Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase II Trial of Stereotactic Body Radiotherapy With Concurrent Anti-PD1 Treatment in 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: NCT02821182
Recruitment Status : Unknown
Verified April 2018 by Radiotherapie, University Hospital, Ghent.
Recruitment status was:  Active, not recruiting
First Posted : July 1, 2016
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
GZA Ziekenhuizen Campus Sint-Augustinus
Information provided by (Responsible Party):
Radiotherapie, University Hospital, Ghent

Brief Summary:

We hypothesize that combining anti-PD1 treatment with radiotherapy might result in improved clinical response rates and PFS compared to anti-PD1 treatment in monotherapy.

The current phase II trial aims at exploring the suggested benefits of the combination and aims to improve local and distant tumour responses by exploiting the pro-immunogenic effects of radiotherapy in addition to anti-PD1 treatment.


Condition or disease Intervention/treatment Phase
Melanoma Radiation: stereotactic body radiotherapy Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Stereotactic Body Radiotherapy With Concurrent Anti-PD1 Treatment in Metastatic Melanoma.
Study Start Date : June 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Anti-PD1 treatment in combination with SBRT
Patients receiving anti-PD1 treatment will be treated with high-dose radiotherapy to one lesion in 3 fractions prior to the second cycle of systemic therapy.
Radiation: stereotactic body radiotherapy

In patients with metastatic melanoma, anti-PD-1 treatment will be combined with stereotactic body radiotherapy (SBRT).

A total dose of 24 Gy SBRT will be delivered in 3 fractions to one measurable lesion and fractions will be separated >48h and <96h.





Primary Outcome Measures :
  1. Efficacy [ Time Frame: 12 weeks ]
    Objective responses will be measured using RECIST v1.1. Objective responses will be defined as the number of patients with complete or partial responses as best response during follow-up.


Secondary Outcome Measures :
  1. Immunologic responses [ Time Frame: 12 weeks ]

    Immunologic responses will be assessed using peripheral blood samples, analyzed with FACS phenotyping, functional testing and ELISA.

    Changes in immunological parameters in tissue will be analyzed using immunohistochemistry.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
  • Histologically confirmed diagnosis of melanoma
  • At least 3 extracranial measurable metastatic lesions per RECIST v1.1. All radiology studies must be performed within 28 days prior to registration
  • First line anti-PD1 treatment.
  • Karnofsky Performance status > 60
  • Age 18 years or older
  • Female participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment
  • Female participants who are breastfeeding or plan to breastfeed should be instructed to discontinue nursing during treatment.
  • Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study treatment
  • Demonstrate adequate organ function defined as the following:

    • AST and ALT ≤2.5 X ULN or ≤5 X ULN with liver metastases
    • Serum total bilirubin ≤1.5 X ULN or direct bilirubin ≤ULN for patient with total bilirubin level >1.5 ULN
    • Serum creatinine ≤1.5 X ULN
    • Absolute neutrophil count >1,000 /mcL
    • Platelets >75,000 /mcL
    • Hemoglobin >9 g/dL or > 5.6 mmol/L
  • No history of active autoimmune disease requiring systemic treatment within the past 3 months or documented history of clinically severe autoimmune disease, or syndrome that requires systemic steroids or immunosuppressive agents
  • Prior malignancy: Subjects who have had another malignancy should be disease-free for 5 years, or should have a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma
  • No evidence of interstitial lung disease
  • No uncontrolled central nervous metastases and/or carcinomatous meningitis.
  • No prior radiotherapy interfering with SBRT.
  • No concomitant therapy with IL-2, interferon, other immunotherapy regimens, chemotherapy, immunosuppressive agent or chronic use of systemic corticosteroids.
  • No active infection requiring systemic therapy
  • No known history of human immunodeficiency virus (HIV)
  • No known active Hepatitis B or Hepatitis C
  • Did not receive a live vaccine within 30 days prior to start of study treatment
  • No mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
  • Patient not unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study

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): NCT02821182


Locations
Layout table for location information
Belgium
University Hospital Ghent
Gent, West Vlaanderen, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
GZA Ziekenhuizen Campus Sint-Augustinus
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Radiotherapie, Prof. Dr. Piet Ost, University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT02821182    
Other Study ID Numbers: EC UZG 2016/0540
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas