Anti-PD-1 agent with radiotherapy in previously untreated, surgically unresectable metastatic melanoma

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0004145
• Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 August 2019
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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 malignant melanoma
4. unresectable stage IIIB, IIIC, IVM1a, IVM1b or IVM1c melanoma
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
6. Screening labs performed within 14 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 mutation positive patients are eligible)

Exclusion Criteria

1. Ocular melanoma
2. Active, uncontrolled brain metastasis (requires 1 month of washout period radiation therapy, surgery or gamma-knife surgery)
3. Previous treatment with chemotherapy, a CTLA-4 or PD-1/PD-L1 antagonist agent, including treatment in adjuvant setting for immunotherapy
4. 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.
5. Has known malignancy diagnosed within three years that is progressing and requires active treatment are excluded.
6. Autoimmune disease requiring chronic treatment with systemic corticosteroids or any other immunosuppressive agents 7 days prior to inclusion
-Exception: intranasal glucocorticoid and intra-articular steroid injections
-Exception: administration of prednisolone 10mg/day or equivalent as physiologic dose for adrenal insufficiency
-Exception: steroid as pre-medication to prevent anaphylactic shock (contrast with CT, other systemic 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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
objective response rate, ORR

Secondary Outcome Measures

Name	Time	Method
1 year PFS (%))