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The Combination of Anti-PD-1 With Radiotherapy in Previously Untreated Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04017897
Recruitment Status : Unknown
Verified July 2019 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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 melanoma has 30-40% response rates to immune checkpoint inhibitors (ICIs). However, response rates are lower in Asians. The reason for this discrepancy is attributed to the difference in subtypes since most of the Asian patients are mostly subgrouped as acral lentiginous or mucosal types that are unrelated to UV exposures. Thus, there is an unmet need to bolster the effect of ICIs in these patients.

The combination of radiotherapy with ICIs have been demonstrated by several pre-clinical studies. High dose radiation has shown to promote STING pathway which activates dendritic cells needed in priming phase. In addition, low dose radiation may activate macrophage differentiation. These mechanisms in turn may enhance responses to immunotherapy.

In this study, the investigators aim to evaluate the efficacy and tolerability of anti-PD-1 blockade in combination with radiotherapy in surgically unresectable, treatment naive metastatic melanoma.


Condition or disease Intervention/treatment Phase
Melanoma Drug: The combination of radiotherapy with anti-PD1 (pembrolizumab or nivolumab) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Combination of Anti-PD-1 With Radiotherapy in Previously Untreated Metastatic Melanoma
Actual Study Start Date : July 3, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Drug: The combination of radiotherapy with anti-PD1 (pembrolizumab or nivolumab)
Subjects with treatment naïve, surgically unresectable metastatic melanoma stages IIIB to IVM1c will be treated with combination of anti-PD1 (pembrolizumab or nivolumab) and radiotherapy.


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 1 year ]
    assessment of efficacy of anti-PD1 with radiotherapy in terms of overall response rate (ORR)


Secondary Outcome Measures :
  1. treatment-related adverse events (TRAE) [ Time Frame: 3 years ]
  2. rate of progression-free survival (PFS) [ Time Frame: 1 year ]
  3. overall survival (OS) [ Time Frame: 1 year ]
  4. disease control rate (DCR) [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017897


Contacts
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Contact: Sang Joon Shin, MD, Ph.D 82-2-2228-8138 ssj338@yuhs.ac

Locations
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Korea, Republic of
Department of Surgery, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Sang-Joon Shin, MD, Ph.D    82-2-2228-8138    ssj338@yuhs.ac   
Sponsors and Collaborators
Yonsei University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04017897    
Other Study ID Numbers: 4-2019-0461
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Pembrolizumab
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action