89Zr-pembrolizumab-PET imaging in patients with locally advanced or metastatic melanoma or non-small cell lung cancer
- Conditions
- Melanoma and non-small cell lung cancer1004090010029107
- Registration Number
- NL-OMON43013
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 21
* Age *18 years.
* Histologically or cytologically documented locally advanced or metastatic melanoma or non-small cell lung cancer.
* 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.
* ECOG performance status 0 or 1.
* Life expectancy * 12 weeks .
* 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:
* ANC * 1500 cells/*L (without granulocyte colony-stimulating factor support within 2 weeks prior to 89Zr-pembrolizumab injection)
* WBC * 2500/*L
* Lymphocyte count * 500/*L
* Platelet count * 100,000/*L (without transfusion within 2 weeks prior to 89Zr-Pembrolizumab injection)
* Hemoglobin *9.0 g/dL. Patients may be transfused or receive erythropoietic treatment to meet this criteria.
* AST, ALT, and alkaline phosphatase *2.5 x the upper limit of normal (ULN), with the following exceptions:
o Patients with documented liver metastases: AST and/or ALT * 5 x ULN
o 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.
* INR and 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).
1. 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.
2. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to the 89Zr-pembrolizumab injection.
3. 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).
4. Pregnant and lactating women.
5. Symptomatic brain metastasis.
6. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
7. Known hypersensitivity or allergy to any component of the pembrolizumab formulation.
8. 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.
9. Positive test for HIV.
10. 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.
11. Signs or symptoms of infection within 2 weeks prior to 89Zr-pembrolizumab injection.
12. 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.
13. Prior allogeneic bone marrow transplantation or solid organ transplant.
14. Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to 89Zr-pembrolizumab injection.
* Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g. a one-time dose of dexamethasone for nausea) may be enrolled in the study after discussion with and approval by the sponsor.
* The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g. fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate whole body distribution of 89Zr-pembrolizumab in patients with<br /><br>locally advanced or metastatic melanoma or NSCLC.</p><br>
- Secondary Outcome Measures
Name Time Method <p>i) To evaluate pharmacokinetics of 89Zr-pembrolizumab;<br /><br>ii) To assess the heterogeneity of 89Zr-pembrolizumab tumor uptake;<br /><br>iii) To describe safety of 89Zr-pembrolizumab<br /><br>iv) To correlate the response of pembrolizumab, as measured by objective<br /><br>response rate (ORR) according to standard RECIST v1.1 with specific tumor<br /><br>tracer uptake. </p><br>