MelanomaNCT02760225
Pembrolizumab-PET Imaging
A study testing 89Zr-Pembrolizumab and 89Zr-Pembrolizumab PET in people with Melanoma and Non-small Cell Lung Cancer, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial summary
This is a two center, single arm, investigator sponsored trial (IST) with the PET tracer 89Zr-pembrolizumab to evaluate in vivo whole body distribution of 89Zr-Pembrolizumab in a registered indication: locally advanced metastatic melanoma or non-small cell lung cancer before Pembrolizumab treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Non-small Cell Lung Cancer
- What is being tested?
- 89Zr-Pembrolizumab and 89Zr-Pembrolizumab PET
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesNetherlands
- Study dates
- 24 Oct 2016to Sep 2020
- 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
- Age ≥18 years.
- Histologically or cytologically documented locally advanced or metastatic melanoma or NSCLC.
- Patients must be eligible for treatment with Pembrolizumab. For patients with NSCLC this includes PD-L1 expression (>1% based on IHC assay) on tumor material.
- Metastatic lesion(s) (≥1,0 cm) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Life expectancy ≥ 12 weeks .
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- Signed Informed Consent Form.
- Ability to comply with protocol.
- Measurable disease, as defined by standard RECIST v1.1. Previously irradiated lesions should not be counted as target lesions.
- Adequate hematologic and end organ function, defined by the following laboratory results obtained within ≤ 14 days prior to 89Zr-pembrolizumab injection:
- Absolute Neutrophil Count (ANC) ≥ 1500 cells/μL (without granulocyte colony-stimulating factor support within 2 weeks prior to 89Zr-pembrolizumab injection)
- White Blood Count (WBC) ≥ 2500/μL
- Lymphocyte count ≥ 500/μL
- Platelet count ≥ 100,000/μL (without transfusion within 2 weeks prior to 89Zr-Pembrolizumab injection)
- Hemoglobin ≥9.0 g/dL. Patients may be transfused or receive erythropoietin treatment to meet this criteria.
- Asparate Aminotransferase (AST), Alanine Aminotransferase (ALT), and alkaline phosphatase ≤2.5 x the Upper Limit of Normal (ULN), with the following exceptions:
- Patients with documented liver metastases: AST and/or ALT ≤ 5 x ULN
- Patients with documented liver or bone metastases: alkaline phosphatase ≤ 5 x ULN
- Serum bilirubin ≤ 1.5 x ULN. Patients with known Gilbert disease who have serum bilirubin level ≤3 x ULN may be enrolled.
- International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (aPTT) ≤1.5 x ULN. This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
- Creatinine clearance ≥30 mL/min
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate [< 1% per year] when used consistently and correctly).
Who cannot join
- Any approved anti-cancer therapy, including chemotherapy of hormonal therapy within ≤14 days prior to 89Zr-pembrolizumab injection; the following exceptions are allowed:
- Hormone-replacement therapy or oral contraceptives.
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to the 89Zr-pembrolizumab injection.
- Malignancies other than melanoma or NSCLC within 5 years prior to 89Zr-pembrolizumab injection, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent or ductal carcinoma in situ treated surgically with curative intent).
- Pregnant and lactating women.
- Symptomatic brain metastasis.
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- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
- Known hypersensitivity or allergy to any component of the pembrolizumab formulation.
- History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
- Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.
- Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.
- Positive test for Human Immunodeficiency Virus (HIV).
- Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C.
- Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible. HBV DNA test must be performed in these patients prior to 89Zr-Pembrolizumab injection.
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Signs or symptoms of infection within 2 weeks prior to 89Zr-pembrolizumab injection.
- Major surgical procedure other than for diagnosis within 28 days prior to 89Zr-pembrolizumab injection or anticipation of need for a major surgical procedure during the course of the study.
- Prior allogeneic bone marrow transplantation or solid organ transplant.
- Treatment with corticosteroids in an increasing dosage in the 7 days prior to 89Zr-pembrolizumab injection. (A stable or decreasing dosage of ≤ 1,5 mg dexamethasone or ≤ 10 mg prednisolone equivalent is allowed. In addition, inhaled or topical steroids and adrenal replacement doses are permitted in the absence of active autoimmune disease.)
- Inability to comply with other requirements of the protocol.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Netherlands Cancer Institute
Amsterdam
University Medical Center Groningen
Groningen, 9713 GZ
About this study
Official title: 89Zr-pembrolizumab-PET Imaging in Patients With Locally Advanced or Metastatic Melanoma or Non-small Cell Lung Cancer
This is a two center, single arm, investigator sponsored trial (IST) with the PET tracer 89Zr-pembrolizumab to evaluate in vivo whole body distribution of 89Zr-Pembrolizumab in a registered indication: locally advanced metastatic melanoma or non-small cell lung cancer before Pembrolizumab treatment.
Read the detailed description
Rationale: Immunotherapy targeting specific immune-regulatory checkpoints, mainly cytotoxic T-lymphocyte antigen-4 (CTLA-4) and Programmed Death (PD1) or PD ligand 1 (PD-L1) have shown spectacular effects in a broad range of solid malignancies, including melanoma and non-small cell lung cancer (NSCLC). Pembrolizumab, is a monoclonal antibody that blocks the interaction between PD-1 on T-cells with its ligands PD-L1 and PD-L2. Anti-tumor activity with an acceptable side effect profile have been shown in melanoma and NSCLC.
Radio-labeling of pembrolizumab with the positron emission tomography (PET) radionuclide 89Zirkonium (89Zr) enables serial non-invasive imaging and quantification of distribution of PD-1 in melanoma patients. By performing a 89Zr-pembrolizumab-PET scan prior to treatment with pembrolizumab, the uptake of the tracer in the tumor lesions and normal organ distribution can be evaluated, this could lead to new insights about heterogeneity of PD-1 expression, as well as the use of a 89Zr-pembrolizumab-PET as a complementary tool for patient selection in the future.
Objective: Primary objective: To evaluate whole body distribution of 89Zr-pembrolizumab in patients with locally advanced or metastatic melanoma or NSCLC. Secondary objectives: i) To evaluate pharmacokinetics of 89Zr-pembrolizumab; ii) To assess the heterogeneity of 89Zr-pembrolizumab tumor uptake; iii) To describe safety of 89Zr-pembrolizumab; iv) To correlate the tumor response of pembrolizumab, as measured by objective response rate (ORR) according to standard RECIST v1.1 as assessed by the investigator, with specific tumor tracer uptake.
Study design: This is a two center, single arm, investigator sponsored trail (IST) with the PET tracer 89Zr-pembrolizumab to evaluate in vivo whole body distribution of 89Zr-pembrolizumab in a registered indication for locally advanced metastatic melanoma or NSCLC before Pembrolizumab treatment.
Study population: Eligible are patients with locally advanced or metastatic melanoma or NSCLC, who are eligible to receive Pembrolizumab treatment and who have at least one tumor site that is accessible for a tumor biopsy.
Intervention : In part A of the imaging trial, a dose finding imaging study will be performed to assess the optimal tracer protein dose of 89Zr-pembrolizumab and the optimal interval between tracer injection and scanning. Approximately 3 cohorts of about 2-3 patients each will undergo 89Zr-pembrolizumab-PET imaging before start of treatment with pembrolizumab. In part B, 12 eligible patients will undergo 89Zr-pembrolizumab-PET imaging at baseline, with the optimal tracer protein dose and scanning schedule as determined in part A. In total, a maximum of 21 patients will be included.The purpose of part B of the study is to analyze the whole body distribution and pharmacokinetics (PK) of 89Zr-Pembrolizumab. Tumor and normal organ radioactive tracer uptake will be quantified as standardized uptake values (SUV). Tumor biopsies will be collected at baseline and studied for various characteristics including Programmed cell death-ligand 1 (PDL-1), PD-1 expression and tumor infiltrating lymphocytes. Pembrolizumab treatment will be administered as standard of care Main study parameters/endpoints: To evaluate whole body distribution of 89Zr-pembrolizumab in patients with locally advanced or metastatic melanoma.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: For this imaging study patients have to make maximal 6 extra visits to the clinic for screening, to receive tracer injection and for maximal 3 PET/CT scans and the biopsy before start of standard treatment with pembrolizumab. The study ends after the last imaging or biopsy (whichever comes first) and will approximately take 7 days. Whenever possible, all procedures that are part of the study protocol will be planned during regular visits to the hospital as part of care as usual.
89Zr-pembrolizumab-PET/CT implements a radiation burden of about 20 millisievert (mSv), and 1.5 mSv per low-dose CT scan. Besides PET imaging, patients will be asked to give in total 12 blood samples (85 mL), which will give minor discomfort. A metastases biopsy will be performed, preferably from an easily accessible lesion to minimize the burden and risk for the patient. Based on a literature review, the risk of tumor biopsies is considered low with a small risk on significant/major complications or death. The risk associated with the 89Zr-pembrolizumab seems minor and although patients do not directly benefit from this study, results of this study will be valuable for our understanding of the tumor immune response and will guide further prospective research.
- Conditions
- Melanoma, Non-small Cell Lung Cancer
- Being tested
- 89Zr-Pembrolizumab, 89Zr-Pembrolizumab PET
- Keywords
- Pembrolizumab, PET imaging, Melanoma, Non-small cell lung cancer
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-PembrolizumabDrug
Also called Injection of 89Zr-Pembrolizumab for imaging
In part A of the imaging trial, a dose finding imaging study will be performed to assess the optimal tracer protein dose of 89Zr-pembrolizumab and the optimal interval between tracer injection and scanning. Approximately 3 cohorts of about 2-3 patients each will undergo 89Zr-pembrolizumab-PET imaging before start of treatment with pembrolizumab. In part B, 12 eligible patients will undergo 89Zr-pembrolizumab-PET imaging at baseline, with the optimal tracer protein dose and scanning schedule as determined in part A.
89Zr-Pembrolizumab PETDevice
Also called 89Zr-Pembrolizumab PET scan(s)
In part A of the imaging trial, a dose finding imaging study will be performed to assess the optimal tracer protein dose of 89Zr-pembrolizumab and the optimal interval between tracer injection and scanning. Approximately 3 cohorts of about 2-3 patients each will undergo 89Zr-pembrolizumab-PET imaging before start of treatment with pembrolizumab. In part B, 12 eligible patients will undergo 89Zr-pembrolizumab-PET imaging at baseline, with the optimal tracer protein dose and scanning schedule as determined in part A.
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-Pembrolizumab PET imaging | Experimental | In part A of the imaging trial, a dose finding imaging study will be performed to assess the optimal tracer protein dose of 89Zr-pembrolizumab and the optimal interval between tracer injection and scanning. Approximately 3 cohorts of about 2-3 patients each will undergo 89Zr-pembrolizumab-PET imaging before start of treatment with pembrolizumab. In part B, 12 eligible patients will undergo 89Zr-pembrolizumab-PET imaging at baseline, with the optimal tracer protein dose and scanning schedule as determined in part A. Receives: Drug: 89Zr-Pembrolizumab; Device: 89Zr-Pembrolizumab PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of whole body 89Zr-pembrolizumab by measuring standardized uptake value (SUV) on the 89Zr-pembrolizumab-PET scans
Measured: 1 year
Secondary outcomes (4)
Tumor and immune cell PD-L1 expression analysis in a fresh pre-treatment biopsy, and if available archival tumor biopsy, will be correlated to 89Zr-pembrolizumab tumor uptake, evaluated by measuring SUV on the 89Zr-pembrolizumab-PET.
Measured: 1 year
Safety assessment through summaries of adverse events, changes in laboratory test results, changes in vital signs, and exposure to 89Zr-pembrolizumab. Adverse event data will be recorded and summarized according to NCI CTCAE v4.0.
Safety assessment through summaries of adverse events, changes in laboratory test results (if evaluation is indicated), changes in vital signs, and exposure to 89Zr-pembrolizumab. Adverse event data will be recorded and summarized according to NCI CTCAE v4.0. Serious adverse events, including deaths, will be listed separately and will be summarized. For events of varying severity, the highest grade will be used in summaries. Relevant laboratory tests and vital signs (heart rate, respiratory rate, blood pressures, and temperature) data will be displayed by time, with Grade 3 and 4 values identified, where appropriate.
Measured: 1 year
89Zr-pembrolizumab normal organ uptake on the 89Zr-pembrolizumab PET scans will be correlated to (89Zr-)pembrolizumab blood kinetics.
89Zr-pembrolizumab normal organ uptake on the 89Zr-pembrolizumab PET scans will be correlated to (89Zr-)pembrolizumab blood kinetics. Aliquots of whole blood and serum will be measured for 89Zr-activity in an isotope well counter and corrected for decay. Whole blood and serum activity will be expressed as standardized uptake value (SUV). Serum blood samples will also be collected regularly during the study to measure unlabeled pembrolizumab. PK parameters will be derived from the serum concentrations.
Measured: 1 year
Evaluation of ORR according to standard RECIST v1,1
Evaluation of ORR according to standard RECIST v1,1. ORR is defined as the proportion of subjects whose best overall response is either a PR or CR.
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 posted3 May 2016 (estimated)
- Study start24 Oct 2016
- Primary completionMar 2019
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- E. G.E. de Vries, Prof., Principal investigator, Universit Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760225
- Sponsor's protocol ID
- 201600163
- Status last verified
- May 2024
- First submitted
- 29 Mar 2016
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Qi C, Guo R, Chen Y, Li C, Liu C, Zhang M, Zhang C, Zhang X, Hou X, Chen B, Jia B, Yang Z, Shen L, Zhu H. 68Ga-NC-BCH Whole-Body PET Imaging Rapidly Targets Claudin18.2 in Lesions in Gastrointestinal Cancer Patients. J Nucl Med. 2024 Jun 3;65(6):856-863. doi: 10.2967/jnumed.123.267110.
PubMed 38604764Li W, Wang Y, Rubins D, Bennacef I, Holahan M, Haley H, Purcell M, Gantert L, Hseih S, Judo M, Seghezzi W, Zhang S, van der Veen EL, Lub-de Hooge MN, de Vries EGE, Evelhoch JL, Klimas M, Hostetler ED. PET/CT Imaging of 89Zr-N-sucDf-Pembrolizumab in Healthy Cynomolgus Monkeys. Mol Imaging Biol. 2021 Apr;23(2):250-259. doi: 10.1007/s11307-020-01558-w. Epub 2020 Oct 26.
PubMed 33104972
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 89Zr-pembrolizumab-PET Imaging in Patients With Locally Advanced or Metastatic Melanoma or Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02760225
- Acronym / sponsor ID
- 201600163
- Conditions
- Melanoma, Non-small Cell Lung Cancer
- Keywords
- Pembrolizumab, PET imaging, Melanoma, Non-small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 24 Oct 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 3 May 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.
This is a two center, single arm, investigator sponsored trial (IST) with the PET tracer 89Zr-pembrolizumab to evaluate in vivo whole body distribution of 89Zr-Pembrolizumab in a registered indication: locally advanced metastatic melanoma or non-small cell lung cancer before Pembrolizumab treatment.
Detailed description
Rationale: Immunotherapy targeting specific immune-regulatory checkpoints, mainly cytotoxic T-lymphocyte antigen-4 (CTLA-4) and Programmed Death (PD1) or PD ligand 1 (PD-L1) have shown spectacular effects in a broad range of solid malignancies, including melanoma and non-small cell lung cancer (NSCLC). Pembrolizumab, is a monoclonal antibody that blocks the interaction between PD-1 on T-cells with its ligands PD-L1 and PD-L2. Anti-tumor activity with an acceptable side effect profile have been shown in melanoma and NSCLC.
Radio-labeling of pembrolizumab with the positron emission tomography (PET) radionuclide 89Zirkonium (89Zr) enables serial non-invasive imaging and quantification of distribution of PD-1 in melanoma patients. By performing a 89Zr-pembrolizumab-PET scan prior to treatment with pembrolizumab, the uptake of the tracer in the tumor lesions and normal organ distribution can be evaluated, this could lead to new insights about heterogeneity of PD-1 expression, as well as the use of a 89Zr-pembrolizumab-PET as a complementary tool for patient selection in the future.
Objective: Primary objective: To evaluate whole body distribution of 89Zr-pembrolizumab in patients with locally advanced or metastatic melanoma or NSCLC. Secondary objectives: i) To evaluate pharmacokinetics of 89Zr-pembrolizumab; ii) To assess the heterogeneity of 89Zr-pembrolizumab tumor uptake; iii) To describe safety of 89Zr-pembrolizumab; iv) To correlate the tumor response of pembrolizumab, as measured by objective response rate (ORR) according to standard RECIST v1.1 as assessed by the investigator, with specific tumor tracer uptake.
Study design: This is a two center, single arm, investigator sponsored trail (IST) with the PET tracer 89Zr-pembrolizumab to evaluate in vivo whole body distribution of 89Zr-pembrolizumab in a registered indication for locally advanced metastatic melanoma or NSCLC before Pembrolizumab treatment.
Study population: Eligible are patients with locally advanced or metastatic melanoma or NSCLC, who are eligible to receive Pembrolizumab treatment and who have at least one tumor site that is accessible for a tumor biopsy.
Intervention : In part A of the imaging trial, a dose finding imaging study will be performed to assess the optimal tracer protein dose of 89Zr-pembrolizumab and the optimal interval between tracer injection and scanning. Approximately 3 cohorts of about 2-3 patients each will undergo 89Zr-pembrolizumab-PET imaging before start of treatment with pembrolizumab. In part B, 12 eligible patients will undergo 89Zr-pembrolizumab-PET imaging at baseline, with the optimal tracer protein dose and scanning schedule as determined in part A. In total, a maximum of 21 patients will be included.The purpose of part B of the study is to analyze the whole body distribution and pharmacokinetics (PK) of 89Zr-Pembrolizumab. Tumor and normal organ radioactive tracer uptake will be quantified as standardized uptake values (SUV). Tumor biopsies will be collected at baseline and studied for various characteristics including Programmed cell death-ligand 1 (PDL-1), PD-1 expression and tumor infiltrating lymphocytes. Pembrolizumab treatment will be administered as standard of care Main study parameters/endpoints: To evaluate whole body distribution of 89Zr-pembrolizumab in patients with locally advanced or metastatic melanoma.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: For this imaging study patients have to make maximal 6 extra visits to the clinic for screening, to receive tracer injection and for maximal 3 PET/CT scans and the biopsy before start of standard treatment with pembrolizumab. The study ends after the last imaging or biopsy (whichever comes first) and will approximately take 7 days. Whenever possible, all procedures that are part of the study protocol will be planned during regular visits to the hospital as part of care as usual.
89Zr-pembrolizumab-PET/CT implements a radiation burden of about 20 millisievert (mSv), and 1.5 mSv per low-dose CT scan. Besides PET imaging, patients will be asked to give in total 12 blood samples (85 mL), which will give minor discomfort. A metastases biopsy will be performed, preferably from an easily accessible lesion to minimize the burden and risk for the patient. Based on a literature review, the risk of tumor biopsies is considered low with a small risk on significant/major complications or death. The risk associated with the 89Zr-pembrolizumab seems minor and although patients do not directly benefit from this study, results of this study will be valuable for our understanding of the tumor immune response and will guide further prospective research.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 89Zr-Pembrolizumab PET imaging | Experimental | Drug: 89Zr-Pembrolizumab, Device: 89Zr-Pembrolizumab PETIn part A of the imaging trial, a dose finding imaging study will be performed to assess the optimal tracer protein dose of 89Zr-pembrolizumab and the optimal interval between tracer injection and scanning. Approximately 3 cohorts of about 2-3 patients each will undergo 89Zr-pembrolizumab-PET imaging before start of treatment with pembrolizumab. In part B, 12 eligible patients will undergo 89Zr-pembrolizumab-PET imaging at baseline, with the optimal tracer protein dose and scanning schedule as determined in part A. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age ≥18 years.
- Histologically or cytologically documented locally advanced or metastatic melanoma or NSCLC.
- Patients must be eligible for treatment with Pembrolizumab. For patients with NSCLC this includes PD-L1 expression (>1% based on IHC assay) on tumor material.
- Metastatic lesion(s) (≥1,0 cm) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Key exclusion criteria (20 listed)
- Any approved anti-cancer therapy, including chemotherapy of hormonal therapy within ≤14 days prior to 89Zr-pembrolizumab injection; the following exceptions are allowed:
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to the 89Zr-pembrolizumab injection.
- Malignancies other than melanoma or NSCLC within 5 years prior to 89Zr-pembrolizumab injection, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent or ductal carcinoma in situ treated surgically with curative intent).
- Pregnant and lactating women.
- Symptomatic brain metastasis.
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 |
|---|---|---|
| 89Zr-PembrolizumabAlso: Injection of 89Zr-Pembrolizumab for imagingIn part A of the imaging trial, a dose finding imaging study will be performed to assess the optimal tracer protein dose of 89Zr-pembrolizumab and the optimal interval between tracer injection and scanning. Approximately 3 cohorts of about 2-3 patients each will undergo 89Zr-pembrolizumab-PET imaging before start of treatment with pembrolizumab. In part B, 12 eligible patients will undergo 89Zr-pembrolizumab-PET imaging at baseline, with the optimal tracer protein dose and scanning schedule as determined in part A. | Drug | 89Zr-Pembrolizumab PET imaging |
| 89Zr-Pembrolizumab PETAlso: 89Zr-Pembrolizumab PET scan(s)In part A of the imaging trial, a dose finding imaging study will be performed to assess the optimal tracer protein dose of 89Zr-pembrolizumab and the optimal interval between tracer injection and scanning. Approximately 3 cohorts of about 2-3 patients each will undergo 89Zr-pembrolizumab-PET imaging before start of treatment with pembrolizumab. In part B, 12 eligible patients will undergo 89Zr-pembrolizumab-PET imaging at baseline, with the optimal tracer protein dose and scanning schedule as determined in part A. | Device | 89Zr-Pembrolizumab PET imaging |
Primary outcome
Description of whole body 89Zr-pembrolizumab by measuring standardized uptake value (SUV) on the 89Zr-pembrolizumab-PET scans
Time frame: 1 year
4 secondary outcomes
Tumor and immune cell PD-L1 expression analysis in a fresh pre-treatment biopsy, and if available archival tumor biopsy, will be correlated to 89Zr-pembrolizumab tumor uptake, evaluated by measuring SUV on the 89Zr-pembrolizumab-PET.
Time frame: 1 year
Safety assessment through summaries of adverse events, changes in laboratory test results, changes in vital signs, and exposure to 89Zr-pembrolizumab. Adverse event data will be recorded and summarized according to NCI CTCAE v4.0.
Time frame: 1 year
89Zr-pembrolizumab normal organ uptake on the 89Zr-pembrolizumab PET scans will be correlated to (89Zr-)pembrolizumab blood kinetics.
Time frame: 1 year
Evaluation of ORR according to standard RECIST v1,1
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 3 May 2024.
- Derived from this study: PubMed 38604764Qi C, Guo R, Chen Y, Li C, Liu C, Zhang M, Zhang C, Zhang X, Hou X, Chen B, Jia B, Yang Z, Shen L, Zhu H. 68Ga-NC-BCH Whole-Body PET Imaging Rapidly Targets Claudin18.2 in Lesions in Gastrointestinal Cancer Patients. J Nucl Med. 2024 Jun 3;65(6):856-863. doi: 10.2967/jnumed.123.267110.
- Derived from this study: PubMed 33104972Li W, Wang Y, Rubins D, Bennacef I, Holahan M, Haley H, Purcell M, Gantert L, Hseih S, Judo M, Seghezzi W, Zhang S, van der Veen EL, Lub-de Hooge MN, de Vries EGE, Evelhoch JL, Klimas M, Hostetler ED. PET/CT Imaging of 89Zr-N-sucDf-Pembrolizumab in Healthy Cynomolgus Monkeys. Mol Imaging Biol. 2021 Apr;23(2):250-259. doi: 10.1007/s11307-020-01558-w. Epub 2020 Oct 26.
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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.
E. G.E. de Vries, Prof. principal investigator
Universit Medical Center Groningen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 89Zr-Pembrolizumab and 89Zr-Pembrolizumab PET in people with Melanoma and Non-small Cell Lung Cancer, run by University Medical Center Groningen at 2 sites 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 22 inclusion and 20 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 3 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 2 sites 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?
Description of whole body 89Zr-pembrolizumab by measuring standardized uptake value (SUV) on the 89Zr-pembrolizumab-PET scans (time frame: 1 year). 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 NCT02760225, which also lists 2 linked publications.
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 3 May 2024.