MelanomaNCT03520634
PD-L1 PET Imaging in Melanoma Patients
A study testing PD-L1 PET imaging in people with Melanoma, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
This is a feasibility study for the use of [18F]PD-L1 as a PET tracer that will be conducted in a single center. The study consists of two phases. The aim of phase one is to provide pharmacokinetic information on the tracer and to determine the optimal time point for imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- PD-L1 PET imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 May 2017to 12 Apr 2021
- Phase
- Interventional
- 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
- Subjects must sign informed consent prior to inclusion in this trial.
- Subjects must be ≥18 years of age and competent to give informed consent.
- Subjects must be diagnosed with histologically confirmed stage IV melanoma.
- At least one radiologic new lesion in the brain by MRI, which should be measurable by RANO-BM criteria (longest diameter ≥ 10 mm and perpendicular diameter ≥ 5 mm). Lesions with prior local treatment (i.e., SRT or surgical resection) can be considered measurable if there has been demonstrated progression since the time of local treatment. Leptomeningeal involvement is allowed, but cannot be used as target lesion.
- At least one easy accessible metastatic melanoma lesion of which a biopsy can be taken.
- Subjects must be treatment-naive to nivolumab. (also as adjuvant treatment)
Show all 17Show fewer
- Subjects must score at least 1 or higher on the Eastern Cooperative Oncology Group (ECOG) Performance Status.(21)
- Subjects must have adequate organ function as defined by the following laboratory values (determined within 28 days prior to randomization/registration):
- White blood cells (WBC) ≥ 2000 /μL
- Absolute neutrophil count (ANC) ≥ 1500 /μL
- Platelets ≥ 100 x103 /μL
- Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN) or creatinine clearance > 40 ml/min (using the Cockcroft-Gault formula)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times ULN
- Bilirubin ≤ 1.5 times ULN (Except patients with the Gilbert Syndrome, for whom a maximum of ≤ 3.0 mg/dL is acceptable)
- Women of childbearing potential (WOCBP) should have a negative urine or serum pregnancy test within 7 days prior to receiving the first administration of nivolumab. Women with non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year.
- WOCBP and men who are sexually active with WOCBP must agree to use appropriate method(s) of contraception. (see section 5.2)
Who cannot join
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways, except anti-CTLA4 antibody.
- Subjects who have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grade 1 or better from the adverse events due to previous cancer therapy.
- Evidence for an active, known or suspected autoimmune disease. Subjects diagnosed with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Treatment with corticosteroids in an increasing dosage in the 7 days prior to the first administration of nivolumab. (A stable or decreasing dosage of ≤ 4 mg dexamethasone or equivalent is allowed. In addition, inhaled or topical steroids and adrenal replacement doses are permitted in the absence of active autoimmune disease.)
- Previous malignancies (except non-melanoma skin cancers, in situ bladder cancer, gastric or colon cancers, cervical cancers/dysplasia or breast carcinoma in situ) unless a complete remission was achieved at least 1 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.
- A severe hypersensitivity reaction to prior treatment with a monoclonal antibody, or known hypersensitivity to study drugs components.
Show all 13Show fewer
- A positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patients to receive protocol therapy.
- A known psychiatric or substance abuse disorder that could interfere with cancer therapy.
- Women of childbearing potential with a positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of nivolumab.
- Breastfeeding women.
- Inability to comply with other requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PD-L1 PET Imaging in Patients With an Inoperable Melanoma With Brain Metastasis and Eligible for Treatment With Nivolumab.
This is a feasibility study for the use of [18F]PD-L1 as a PET tracer that will be conducted in a single center. The study consists of two phases. The aim of phase one is to provide pharmacokinetic information on the tracer and to determine the optimal time point for imaging. In the second phase the main study objective will be assessed.
Read the detailed description
This is a single center feasibility study for the application of [18F]PD-L1 PET in patients with metastatic melanoma and NSCLC treated with anti-PD-1 therapy. The study will consist of a pharmacokinetics phase (phase one) and tracer validation phase (phase two). Phase one will be performed in a maximum of 5 patients. A [18F]PD-L1 PET scan will be performed at baseline and six weeks after treatment initiation. Upon finishing phase one, the optimal time for tracer injection will bedetermined prior to the start of phase two. In phase two a [18F]PD-L1 PET-CT scan will be performed in 10 patients at baseline and six weeks after treatment initiation. Also, when it is feasible a biopsy will be taken from at least one accessible tumor location after the PET-scan at baseline and the PET-scan after six weeks of therapy.
- Conditions
- Melanoma
- Being tested
- PD-L1 PET imaging
- Keywords
- Melanoma, PD-L1, Brain metastases, PET imaging
- Medical subject headings
- Melanoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-L1 PET imagingOther
Also called [18F]BMS-986192
PD-L1 PET imaging
| Study group | Role | What they receive |
|---|---|---|
| PD-L1 PET imaging in melanoma patients | Experimental | The main intervention of this study is a [18F]PD-L1 PET scan. In both phase one and phase two a scan sequence will be performed both at baseline and 6 weeks after initiation of nivolumab treatment. The PET scans will be combined with either a low dose or diagnostic CT scan of chest, abdomen and pelvis and a MRI of the brain. In phase two, a biopsy of at least one accessible lesion will be performed to analyze PD-L1 expression using immunohistochemical staining after each PET scan. Receives: Other: PD-L1 PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the optimal dose of tracer and timing of imaging for [18F]PD-L1 tracer imaging of inoperable melanoma.
By the performing dynamic PET scans.
Measured: 1 year
Assess the association of PD-L1 expression as measured by PD-L1 tracer uptake on PET and PD-L1 expression as measured by immunohistochemical (IHC) staining for PD-L1 of corresponding tumor lesions.
By the performing Full body PET scans.
Measured: 1 year
Secondary outcomes (2)
Characterize between-subject and within-subject variability in accumulation of the [18F]PD-L1 tracer in melanoma metastases.
By the quantification of Full body PET scans.
Measured: 1 year
Correlate response to anti-PD1 treatment with differences in tumor PD-L1 and PD1 expression between baseline and after 6 weeks of treatment.
As quantified by PET and IHC analysis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start22 May 2017
- Primary completion12 Apr 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- G.A. P Hospers, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520634
- Sponsor's protocol ID
- 31052016
- Status last verified
- Apr 2021
- First submitted
- 31 May 2016
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-L1 PET Imaging in Patients With an Inoperable Melanoma With Brain Metastasis and Eligible for Treatment With Nivolumab.
- ClinicalTrials.gov ID
- NCT03520634
- Acronym / sponsor ID
- 31052016
- Conditions
- Melanoma
- Keywords
- Melanoma, PD-L1, Brain metastases, PET imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 11 May 2018 (actual)
- 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.
This is a feasibility study for the use of [18F]PD-L1 as a PET tracer that will be conducted in a single center. The study consists of two phases. The aim of phase one is to provide pharmacokinetic information on the tracer and to determine the optimal time point for imaging. In the second phase the main study objective will be assessed.
Detailed description
This is a single center feasibility study for the application of [18F]PD-L1 PET in patients with metastatic melanoma and NSCLC treated with anti-PD-1 therapy. The study will consist of a pharmacokinetics phase (phase one) and tracer validation phase (phase two). Phase one will be performed in a maximum of 5 patients. A [18F]PD-L1 PET scan will be performed at baseline and six weeks after treatment initiation. Upon finishing phase one, the optimal time for tracer injection will bedetermined prior to the start of phase two. In phase two a [18F]PD-L1 PET-CT scan will be performed in 10 patients at baseline and six weeks after treatment initiation. Also, when it is feasible a biopsy will be taken from at least one accessible tumor location after the PET-scan at baseline and the PET-scan after six weeks of therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-L1 PET imaging in melanoma patients | Experimental | Other: PD-L1 PET imagingThe main intervention of this study is a [18F]PD-L1 PET scan. In both phase one and phase two a scan sequence will be performed both at baseline and 6 weeks after initiation of nivolumab treatment. The PET scans will be combined with either a low dose or diagnostic CT scan of chest, abdomen and pelvis and a MRI of the brain. In phase two, a biopsy of at least one accessible lesion will be performed to analyze PD-L1 expression using immunohistochemical staining after each PET scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects must sign informed consent prior to inclusion in this trial.
- Subjects must be ≥18 years of age and competent to give informed consent.
- Subjects must be diagnosed with histologically confirmed stage IV melanoma.
- At least one radiologic new lesion in the brain by MRI, which should be measurable by RANO-BM criteria (longest diameter ≥ 10 mm and perpendicular diameter ≥ 5 mm). Lesions with prior local treatment (i.e., SRT or surgical resection) can be considered measurable if there has been demonstrated progression since the time of local treatment. Leptomeningeal involvement is allowed, but cannot be used as target lesion.
- At least one easy accessible metastatic melanoma lesion of which a biopsy can be taken.
Key exclusion criteria (13 listed)
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways, except anti-CTLA4 antibody.
- Subjects who have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grade 1 or better from the adverse events due to previous cancer therapy.
- Evidence for an active, known or suspected autoimmune disease. Subjects diagnosed with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Treatment with corticosteroids in an increasing dosage in the 7 days prior to the first administration of nivolumab. (A stable or decreasing dosage of ≤ 4 mg dexamethasone or equivalent is allowed. In addition, inhaled or topical steroids and adrenal replacement doses are permitted in the absence of active autoimmune disease.)
- Previous malignancies (except non-melanoma skin cancers, in situ bladder cancer, gastric or colon cancers, cervical cancers/dysplasia or breast carcinoma in situ) unless a complete remission was achieved at least 1 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.
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 |
|---|---|---|
| PD-L1 PET imagingAlso: [18F]BMS-986192PD-L1 PET imaging | Other | PD-L1 PET imaging in melanoma patients |
Primary outcome
Determine the optimal dose of tracer and timing of imaging for [18F]PD-L1 tracer imaging of inoperable melanoma.
Time frame: 1 year
By the performing dynamic PET scans.
Assess the association of PD-L1 expression as measured by PD-L1 tracer uptake on PET and PD-L1 expression as measured by immunohistochemical (IHC) staining for PD-L1 of corresponding tumor lesions.
Time frame: 1 year
By the performing Full body PET scans.
2 secondary outcomes
Characterize between-subject and within-subject variability in accumulation of the [18F]PD-L1 tracer in melanoma metastases.
Time frame: 1 year
Correlate response to anti-PD1 treatment with differences in tumor PD-L1 and PD1 expression between baseline and after 6 weeks of treatment.
Time frame: 1 year
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 6 May 2024.
- Individual participant dataSharing planned: No
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
G.A. P Hospers, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PD-L1 PET imaging in people with Melanoma, run by University Medical Center Groningen at 1 site in Netherlands.
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 17 inclusion and 13 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 6 May 2024. 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 Netherlands. 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.
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?
Determine the optimal dose of tracer and timing of imaging for [18F]PD-L1 tracer imaging of inoperable melanoma. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2024.