MelanomaPhase 2NCT02821182
A Phase II Trial of Stereotactic Body Radiotherapy With Concurrent Anti-PD1 Treatment in Metastatic Melanoma.
A Phase 2 study testing stereotactic body radiotherapy in people with Melanoma, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- stereotactic body radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2016to 31 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 28Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Melanoma
- Being tested
- stereotactic body radiotherapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic body radiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Anti-PD1 treatment in combination with SBRT | Experimental | 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. Receives: Radiation: stereotactic body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
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.
Measured: 12 weeks
Secondary outcomes (1)
Immunologic responses
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study start1 Sep 2016
- Primary completion9 Sep 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- GZA Ziekenhuizen Campus Sint-Augustinus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821182
- Sponsor's protocol ID
- EC UZG 2016/0540
- Status last verified
- Dec 2022
- First submitted
- 24 Jun 2016
- Last updated
- 29 Dec 2022
- Results posted
- No
Publications
De Wolf K, Kruse V, Sundahl N, van Gele M, Chevolet I, Speeckaert R, Brochez L, Ost P. A phase II trial of stereotactic body radiotherapy with concurrent anti-PD1 treatment in metastatic melanoma: evaluation of clinical and immunologic response. J Transl Med. 2017 Jan 31;15(1):21. doi: 10.1186/s12967-017-1123-x.
PubMed 28137295
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Stereotactic Body Radiotherapy With Concurrent Anti-PD1 Treatment in Metastatic Melanoma.
- ClinicalTrials.gov ID
- NCT02821182
- Acronym / sponsor ID
- EC UZG 2016/0540
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- GZA Ziekenhuizen Campus Sint-Augustinus
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 9 Sep 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-PD1 treatment in combination with SBRT | Experimental | Radiation: stereotactic body radiotherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stereotactic body radiotherapyIn 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. | Radiation | Anti-PD1 treatment in combination with SBRT |
Primary outcome
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.
1 secondary outcome
Immunologic responses
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Derived from this study: PubMed 28137295De Wolf K, Kruse V, Sundahl N, van Gele M, Chevolet I, Speeckaert R, Brochez L, Ost P. A phase II trial of stereotactic body radiotherapy with concurrent anti-PD1 treatment in metastatic melanoma: evaluation of clinical and immunologic response. J Transl Med. 2017 Jan 31;15(1):21. doi: 10.1186/s12967-017-1123-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing stereotactic body radiotherapy in people with Melanoma, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02821182, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.