July 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04017897
Start Date
July 3 2019
End Date
July 1 2022
Last Update
July 12 2019
Active Locations (1)
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1
Department of Surgery, Yonsei University College of Medicine
Seoul, South Korea, 120-752