A Phase II Trial of Stereotactic Body Radiotherapy With Concurrent Anti-PD1 Treatment in Metastatic Melanoma.
December 28, 2022 updated by: University Hospital, Ghent
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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West Vlaanderen
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Gent, West Vlaanderen, Belgium, 9000
- University Hospital Ghent
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
September 9, 2018
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
June 24, 2016
First Submitted That Met QC Criteria
June 28, 2016
First Posted (Estimate)
July 1, 2016
Study Record Updates
Last Update Posted (Estimate)
December 29, 2022
Last Update Submitted That Met QC Criteria
December 28, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC UZG 2016/0540
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